Allergan IPPC Licence Application
Attachment D
Allergan
IPPC Licence Application
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Attachment D – Infrastructure & operation
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Allergan IPPC Licence Application
Attachment D
Contents
Attachment D.1 – Operational Information
Attachment D.1.A- A description of the plant methods, processes,
ancillary processes, abatement, recovery and treatment systems, and
operating procedures for the activity carried out at the Allergan facility:
Attachment D.1.B– Map of Operational Facilities
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Attachment D.1.C– Process Water Diagram
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Attachment D.1.D– Wastewater Treatment Diagram
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Allergan IPPC Licence Application
Attachment D.1.A
Allergan
IPPC Licence Application
Attachment D.1 – Operational Information
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Attachment D.1.A – A description of the plant methods, processes, ancillary processes,
abatement, recovery and treatment systems, and operating procedures for the activity carried
out at the Allergan facility
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Allergan IPPC Licence Application
Attachment No. D1. Operational Information
D1.A. Review of Site Activities
Allergan Pharmaceuticals Ireland is situated in Westport, Co. Mayo, a town of approximately
6000 people. The original plant was built in 1977, and has been expanded a number of times
since then. The area where the plant is located is not extensively developed industrially;
however, recently activity adjacent to the facility has seen the development of a new IDA
industrial site.
The site is a stand alone privately owned property adjoining the Westport-Castlebar road and
serviced by public access road. The site is 28 acres in area with boundaries to the North by a
stream and fencing, to the South by the Castlebar road, to the east by an industrial unit and to
the West by a housing scheme.
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The activities at the site comprise of aseptic manufacture (formulation) of all classes of
Ophthalmic preparations, including prescription drugs (containing antibiotics and
corticosteroids), and tablets, optic muscle relaxants and ophthalmic surgery solutions. The
facility also manufactures the plastic bottles to contain and package the Ophthalmic solutions
produced. Product sterilisation of the plastic components is carried out off-site by an external
contractor.
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The Allergan Pharmaceuticals Ireland (Botox facility) was formed in 1993. The Botox plant
went through a number of expansion phases since 1993. The plant is a dedicated facility and
currently manufactures the Botox product. This is a stand alone facility.
General Overview
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Raw materials and ancillaries are delivered to the warehouse where they are quarantined
until Quality Control inspections have been carried out. Materials of unacceptable quality are
rejected and returned to the supplier where necessary. Only approved materials are racked
until required for Production purposes. The Production Activities at the site can be classified
by Department, as follows:
x
Engineering and Technology
x
New product development: Product A
x
New product development: Product B
x
Botox
x
Product C
x
Tabletting and Product D
x
Plastic manufacture
x
Compounding (Formulation of solutions)
x
Filling
x
Unit Dose Manufacturing
x
Unit Dose Packaging
x
Packaging
x
Laboratories on site
x
Canteen
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The endpoint from one department often feeds the manufacturing lines of another
department. Notably, the facility is laid out in such a manner as to facilitate the easy of
product flow between departments.
At each stage of the process, QC inspections are carried out to ensure that the product is of
an acceptable quality. Product failing QC testing is rejected and investigated. A
comprehensive quality management system is in place to ensure the minimisation of product
of poor quality. This system forms part of the waste minimisation programme in operation at
the site. ‘Work in progress’ (WIP) is intermittently stored in the warehouse whilst on route
from one department to another for further processing.
After the final QC inspection has taken place, the product is packaged into shippers and
forwarded to customers.
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The ranges of activities carried out on site are related to the production of ophthamalic
solutions, tablet production, Botox manufacture and the planned manufacture of Trivaris
active suspension, Posurdex solid product and Restasis solution. In addition, the primary
packaging for the solutions (i.e. plastic bottles) are manufactured on site. The operations
consist of formulation, manufacturing, milling, compounding and packaging operations. A
range of raw materials is dispensed and mixed with mainly aqueous solutions, filter sterilised
and filled into bottles, labelled and packaged. Tablet production consists of blending of raw
materials, pressing, coating and packaging.
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The Tabletting coating operations using acetone ceased in 2005 as a result of changes made
to site manufacturing activities conducted at the facility. This change impacting our business
model was made by Allergan’s Corporate Officers.
In addition to the manufacturing activities, there are a number of support functions carried out
at the site. These support functions include: extensive Laboratories, Maintenance, Research
and Development, Engineering, Validations, Financial Services, Environmental Health and
Safety (EHS) and Administration departments which support the business activities.
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As the majority of environmental emissions arise from Production Departments, this summary
will focus primarily on emissions arising from these relevant production operations.
Warehouse
Warehousing activities comprise of:
x
receiving raw materials, ancillaries and other incoming material,
x
storage within the warehouse racking as required, and
x
delivery to the relevant departments as required.
x
handling, moving and loading of all waste materials in conjunction with the (EHS)
Department.
Intermediate packaged product may also be transferred to the warehouse for storage as WIP.
Thereafter it is transported to the required departments as needed for further packaging.
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Final packaged product is held on racking in the warehouse until it is released by the QA
Department and is ready to be shipped off site. It is then stretch wrapped and loaded onto
containers in the Shipping Dock.
All non–production chemicals are taken to the Chemical Store (Pharma) for intermediate
storage. Laboratory solvents are taken directly to the relevant Laboratory where they will be
stored in designated solvent storage areas.
Non-hazardous waste is collected at various centres throughout the facility and taken to
recycling centre waste areas at Receiving or Shipping. The Warehouse Supervisor ensures
that plastic regrind from plastics manufacture for recycling is removed from the site to an EHS
approved waste contractor. The Supervisor also ensures all other recyclable materials are
sent to various licensed recycling companies.
Reject product, if it arises, is written off the stock control system by raising a Material
Deposition (MD) form. The EHS Department is responsible for ensuring the correct disposal
of this material via an EPA approved licenced, permitted waste contractor.
Emissions to environment
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There is minimal waste resulting from warehouse activities, as the majority of packaging from
raw materials, etc is removed elsewhere. Energy is used in the form of warehouse lighting
(motion sensor) and for charging forklift batteries. Diesel fuel used to operate forktrucks
results in minor carbon dioxide emissions to atmosphere.
The following is a list of waste materials arising from Warehouse operations:
Stretch wrap from packaging activities
-
Paper/ cardboard
-
Wooden pallets
-
Used batteries
-
Waste packaging
-
Burning of diesel which produces carbon dioxide.
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D1.A.1. Product A
Product A Drug Delivery System is intended for the treatment of macular and retinal diseases.
The Product A system consists of a drug product and a special applicator (Applicator)
designed to deliver a single DDS to the posterior segment of the eye. The drug product
consists of active pharmaceutical ingredient dispersed in a biodegradable polymer matrix. It
is formed into a rod-shaped implant by hot extrusion, and cut to length for the appropriate
dose strengths of 350 mg and 700 mg.
The Product A DDS controlled-release implant is inserted into the posterior segment of the
eye using the DDS Applicator.
This is a dry manufacturing process within a classified area in the Pharmaceutical Plant. For
manufacture, the following steps take place:
Milling of excipients using jet mill
-
Blending of micronized API and Excepients (Turbula shaker)
-
First extrusion - The powder blend is processed through a twinscrew extruder
producing a continuous output.
-
Pelletisation (Turbula shaker)
-
Second extrusion - Filaments from the second extrusion are cut into different lengths
for different dosages.
-
Cutting of dosage strengths (Guillotine)
-
Inspection of DDS for length and diameter (VIS)
-
Loading of DDS into applicator and assembly of Applicator
-
Imprinting of Lot# on name plates
-
Packaging and Labelling
-
Sterilisation of DDS applicator system by gamma radiation
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Pending successful validation and regulatory approval it is expected that this product will be
manufactured in 2008.
Emissions to environment
Emission Type
Solid waste
Emissions to Air
Emissions to process drain
Description
Plastics, Paper, Cardboard sent off-site for recycling
General waste sent to landfill
Contaminated PPE, waste reject batches, waste liner bags
and spilled powders are sent off site for incineration.
General exhausted air from cleanroom.
Fugitive emissions arising from isopropyl alcohol and other
alcohol based sprays used.
Wash waters arising from process are sent to the process
drain
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Allergan IPPC Licence Application
Flow diagram D1.A.1.:
generation
Product A- Process showing unit operations and waste
HEPA filter from mill
enclosure sent off for
incineration.
Milling of Excipients using jet mill
Blending of Active ingredient and Excipients (Turbula shaker)
Extrusion (Haake MiniLab extruder)
Pelletisation (Turbula shaker)
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Second extrusion (Haake MiniLab extruder)
Cutting and inspection of dosage strengths (Guillotine)
Reject applicator
assemblies sent off site.
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Final Assembly
Reject filaments and
contaminated PPE sent
off-site for incineration
Uncontaminated cardboard
& paper sent off site for
recycling
Packaging and Labelling
Sterilisation of product by gamma radiation
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D1.A.2. Product B
Product B is a sterile, preservative-free, droppable oil-in-water emulsion, which will be used in
the treatment of moderate to severe kerato conjunctivitis sicca (KCS). The active ingredient
in this process is Cyclosporine, USP, which will be used in small concentrations. This
material will be packaged in low density polyethylene (LDPE) unit dose vials, inserted into a
plastic container, palletized and shipped to the customer.
The first part (oil phase) of the process involves mixing the active ingredient, in castor oil
followed by sterile filtration of the mix. In the Part 2 of the process (Aqueous phase), involves
mixing with purified water and sterile filtered in a separate vessel. Parts 1 and 2 are then
transferred to the main batch vessel and homogenized at a set temperature. Part 3
(Carbomer dispersion) involves mixing carbomer and purified water together followed by
sterile filtration and transfer to the main batch vessel. Part 4 is the neutralizer phase whereby
sodium hydroxide solution is transferred to the main batch vessel to adjust the pH. All four
parts are mixed together in the main batch vessel. This bulk emulsion goes through form-fillseal filling and the filled vials are then packaged. The batch size for commercial production
will be approximately 600kg with the active ingredient comprising 0.05% of the batch size.
Emissions to environment
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Description
All materials potentially contaminated with product are
treated as hazardous waste.
Disposable materials (contaminated bags, gloves, clothing,
pureflo filters, masks, hairnets) are sent off site for
incineration to an approved waste contractor.
Waste powders, waste vacuum filters from vacuum transfer
system and hoover waste is sent off site for incineration.
Contaminated labels & cartons sent off site for incineration.
Contaminated wipes sent for incineration
Contaminated bag mitos sent for incineration
Paper, cardboard sent for recycling
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Non-hazardous
waste
Waste non-contaminated packaging is sent for recycling
IPA & Chloroclens waste placed into non-chlorinated waste
can and sent off site for incineration.
Liquid waste
Emissions to Air
Emissions
drain
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Emission Type
Solid hazardous waste
to
process
General exhausted air from cleanroom is vented to
atmosphere
Fugitive emissions arise from isopropyl alcohol and other
alcohol based sprays used.
Uncontaminated water from general areas is discharged to
foul sewer.
Diluted cleaning agents (chloroclens, clinchem, CIP100
wash) sent to process drain.
Cleaning wastes sent to process drain
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Flow diagram D1.A.2.: Product B- Process map showing unit operation
Allergan IPPC Licence Application
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Allergan IPPC Licence Application
D1.A.4. Botox and Product C
In 1993, a separate plant referred to as Allergan Pharmaceuticals Ireland BOTOX® Facility
(APIB) was built on this site to manufacture two products for global distribution: BOTOX and
VITRAX (manufacture of VITRAX was discontinued at the facility in 2005 and the dedicated
manufacturing core is currently being validated to support the manufacture of a new product
(Product C).
There are currently two products manufactured under clean room conditions in the facility:
1. Botox
2. Product C (Development product)
D1.A.4.1. Botox:
.
Botox product is primarily used for the treatment of muscular disorders. It is a sterile,
injectable, vacuum dried form of purified botulinum toxin, produced from a culture of the
bacteria, Clostridium botulinum. The toxin concentrate, which is used in the manufacture
process, is imported into Ireland under strict licence conditions.
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Manufacturing process
The active ingredient in the BOTOX product is Botulinum Toxin Type A. The BOTOX facility
has been designed and operators are trained to process the material properly.
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Emissions to environment
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Under strict operating conditions, the toxin concentrate (micrograms) is diluted to a final
volume of 1-2 L in a solution containing saline and human serum albumin. This solution is
sterile filtered, filled into sterile, prewashed and depyrogenated vials and then vacuum dried,
stoppered and capped. The vials are then labelled and packaged. In its final form, the
product is ready to be reconstituted with sterile saline prior to use.
All raw materials from the process are non-hazardous, except for the toxin concentrate which
is hazardous. The toxin is treated and inactivated in two ways:
-
autoclaved at over 121 degrees centigrade in dedicated autoclave.
-
treated with 0.5% sodium hypochlorite solution.
Emission Type
Solid hazardous waste
Description
All materials potentially contaminated with product are
treated as hazardous waste.
Disposable materials (sharps, gloves, clothing) are
autoclaved and sent off site for incineration to an approved
waste contractor.
Reusable materials are either autoclaved and then
rewashed before use or swabbed with sodium hypochlorite.
Any washwater from above processes is sent to a special
holding tank for further treatment and inactivation prior to
discharge to the process drains.
Reject vials are either reconstituted and treated with water
and autoclaved or reconstituted with sodium hypochlorite.
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Emission Type
Description
Vials are then incinerated sent off site for incineration to an
approved waste contractor.
Empty contaminated bulk bags are sent for autoclaving.
Waste non contaminated packaging is sent for recycling
Reject compounding bulk bags are treated with sodium
hypochlorite. The contents of bag are emptied to
decontamination tank and to the process drain.
General exhausted air from clean room is vented to
atmosphere
Fugitive emissions arise from isopropyl alcohol and other
alcohol based sprays used.
Uncontaminated water from general areas is discharged to
foul sewer.
Wash water from areas contaminated with toxin (after
autoclaving and sodium hypochlorite treatment) is
discharged to a stainless steel holding tank with an agitator
and sight glass. Sodium hypochlorite is added to tank to
inactivate the toxin. The outlet valve from the tank is locked,
and is only open for release to the foul sewer after a trained
person is satisfied that the material has been correctly
treated prior to discharge to the process drain.
Liquid waste
Emissions to Air
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Emissions to process drain
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Re-dissolved
Diluted
Steriliser
Vial
washer
Vials
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Washwater from washing
autoclaved components,
materials sent to holding tank
where sodium hypochlorite is
added & washwater inactivated
before discharge to the process
drain
Reject vials –
autoclaved and treated
with sodium
hypochlorite & then
sent off site for
incineration.
Stopper/ Capper
Waste packaging
– cardboard &
paper recycled
Labelling
Reject vials are shredded and sent to
landfil
Washwater (to foul drain)
Condensate from
cleaning operation
after vacuum drying
cycle is sent to
decontamination tank
and purged with steam
and released to drain
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Sterile filtered
Lyophiliser
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Human Albumin Solution
Solid hazardous waste
(toxin contaminated) –
autoclaved, then sent off
site for incineration.
Add Concentrated toxin
Flow diagram D1.A.4.1: Botox unit operation and waste generation
Allergan IPPC Licence Application
Allergan IPPC Licence Application
D1.A.4.2. Product C
Injectable drug suspension is to be used in clinical trials for the treatment of Diabetic Macular
Edema (DME) and Retinal Vein Occlusion (RVO). It is a unit dose, sterile which is injected
into the eye.
This is a development product, which will be manufactured in the Botox Plant at Allergan,
Westport. In order to manufacture the product the former Vitrax suite has been upgraded and
modified for this purpose. The upgraded suite will include a new compounding and filling area
with gowning/degowning and material transfer rooms.
The batch size for this process is approximately 4kg.
Pending successful validation and regulatory approval commercial production is scheduled for
2008.
The process is described in two main steps – compounding and filling:
Step 1. Compounding
Part 1 of the compounding process is the bulk heat sterilization of a slurry. Water is
added to a mixing vessel. Then the active ingredient, and sodium chloride are added
into the vessel. The contents of the vessel are mixed for a specified time at varying
speeds.
x
Part 2 of the compounding step is the preparation and addition of phosphate buffer
solution. This mixture is transferred to the slurry in the batch mixing vessel and then
mixed at varying speeds over a set time.
x
Part 3 of the compounding process involves the addition of sodium hyaluronate to the
batch mixing vessel. Sodium hyaluronate granular powder is added to the mixing
vessel and again the contents of the vessel are mixed for a set period at varying
speeds.
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x
Step 2. Filling
x
The next step involves filling and packaging. The product will be filled into sterile
glass syringes and rubber stopper on the plunger. The syringes will be blister packed
before cartoning.
Emissions to environment
Emission Type
Solid waste
Emissions to Air
Emissions to process drain
Description
Plastics, Paper, Cardboard sent off-site for recycling
General waste sent to landfill
Contaminated PPE, waste reject batches, waste liner bags
and spilled powders are sent off site for incineration.
General exhausted air from cleanroom vented to
atmosphere
Fugitive emissions arising from isopropyl alcohol and other
alcohol based sprays used.
Wash waters arising from process are sent to the process
drain.
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Flow diagram D1.A.4.2.: Product C – Process flow map showing unit operations
Weighed Raw Materials:
Active pharmaceutical ingredients
& excipients 1, 2, 3, & 4.
Syringe Tubs:
Outer tub packaging, Nest, tub,
tub cover and
syringes (leurcone or stakeneedle).
Utilities:
N2, Compressed Air, Clean Steam,
Electrical Power, AHU air.
Utilities:
Compressed Air, Electrical Power,
AHU air.
Compounding Room
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Debag Room
Nested syringes
Suspension Gel.
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Utilities:
N2, Compressed Air, Clean Steam,
Electrical Power, AHU air.
Filling Room
Filled syringes in nests
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Product D
Tabletting Department – Product D
Production of this product has been suspended and there are no plans to continue
manufacturing activities for Product D. The plant and equipment remains in place and
pending review, may be utilised for production of development products.
Product D is a pharmaceutical drug substance intended for preservation of visual
function for glaucoma patients. Product D tablets are formulated at five strengths of
5mg, 10mg, 15mg and 20mg. Product D tablets contain 4% (w/w) active
pharmaceutical ingredient. The process batch is approximately 350kg.
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Product D tablets are formulated by direct compression, immediate release and film
coated for oral administration. Active pharmaceutical ingredients and excipient 1 are
mixed in a V blender. The milled mixture is then combined with 4 excipients.
Excipents 2, 3, 4 & 5 are added via sieve and the mixture is then blended and tabletted
by direct compression. The tablets are then film coating using a clear and a purple
colourant and then blister packaged. It is anticipated that all the materials will be
consumed in the process and therefore there would be a minimal risk of any active
materials entering the environment. There are no organic solvents used in this
manufacturing process.
Emissions to Environment
Description
All materials potentially contaminated with product
(including drum liners, PPE) are treated as hazardous
waste.
Disposable materials (contaminated bags, gloves,
clothing, pureflo filters, masks, hairnets) are sent off
site for incineration to an approved waste contractor.
Waste powders, waste vacuum filters from vacuum
transfer system and hoover waste is sent off site for
incineration.
Waste HEPA/ bag filters from tabletting extraction are
sent off site for incineration
Waste tablets from processing operations
Contaminated labels & cartons sent off site for
incineration.
Contaminated wipes sent for incineration
Paper, cardboard sent for recycling
Waste non-contaminated packaging is sent for
recycling
IPA waste placed into non-chlorinated waste can and
sent off site for incineration.
General exhausted air from cleanroom is vented to
atmosphere via HEPA/ bag filters.
Fugitive emissions arise from isopropyl alcohol and
other alcohol based sprays used.
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Emission Type
Solid hazardous waste
Non-hazardous solid waste
Liquid waste
Emissions to Air
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Emission Type
Emissions to process drain
Description
Cleaning wash water from cleaning active, excipients
and tabletting drums is discharged to foul sewer.
Diluted cleaning agents (chloroclens, clinchem,
CIP100 wash) sent to process drain.
Cleaning wastes sent to process drain
Product D
Preblending of Active Ingredient
Add excipient (1 Filler/Binder)
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Blending of Active ingredient & Excipients
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Milling (Screened) of Active ingredient preblend using a Quadro Comil
97.
Excipients added (4)
Add Colourants (2)
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Tabletting (Direct Compression)
Film Coating
Blister packaging
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D1.A.5. Plastics manufacture
Plastics manufacture has been carried out since 1980, but has increased greatly in size since
then. The Plastics Department runs on a 3 shift system operating 5 days per week with a
skilled, highly experienced workforce.
All product bottles are produced on site. Currently 3 different sizes of bottle are produced
ranging in volume size from 5ml to 15ml.
The raw materials for the bottle blowing processes are resins (low density polyethylene) and
colourants. There are 2 distinctly different system for plastic manufacture:
1. Injection blow moulding. See diagram below.
2. Injection moulding
D1.A.5.1. Injection blow moulding:
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There are currently 5 Jomar injection blow moulding machines (with only 2 operational at
present), which blow the small bottles produced. Resin and colourant pellets are vacuum fed
to hoppers above the machines. The mixture is then fed by a series of T pieces down into a
narrow barrel which passes from the hopper right down to the machine moulding parts. This
barrel has a revolving work which forces the resin downwards. As its passes past a bank of
electrically heated steel plates it is melted into a liquid plastic. Two separate blows are used
to form the bottles.
For the 1st blow, at Station , the top and bottom mould parts of a narrow mould form around a
series of core rods, and the plastic is blown into the mould, forming a thick walled, narrow
bottle. The moulds are then released and the rods move to the 2nd station, the moulds of
which form the actual shape of the finished bottle.
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The tips of the core rods open to allow compressed air to be blown in, and the second blow
ensures that the still-hot plastic takes up the shape of the mould cavity. The head then moves
onto the third station, where the bottles are ejected from the heads and fall into a waste bin.
A counter on the machine indicates when the bin is full and the bin moves along a set of
rollers to be packed off.
D1.A.5.2. Injection Moulding
There are currently 4 Engel machines used for injection moulding. These machines produce
bottle tips and caps. Resin is fed into the machine and heated within the system. Molten
plastic is injected into moulds and parts (tips and caps) are formed in the mould. The mould
opens and the parts are ejected onto a conveyer belt or a bin. The sprue (i.e. excess plastic)
is separated from the bottle tips and caps and is sent to a regrinder where it is used in the
next batch.
All bottles are emptied into labelled bags and placed into cardboard bags. Any bottles
determined to be defective by visual inspection of line operators or packers are rejected to
bins.
Plastic components - offsite sterilisation/ further use: blank (non printed) bottles are sent
offsite to an external contractor where they undergo sterilisation. Post sterilisation, the bottles
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Allergan IPPC Licence Application
are returned to the site where the are filled with solution, printed and packed for distribution to
the customer.
Quality Control inspections are carried out to ensure bottles are of an adequate quality and
specification. Any out of specification bottles are rejected and must go for recycling.
Emissions to environment
Emission Type
Solid waste
Description
Reject raw materials are returned to supplier
Reject plastic bottles are fed to regrinder and recycled in
the next batch
Excess plastic (sprue) from the process is recycled by
regrinding
Cardboard sent off site for recycling
Plastics sent off site for recycling
Waste heat produced by the processing operations is
dissipated in the general ventilation system
Any residues – clarify for disposal are incinerated off site
Emissions to Air
Co
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Hazardous waste
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Injection Moulding
Resins/ Colourants
Heat/ Compressed Air
Injection Blow
Moulding
BINS
BINS
ORIENTATION
PACKING
Cardboard
Boxes
17
Reject plastic regrinded and/or sent offsite for recycling
PACKING
to
f c Fo
Reject plastic regrinded and/or sent offsite for
op r i
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Recycling.
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HOPPER
Cardboard
Boxes
Resins/ Colourants
Heat/ Compressed Air
Flow diagram D1.A.5: Plastics: Unit operations and waste generation
Allergan IPPC Licence Application
Plastic
bags
Plastic
bags
To off-site
Sterilisation
Allergan IPPC Licence Application
D1.A.6. Conventional Compounding
The range of solutions manufactured covers cleaning solutions, disinfecting solutions and
prescription products. These are carried out under clean room conditions with the use of
general services such as Air Handling Units, Steam, Cooling water (for jacket vessels),
Purified water and Compressed Air.
Process details:
Raw materials are dispensed and, after initial mixing are added to stainless steel tanks where
agitation results in a mixed aqueous solution. The 3 main processes involved in
Compounding are as follows:
1. Open tank processes
-
Raw materials are dispensed and charge to a tank containing distilled
water. The resulting solution is agitated and pH adjusted (product
dependant). Depending on batch size, the mixed product is filtered
through a pre-filter and sterilising filter. After filtration, the solution is
transferred to a filling line.
Pressure vessels are jacketed with both steam and cooling water.
Dispensed ingredients are charged to a tank containing water which has
been steam heated, and is then further steam sterilised. Salt solutions
are premixed in an open tank and added to the pressure vessel through a
sterilising filter. The final solution is further mixed and clarity filtered to a
filling line.
3. Steroid product process
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2. Pressure vessel processes
At present, 2 different steroids are used to formulae the range of products
(i.e. fluorometholone and prednisolone acetate). Dispensed steroid is
premixed in a small volume glass jar, and pre-mixed with glass beads on
a rolling drum to facilitate wetting. After autoclaving and further mixing for
a predetermined time it is ready for addition of the base ingredients.
-
The base is made up separately in an Open tank, and the combined
solution is mixed with the steroid solution in a large tank, having passed
through a sterile filter. The solution is then clarity filtered and pumped to a
filling line.
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-
The process used depends on the type of product being made. Tanks of various size
represent the bulk of the equipment in the area, together with filter set-up, line and pumps.
Autoclaving facilities are also present for sterilising components used in the process. Tank
sizes used in the manufacturing process vary from 90L to 5000L, and are of 316 stainless
steel. Solutions are made in batch processes to specific formulae. At present over 70
different products are formulated.
Antibiotics containing solutions are manufactured in a dedicated area of Compounding
department.
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Allergan IPPC Licence Application
Mercury containing preservative (i.e. thimerosal) is added to some of the products. Products
containing thimerosal are controlled to ensure that emissions to the environment are
minimised and the spend solutions are stored in an on-site storage tank for processing by a
hazardous waste contractor.
Solutions of HCI, Phosphoric acid and Sodium Hydroxide used for pH adjustment are made
up in smaller plastic tanks and used as required.
Post compounding, the batch solution is pumped to a filling line where it is filled into bottles
or, alternatively, the solution is transferred to the Unit Dose Department where a
Blow/Fill/Seal process takes place.
Emissions to environment
Emission Type
Solid waste
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process
Clean In Place (CIP)/ Steam In Place systems resulting in
wastewater and steam to drain.
Mercury containing reject product is collected in dedicated
drains and stored in an on-site holding tanks. The waste is
sent for off site incineration
Non-mercury containing residual solutions are sent to the
process drains.
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Emissions
drains
ru
se
.
Emissions to Air
Description
Cleanroom uniforms are recycled
Plastics, cardboard, paper are recycled
Contaminated packaging, wipes and cleanroom uniforms
are disposed off site.
General exhausted air from cleanroom and from Local
Exhaust Ventilation exhausts in make-up areas.
Fugitive emissions from isopropyl alcohol and other alcohol
based glove sprays used.
Wash water consisting of pure steam and distilled water.
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20
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Flow Diagram D1.A.6.1: Compounding Open Tank. Process Flow showing Unit Operations & Waste Generation
Allergan IPPC Licence Application
EPA Export 26-07-2013:00:39:30
Filling Line
Waste packaging for off site
incineration
Weigh Chemicals
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Heat
Clarity
Filtration
Mixing
21
Cool
Open tank process
Open vessel
vent
Heating &
Cooling
Open tank
process
added
se
.
Heat
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Add raw
materials
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Wastewater to drain
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Add
Water
Heat
Flow Diagram D1.A.6.2: Compounding.: Pressure vessel process showing unit operations and waste generation
Allergan IPPC Licence Application
EPA Export 26-07-2013:00:39:30
22
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Flow Diagram D1.A.6.3: Steroid Process. Process flow showing unit operations and waste generation
Allergan IPPC Licence Application
Allergan IPPC Licence Application
D1.A.7. Conventional Filling
In continuation with the manufacturing process, following online filtration, solution from
Compounding is transferred from the Compounding area to the filling lines. The filling lines
have an initial solution discard from the fixed pipework prior to being connected to the filling
machines.
From the filling lines, the solution is dosed into the filling machines (cleanroom areas), where
it is filled into sterile bottles (from Plastics Department) and sent off-site for sterilisation. The
bottles are then fitted with a tip/cap, and leave the area, being forwarded to the adjacent
Packaging Department.
There are currently 4 filling lines in operation at present, most of which are equipped with a
CIP/SIP system.
Emissions to environment
Description
Cleanroom uniforms
Plastics, cardboard, paper are recycled
Bottle liquid wastes are collected in bins and brought to the
shredder for disposal. Bottles are shredded and resulting
liquid product is directed for treatment via a dedicated line.
Mercury containing wastes are directed to the mercury
storage tank prior to being treated off site.
Reject waste bottles are recycled.
Contaminated packaging, wipes and cleanroom uniforms
are disposed off site.
General exhausted air from cleanroom and from Local
Exhaust Ventilation exhausts in make-up areas.
Fugitive emissions from isopropyl alcohol and other alcohol
based sprays used.
Initial solution discard from lines range in volume from 1040L, depending on solution and filter type. This discard is
measured into calibrated, labelled containers, and removed
to the Filling/Compounding transfer room, where they are
discharged to the appropriate discharge line (i.e. to process
drains if solutions do not contain mercury or otherwise to
the
Mercury
storage
tank
for
subsequent
storage/treatment).
Wastewater from CIP/SIP operations are sent to process
drains
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Emission Type
Solid waste
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Emissions to process drain
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Emissions to Air
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From Compounding
Sterile Solution
FILLING : Process flow map
FILLING
24
to
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op r i
MACHINES
WITH ON-LINE
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CHECKS
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Flow Diagram D1.A.7: Conventional Filling-Process flow
Sterile bottles
from Plastics
Allergan IPPC Licence Application
Wash water from
cleaning
(to drain)
Plastic packaging waste
from bottles etc.
General cleanroom waste
(mophats, overshoes etc)
Reject plastic (bottles,
tips, caps) recycled
Reject product from on
line checks :
- Solution pumped to
appropriate waste line
(non TMS/ TMS)
- Plastic recycled
Fugitive emissions from
IPA
Tips
Caps
Filled, Tipped, Capped
Bottles to Packaging
Allergan IPPC Licence Application
D1.A.8. Unit Dose Filling
Product for filling is pressurised from the Unit Dose Manufacturing area to the Unit Dose
Filling machines. The vials / ampoules that contain the product are formed as part of the Unit
Dose Filling operation process. This process is known as a Blow Fill Seal (BFS) operation.
Filled product in Unit Dose may be in the form of a single or card of vials / ampoules. The
card of vials can be separated into single units as required.
The products produced in Unit Dose are for direct application to the eye, presented in a single
dose package. Therefore, the usage of preservative is not required.
D1.A.9.: Blow/ Fill/ Seal process
There are at present seven PLC controlled Rommelag BFS machines in operation in Unit
Dose.
The raw materials for the process are solutions / products, low density polyethylene (LDPE)
resin and packaging materials.
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The product is pressure filled from Unit Dose Manufacturing into the Unit Dose Filling
machines passing first through a sterilising grade product filter into the pressurised buffer /
holding tank at the head of the machine. As it exits the buffer tank it once again passes
through a sterilising grade product filter and proceeds to the dosing chambers under “Class
100” conditions. (There are different filter trains in place for different products)
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The resin is supplied to the Unit Dose Filling machines via vacuum from dedicated silos into
receiver units / hoppers located at the Unit Dose Filling machines. The resin is heated by a
number of electrical heating bands and extruded out as a hollow bag (parison). A combination
of sterile air in the parison and vacuum in the Unit Dose Filling machine molds enables the
parison to remain inflated. The machine mold(s) engage the plastic forming a single or card of
empty vials. The filling nozzle(s) is now inserted into the newly formed vial and delivers the
appropriate solution dose. Once the unit is filled the mold(s) seal the filled vial(s). A cutting
instrument heated to 300ºC then dissects the filled vials from the core of extruded plastic (this
occurs on two machines only). The vials are then taken up by a punch unit, which removes
the filled vials from its plastic frame, this results in excess plastic (flash) dropping to a
conveyor which proceeds to a repelletising machine (Erema) located outside of the
cleanrooms.
Single vials are fed from the Unit Dose Filling machine to an unscrambler unit which in turn
feeds the vials to a capping unit. Correctly capped vials are fed by conveyor to the Unit Dose
Packaging line outside the cleanroom; uncapped vials are ejected to a reject bin.
Vial volumes range from 0.4ml to 10ml.
Emissions to environment
Emission Type
Liquid waste
Description
All waste Unit Dose plastic vials are collected as Non
Mercury containing waste and shredded on-site. Liquid
waste is sent to process drain. Plastic waste vials are sent
to landfill.
The Alcohol/water waste solution used for flushing the filters
must be collected in a designated labelled container and
disposed in the Non-chlorinated Solvent Waste Drum for
incineration off site.
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Allergan IPPC Licence Application
Plastics, Paper, Cardboard sent off-site for recycling
General waste sent to landfill
Filter cartridges used for filling media solution are taken to
the compactor in the receiving dock
Residual flash after the filled vials are punched from the
plastic frame is repelletised. Other waste plastic from the
regrind area is collected and sold for off-site reprocessing.
Fugitive emissions of particulates and heat arising from
molten plastic cutting operations exhausted via general air
exhaust system from cleanrooms.
Fugitive emissions from isopropyl alcohol and other alcohol
based sprays used.
All wastewater sent to process drain.
All wash waste from filter flush is sent to process drain
Solid waste
Emissions to Air
Emissions to process drain
D1.A.10. Unit Dose Packaging
ru
se
.
With the exception of Line 2, as all vials come out the conveyors from the Unit Dose Filling
department, a Lot & Expiry is applied to the tab of the each vial by way of inkjet coding. The
vials then pass by a second inkjet coder which applies a 2D code to the tab of each vial. The
2D code represents the Lot number and Label been applied to the vial for quality purposes.
The vials then pass by the 2D camera which verifies that the correct code has been applied.
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At this point vials run along the conveyor into a Tampoprint machine. Tampoprint machines
are automated printing lines which uses Black ink to print the label text onto the vials. The
machine consist of an in-feed conveyor, corona treatment unit, printing station, printing plates
known as clichés, IR curing station and out-feeds. Vials are transferred from the in-feed
conveyor by vacuum to the gigs on the main conveyor. Vials pass under a Corona treatment
unit which pre-treats the surface of the vial to improve the bonding of ink to plastic. The vials
are then presented to the print station and a film of ink is picked from the cliché by way of
silicone rubber and placed on the pre-treated surface of the vial. The vials then pass under a
drying station where the ink is dried by IR curing. Vials are then transferred to the outlet
conveyor for packing into trays.
Co
The exception to this is Line 2 where single vials come out the conveyor from Unit Dose
Filling where they pass by a labeller and an Adhesive product label is applied to the vials, the
Lot and Expiry is printed on the label and the vials are then placed in WIP boxes to be packed
in Conventional Packaging. These vials come in 5ml and 10ml.
All vials are 100% leak tested after Labelling/Tampoprinting in both the upright and inverted
position by way of using Vacuum Chambers that are situated on each line.
Any vials that
leak are detected by checking the Leak detector sheet within the WIP box and are removed
and rejected.
Pouching /Labelling:
Products which are light sensitive such as Betagan and Ocufen are not Tampoprinted but are
labelled on a Neri Labeller which applies a small adhesive label to the tab of each vial which
are required to be pouched. An aluminium/ PVC foil is used to form a pocket around the vial
which is then sealed using our Klockner pouching machine. These pouches are then
handpacked into various pack sizes varying from 5 packs up to 90 packs.
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Allergan IPPC Licence Application
Packaging:
All trayed vials from the Tampoprint Lines are packed on IPS lines. IPS machines are
automated packaging lines which can pack various pack sizes from 5 packs up to 70 packs.
The machines automatically form the carton, place the insert and vials into the carton before
sealing the carton. The carton is then laser coded with the Lot & Expiry. The machine
incorporates an on line verification system for the inserts, cartons and vials. The cartons are
then packed into shippers for export.
Cleaning
The Unit Dose Filling machines are equipped with a CIP/SIP facility. Process water is used for
cleaning. Machine surfaces are cleaned with approved disinfectant.
Description
The alcohol/water waste solution used for flushing the filters
must be collected in a designated labelled container and
disposed in the Non-chlorinated Solvent Waste Drum for off
site incineration.
All inks and make-up for domino coders are discarded to
the designated ink waste container and disposed off site as
hazardous waste. All empty ink containers are also
disposed as hazardous waste.
Plastics, Paper, Cardboard sent off-site for recycling
General waste sent to landfill
Residual flash after the filled vials are punched from the
plastic frame is repelletised.
Waste foil from overwrap machine is collected into the
metal waste bin and sent for recycling.
Minimal fugitive emissions of particulates and heat arising
from molten plastic cutting operations exhausted via
general air exhaust system from cleanrooms.
Minimal fugitive emissions arise from isopropyl alcohol and
other alcohol based sprays used.
Reject product vials are transferred in bins to the shredder
where they are shredded and liquid waste is sent to process
drains. Shredded plastic is sent to landfill.
All wash waste from filter flush is sent to drain
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Emission Type
Liquid waste
Solid waste
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Emissions to Air
Emissions to process drain
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Flow diagram D1.A.10.: Unit Dose Packaging
Allergan IPPC Licence Application
28
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Allergan IPPC Licence Application
D1.A.11. Conventional Packaging
Packaging of product is the next step in the production process. Downstream from the filling
lines are a number of corresponding Packaging lines.
The filled bottles exit the cleanroom and onto the packaging line where
x
a celloproof seal is added
x
batch and product information is printed onto the blank bottle.
The filled bottles, together with a leaflet are automatically packaged into a carton. Then, 12
cartons are shrink wrapped before manual packing into shippers. Shippers are stacked on
pallets and shrink wrapped for dispatch post Quality Assurance release.
Triple packs, are where 3 single pack cartons or 3 bottles are packed into a triple carton as
per customer requirement.
Brief description of unit operation equipment:
Cellosealers: Celloseal is fed into the line, cut to size to surround the lid of the bottle
and heated on line by heating blocks. The celloseal shrinks to form a neat seal around
the neck of the bottle.
x
Bottle labellers: Unlabelled bottles, rolls of labels are fed onto the line and removed
from backing paper and attached to the bottle at high speed.
x
Vignetter Labellers: Vignette stickers are applied to the carton as they pass through
the vignette labeller as per customer requirement.
x
Inkjet printers: These printers print variable batch data directly onto the product.
Solvent based inks are used which will result in some fugitive emissions.
x
Checkweighers: These on-line weighers reject product outside pre-set limits offline,
where they are manually checked and re-introduced into the line where applicable.
Rejects are discarded to appropriate bins.
x
Automatic/semiautomatic cartoners: The carton is formed by a series of vacuums
and flap directors. A leaflet is added and bottle and leaflet are inserted to the carton
which is then closed and shrink wrapped into bundles of 12 units and packed into
shippers.
x
Overwrappers: Bundles of cartons are overwrapped in clear film.
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x
Emissions to environment
In process checks result in rejects as follows:
x
Volume checks/ Cello seal checks
x
Bottle product defects
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Allergan IPPC Licence Application
Emission Type
Solid waste
Description
Vendor carton boxes, damaged shippers and damaged/
reject cartons are baled in the cardboard bailer outside
packaging. Inserts are placed into bins outside packaging
and sent off site for recycling
White cardboard sheets are removed from the carton boxes
and collected for recycling off-site.
Elastic bands are recycled from the insert tray boxes for
recycling off-site.
Backing paper from bottle labels and case labels, tie wraps
from shippers, black ribbon waste from labellers are also
segregated for general waste.
Minimal fugitive emissions arise from inks used in labelling
process
Reject bottles are collected in bins and removed to the
TMS/ Non-TMS bins located in Warehouse outside
Packaging Dept from where they are brought to the
shredder to remove the waste liquid. Waste liquid is then
diverted to the relevant dedicated line – mercury containing
or non-mercury containing. Mercury containing waste is
contained and removed off site for incineration.
Emissions to Air
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Emissions to process drains
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Filled, tipped &
capped bottles
- Waste heat
- Waste celoseal
TAMPER
PROOF
SEAL
- Celloseal
- Heat
- Rejects shredded
- Liquid Treatment if
required (TMS
containing)
ON-LINE
CHECK
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- Cartons
31
- Rejects shredded
- Liquid Treatment if
required (TMS
containing)
h
ot
PACKING
- Bundle wrap
- Shippers
er Packaging
- Reject
- Rejectusproduct
e
shredded .
- Liquid Treatment if
required (TMS
containing)
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CHECK
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- Solvent from inks
(Hazardous waste)
- Waste Labels
APPLY
LABELS
- Inks
- Labels
Flow diagram D1.A.11.: Process flow of Packaging. Showing Unit Operations & Waste Generations
Allergan IPPC Licence Application
- Waste bundle wrap
-Waste cardboard
To Warehouse
Allergan IPPC Licence Application
D1.A.12.Laboratories on site
Chemistry laboratory carries out chemical testing on raw materials and products at all stages
of production
Microbiology laboratory carries out microbiological testing on raw materials and products at all
stages of production as per individual product requirement.
ETC laboratory carries out stability testing for new and commercial products, issues Allergan
secondary reference standards, manages the 3rd party manufacturers contractors used by
Allergan and approves their product release. ETC also release US manufactured product for
distribution within the EU.
Validation/ Calibration Department carry out validation on new processes and new plant to be
used at the Westport facility.
Emissions to environment
Description
Plastics, Paper, Cardboard are sent off-site for recycling
General waste is sent to landfill
All agar plates from the Microbiology laboratory are
autoclaved prior to going to landfill.
Expired solid chemical are sent off-site for incineration by
an approved waste contractor.
Minimal fugitive emissions arising from isopropyl alcohol
and other alcohol based sprays used as a germicidal agent
in the Microbiology laboratory.
Minimal fugitive emissions from chemical use in laboratory
fumehoods.
Non-mercury containing product wastes are disposed to
drain.
Mercury-containing product wastes are collected and
incinerated off-site by an approved waste contractor. These
wastes are prohibited from entering process drains.
Solvent wastes/ hazardous chemical wastes are collected
for disposal and incinerated off-site. These wastes are
prohibited from entering process drains.
Culture broths from the Microbiology lab are sent to process
drain.
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Emission Type
Solid waste
Emissions to Air
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Allergan IPPC Licence Application
D1.A.13. Canteen
The activities of the facility restaurant service comprises preparing, cooking and serving food
and post service operations such as washing, cleaning.
The restaurant service is operated by Sodexho Ltd under contract to Allergan, Westport. The
facilities consist of a:
- storage room for food storage,
- washroom for cleaning/washing operations,
- preparatory area for food preparation and cooking,
- serving area where food is served
-
dining area for food consumption.
Emissions to environment
Description
Plastic bottles, drink cans, glass, Paper, Cardboard, sent
off-site for recycling
General waste such as food waste, contaminated food
packaging are sent to landfill
Waste cooking oil is collected in dedicated containers and
collected by an approved waste contractor where it is
recycled.
Steam and vapour from ovens, cooking operations.
Cleaning agents such as diluted detergents and sanitising
agents are sent to drain.
Liquid food wastes are sent to process drain.
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Emission Type
Solid waste
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Emissions to Air
Emissions to process drain
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Allergan IPPC Licence Application
D.1.A.14
Abatement, Treatment and Control Systems
Air Abatement
HEPA filtration is used to filter air at the facility. The HEPA filters are highly effective at
removing dust particles prior to discharge to atmosphere. The HEPA’a are employed in any
area where active ingredients are used or where biocabinets and isolators are used. Table 1
details the HEPA filters currently in use at the facility.
Loss of any critical HVAC system generates an alarm which signals to the production area
alarm lights. Alarms generated within the HVAC control system are for temperature, relative
humidity and filter pressure differentials, which are acknowledged, logged and acted upon by
the maintenance department.
The HEPA filters are changed on a need basis as per our outside consultant.
x
x
x
HEPA filters are integrity tested twice yearly by introducing heated vaporised Ondinaoil on
the upstream side of the filters.
The system is revalidated twice a year.
This is done by an approved outside contractor
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The minor emission points, which have abatement on them, are described in Table 1.
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Table 1: Minor emission points, abatement.
Emission Reference
A3-9
Description
Botox Class 2 Safety Cabinet Room 508 - Biotech Lab
Botox Class 2 Safety Cabinet Room 507 – Cell Culture Lab
Botox Class 2 Safety Cabinet Room 507 – Cell Culture Lab
Botox Class 2 Safety Cabinet Room 507 – Cell Culture Lab
Microbiology Sterility Isolator
A3-11
A3-12
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A3-13
Abatement
HEPA filter
Designation
Minor
HEPA filter
Minor
HEPA filter
Minor
HEPA filter
Minor
Catalytic
converter
Minor
The operation of the Air Handling Units is by means of a dedicated, validated computerized
building management system (BMS). The facility monitoring system (FMS) monitors the
environmental conditions (particulates, temperature, relative humidity) within the classified
areas to ensure that the validated room environments are being maintained.
Loss of any critical HVAC system generates an alarm which signals to the production area
alarm lights. Alarms generated within the HVAC control system are for temperature, relative
humidity and filter pressure differentials, which are acknowledged, logged and acted upon by
the maintenance department.
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Allergan IPPC Licence Application
Emissions to Sewer Abatement
Wastewater from the Botox operation is routed to a stainless steel tank for treatment with
sodium hypochlorite and only when trained staff are satisfied that the toxin is inactivated is the
washwater released to the process water treatment tank.
The process wastewater within the Allergan Pharmaceutical site is collected and conveyed by
the process wastewater network and discharged to the process water treatment facility
(balancing tank), which is located on the northern perimeter of the site. The treated process
water is then discharged to the municipal sewerage system, operated by Mayo County
Council.
The process wastewater collection network consists of both gravity and a pumped system.
There are two main pumping stations, S1 and S2 within the process water network that
convey the flows to the balancing tank.
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S1 receives flows from both the Botox plant, including effluent generated by the canteen
located in the Pharmaceutical Plant. S2 receives flows from the Pharmaceutical Plant only.
The majority of the gravity network is made up of 150mm diameter pipes. The rising main
from S1 to the balancing tank is 100mm diameter plastic pipe and the rising main from S2 is a
75mm diameter. The discharge rising main feeding from the balancing tank to Mayo County
Council is a 100mm diameter plastic pipe.
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The process wastewater treatment facility consists of a 1000m3 internally lined balancing tank
and a pH neutralisation system. The pH neutralisation system consists of a mixing tank, a
caustic dosing tank and acid dosing tank. Process water is pumped into the balancing tank
from pumping stations S1 and S2.
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From here forward feed pumps then lift the process water to the mixing tank (pH
neutralisation). These forward feed pumps pump at a rate of 23m3/hr. The pH is monitored
and if the pH level is outside the EPA licence parameters then acid or caustic dosing is
applied. The discharge from the tank is then monitored to ensure the correct level of dosing
has been applied.
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The treated flow is then discharged via a pumped rising main to the municipal sewerage
system, operated by Mayo County Council. The final discharge pump rate is approximately
23m3/hr and operates on a duty/standby basis. Should the discharge from the mixing tank be
outside the EPA licence pH parameters, the effluent can returned to the balancing tank to go
through the treatment process again.
A high level alarm has been installed in the balancing tank. The pump sumps on site also
have high-level alarms.
A new refrigerated flow proportional sampler has been installed at SE-1.
A new effluent flow chart recorder has also been installed.
New flow meters for S1 and S1 pump sumps are to be installed in 2008.
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Allergan IPPC Licence Application
Attachment D.1.B
Allergan
IPPC Licence Application
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Attachment D.1.B – Map of Operational Facilities
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EPA Export 26-07-2013:00:39:30
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Allergan IPPC Licence Application
Attachment D.1.C
Allergan
IPPC Licence Application
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Attachment D.1.C – Process Water Diagram
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EPA Export 26-07-2013:00:39:31
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Allergan IPPC Licence Application
Attachment D.1.D
Allergan
IPPC Licence Application
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Attachment D.1.D – Wastewater Treatment Diagram
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EPA Export 26-07-2013:00:39:31
Process Water In
BALANCE TANK
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NEUTRALISATION SYSTEM
Allergan IPPC Licence Application
Attachment E
Allergan
IPPC Licence Application
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Attachment E
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Allergan IPPC Licence Application
Attachment E
Contents
Attachment E.1 – Emissions to Atmosphere
Attachment E.1.A – Description of Air Handling System & Boiler Efficiency Test
Attachment E.2 – Emissions to Surface Water
Attachment E.2.A – Surface Water Monitoring Points
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Attachment E.3 – Emissions to Sewer
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Attachment E.3.A – Details of all List I and List II substances listed in the Annex to EU
Directive 76/464/EEC
Attachment E.5 – Noise Emissions
Attachment E.5.A – Allergan Noise Attenuation Survey
Attachment E.5.B – Allergan Annual Noise Survey, IPPC Noise Report 2007
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Attachment E.6 – Tabular Data for Emissions
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Attachment E.6.A - Table of Emissions Points
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Allergan IPPC Licence Application
Attachment E.1.A
Allergan
IPPC Licence Application
Attachment E.1 – Emissions to Atmosphere
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Attachment E.1.A – Description of Air Handling System & Boiler Efficiency Test
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Allergan IPPC Licence Application
E.1.A.1
Emissions to Atmosphere
Inventory of Air Emissions
There are three Boiler Emission points (A1-1, A1-2, A1-3).
There are no main emission points.
There are a number of minor emission points. These include 4 stand-by generators; fume hoods, local
dust extraction points and kitchen boiler.
There are two potential emission points consisting of the fire engines, which will only operate in event of
fire incident.
The inventory of emissions to atmosphere is presented here.
Description
Boiler No. 1
Abatement
None
Designation
Boiler
A1-2
Boiler No.2
None
Boiler
A1-3
Boiler No.3
None
Boiler
A3-1
Botox generator No 1
None
Minor
A3-2
Botox generator No 2
None
A3-3
Pharma generator No 1
A3-4
Minor
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Emission Reference
A1-1
Minor
Pharma generator No 2
None
Minor
A3-5
Kitchen gas burner
None
Minor
A3-6
A3-16
Posurdex
washroom
fumehood
Pharma Chemistry/ ETC/ PSR
labs – fumehoods
Pharma Chemistry/ ETC/ PSR
labs – fumehoods
Botox Class 2 Safety Cabinet Room 508 - Biotech Lab
Botox Fumehood- Room 508 Biotech Lab
Botox Class 2 Safety Cabinet Room 507 – Cell Culture Lab
Botox Class 2 Safety Cabinet Room 507 – Cell Culture Lab
Botox Class 2 Safety Cabinet Room 507 – Cell Culture Lab
Botox Chemistry Labs fumehood
Botox Chemistry Labs fumehood
Microbiology Sterility Isolator
A4-1
Fire engine 1
None
Potential
A4-2
Fire engine 2
None
Potential
A3-9
A3-10
A3-11
A3-12
A3-13
A3-14
A3-15
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None
None
Minor
None
Minor
None
Minor
HEPA filter
Minor
None
Minor
HEPA filter
Minor
HEPA filter
Minor
HEPA filter
Minor
None
Minor
None
Minor
Catalytic
converter
Minor
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Allergan IPPC Licence Application
Emissions to Atmosphere
A description of the Air Handling Units and filter units is presented below. The AHU’s in the Botox and
Pharma operations are described.
E.1.A.2
Description of Air Handling Units
Botox - Description of Air handling systems
x
x
x
x
x
x
x
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In Trivaris™ the Grade A system consists of one central AHU supplying conditions HEPA
filtered air to a number of recirculation air handling units each serving a particular ULPA
filtered ceiling plenum over a Grade A room. The Grade B & C rooms in Trivaris™,
consists of one central AHU supplying conditions air to terminal HEPA filter boxes local to
each room.
In Core 1 the Grade A system consists of one central AHU supplying conditioned HEPA
filtered air to a number of recirculation air handling units, each serving a particular ULPA
filtered ceiling plenum over a Grade A room.
In Core 2 the Grade A area has a single AHU supplying conditioned air to four plenums.
Each plenum has an array of fan filter units, which supply HEPA filtered air to the grade A
rooms.
The Grade B & C system consists of one central AHU supplying conditioned air to
terminal HEPA filter boxes local to each room.
Air within Grade A rooms returns to the recirculation air handling units and main air
handling unit through air walls linked to the ductwork system. Air within the Grade B & C
rooms returns to the air handling system via return air grilles at low level in the rooms.
Core 3 Grade A area consists of two AHUs, identified as AHU 21 and AHU 23. The first,
AHU 21 supplies conditioned air to four plenums. Each plenum has an array of filter fan
units, which supply HEPA filtered air to the Grade A rooms. The second, AHU 23,
supplies conditioned HEPA filtered air to a number of recirculation air handling units,
each serving a particular ULPA filtered ceiling plenum over Grade B sterile corridor and
ancillary areas.
A single AHU, AHU 20, also supplies conditioned air to a ULPA filtered ceiling plenum to
supply the Grade A sterility test suite.
The Grade B/C system consists of one central AHU, AHU 22, and supplying conditioned
air to terminal HEPA filter boxes located to each room.
Air within Grade A room’s returns to the recirculation air handling units and main air
handling unit through air walls linked to the ductwork system.
Air within the Grade B & C rooms returns to the air handling system via return air grilles
at low level in the rooms.
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There are 13 Critical HVAC Systems which supply conditioned air to the Trivaris™, Core 1, Core 2 and
Core 3 facilities. The Core 3 HVAC Systems consist of 14 air handling units (AHUs) and their
associated filter fan units. The operation of the AHUs is by means of a dedicated, validated
computerized building management system (BMS). The facility monitoring system (FMS) monitors the
environmental conditions (particulates, temperature, relative humidity) within the classified areas to
ensure that the validated room environments are being maintained.
Within the Trivaris™, Core 1 and Core 2 facility there are 7 critical HVAC systems serving the Grade A
(Class 100) and Grade B & C (Class 10,000). There are also 4 general HVAC systems serving the non
classified area.
The classified area air supply design is based on achieving an air quality as set out in ISO 146441 and EU guidelines.
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Allergan IPPC Licence Application
x
x
x
x
x
x
x
Emissions to Atmosphere
Temperature: 20 deg. C ± 3 deg. C
Relative humidity: 35 - 65% RH
Minimum Pressure differentials: 10 - 15PA between Grade A (Class 100)
>15PA between Grade B & C (Class 10 000) and Grade D (Class 100,000)
>15PA >15PA between Grade D (Class 100 000) and unclassified areas.
Minimum air changes Grade B & C (Class 10,000) - 20 changes/hour.
Recirculation of air is utilised on the air handling systems with a maximum intake of freshair of up to 10%.
Loss of any critical HVAC system generates an alarm which signals to the production area alarm
lights.
Alarms generated within the HVAC control system are for temperature, relative humidity and filter
pressure differentials, which are acknowledged, logged and acted upon by the maintenance dept.
The FMS (facility monitoring system) which monitors environmental conditions within the
classified areas is capable of activating a similar alarm light as a result of temperature, relative
humidity, pressure differentials or particle counts, going outside set limits.
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The minimum average velocity of filters is 0.36m/sec. The limit for changing filters in units of Pa
(final) is illustrated in Table 3.3.1-1 in
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Allergan IPPC Licence Application
Emissions to Atmosphere
Pharma: Description of Air Handling Unit.
Air handling systems for the Pharma facility are serviced by air handling units located on the
technical floors. Air intake louvers are situated to the side of the building with Air exhausts
discharged through the roof. The air-handling units consist of the following:
1. Supply air fan and ductwork.
2. Return air fan and ductwork.
3. Mixing section: including fresh air, spill air and mixing dampers.
4. Panel filters: typically 60% efficiency ASHRAE 52-76. (EU3)
5. Bag filters: typically 90% efficiency ASHRAE 52-76. (EU7)
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The air handling systems may be grouped into the type of areas being serviced as follows:
Warehousing
Plastics moulding
Compounding
Sterile Storage
Filling Rooms
Memantine
Packaging
Unit Dose
Posurdex
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Warehouse areas
The warehouse areas are heated by means of low pressure hot water (L.P.H.W.) unit heaters.
Heating is provided via heat exchangers supplied from the boilers.
Plastics moulding
The plastics moulding area is cooled and ventilated by one air handling unit mounted on an
adjacent technical floor.
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There may be some minor fugitive emissions from ink storage room in Plastics Department.
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No significant emissions to atmosphere
Conventional Compounding area
The compounding areas are serviced by air handling units located on the technical floors.
The existing compounding areas are provided with 20-40 air changes per hour, and some
terminal HEPA filtration is provided.
Compounding weigh booth exhaust is HEPA filtered with filter changed out each month. Air is
recirculated within the area.
No significant emissions to atmosphere
Conventional Sterile Storage
The sterile storage areas are serviced by air handling units generally as described for the
compounding areas. Air change rates vary from 20 - 60 air changes per hour. Terminal HEPA
filtration is provided throughout sterile storage areas.
No significant emissions to atmosphere
Conventional Filling Rooms
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Allergan IPPC Licence Application
Emissions to Atmosphere
There are at present five active conventional filling rooms and one storage room. These rooms
are a mixture of partial and full grade A rooms.
No significant emissions to atmosphere
Memantine
The Memantine area is serviced by five air handling units, made up as described
previously.
No significant emissions to atmosphere
Posurdex
The Posurdex area is serviced by 1 air handling unit, made up as described previously.
In addition, there is a containment booth which encloses the mill used in this process operation.
The booth is HEPA filtered and air recirculated back into room. Also there is a fumehood venting
directly to atmosphere in the area washroom which is used for cleaning purposes. The use of
small amounts of solvents during this operation may give rise to fugitive emissions.
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No significant emissions to atmosphere
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Packaging
The packaging areas are served by air handling units as described previously. 15 air changes per
hour are provided throughout the packaging area.
No significant emissions to atmosphere
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Unit Dose Manufacturing areas
The unit dose manufacturing areas are serviced by air handling units located on the technical
floors.
Unit dose manufacturing areas are serviced with between 20 and 35 air changes per hour. All unit
dose manufacturing areas are serviced by HEPA filtered air.
No significant emissions to atmosphere
Unit Dose Filling Rooms
At present, there are seven Unit Dose filling rooms. These rooms are full grade B rooms.
No significant emissions to atmosphere
Maintenance Workshop
The maintenance workshop is serviced by 1 air handling unit.
Welding bay has a local ventilation system venting to atmosphere to prevent occupational
exposure to welding fumes. Welding fumes are not of environmental significance.
No significant emissions to atmosphere
Microbiology/ Chemistry/ETC Laboratories
The labs are serviced by air handling units.
Microbiology - Biocabinets
- Heraeus 9117366: contains exhaust HEPAs
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Allergan IPPC Licence Application
Emissions to Atmosphere
- Microflow 8281/2001/11: contains exhaust HEPAs
- Microflow 2000012033: contains exhaust HEPAs
- Bio airL20NA9717: contains exhaust HEPAs
- Isolator: contains exhaust HEPAs
- Laminar Flow Devices - HLF 16019: No HEPAs
- LAF1: No HEPAs
- LAF2: No HEPAs
There are 13 fumehoods in the ETC/ Chemistry/ PSR labs which vent straight to atmosphere.
The fumehood extracts are not of environmental significance due to the small quantities involved.
No significant emissions to atmosphere
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There are three main filters used;
x Bag Filters - Bag filters have an arrestance rating of 85%.
x HEPA Filters -These are individually integrity tested and certified
to have a minimum efficiency of 99.997% on 0.3Pm particles and
scan tested to be leak-free in accordance with ISO 14644-1.
x Panel Filters -These are rated at 50-55% with an arrestance
rating of 95%.
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Alarms:
If either a supply air fan or a return air fan stops, a visual alarm will show in the
engineering/maintenance department.
Bag filters are changed yearly.
HEPA filters are changed on a need basis as per our outside consultant.
Panel filters are changed twice yearly.
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HEPA filters are integrity tested twice yearly by introducing heated vaporised Ondina
oil on the upstream side of the filters.
The system is revalidated twice a year. This is done by an approved outside contractor.
List of Air Handling Units in Pharma
AHU Number
1a
2a
3a
4a
5a
6
7
8
9
10
11
12
13
14
15
16
Location
Packaging
Compounding
Filling Lines 1 & 2
Compounding 2
Filling Line 3
Westend Offices
N/A
Compounding
Fill Line 7
Packaging Lines 6 & 7
Plastics Locker Area
Unit Dose Packaging
Fill Line 5/8 & Ster. Str
Compounding 4 & 5, Filling Line 9
Tablet Manufacturing
Tablet Utilities
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Location
Tablet Cartoning
Tablet Blister Pack
Unit Dose Packaging 6 & 7
Regrind Area
Kits Packaging
Unit Dose Filling Corridor
Unit Dose 5, 6 & 7
Unit Dose 1, 2, 3 & 4
Packaging
Unit Dose Manufacturing
Unit Dose Manufacturing
Ground Floor Labs
Ground Floor Toilets
1st floor lab Env/ Bio./ EHS
Preparation Lab
1st floor Laboratory Test Room 1
1st floor validations office
1st floor Lab Test Room 2
1st floor lab
1st floor lab hot room
1st floor lab hot room
Store
Maintenance W/Shop
Formerly papain area
Plastics area
Sterile storage area
Class 10 Support Rooms
N/A
Fill Line 9 Packaging
Posurdex
Temp Changing
Restasis
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AHU Number
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
32a
33
34
35
35a
36
37
39
40
41
42
43
44
45
50
27.1
Emissions to Atmosphere
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Allergan IPPC Licence Application
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Allergan IPPC Licence Application
Attachment E.2
Allergan
IPPC Licence Application
Attachment E.2 – Emissions to Surface Water
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Attachment E.2.A – Surface Water Monitoring Points
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Allergan IPPC Licence Application
Attachment E.3
Allergan
IPPC Licence Application
Attachment E.3 – Emissions to Surface Water
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Attachment E.3.A – Details of all List I and List II substances listed in the Annex to EU
Directive 76/464/EEC
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Allergan Pharmaceuticals IPPC licence Review
E.3.B. LIST I AND LIST II Substances in sewer emissions
With regard to the List I and List II substances listed in the Annex to EU Directive 76/464/EEC (as
subsequently amended), following assessment of site processes and materials, tables below present
the materials in wastewater onsite which are List I and List II substances.
List I Substances
Potential Presence in Wastewater
Not present
Not present
Not present
Not present
Mercury may be present in small amounts.
Monitoring takes place
Not present
Not present
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List II Substances:
Suspended solids presents and monitored.
Quantities of IPA, and acetone are present
and monitored. Some oils/fats and greases
also present and monitored
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Cadmium and its compounds
Persistent mineral oils and
hydrocarbons
of
petroleum
origin
Persistent synthetic substances
which may float, remain in
suspension or sink and which
may interfere with any use of
the water
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List I Categorisation
Organohalogen compounds and
substances which may form
such compounds in the aquatic
environment
Organophosphorus compounds
Organotin compounds
Substances in respect of which
it has been proved that they
possess carcinogenic properties
in
or
via
the
aquatic
environment
Mercury and its compounds
List II Categorisation
Substances which have a
deleterious effect on the taste
and/or smell of the
products
for
human
Potential Presence in Wastewater
Detergents, which are monitored and
below the emission limit value
consumption derived from the
aquatic environment,
Inorganic
compounds
of
phosphorus
and
elemental
phosphorus
Substances which have an
adverse effect on the oxygen
balance, particularly:
ammonia, nitrites.
Total phosphorus which is monitored and
below the emission limit value
Ammonia and nitrates which are monitored
and below the emission limit value
1
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Allergan IPPC Licence Application
Attachment E.5
Allergan
IPPC Licence Application
Attachment E.5 – Noise Emissions
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Attachment E.5.A – Allergan Noise Attenuation Survey
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Allergan IPPC Licence Application
Noise Sources
There have been significant noise abatement works carried out on both of the major noise
emission sources at the Allergan site, namely the Boiler house(N1) and the Chiller area (N2).
In the case of the former, the timber gate enclosing the chiller area, has been upgraded, and
is now a complete surface with no gaps, the gate now runs down to the ground surface, and
no longer has a significant gap between the ground and the base of the gate. This gate is also
now kept closed at all times save of access/egress.
In regard to the Boiler house, the original boiler house doors have been replaced by purpose
built louvered acoustic doors, which consists of a double acoustic metal door construction
complete with frame, giving a Rw of 48.8dB.
In addition, a new 90-degree bend attenuator and a 760mm straight attenuator has been
installed, connected to the existing outlet in the cladding of the building.
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The most recent environmental noise survey carried out in September 2007 is attached in
Attachment E. This survey details the specified noise sources specified above and noise
monitoring locations around the site boundary.
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RPS conducted a noise survey within the Allergan site at the two main noise sources and at
the nearest noise sensitive location in order to establish current compliance with Condition 8 of
Allergan’s IPC Licence (Reg. No 126), following indication of potential non-compliance.
Mitigation works undertaken at Allergan have eliminated reception of any tonal noise from the
Allergan site at the nearest sensitive receptor. This report is included as Attachment E.5.C.
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Allergan Annual Noise
Survey
IPPC Noise Report 2007
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DOCUMENT CONTROL SHEET
Client
Allergan Pharmaceuticals Ltd
Project Title
Allergan Annual Noise Survey 2007
Document Title
IPPC Noise Report 2007
Document No.
MDE0710Rp0001
1
TOC
Text
List of Tables
List of Figures
No. of
Appendices
1
8
1
1
4
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DCS
Co
This Document
Comprises
Rev.
Status
Author(s)
Reviewed By
D01
Draft
Ross Daly
F01
Draft
Ross Daly
Paul Chadwick
F02
Draft
Ross Daly
Paul Chadwick
Approved By
Office of Origin
Issue Date
West Pier
05/10/07
Paul Chadwick
West Pier
17/10/07
Paul Chadwick
West Pier
18/10/07
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Allergan Annual Noise Survey 2007
IPPC Report - FINAL
TABLE OF CONTENTS
1.1
EXISTING ENVIRONMENT ................................................................................................... 1
1.2
NOISE SURVEY ASSESSMENT METHODOLOGY ..................................................................... 1
SURVEY RESULTS......................................................................................................................... 3
2.1.1
Boiler house Doors: N1 ..................................................................................... 3
2.1.2
Chiller Unit: N2 .................................................................................................. 3
SITE BOUNDARIES ............................................................................................................ 4
2.2.1
Southern Site Boundary: N3 ............................................................................. 4
2.2.2
Eastern Site Boundary: N4 ............................................................................... 4
2.2.3
Northern Site Boundary: N5.............................................................................. 4
2.2.4
North western Site Boundary: N6 ..................................................................... 5
NOISE SENSITIVE LOCATIONS............................................................................................ 5
2.3.1
Mid-West Boundary of Site: NSL1 .................................................................... 5
2.3.2
South of Site: NSL2........................................................................................... 6
2.3.3
South West of Site: NSL3 ................................................................................. 6
3.1
ONSITE SOURCE MEASUREMENTS ............................................................................ 7
3.2
SITE BOUNDARIES ............................................................................................................ 7
3.3
NOISE SENSITIVE LOCATIONS............................................................................................ 7
CONCLUSIONS............................................................................................................................... 8
Co
4
DISCUSSION ................................................................................................................................... 7
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2.3
3
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2.2
ON SITE SOURCES ............................................................................................................
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INTRODUCTION.............................................................................................................................. 1
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1
LIST OF TABLES
Table 1.1: Description of Noise Monitoring Locations............................................................................. 2
Table 2.1: Point Source Noise Measurements at N1 .............................................................................. 3
Table 2.2: Point Source Noise Measurements at N2 .............................................................................. 3
Table 2.3: Noise Measurements at N3.................................................................................................... 4
Table 2.4: Noise Measurements at N4.................................................................................................... 4
Table 2.5: Noise Measurements at N5.................................................................................................... 5
Table 2.6: Noise Measurements at N6.................................................................................................... 5
Table 2.7: Noise Measurements at NSL1 ............................................................................................... 5
Table 2.8: Noise Measurements at NSL2 ............................................................................................... 6
Table 2.9: Noise Measurements at NSL3 ............................................................................................... 6
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LIST OF FIGURES
Figure 1.0
Location N1
Figure 1.2
Location N2
Figure 1.3
Location N3
Figure 1.4
Location N4
Figure 1.5
Location N5
Figure 1.6
Location NSL1
Figure 1.7
Location NSL2
Figure 1.8
Location NSL3
APPENDICES
SURVEY DETAILS
APPENDIX B
ACOUSTIC PARAMETERS
APPENDIX C
FREQUENCY ANALYSIS
APPENDIX D
SITE MAP
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APPENDIX A
MDE0720Rp001
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Allergan Annual Noise Survey 2007
1
IPPC Report - FINAL
INTRODUCTION
RPS Group was commissioned by James Mulrennan of Allergan Pharmaceuticals, Westport, Co.
Mayo, to conduct a noise survey at in order to comply with Condition 8 of Allergan’s IPPC Licence
(Reg. No P0126-01), and to prepare a Technical Report giving full details of the noise surveys, results
and conclusions. Condition 8.2 of the licence states that
‘………..noise from the facility shall not give rise to noise levels off site, at noise sensitive locations, as
specified in Schedule 4(i) which exceed the following sound pressure limits (Leq)
8.2.1
Day: 55dB(A)
8.2.2
Night: 47dB(A)
8.2.3
There shall be no clearly audible tonal component or impulsive component in the noise
emission from the activity at any noise sensitive location.’
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th
1.1
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RPS subsequently visited the site on September 6 – 7 , 2007 to conduct a noise survey within and
surrounding the site in order to establish if the criteria outlined above are currently being complied with.
The findings of the survey are summarised in this report. (A summary of the terminology used in this
report is given in Appendix B).
EXISTING ENVIRONMENT
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The Allergan site is located on the outskirts of Westport town, Co Mayo. The eastern and south
western boundaries of the site are bordered by industrial and warehouse units. The northern site
boundary is bounded by agricultural lands, the N57 Castlebar to Westport Road borders the southern
boundary and a number of residential properties are located along the western boundary. An
extension to the Allergan site is currently being constructed along the southern boundary. The site
operates over a 24 hour period therefore night time noise levels were measured at the nearest noise
sensitive locations.
1.2
NOISE SURVEY ASSESSMENT METHODOLOGY
A noise survey was conducted on the boundary of the site, at the dominant noise sources and at the
nearest noise sensitive locations. Two of the monitoring locations were at the dominant noise sources
(Locations 1 and 3), four were measured at the sites boundary locations (Locations 4 to 7) and three
locations were at the nearest noise sensitive properties (Locations 8 and 9). A description of each
location is included in Table 1 below and illustrated in Appendix D.
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IPPC Report - FINAL
Location Ref
Description
N1
N2
N3
N4
Outside Boiler House, south of phase 2 building. (2m from source)
Chiller unit, north of Botox/Vitrax building (2m from source)
Southern site boundary – off the main Castlebar to Westport Road
Eastern boundary of site opposite ‘Carrig Donn’ facility
N5
Northern site boundary beside contractors compound
N6
Northern site boundary of site beside pallet store
NSL1
Western site boundary beside entrance gate
NSL2
Noise sensitive property to west of site entrance
Noise sensitive property to South of Site boundary, nearest noise
sensitive property to the south of the site boundary was used, on
direction of Allergan (adj. N57 road).
Table 1.1: Description of Noise Monitoring Locations
NSL3
The following equipment was used for the noise survey:
Brüel & Kjær Type 2250 Sound Level Meter
•
Brüel & Kjær Type 4231 Sound Level Calibrator
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Measurements were made at a height of 1.5m above ground level, and measurements were free field,
taken 1-2m from reflecting surfaces. The weather conditions were in accordance with the requirements
of ISO 1996: Acoustics – Description and Measurement of Environment Noise. Further Survey details
are included in Appendix A. Some light wind conditions and light infrequent rain showers were present
during the survey, however all measurements were paused during adverse weather conditions, and
hence weather conditions during all surveys were in accordance with the requirements of ISO 1996.
(See Appendix A for details weather data).
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The instrumentation was checked and calibrated before and after the survey period to ensure no drift
in the instruments sensitivity had occurred. Further survey details are included in Appendix A.
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IPPC Report - FINAL
2 SURVEY RESULTS
A summary of the measured noise levels is presented below for each location as specified in the
licence.
2.1
2.1.1
ON SITE SOURCES
Boiler house Doors: N1
During the night time period, plant noise from the boiler house and background noise from the chillers
was audible. Meter was paused for passing traffic. Alarm also audible from vehicle entrance barriers.
Plant noise from the Boiler house and passing internal traffic were the dominant noise sources during
the day time survey. Also staff working in the truck dock of Botox Building also audible. These results
are described in Table 2.1 below.
2.1.2
Chiller Unit: N2
LA10
LA90
56.2
60.0
59.3
54.7
57.4
58.1
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53.7
55.8
57.5
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LAmin
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Measurement
LAeq
LAmax
Time
22.05
55.5
68.7
13.15
59.2
65.9
13.20
58.7
66.0
Table 2.1: Point Source Noise Measurements at N1
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During the night period the chiller compound was audible from inside the compound wall. The meter
was paused for any of the frequent passing traffic.
Co
During the daytime survey two measurements were made under two separate conditions. The 13.25
measurement was made while the gates to the chiller unit were opened as staff disposed of hazardous
waste. A constant noise was audible, but a compressor cut in and out during the measurement hence
varying the noise level of the chiller unit. The second measurement made at 13.30 was made when
the gate to the chiller compound was closed and no staff was present.
Measurement
LAeq
LAmax
Time
22.30
56.3
71.7
13.25
63.9
76.6
13.30
59.5
72.5
Table 2.2: Point Source Noise Measurements at N2
MDE0710Rp001
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LAmin
LA10
LA90
54.2
61.1
57.4
56.4
64.9
60.3
55.3
61.9
58.2
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2.2
2.2.1
IPPC Report - FINAL
SITE BOUNDARIES
Southern Site Boundary: N3
During the night time period a slight hum from the plant was audible, the most noticeable plant noise
was emitted from a single vent rattling on the upper end of the wall of the Laboratory building. The
majority of noise was from road traffic on the N57.
During the daytime survey period the dominant noise source was constant traffic on the N5.
Construction was also ongoing on the N57. A background hum was audible from the Allergan site at
this location, as well as some infrequent local traffic on the approach to the Allergan entrance gates.
These results are described in Table 2.3 below.
LAmin
LA10
LA90
41.2
42.2
50.7
56.2
42.8
47.3
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Eastern Site Boundary: N4
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Measurement
LAeq
LAmax
Time
22.50
48.2
64.7
12.55
53.2
68.2
Table 2.3: Noise Measurements at N3
During the night period, the noise climate was dominated by a hum silos to the side of the Allergan
plant and by noise from passing traffic on the N57. Neighbouring businesses were inaudible during the
nighttime monitoring period.
Daytime noise was again dominated by a hum from the silos with some frequent site traffic including
some HGV’s. These results are described in Table 2.4 below
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Measurement
LAeq
LAmax
Time
23.15
55.1
58.4
12.35
54.7
65.3
Table 2.4: Noise Measurements at N4
2.2.3
LAmin
LA10
LA90
51.2
50.5
56.2
56.3
52.5
51.8
Northern Site Boundary: N5
Night time noise was due to a hum from pump house/cooling tower area. No traffic was observed or
audible from the main road.
The noise climate during the daytime period at this location was dominated by the pump house/cooling
tower area, shipping dock and adjacent contractors cabins. Passing HGV’s was also audible on
Allergan
traffic
routes.
These
results
are
described
in
Table
2.5.
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IPPC Report - FINAL
Measurement
LAeq
LAmax
Time
23.35
48.2
56.7
12.15
51.7
73.0
Table 2.5: Noise Measurements at N5
2.2.4
LAmin
LA10
LA90
45.9
44.2
48.5
52.7
47.8
46.5
North western Site Boundary: N6
During the nighttime survey, a low hum from the plant was an audible source. Traffic at the entrance
was also audible as was an alarm/siren which sounded when the barrier was raised.
Allergan plant audible during the daytime monitoring period. Construction noise from neighbouring site
noted, dog barking and leave rustle also noted. These results are described in Table 2.6 below.
2.3.1
LA90
37.4
34.9
45.3
44.9
39.5
37.6
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2.3
LAmin
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Measurement
LAeq
LAmax
Time
00.00
43.3
58.9
12.00
47.6
77.0
Table 2.6: Noise Measurements at N6
NOISE SENSITIVE LOCATIONS
Mid-West Boundary of Site: NSL1
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During the nighttime survey, passing traffic entering and exiting the Allergan site, in conjunction with
traffic on the N57 were the dominant factors. A background hiss from the site was audible during lulls
in traffic.
Passing traffic on the approach road to Allergan was by far the dominant noise source during the
daytime period at this location. Foliage noise, birdsong, staff talking at the entrance and a background
hum from the Allergan site were also audible. Road works were also noted during the 11.45
measurement. These results are described in Table 2.7 below.
No tonal or impulsive noise was noted at this location from the operation of the plant or any other
source of noise.
Measurement
LAeq
LAmax
Time
00.40
47.3
66.4
11.25
51.6
77.2
11.45
53.5
75.2
Table 2.7: Noise Measurements at NSL1
MDE0710Rp001
5
LAmin
LA10
LA90
43.4
40.3
40.8
48.0
52.4
54.7
44.7
42.1
42.1
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Allergan Annual Noise Survey 2007
2.3.2
IPPC Report - FINAL
South of Site: NSL2
The Allergan site was inaudible at this location over the traffic noise on the N57 and local approach
road to Allergan during the nighttime measurement. However, a plant hum was audible during lulls in
traffic but not pronounced.
Passing traffic on the busy N57 was the single dominant noise source at this location during the
daytime survey of varying levels of traffic. A chainsaw was also audible from the end of the cul-de-sac
nd
in the 2 daytime measurement at 11.10. These results are described in Table 2.8.
No tonal or impulsive noise was noted at this location from the operation of the plant or any other
source of noise.
LAmin
LA10
LA90
38.1
42.1
41.3
46.3
59.7
62.1
39.2
42.1
46.3
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South West of Site: NSL3
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Measurement
LAeq
LAmax
Time
01.00
51.2
73.2
10.52
57.1
73.4
11.10
59.4
75.2
Table 2.8: Noise Measurements at NSL2
Passing traffic on the N57 was dominant again during the nighttime survey as was the addition of local
traffic to and from the hotel. No plant noise was audible at this location; it seems that the tree cover at
the southern end of the site and local foliage tends to inhibit plant noise during lulls in traffic.
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As per NSL2 passing traffic, including HGV’s, on the busy N57 was the single dominant noise source
at this location during the daytime survey. The Allergan site was inaudible at this location over the
traffic noise in the daytime period. Construction noise from the housing estate to the west of the site
was also audible during both measurements. These results are described in Table 2.9 below.
No tonal or impulsive noise was noted at this location from the operation of the plant or any other
source of noise.
Measurement
LAeq
LAmax
Time
00.18
56.1
74.3
10.15
60.8
74.0
10.35
60.6
78.3
Table 2.9: Noise Measurements at NSL3
MDE0710Rp001
6
LAmin
LA10
LA90
34.9
44.6
44.2
60.3
63.7
62.8
37.5
53.9
53.3
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3
3.1
IPPC Report - FINAL
DISCUSSION
ONSITE SOURCE MEASUREMENTS
Locations N1 and N2 consists of a boiler house and chiller unit respectively, noise measurements
show that each location produces consistent continuous noise over a 24-hour period. Over the past
numbers of years efforts have been made to contain the noise level emitted form these locations. Most
notably a wall and gate has been constructed about the chiller unit compound. The effect of this wall
show that when the gate is opened the LAeq level was 63.9db, while when the gate was closed the LAeq
level only reached 59.5dB, thus showing the effect that a enclosed structure has on noise attainment.
Nighttimes noise levels show that both locations produce a similar noise climate, differing by less than
a single decibel i.e. N1 - LAeq 55.5dB, N2 - LAeq 56.3dB. Also no tonal or impulsive noise was detected
from either unit – See Appendix C.
3.2
SITE BOUNDARIES
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Daytime noise levels surveyed at each site boundary show that although site noise is audible at a
numbers of locations; construction noise, site traffic and external traffic all contribute to the daytime
noise climate.
Nighttime noise levels all tend to show considerably less levels of noise, typically 3-4dB less than
daytime levels. While the site operations are audible throughout the nighttime period, traffic about the
site as well as on the main roads also contribute to noise levels. In this case LA90 levels may indicate
more accurately that the nighttime noise climate is typically less than 50dB. One exception is Location
N4, where plant silos are located approximately 20m from the site boundary, hence creating a
background level of 52.5dB.
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NOISE SENSITIVE LOCATIONS
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3.3
Daytime noise at noise sensitive locations was dominated by passing traffic on the N57. LA90 values
show levels are well below the daytime limit values at all three noise sensitive locations (LA90 values
can be better used to quantify background noise i.e. plant noise).
Nighttime noise at the noise sensitive locations is quite similar in nature. The LA90 results show that
background noise levels were less than 44.7dB at each location; this is below the IPPC limit of 47dB.
The LA90 result gives a greater indication of true noise levels without the addition of traffic noise.
Also no tonal or impulsive noise was noted at noise sensitive locations, therefore complying with the
requirements of IPPC Licence P0126-01, under Condition 8.2.3. See Appendix C.
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Allergan Annual Noise Survey 2007
IPPC Report - FINAL
4 CONCLUSIONS
The 2007 environmental noise survey has been successfully conducted within the boundary of the
Allergan site and at the nearest noise sensitive locations as proscribed by the IPPC Licence at the
request of Allergan Pharmaceuticals.
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While levels in excess of the IPPC licence limit values were obtained during the course of the surveys
it is the conclusion of this report that these levels are neither attributable to nor representative of, the
noise contribution of the Allergan site, to the local noise climate.
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APPENDIX A
SURVEY DETAILS
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A.1
Location of Survey
Allergan Pharmaceuticals (Ireland) Limited, Inc.
Westport
Co. Mayo
A.2
Date & Time of Survey
th
th
Sept 6 , 2007 14.00 – 01.30
A.3
Sept 7 , 2007 08.30 – 15.00
Weather Conditions
Weather conditions were dry, calm and warm during daytime periods. Nighttime
periods conditioned continued dry and calm, but cool.
19.2
11.8
7/9/2007
0
21.5
8.2
Windspeed
gmin
0
1.4
6.2
0
3
4.4
.
0
Gusts
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6/9/2007
Sunshine
(hours)
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Min
Temp
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Temp
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Rainfall
(mm)
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Weather Data – Claremorris Met Éireann Climate Station
A.4
Personnel Present During Survey
Instrumentation
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A.5
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Ross Daly - RPS Group
Brüel & Kjær Type 2250 Investigator
Brüel & Kjær Type 4231 Sound Level Calibrator
A.6
Calibration
Before and after the survey the measurement apparatus was check calibrated to an
accuracy of +0.3dB using the Type 4231 Sound Level Calibrator. The calibrator
-5
produces a sound pressure level of 94.0dB re 2x10 Pa at a frequency of 1kHz.
A.7
Methodology
Noise levels were measured on a cyclical basis throughout the course of the survey.
Sample periods at the noise-sensitive locations were 30 minutes during day-time (i.e.
08:00 to 22:00) and 15 minutes during night-time (i.e. 22:00 to 08:00). All
measurements were carried out generally in accordance with ISO 1996: Description
and Measurement of Environmental Noise.
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ACOUSTICAL PARAMETERS
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APPENDIX B
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.
is the A-weighted equivalent continuous steady sound level and effectively
represents an average value.
LAmax
is the maximum A-weighted sound level measured during the sample period.
LAmin
is the minimum A-weighted sound level measured during the sample period.
LA90
is the A-weighted sound level, which is exceeded for 90% of the sample
period; used to quantify background noise.
LA10
is the A-weighted sound level, which is exceeded for 10% of the sample
period; used to quantify traffic noise.
A-weighting
is the process by which noise levels are corrected to account for the nonlinearity of human hearing.
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All quoted noise levels are relative to 2x10 Pa.
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LAeq
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FREQUENCY ANALYSIS – 1/3 OCTAVE TRENDS
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APPENDIX C
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.
Night 22.30
Day 13.25
0
5000
3150
2000
1250
800
500
315
200
125
80
50
31.5
20
12.5
20000
20
20000
40
12500
Figure 1.0: Location N1
12500
Day 13.20
8000
.
Frequency Hz
8000
5000
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Day 13.15
3150
2000
1250
800
Night 22.05
500
315
200
125
80
80
1/3 Octave Trend - N2
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60
50
31.5
20
12.5
Sound Pressure dB
Sound Pressure dB
1/3 Octave Trend - N1
80
70
60
50
40
30
20
10
0
Frequency Hz
Day 13.30
Figure 1.1: Location N2
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Night 23.15
12500
20000
12500
20000
3150
2000
1250
800
500
315
200
125
80
50
31.5
20
12.5
8000
Figure 1.2: Location N3
8000
.
Day 12.55
5000
se
Frequency Hz
5000
3150
2000
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Night 22.50
1250
800
500
315
200
125
80
1/3 Octave Trend - N4
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70
60
50
40
30
20
10
0
50
31.5
20
12.5
Sound Pressure dB
Sound Pressure dB
1/3 Octave Trend - N3
80
70
60
50
40
30
20
10
0
Frequency Hz
Day 12.35
Figure 1.3: Location N4
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Night 00.00
12500
20000
12500
20000
3150
2000
1250
800
500
315
200
125
80
50
31.5
20
12.5
8000
Figure 1.4: Location N5
8000
.
Day 12.15
5000
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Frequency Hz
5000
3150
2000
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Night 23.35
1250
800
500
315
200
125
80
1/3 Octave Trend - N6
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70
60
50
40
30
20
10
0
50
31.5
20
12.5
Sound Pressure dB
Sound Pressure dB
1/3 Octave Trend - N5
70
60
50
40
30
20
10
0
Frequency Hz
Day 12.00
Figure 1.5: Location N6
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Night 01.00
Day 10.52
5000
3150
2000
1250
800
500
315
200
125
80
50
31.5
20
12.5
20000
70
60
50
40
30
20
10
0
20000
1/3 Octave Trend - NSL2
12500
Figure 1.6: Location NSL1
12500
Day 11.45
8000
.
Frequency Hz
8000
5000
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Day 11.25
3150
2000
1250
800
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Night 00.40
500
315
200
125
80
50
31.5
20
12.5
Sound Pressure dB
Sound Pressure dB
1/3 Octave Trend - NSL1
70
60
50
40
30
20
10
0
Frequency Hz
Day 11.10
Figure 1.7: Location NSL2
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Night 00.18
Day 10.15
20000
12500
8000
5000
3150
2000
1250
800
500
315
200
125
80
50
31.5
20
12.5
Sound Pressure dB
1/3 Octave Trend - NSL3
70
60
50
40
30
20
10
0
Frequency Hz
Day 10.35
Figure 1.8: Location NSL3
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APPENDIX D
Site Map
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Allergan IPPC Licence Application
Attachment E.5
Allergan
IPPC Licence Application
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Attachment E.5.B – Allergan Annual Noise Survey, IPPC Noise Report 2007
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Allergan Noise Attenuation
Survey
Tonal Noise Report
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DOCUMENT CONTROL SHEET
Client
Allergan Pharmaceuticals Ltd
Project Title
Allergan Annual Noise Attenuation Survey
Document Title
Allergan Annual Tonal Noise Report
Document No.
MDE0642Rp001
TOC
Text
List of Tables
List of Figures
No. of
Appendices
1
9
1
1
3
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DCS
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This Document
Comprises
1
Rev.
Status
Author(s)
Reviewed By
F01
Final
Barry Sheridan
J. Harmon
Approved By
Office of Origin
Issue Date
West Pier
05/03/07
Confidentiality statement: The information disclosed in this proposal should be treated as being strictly
private and confidential and you are requested to take all reasonable precautions to maintain its status
as such. You are requested to use and apply the information solely for the purpose of evaluating this
proposal and are asked not at any time to disclose or otherwise make available the information to any
third party except for those officers, employees and professional advisers who are required by you in
the course of such evaluation to receive and consider the information and who agree to be bound by
these non-disclosure terms.
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Allergan Noise Attenuation Survey
Tonal Noise Report
TABLE OF CONTENTS
1
2
INTRODUCTION.............................................................................................................................. 1
1.1
EXISTING ENVIRONMENT ................................................................................................... 1
1.2
NOISE SURVEY ASSESSMENT METHODOLOGY ..................................................................... 1
SURVEY RESULTS......................................................................................................................... 1
2.1.1
Boiler house Doors: N1..................................................................................... 1
2.1.2
Chiller Unit: N2 .................................................................................................. 1
2.1.3
Mid west Boundary of site: NSL1...................................................................... 8
3
DISCUSSION ................................................................................................................................... 8
4
CONCLUSIONS............................................................................................................................... 9
LIST OF FIGURES
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LIST OF TABLES
.
Figure 1.0: Third Octave Data ...................................................................................................................i
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Table 1: Description of noise monitoring locations.................................................................................. 1
Table 2.4: Noise measurements at N1.................................................................................................... 1
Table 2.5: Noise measurements at N2.................................................................................................... 8
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Table 2.6: Noise measurements at NSL1 ............................................................................................... 8
APPENDICES
APPENDIX A .............................................................................................................................................i
APPENDIX B ............................................................................................................................................ii
APPENDIX C............................................................................................................................................ii
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1
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INTRODUCTION
RPS Group was commissioned by Tom Quinn of Allergan Pharmaceuticals, Westport, Co. Mayo, to
conduct a noise survey in order to establish current compliance with Condition 8 of Allergan’s IPC
Licence (Reg. No 126), following indication of potential non-compliance by the E.P.A. Condition 8.2 of
the licence states that
‘………..noise from the facility shall not give rise to noise levels off site, at noise sensitive locations, as
specified in Schedule 4(i) which exceed the following sound pressure limits (Leq)
8.2.1
Day: 55dB(A)
8.2.2
Night: 47dB(A)
8.2.3
There shall be no clearly audible tonal component or impulsive component in the noise
emission from the activity at any noise sensitive location.’
1.1
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RPS subsequently visited the site on 02nd March 2007 to conduct a 1/3 Octave noise survey of the main
noise sources (N1 and N2) and the relevant receptor (NSL1) in order to establish if the criteria outlined
above are currently being complied with, following significant noise abatement works, since the last
noise survey on September 28th 2006. The findings of the survey are summarised in this report. (A
summary of the terminology used in this report is given in Appendix B).
EXISTING ENVIRONMENT
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The Allergan site is located on the outskirts of Westport town, Co Mayo. The eastern and south
western boundaries of the site are bordered by industrial and warehouse units. The northern site
boundary is bounded by agricultural lands, the N57 Castlebar to Westport Road borders the southern
boundary and a number of residential properties are located along the western boundary. The site
operates over a 24 hour period therefore night time noise levels were measured at the nearest noise
sensitive locations.
1.2
NOISE SURVEY ASSESSMENT METHODOLOGY
A noise survey was conducted at the Boiler house N2 and the Chiller unit N1, which are the dominant
noise sources at the Allergan site. Noise sensitive location NSL1 was also surveyed, in order to
establish if any tone attributable to Allergan was present at this location. A description of each location
is included in Table 1 below.
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Location Ref
Location N1
Location N2
Location NSL1
Tonal Noise Report 2006
Description
Outside Boiler House, south of phase 2 building. (2m from source)
Chiller unit, north of Botox/Vitrax building (2m from source)
Western site boundary beside entrance gate
Table 1: Description of noise monitoring locations
The following equipment was used for the noise survey:
x
Brüel & Kjær Type 2250 Sound Level Meter
x
Brüel & Kjær Type 4231 Sound Level Calibrator
Measurements were made at a height of 1.5m above ground level, and measurements were free field,
taken 1-2m from reflecting surfaces. The weather conditions were in accordance with the requirements
of ISO 1996: Acoustics – Description and Measurement of Environment Noise. Further Survey details
are included in Appendix A. Some light breeze conditions were present during the survey, and
weather conditions during all surveys were in accordance with the requirements of ISO 1996.
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The instrumentation was checked and calibrated before and after the survey period to ensure no drift
in the instruments sensitivity had occurred. Further survey details are included in Appendix A.
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2 SURVEY RESULTS
A summary of the measured noise levels is presented below for each location as specified in the
licence.
Boiler house Doors: N1
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2.1.1
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Steady state hum audible from boiler house, noise from Chillers and passing traffic audible. No tone
audible to ear. These results are described in Table 2.4 below.
Measurement
time
09:59
2.1.2
LAeq
57.3
LAmax
LAmin
72.6
53.9
Table 2.4: Noise measurements at N1
LA10
LA90
58.2
55.6
Chiller Unit: N2
Noise from the Chiller units was dominant at this location, noise from the Boiler house area was
audible in the background. The noise levels from this source are included herein to show that no tonal
noise is output from this source to receptors. These results are described in Table 2.5.
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Allergan Annual Noise survey 2006
Measurement
time
17:35
2.1.3
Allergan Annual Noise Report 2006
LAeq
60.7
LAmax
LAmin
73.2
58.6
Table 2.5: Noise measurements at N2
LA10
LA90
61.3
59.7
Mid west Boundary of site: NSL1
Noise at this location was dominated by a barking dog throughout the survey period. A low hum from
Allergan was audible in lulls of barking and traffic passing. Birdsong and distant traffic noise from the
N57 were also noted noise sources. It should be noted that the noise levels are actually higher here at
the NSL than at the closest main Allergan noise source (Boiler House). These results are described in
Table 2.6 below.
Measurement
time
10:39
LAeq
59.7
LAmax
LAmin
83.7
43.9
Table 2.6: Noise measurements at NSL1
LA10
LA90
54.8
46.2
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3 MITIGATION WORKS
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Since the last Annual noise survey in Allergan was carried out, there have been significant noise
abatement works carried out on both of the major noise sources at the Allergan site, namely the Chiller
area and the Boiler house.
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In the case of the former, the timber gate enclosing the chiller area, has been upgraded, and is now a
complete surface with no gaps, the gate also now runs down to the ground surface, and no longer has
a significant gap between the ground and the base of the gate. This gate is also now kept closed at all
times save of access/egress.
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In regard to the Boiler house, the original boiler house doors have been replaced by purpose built
louvered acoustic doors by Allaway Acoustics ltd, which consists of a double acoustic metal door
construction, (Model D170), complete with frame, giving an RW of 48.8dB.
In addition, a new 90 degree bend attenuator and a 760mm straight attenuator has been installed,
connected to the existing outlet in the cladding of the building.
4 DISCUSSION
Mitigation works undertaken since the last annual noise survey at Allergan, have eliminated reception
of any tonal noise from the Allergan site at the nearest noise sensitive receptor. The results of this
survey are quite self evident. There is no tonal component, attributable to Allergan, at NSL1. While a
tone remains at 31.5Hz at the boiler house, this tone is not received at the nearest sensitive receptor.
This is due to noise abatement works undertaken by Allergan since the last annual noise survey. That
survey showed a tone at 31.5Hz was audible at NSL1 before the noise abatement works, this is no
longer the case.
The tonality registered in the original survey was observed in one of two surveys at noise sensitive
location NSL1 during the day and night monitoring period. In this instance the background noise
levels at this location were 46.8dBLA90 which was an accurate depiction of the Allergan noise emission
at the receptor.
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This tone was not present during the night time survey when the LAeq had dropped significantly from
64.3dBLAeq to 59.6dBLAeq. Allergan is a steady state noise source noise source and is in operation
24hr. This is reflected in the fact that the LA90 day and night noise levels at this receptor are 46.8LA90
44.6LA90 respectively.
Hence, as the contribution to the noise climate at this receptor includes the contribution from Allergan,
and that this level is some 9dB below the daytime licence limit, it would seem to be very harsh to
consider the facility non compliant, when a tone is detected during a single survey run at a receptor.
It would seem prudent in this regard to examine the rational behind a licence condition stipulating tonal
character. Tonal character is mentioned, as it considered to be subjectively ‘more annoying’ than
broadband noise. Hence it is custom in practice to weight the tonal component by 5dB in
recognisance of this subjective weighting. It would seem in this light to be harsh, to consider a facility
to be non-compliant, when there licence limit for noise is not breached, even in the case of the addition
of a 5dB penalty (bringing the Allergan noise emission up to 52dB) for a single transient observation of
a tone, that was not present in subsequent surveys at the same location on the same day.
Regardless of the putting forward of the case above, the noise abatement works undertaken, since the
September annual noise survey have eliminated the tone at the receptor.
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5 CONCLUSIONS
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A noise survey has been conducted within the Allergan site at the two main noise sources and at the
nearest noise sensitive location as proscribed by the IPPC Licence at the request of Allergan
Pharmaceuticals.
No tonal noise from the Allergan site is present at this receptor. Noise abatement works undertaken
since the last annual survey have mitigated this tonality. The closest noise source from the Allergan
site to this receptor is the Boiler compound, The Leq at the boiler compound was 57.3LAeq30mins. The
Leq at the nearest receptor was 59.7LAeq30mins.
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Hence it is evident, that Allergan is not the dominant noise source at this location. There is no tonal
noise from Allergan received at this location, as can be seen in Figure 1.0 in Appendix C to the rear of
this report.
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APPENDIX A
SURVEY DETAILS
A1
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APPENDICES
A.1
Location of Survey
Allergan Pharmaceuticals (Ireland) Limited, Inc.
Westport
Co. Mayo
A.2
Date & Time of Survey
02nd March 2007 - 09:30hrs to 13:00hrs
A.3
Weather
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Personnel Present During Survey
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Weather conditions were overcast with intermittent drizzle showers. Some light
breeze conditions existed.
Barry Sheridan- RPS Group
A.5
Instrumentation
Brüel & Kjær Type 2250 Investigator
A.6
Calibration
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Brüel & Kjær Type 4231 Sound Level Calibrator
Before and after the survey the measurement apparatus was check calibrated to an
accuracy of +0.3dB using the Type 4231 Sound Level Calibrator. The calibrator
produces a sound pressure level of 94.0dB re 2x10-5Pa at a frequency of 1kHz.
A2
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ACOUSTICAL PARAMETERS
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APPENDIX B
B1
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LAeq
is the A-weighted equivalent continuous steady sound level and effectively
represents an average value.
LAmax
is the maximum A-weighted sound level measured during the sample period.
LA90
is the A-weighted sound level, which is exceeded for 90% of the sample
period; used to quantify background noise.
LA10
is the A-weighted sound level, which is exceeded for 10% of the sample
period; used to quantify traffic noise.
A-weighting
is the process by which noise levels are corrected to account for the nonlinearity of human hearing.
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All quoted noise levels are relative to 2x10-5 Pa.
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FREQUENCY ANALYSIS
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APPENDIX C
C1
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APPENDICES
20000
12500
8000
5000
3150
2000
1250
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800
500
315
200
125
80
50
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Frequency
Boiler House
NSL 1
Chiller unit
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Figure 1.0: Third Octave Data
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31.50
20
77
72
67
62
57
52
47
42
37
32
27
22
17
12
7
12.50
dB
Allergan 1/3 Octave Attenuation Survey
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Allergan IPPC Licence Application
Attachment E.6
Allergan
IPPC Licence Application
Attachment E.6 – Tabular Data for Emissions
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Attachment E.6.A – Table of Emissions Points
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PT_CD
A1-1
A1-2
A1-3
A3-1
A3-2
A3-3
A3-4
A3-5
A3-6
A3-7
A3-8
A3-9
A3-10
A3-11
A3-12
A3-13
A3-14
A3-15
SE1
N1
N2
PT_TYPE
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
EASTING
NORTHING
100490
100490
100490
100526
100536
100582
100535
100452
100607
100440
100441
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ns 100524
en 100531
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100522
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100529
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100536
o io
100504 wne n pu
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100510
eq os
ui es
100489
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fo y.
100500
ra
100530
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.
285003
285011
284995
284970
284972
284866
285115
285038
285004
285053
285047
284850
284852
284860
284862
284863
284922
284923
285143
284973
284956
VERIFIED
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
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Allergan IPPC Licence Application
Attachment F
Allergan
IPPC Licence Application
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Attachment F
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Allergan IPPC Licence Application
Attachment F
Contents
Attachment F.1 – Treatment, Abatement and Control Systems
Attachment F.1.A – Description of Air and Sewer Abatement
Attachment F.1.B – Diagram of Wastewater Treatment System.
Attachment F.1.C – Process Waste Water Network Risk Assessment and Mitigation
Measures
Attachment F.1.D – Drawing showing overall wastewater system
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Attachment F.2 – Standard Operating Procedures for Surface water and
effluent monitoring
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Attachment F.3 - Tabular Data on Monitoring and Sampling Points
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Allergan IPPC Licence Application
Attachment F.1.A
Allergan
IPPC Licence Application
Attachment F.1 – Treatment, Abatement and Control
Systems
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Attachment F.1.A – Description of Air and Sewer Abatement
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Allergan IPPC Licence Application
Treatment, Abatement and Control Systems
Abatement, Treatment and Control Systems
F.1.A.1
Air Abatement
HEPA filtration is used to filter air at the facility. The HEPA filters are highly effective at
removing dust particles prior to discharge to atmosphere. The HEPA’a are employed in any
area where active ingredients are used or where biocabinets and isolators are used. Table
1 details the HEPA filters currently in use at the facility.
The operation of the Air Handling Units is by means of a dedicated, validated
computerized building management system (BMS). The facility monitoring system (FMS)
monitors the environmental conditions (particulates, temperature, relative humidity)
within the classified areas to ensure that the validated room environments are being
maintained.
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Loss of any critical HVAC system generates an alarm which signals to the production area
alarm lights. Alarms generated within the HVAC control system are for temperature,
relative humidity and filter pressure differentials, which are acknowledged, logged and
acted upon by the maintenance department.
x
x
x
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The HEPA filters are changed on a need basis as per our outside consultant.
HEPA filters are integrity tested twice yearly by introducing heated vaporised
Ondinaoil on the upstream side of the filters.
The system is revalidated twice a year.
This is done by an approved outside contractor
The minor emission points, which have abatement on them, are described in Table 1.
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Table 1: Minor emission points, abatement.
Emission Reference
A3-9
A3-11
A3-12
A3-13
A3-16
Description
Botox Class 2 Safety Cabinet Room 508 - Biotech Lab
Botox Class 2 Safety Cabinet Room 507 – Cell Culture Lab
Botox Class 2 Safety Cabinet Room 507 – Cell Culture Lab
Botox Class 2 Safety Cabinet Room 507 – Cell Culture Lab
Microbiology Sterility Isolator
Abatement
HEPA filter
Designation
Minor
HEPA filter
Minor
HEPA filter
Minor
HEPA filter
Minor
Catalytic
converter
Minor
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Allergan IPPC Licence Application
F.1.A.2
Treatment, Abatement and Control Systems
Emissions to Sewer
The process wastewater within the Allergan Pharmaceutical site is collected and conveyed
by the process wastewater network and discharged to the process water treatment facility
(balancing tank), which is located on the northern perimeter of the site. The treated
process water is then discharged to the municipal sewerage system, operated by Mayo
County Council.
The process wastewater collection network consists of both gravity and a pumped system.
There are two main pumping stations, S1 and S2 within the process water network that
convey the flows to the balancing tank.
S1 receives flows from both the Botox plant, including effluent generated by the canteen
located in the Pharmaceutical Plant. S2 receives flows from the Pharmaceutical Plant only.
The majority of the gravity network is made up of 150mm diameter pipes. The rising
main from S1 to the balancing tank is 100mm diameter plastic pipe and the rising main
from S2 is a 75mm diameter. The discharge rising main feeding from the balancing tank
to Mayo County Council is a 100mm diameter plastic pipe.
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The process wastewater treatment facility consists of a 1000m3 internally lined balancing
tank and a pH neutralisation system. The pH neutralisation system consists of a mixing
tank, a caustic dosing tank and acid dosing tank. Process water is pumped into the
balancing tank from pumping stations S1 and S2.
From here forward feed pumps then lift the process water to the mixing tank (pH
neutralisation). These forward feed pumps pump at a rate of 23m3/hr. The pH is
monitored and if the pH level is outside the EPA licence parameters then acid or caustic
dosing is applied. The discharge from the tank is then monitored to ensure the correct
level of dosing has been applied.
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The treated flow is then discharged via a pumped rising main to the municipal sewerage
system, operated by Mayo County Council.
The final discharge pump rate is
approximately 23m3/hr and operates on a duty/standby basis. Should the discharge from
the mixing tank be outside the EPA licence pH parameters, then the effluent can returned
to the balancing tank to go through the treatment process again.
A risk assessment of the process wastewater collection and treatment system was carried
out. This report is in Attachment F.1.C . This report details the existing process waste
water system in place, identifies system deficiencies, and makes recommendations to
mitigate against the identified risks. A flow diagram showing the wastewater abatement
system is also included in Attachment F.1.B. A drawing with the overall site wastewater
layout is included as Attachment F.1.D.
A high level alarm has been installed in the balancing tank. The pump sumps on site also
have high level alarms.
A new refrigerated flow proportional sampler has been installed at SE-1.
A new effluent flow chart recorder has also been installed.
New flow meters for S1 and S1 pump sumps are to be installed in 2008.
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Allergan IPPC Licence Application
Attachment F.1.B
Allergan
IPPC Licence Application
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Attachment F.1.B – Diagram of Wastewater Treatment System
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Process Water In
BALANCE TANK
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NEUTRALISATION SYSTEM
GRAPH 1
Allergan IPPC Licence Application
Attachment F.1.C
Allergan
IPPC Licence Application
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Attachment F.1.C – Process Waste Water Network Risk Assessment and Mitigation
Measures
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Allergan Pharmaceuticals Ltd
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Process Waste Water Network
Risk Assessment and Mitigation
Measures
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DOCUMENT CONTROL SHEET
Allergan Pharmaceuticals Limited
Project Title
Process Waste Water Network & Treatment
Document Title
Process Waste Water Network - Risk Assessment & Mitigation Measures
Document No.
MDE0754RP0001
This Document
Comprises
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Client
DCS
TOC
Text
List of Tables
List of Figures
No. of
Appendices
1
1
19
3
2
3
Rev.
Status
Author(s)
Reviewed By
Approved By
Office of Origin
Issue Date
F02
Final
NM / MG
Malcolm Doak
Shane Herlihy
West Pier
th
29 January
2008
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Risk & Mitigation Assessment
TABLE OF CONTENTS
Page No
1
INTRODUCTION.............................................................................................................................. 1
1.1
2
SYSTEM DESCRIPTION................................................................................................................. 2
2.1
2.2
PROCESS WASTE WATER COLLECTION NETWORK ............................................................ 2
2.1.1
Pumping Station S1 .......................................................................................... 2
2.1.2
Pumping Station S2 .......................................................................................... 3
PROCESS WASTE WATER TREATMENT FACILITY ................................................................. 5
SYSTEM DEFICIENCIES ................................................................................................................ 7
3.1
NON-COMPLIANCE DESCRIPTION ...................................................................................... 7
3.2
EXISTING PROCESS WASTE WATER NETWORK AND TREATMENT DEFICIENCIES................... 7
3.2.1
S1 Pumping Station .......................................................................................... 7
3.2.2
S2 Pumping Station .......................................................................................... 8
3.2.3
Process Treatment Facility Deficiencies........................................................... 8
3.2.4
Process Waste Water Quality ........................................................................... 8
6
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4.1
INTRODUCTION ................................................................................................................. 9
4.2
CONCEPTUAL SITE MODEL ................................................................................................ 9
4.3
5
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RISK ASSESSMENT ....................................................................................................................... 9
Source............................................................................................................. 10
4.2.2
Pathway .......................................................................................................... 11
4.2.3
Receptor.......................................................................................................... 12
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3
BACKGROUND .................................................................................................................. 1
RISK CLASSIFICATION ..................................................................................................... 12
4.3.1
Risk Assessment............................................................................................. 14
4.3.2
Risk Matrix ...................................................................................................... 15
MITIGATION MEASURES............................................................................................................. 16
5.1
ALLERGAN MITIGATION MEASURES CARRIED OUT TO DATE ............................................. 16
5.2
RPS PROPOSED MITIGATION MEASURES ........................................................................ 16
CONCLUSIONS............................................................................................................................. 19
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LIST OF PHOTOS
S1 Pumping Station ................................................................................................................ 2
Photo 2
S1 Pumping Station Wet Well................................................................................................. 3
Photo 3
S1 Wet well showing connection flange seal compromised ................................................... 3
Photo 4
S2 Pumping Station ................................................................................................................ 4
Photo 5
S2 Pumping Station Wet Well................................................................................................. 4
Photo 6
Balancing Tank ....................................................................................................................... 5
Photo 7
pH Neutralisation Mixing Tank ................................................................................................ 5
Photo 8
pH monitoring prior to treatment ............................................................................................. 6
Photo 9
pH monitoring post treatment.................................................................................................. 6
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Photo 1
LIST OF FIGURES
Schematic of Process Waste Water Treatment Process
Figure 2
Process Waste Water System Layout
Figure 3
Conceptual Site Model (see page 10)
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Figure 1
LIST OF TABLES
Table 4.1
BOD Results
Table 4.2
Risk Classification Table (Occurrence)
Table 4.3
Risk Classification Table (Severity)
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APPENDICES
Details of Waste Water System Alarms
Appendix B
Process Waste Water Chemical Results 2007
Appendix C
Surface water Chemical Results 2007
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Appendix A
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1
Risk & Mitigation Assessment
INTRODUCTION
RPS Group were commissioned by Allergan Pharmaceuticals Ltd in January 2008 to undertake a risk
assessment of the process wastewater collection and treatment installation system. As part of this
assessment, RPS Group reviewed measures implemented by Allergan Pharmaceuticals since receipt
of 2 no. notification of non-compliance notices by the EPA. Additional recommendations will also be
outlined to ensure future compliance with EPA requirements.
1.1
BACKGROUND
On the 22nd of October and 10th of December, 2007, Allergan Pharmaceuticals Ltd were issued with 2
no. EPA notification of non-compliance letters. The first non-compliance was in relation to the
overflowing of the balancing tank on the weekend of October 6th. The second non-compliance issued
by the EPA on December 10th, 2007 was in relation to the temporary installation of a submersible
pump in the wet well of Pumping Station S1, during a balancing tank pump failure caused by a
lightning strike, and the direct pumping (by-passing) to the Westport UDC of a portion (~10m3/hr) of
process effluent.
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RPS undertook a site walkover on the 14th January 2008 to assess the process wastewater network
and treatment facilities.
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The following sections provide:
ƒ A description of the existing process waste water system in place at the plant;
ƒ An identification of the system deficiencies;
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ƒ A risk assessment of the system and the risk posed to the environment using EPA approved
methodologies; and,
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ƒ Proposed recommendation to mitigate against the identified risks.
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Process Waste Water Network
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Risk & Mitigation Assessment
SYSTEM DESCRIPTION
The process wastewater within the Allergan Pharmaceutical site is collected and conveyed by the
process wastewater network and discharged to the process water treatment facility (balancing tank),
which is located on the northern perimeter of the site. The treated process water is then discharged to
the Westport Urban District Council (UDC) sewer and tertiary treatment biological wastewater
treatment plant. The collection system and treatment are described in greater detail in the following
sections and are graphically represented on Figure 1.
2.1
PROCESS WASTE WATER COLLECTION NETWORK
The process wastewater collection network consists of both gravity and a pumped system. There are
two main pumping stations, S1 and S2 within the process water network that convey the flows to the
balancing tank. S1 receives flows from both the Botox plant, including effluent generated by the
canteen located in the Pharmaceutical Plant. S2 receives flows from the Pharmaceutical Plant only.
The majority of the gravity network is made up of 150mm diameter pipes. The rising main from S1 to
the balancing tank is 100mm diameter plastic pipe and the rising main from S2 is a 75mm diameter.
The discharge rising main feeding from the balancing tank to the UDC is a 100mm diameter plastic
pipe.
Pumping Station S1
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2.1.1
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S1 is located along the western boundary of the site adjacent to the southern-most entrance. S1
receives approximately 80-90% (this needs to be quantified and verified by flow measurement) of the
process wastewater generated and is conveyed to S1 via a predominately gravity network. There are
two small feeder pumps on the southern side of the Pharmaceutical Plant, which feed into the gravity
system at S1. The pumping station wet well is of insitu reinforced concrete construction and is lined.
The wet well has two pumps working on a duty / assist basis. The combined maximum rate of the
pumps when initially installed was 45m3/hr but operation staff believe the pumping station is
realistically operating between 35m3/hr - 40m3/hr. The volume of the wet well is 4.7m3. Photos 1
shows pumping station S1 and Photo 2 shows the wet well of pumping station S1.
Photo 1
MDE754Rp0001
S1 Pumping Station
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Photo 2
S1 Pumping Station Wet Well
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On the RPS site inspection, it was observed that the flange connection on the rising main seal leaving
the wet well was compromised resulting in flow leaking from the rising main, as per Photo 3. This in
turn will reduce the flow rate to the balancing tank from S1.
Photo 3
2.1.2
S1 Wet well showing connection flange seal compromised
Pumping Station S2
S2 is located adjacent to the cooling towers on the northern side of the site. S2 receives
approximately 10-20% (this needs to be verified by flow measurement) of the process wastewater
generated and is received via a gravity network which services the northeastern corner of the
Pharmaceutical Plant. The pumping station wet well is constructed of insitu reinforced concrete
construction and is lined. The wet well has two pumps working on a duty/assist basis. The combined
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Risk & Mitigation Assessment
maximum rate of the pumps when initially installed was 10m3/hr. The volume of the wet well is 4.3m3.
Photos 4 and 5 show S2 and the wet well respectively.
S2 Pumping Station
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Photo 4
Photo 5
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S2 Pumping Station Wet Well
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Process Waste Water Network
2.2
Risk & Mitigation Assessment
PROCESS WASTE WATER TREATMENT FACILITY
The process wastewater treatment facility consists of a 1000m3 internally lined balancing tank and a
pH neutralisation system. The pH neutralisation system consists of a mixing tank, a caustic dosing
tank and acid dosing tank. Process water is pumped into the balancing tank from pumping stations S1
and S2. From here forward feed pumps then lift the process water to the mixing tank (pH
neutralisation). These forward feed pumps pump at a rate of 23m3/hr. The pH is monitored and if the
pH level is outside the EPA licence parameters then acid or caustic dosing is applied. The discharge
from the tank is then monitored to ensure the correct level of dosing has been applied. The treated
flow is then discharged via a pumped rising main to the UDC sewer. The final discharge pump rate is
approximately 23m3/hr and operates on a duty/standby basis. Should the discharge from the mixing
tank be outside the EPA licence pH parameters, then the effluent can returned to the balancing tank to
go through the treatment process again.
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Photos 6 to 9 shows the balancing tank, pH Neutralisation unit including the mixing tank, pH
monitoring prior to treatment and pH monitoring post treatment. Figure 2 shows a detailed schematic
of the treatment process.
Photo 6
Photo 7
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pH monitoring prior to treatment
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Photo 9
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3 SYSTEM DEFICIENCIES
At the time of the non-compliance incidents in October and December there were a number of
deficiencies within the process wastewater network and treatment facility. This section identifies
deficiencies that were evident during the non-compliance incidents in November and December and
during the RPS site walkover on the 14th January 2008.
3.1
Non-Compliance Description
The first non-compliance, which occurred on October 5th 2007, resulted in the overflow of the
balancing tank and a gap in the process data being logged for the effluent discharging to sewer (i.e.
flow readings were unavailable on the 21st September and between the 19th November and the 21st
November 2007 due to an impaired data recorder).
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On 1st December 2007, failure of the forward feed pumps from the balancing tank occurred due to a
lighting strike. These pumps did not become fully operational until approximately 24 hours later.
During this period pumping stations S1 and S2 continued pumping to the balancing tank. The
continued pumping of process water resulted in the top water level (TWL) in the balancing tank to
reach a critically high level. To reduce the levels within the tank a submersible pump was temporary
installed in the wet well of pumping station S1. This submersible pump had a nominal operating
capacity of 10m3/hr and discharged directly to the nearby UDC sewer (see Figure 1). Effluent samples
were taken every 2 hours and tested for pH. All grab samples obtained during the period of the
diversion were amalgamated and forwarded to the Bord na Mona laboratory as a composite sample
for a full suit of analysis. The results of these tests have been obtained from Bord na Mona and all
results were found to be within IPCL limits. The EPA was notified of this incident on Monday 3rd
December 2007 and Mayo County Council was notified on 14th December 2007.
3.2
Existing Process Waste Water Network and Treatment Deficiencies
x
x
x
x
x
S1 Pumping Station
Co
3.2.1
ns
en
RPS determined a number of deficiencies with the process wastewater network as detailed in the
following sub-sections.
S1 receives flows from both the Botox plant the canteen from the Pharmaceutical Plant. There
is a high level liquid alarm installed in the sump. In the event of pump failure the timeline from
pump failure to the water level compromising the wet well cover level is approximately 10
minutes. This is not a sufficient reaction time for Allergan maintenance and operations staff to
implement rectification measures;
Both the Pharmaceutical and Botox plants have their own power supply. The power source
for the S1 pumping station is currently sourced from the Pharmaceutical Plant. The
Pharmaceutical Plant in the event of power failure has a 5 Megawatt backup generator to
power essential services of which Pumping Station S1 is listed as an essential service.
However this generator requires manual start up. The Botox plant will still continue to
contribute significant volumes of water to pumping station S1.
No flow meter is installed on the process water outflows from the Botox Plant to measure
flows into S1 pumping station.
The flow meter located in S1 is not maintained or calibrated.
No flow meter is installed on the Pharma process line feeding into S1.
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3.2.2
x
x
x
x
3.2.3
Risk & Mitigation Assessment
S2 Pumping Station
S2 receives flows from the Pharmaceutical Plant only. The power supply to S2 pumping
station is as discussed above.
The flow meter measuring flow from Pharmaceutical Plant is not properly maintained or
calibrated.
There is an alarm for level and power of pumps in S2.
The maintenance and calibration programme for the pumps and flow meters must be updated
to meet standards.
Process Treatment Facility Deficiencies
Deficiencies identified for the treatment facility which incorporates the Balancing tank, pH
Neutralisation and discharge pumps, are as follows:
x
x
x
3.2.4
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The power source for treatment facility is currently sourced from the Pharmaceutical Plant. As
mentioned previously when this fails manual start up is required.
The effluent from the Pharma canteen contributes to the process water network adding
unnecessary loading on the treatment facility;
There are no spare pumps stored on site to replace broken pumps in the event of mechanical
pump failure.
There are no housing of services to and from the pH neutralisation-mixing tank. This may
have prevented lighting strike on the forward feed pumps.
Process Waste Water Quality
Co
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The quality of the process water discharged to the UDC sewer is stipulated by the discharge licence
granted by Westport Town Council and confirmed by the IPC licence. The results of the process water
analysis throughout 2007 highlight levels of OFGs slightly exceeding the Allergan internal alert limit on
3 occasions – although not exceeding the action (licence) limits. The levels of mercury detected were
at the alert limit level but appear to be recording at the limit of detection of the laboratory rather than
actual values – this Hg tests cannot detect at lower concentrations hence the results are at the Limits
of Detection. The reading of 0.001 mg/l appears consistent in every sample result. The analytical
laboratory should be contact to clarify their detection levels of the testing equipment and provide a
quality assistance/quality control report.
Consultations between Allergan and the EPA, regarding Active Pharmaceutical Ingredients (API’s),
determined (following water sampling test results) that the API’s detected within the process
wastewater were not deemed to “Present significant Persistence, Bioaccumulation or Toxicity threat to
the environment”.
Given the proximity of the balancing tank to the surface water stream, any overflows or leakages from
the balancing tank may pose a risk to the quality of this surface water feature and to a lesser extent
groundwater (given the fact that the base of the Balance tank lies within 1.0 metre of the surface water
level of the stream channel). A risk assessment on the balance tank in which potential for overflow or
leakages of effluent from the balancing tank and the subsequent impact of overflow on the surrounding
environment in including in Section 4.
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4 RISK ASSESSMENT
4.1
Introduction
The following risk assessment on the Balance Tank was carried out in accordance to:
ƒ IPC Guidance Note on Storage and Transfer of Materials for Scheduled Activities (EPA,
2004); and,
ƒ Guidance on Environmental Liability Risk Assessment, Residuals management Plans and
Financial Provision (EPA, 2006)
This EPA, 2004 guidance note provides guidance on the design, construction, operation, maintenance
and monitoring for tanks which store or transmit potentially polluting substances. The EPA, 2006
provides a systematic approach to the assessment and management of Environmental Liabilities in
order to comply with IPPC and Waste Licence conditions for Environmental Liability Risk Assessment
(ELRA).
Scenario 1
Overflow of the balance tank
x
Scenario 2
Complete failure of the tank
Conceptual Site Model
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The first step of EPA, 2004 is to carry out a risk assessment of the balance tank and determine the
potential impacts to the environment by any leakages/failures or overflows of the tank. The risk
assessment is based on the source-pathway-receptor method. For a particular contaminant to present
a risk to receptors, three components must be present:
x
Source
An entity or action, which releases contaminants to the environment.
x
Pathway
A mechanism by which receptors can become exposed to contaminants.
x
Receptor
The component at risk of experiencing an adverse response following
exposure to a contaminant.
If one of these three components is missing, then there can be no risk. Defining the conceptual model
of risk requires identification of all potential sources, pathways and receptors of contamination and
identifying plausible combinations of these three components. Figure 3 illustrates our conceptual
model for both scenarios.
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Inputs from S1
and S2
Source
Pathway (a & c)
(surface water runoff)
(i.e. Balance tank)
Pathway (b)
(infiltration to
groundwater)
Receptor
(surface water feature)
Pathway (d)
(through substrate)
Groundwater
Figure 3
Source
se
.
4.2.1
Conceptual Site Model
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A source is defined as a substance, which has the potential to cause harm to human health, water
resources or to the wider environment.
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As mentioned in section 2.0, the process wastewater that is temporarily stored within the balance tank
is lifted by forward feed pumps to the mixing tank or pH Neutralisation Tank. The pH is monitored and
if the levels are outside the EPA licence parameters, acid or caustic dosing is then applied. It should
be noted that pH adjustment has not been required to date due to the high quality of the process water
from the balance tank. The discharge from the tank is then regularly sampled to ensure the correct
level of dosing (if any) has been applied. The treated flow is discharged via a pumped rising main to
the UDC sewer.
Co
Water sample results from the process wastewater to sewer (see Appendix B). The chemical results
indicate that wastewater discharged to sewer throughout 2007 is deemed to present low toxicity nonhazardous properties to aquatic systems. All results indicate levels below the EU Drinking water
guidelines for surface waters.
According to EPA (2004) above, “substances, which exhibit low toxicity or are deemed as nonhazardous to waters based on the German WGK (Water Hazard Classification) system may elicit a
pollution response due to their Biochemical Oxygen Demand (BOD) levels and should be addressed
accordingly. Therefore although the process wastewater is not deemed toxic or hazardous it may
pose a risk to the aquatic environment with regard to its organic loading.
These results from the process wastewater indicate levels of BOD ranging between 2 mg/l and 15 mg/l
throughout the monitoring period of 2007 (see Table 4.1 below)
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Table 4.1
Risk & Mitigation Assessment
BOD Results
Date
08/01/07
19/02/07
19/03/07
07/05/07
14/05/07
11/06/07
16/07/07
BOD Level of
Effluent from
Balance Tank (mg/l)
15
12
4
2
14
3
8
Date
20/08/07
10/10/07
15/10/07
19/11/07
26/11/07
10/12/07
BOD Level of
Effluent from
Balance Tank (mg/l)
6
8
5
7
2
4
To put this into perspective, the following calculations were carried out:
Using the highest BOD result recorded of 15 mg/l, this equates to 3kg of BOD loading assuming an
operational value of 200 m3 within the tank i.e.
(15 mg/l * 200 m3)/1000 = 3.0 kg of BOD loading
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A standard population equivalent is 0.06 BOD/person/day. Therefore, the 200m3 balance tank has the
equivalent pollution loading of discharge of treated effluent from an 8-house wastewater treatment with
plant all at once (i.e. (3.0kg) / (0.06 BOD/person/day) / (6 persons))
Alternatively the BOD loading of the Balance tank has the equivalent BOD loading of 4 septic tanks
assuming a volume of 4,000 litres per septic tank (see below):
200 mg/l (typical BOD concentration of domestic wastewater) x 4,000 litres / 10-6 = 0.8 kg BOD.
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3.0 kg (BOD loading within Balance tank) / 0.8 kg (BOD loading from standard septic tank) = 3.75
tanks (or 4 tanks).
Assuming a 450 m3 volume (the current operational volume) of process wastewater within the tank,
this would equate to a 6.75 kg of BOD loading within the tank.
(15 mg/l * 450 m3)/1000 = 6.75 kg of BOD loading
This has the equivalent pollution loading of discharge of treated effluent from a 19-house wastewater
treatment plant all at once (i.e. (6.75kg) / (0.06 BOD/person/day) / (6 persons))
Therefore the risk is as great from treated septic tank effluent from 8 households from complete failure
4.2.2
Pathway
The pathway is defined as the physical route by which released materials may travel form the source
to an environmental receptor.
The potential pathways identified in the vicinity of the Balance tank are:
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a) Overflow of Tank and water runoff flow to the stream;
b) Overflow of Tank and Infiltration to groundwater and possible recharge to stream;
c) Failure/Leakage of Tank and runoff to the stream through the stream embankment;
and,
d) Failure/Leakage of Tank and infiltration to groundwater and possible recharge to
stream.
4.2.3
Receptor
The potential receptors identified in this assessment are the adjacent surface water stream in the main
and groundwater.
The groundwater contours determine all groundwater underlying the facility flows towards the stream.
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The surface water feature appears to be a tributary to the Carrowbeg River, which ultimately flows into
Clew Bay. Surface water sampling is carried out by Allergan Pharmaceuticals on a monthly basis and
all levels are below the EU Drinking Water Guidelines for Surface waters. Surface water sampling
results are included in Appendix C.
Risk Classification
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4.3
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No river water or groundwater abstractions occur down gradient of the site. Special Areas of
Conservation (SAC), Natural Heritage Areas (NHA), Special Protection Area (SPA) or wetland of
international importance were not identified in the vicinity of the site. The stream flows into the
Carrowbeg River 400 to 500m downstream. The Carrowbeg River was rated at Q3 to 4 (moderate
quality status) in 2003 by the EPA.
Environmental Risk is a combination of the likelihood of the event occurring (in this case the probability
of potentially polluting substances being discharged to the environment) and the consequence of the
event on the environment.
The following Risk Classification Tables (RCT) have been designed to reflect the levels of risk and
mitigation measures appropriate to the Process Water system at the Allergan Pharmaceuticals plant.
The RCT provides probability and severity for the ranking of risks. The occurrence probability bands
are presented in Table 4.1 below:
Table 4.2: Risk Classification Table (Occurrence)
Occurrence
Rating
1
2
3
4
5
Category Description
Very Low
Very low chance (0-5%) of hazard occurring in 1yr period
Low
Low chance (5-10%) of hazard occurring in 1 yr period
Medium
Medium chance (10-20%) chance of hazard occurring in 1 yr period
High
High chance (20-50%) chance of hazard occurring in 1 yr period
Very High Very high chance (>50%) chance of hazard occurring in 1 yr period
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The severities identified are those, which are considered by RPS Group to represent most likely
impact on the environment and are presented in Table 2.2.
Table 4.3: Risk Classification Table (Severity)
Rating
1
2
3
4
5
Severity
Category Description
Trivial
No damage or negligible change to the environment
Minor
Minor/localised impact or nuisance
Moderate
Moderate damage to the environment
Major
Severe damage to the environment
Massive
Massive damage to a large area, irreversible in the medium term
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Following identification of the risks, a risk assessment is outlined in Section 4.3.1 listing the risks to be
assessed during the assessment. Each risk is allocated an initial Risk Score based on severity and
occurrence ratings. The risks are ranked based on the Risk Scores and tabulated in a Risk Matrix
(see Table 4.3.2), which provides a pictorial illustration of the level of each risk. The required
mitigation actions are outlined in Section 5.
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4
3
2
1
Risk ID
Complete
failure of
Balance Tank
Complete
failure of
Balance Tank
Overflow of
Balance Tank
Overflow of
Balance Tank
Potential
Hazard
Table 4.3 Risk Assessments
4.3.1
Process Waste Water Network
14
Contamination
of
Groundwater
Contamination
of Surface
water
Contamination
of
Groundwater
Contamination
of Surface
water
Environmenta
l Effect
2
2
2
The tank has overflowed on
one occasion since installation
in 1997 (date of installation)
Basis of Occurrence
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The tank has rnot
an shown any
signs of distress y oto date. A
th
er
structural integrity assessment
us out.
is currently being carried
e.
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Occurrence
rating
Risk & Mitigation Assessment
1
3
1
2
Severity
Rating
Complete failure of tank is
equivalent to the failure of 4
septic tanks with regard to
organic loading.
The majority of flow from
tank, during complete tank
failure, will flow directly to
surface water with low
volumes filtering vertically to
groundwater.
Subsoil’s to filter overflows
before reaching groundwater
Moderately low levels of
organic
loading
(BOD)
detected.
Any overflow
volumes are anticipated to
be low.
Chemical results indicate
wastewater is deemed to
present low toxicity and nonhazardous
properties
to
aquatic systems.
Basis of Severity
2
6
2
6
Risk
Score
Process Waste Water Network
Risk Matrix
Occurrence
4.3.2
Risk & Mitigation Assessment
Very
High
5
High
4
Medium
3
Low
2
V Low
1
2,4
1
3
Trivial
Minor
Moderate
Major
Massive
1
2
3
4
5
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Severity
The risk matrix displayed above allows the risks to be easily developed and prioritised. The risks have
been colour coded in the matrix to provide a broad indication of the critical nature each risk. The
colour code is as follows:
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ƒ Red – Considered high-level risks requiring priority attention. These risks have the potential to
be catastrophic and as such should be addressed quickly.
Co
ƒ Amber/Yellow – These are medium-level risks requiring action, but are not as critical as a red
coded risk.
ƒ Green (light and dark green) – These are lowest-level risks and indicate a need for continuing
awareness and monitoring on a regular basis. Whilst they are currently low or minor risk,
some have the potential to increase to medium or even high-level risks and must therefore be
regularly monitored and if cost effective mitigation can be carried out to reduce the risk even
further this should be pursued.
The risk rating determined above indicates that the risk posed by Balance Tank overflow or leakage is
likely to pose a low level of risk to the surface water stream or to groundwater. The mitigation
measures implemented by Allergan Pharmaceuticals prior to this assessment have been successful in
reducing the above-mentioned risks and mitigation measures outlined by RPS in Section 5 below are
currently being implemented.
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5 MITIGATION MEASURES
5.1
Allergan Mitigation Measures Carried Out To Date
In the case of the 22nd October 2007 non-compliance incidents the following corrective measures have
been undertaken:
x
A back up flow recorder for the final effluent to the UDC sewer has been installed and final
effluent flow data is now downloaded on a weekly basis.
x
Retraining of relevant staff members. A system is now in place whereby a second member of
staff is present to verify that the flow recorder is working correctly after data downloads.
x
High-level alarms have been installed in the balancing tank and in the wet wells of pumping
stations S1 and S2.
x
EPA shall be notified of future environmental incidents on the day of occurrence and standard
operating procedures shall be revised to address notification requirements.
th
In the case of the non-compliance incidents reported in the EPA correspondence dated 10 December
2007, the following corrective measures have been undertaken:
A structural assessment of the balancing tank was being undertaken at the time of this report.
x
Additional staff training has been incorporated into the daily operating procedures.
x
All sampling results will be forwarded to EPA as soon as they are available from the
laboratory.
x
A new Building Management System (BMS) incorporating a failure alarm system is currently
being installed so in the event of any alarms being triggered a member of the EHS/
Maintenance staff are immediately notified by phone by an external alarm company, CP Bell.
Details of all existing alarms are given in Appendix 1.
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RPS PROPOSED MITIGATION MEASURES
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5.2
S1 Pumping Station
x
Flow meter to be installed on Botox plant inlet pipe to the process water system to determine
actual flows from the plant to the S1 pumping well.
x
Flow meter to be installed on wastewater feed from Botox and Pharma canteens.
x
Power source supplying pumps to be supplied from the Botox plant rather than the
Pharmaceutical Plant as the Botox electrical supply is more immediate i.e. automatic
synchronisation.
x
An additional storage tank, adjacent to the existing wet well S1 (in the form of an off-line tank)
to be provided to increase response time during periods of any pump failure. To achieve 2
hours reaction time a storage volume of 55m3 is required for S1. This is based on 90% of the
overall process flow entering S1 (maximum flow assumed = 0.9*700,000, = 7.2 l/s entering
S1). A submersible pump to be installed within the additional storage tank and connected to
the rising main to the balancing tank.
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x
Additional pump to be available on site in the case of any pump failure.
x
Additional high water level alarm equipment to be available in case of equipment failure.
x
Significantly reduce flows from Botox and Pharmaceutical Plants to S1 pumping station during
any period of pump failure. Training of relevant employees to reduce the flows during these
periods should be undertaken.
S2 Pumping Station
x
Existing flow meter in pumping station to be properly and regularly calibrated and maintained
and all records to be incorporated into the Environmental Management System (EMS)
Balancing Tank
Power source supplying pumps to be supplied from the Botox plant rather than the
Pharmaceutical Plant.
x
Additional forward feed pumps to be kept on site should pumps fail for any other reason other
than power failure to ensure level in balancing tank remains under the critical level.
x
Flow meter to be installed on inlet to Balance tank.
x
Flow meter on outlet pipe discharging to sewer to record flows for each individual days during
the weekend.
x
Additional flow monitoring devices to be kept on site should failure of existing monitors occur.
x
Effluent generated by the Pharma Canteen should be removed from the process water
network and connected to the foul water system onsite. This will remove existing loading on
the process water system.
x
Reduce operating capacity of the balancing tank by approximately 20% by reducing the high
level alarm limit and thereby increasing the retention time during periods of pump failure.
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x
General
x
All flow meters to be properly and regularly calibrated
x
High-level flow alarms to be installed on all flow meters and connected to the BMS system to
notify system owners of water flow issues.
x
The installation of the above-mentioned flow meters will allow a more detailed process water
flow assessment (i.e. mass balance) be carried out at any given time to determine the loading
of each building on the process water system.
x
Allergan have reduced the operating capacity of the balance tank from approximately 450 m
to 200 m3. Contingency Plans for various elevated levels (i.e. wastewater level at 40%, 60%,
80% of full capacity) within the tank should be incorporated into the High-level alarm system
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and into the subsequent EMS system. Dedicated staff should be trained to adequately deal
with occurrences of alarm activation.
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6 CONCLUSIONS
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The risk assessment carried out in Section 4 concludes that all risks identified with regard to the
Allergan Balance Tank are in the green zone indicating a need for continuing awareness, incorporating
mitigation measures where deemed necessary (Section 5) and regular monitoring.
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DETAILS OF NEUTRALISATION ALARMS
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se
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Alerts
Level > 40%
Trip
Trip
Trip
Trip
Trip
Low level
Low level
Trip
Trip
Trip
High level
Trip
Trip
High Level
pH>6
pH< 9
High Level
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
Emergency Alarm
1.
Balancing tank level
2.
Balancing tank mixer
3.
Air blower No. 1
4.
Air blower No. 2
5.
Feed forward pump No. 1
6.
Feed forward pump No. 2
7.
Acid tank low level
8.
Caustic tank low level
9.
Neutralisation tank mixer
10. Outlet pump No. 1
11. Outlet pump No. 2
12. Outlet sump Hi-Hi-Level
13. Sump No.1 Common Alarm
14. Sump No.2 Power failure
15. Sump No.2 Hi-Hi-Level
16. Final Output pH Low
17. Final Output pH High
18. Sump No.1 Boiler House Hi Hi Level
.
Waste Water System Alarms
EPA Export 26-07-2013:00:39:36
PROCESS WASTE WATER CHEMICAL RESULTS 2007
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
APPENDIX B
EPA Export 26-07-2013:00:39:36
EPA Export 26-07-2013:00:39:36
30
5.5-9
6.0 - 9.0
7.7
7.65
7.87
7.65
7.61
7.72
7.58
7.7
7.63
7.63
7.9
7.82
7.84
7.83
7.69
7.88
7.82
7.83
7.61
7.56
7.62
7.55
7.75
7.36
7.91
7.22
7.2
7.42
7.2
7.29
7.81
7.14
6.94
7.12
7.44
7.32
7.44
7.77
7.44
7.62
7.54
7.28
7.59
7.32
7.49
7.59
7.49
7.79
7.86
7.18
7.51
Surface Water Guidelines
Action Limit
Alert Limit
8-Jan-07
15-Jan-07
22-Jan-07
29-Jan-07
5-Feb-07
12-Feb-07
19-Feb-07
26-Feb-07
5-Mar-07
12-Mar-07
19-Mar-07
26-Mar-07
2-Apr-07
9-Apr-07
16-Apr-07
23-Apr-07
30-Apr-07
7-May-07
14-May-07
21-May-07
28-May-07
4-Jun-07
11-Jun-07
18-Jun-07
25-Jun-07
2-Jul-07
9-Jul-07
16-Jul-07
23-Jul-07
30-Jul-07
6-Aug-07
13-Aug-07
20-Aug-07
27-Aug-07
3-Sep-07
10-Sep-07
17-Sep-07
24-Sep-07
1-Oct-07
8-Oct-07
15-Oct-07
22-Oct-07
29-Oct-07
5-Nov-07
12-Nov-07
19-Nov-07
26-Nov-07
3-Dec-07
10-Dec-07
17-Dec-07
24-Dec-07
Denotes an exceedance in EU Surface Water Guidlines
Denotes an exceedance in Alert Limit.
2200
250
73
67
58
61
45
41
53
52
38
48
44
48
33
51
52
33
39
41
31
30
37
30
37
31
45
35
43
87
41
39
59
62
50
67
55
41
50
63
50
47
68
33
44
49
49
45
55
82
94
COD
mg/L
pH
pH units
Parameters
Units
50
15
16
5
12
7
6
13
9
5
7
8
6
5
5
8
10
8
7
5
8
9
8
9
5
5
8
5
5
11
7
5
5
5
8
12
8
18
5
5
5
6
7
12
11
16
13
21
7
5
18
24
25
Sus. Solids
mg/L
0.005
0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
0.0005
Hg
mg/L
5
2
0.28
0.03
0.03
0.02
0.06
0.02
0.04
0.06
0.03
0.02
0.02
0.03
0.02
0.04
0.04
0.05
0.04
0.02
0.04
0.07
0.04
0.02
0.08
0.08
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.04
0.03
0.06
0.09
0.1
0.04
0.04
0.02
0.06
0.03
0.05
0.07
0.08
0.03
0.04
0.05
0.04
0.02
0.02
0.06
-
Chlorine
<7
BOD
mg/L
-
Detergents
2
0.31
0.06
0.14
0.22
0.31
0.06
0.54
0.02
0.53
0.21
0.24
0.27
0.27
0.61
0.68
0.41
0.44
0.74
0.02
0.2
0.2
0.47
0.2
0.2
0.25
2
Ammonia
mg/L
1
0.05
25
Nitrates
mg/L
500
6
5
40
2
0
15
0.05
0
0
0
0
0
0
12
0.05
0
0
0
0
4
0.05
0
0
0
0
0
0
0
2
0.05
0Co
14
0.05
0 nse
nt
0
of F
co or
0
py in
0
0.05
ri3g sp
ht ect
0
ow ion
0
ne pu
r r rp
0
eq os
0
ui es
re0.05o
0
8
d nl
fo y.
0
ra
ny
0
ot
0
he
ru
0
se
.
0
6
0.08
0
0
0
8
0.05
0
0
0
0
0
5
0.16
0
0
0
0
0
7
0.2
0
2
0.05
0
0
4
0.05
0
0
-
Peroxide
0.63
1.2
1.37
0.52
0.45
1.51
0.68
0.46
0.48
0.91
0.63
0.63
25
5
0.52
-
Total P
1
1
17
6
10
1
2
6
9
4
1
15
15
32
-
OFG
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.5
0.50
-
Methanol
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.5
0.50
-
Ethanol
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.5
0.50
-
Acetonitrile
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.5
0.50
-
Acetone
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.5
0.50
-
IPA
SURFACE WATER CHEMICAL RESULTS 2007
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
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ns
en
Co
se
ru
he
ot
.
APPENDIX C
EPA Export 26-07-2013:00:39:36
Surface Water Quality Results from Stream - 2007
Date pH
Stream Alert
7.63
7.44
7.49
7.4
7.49
7.43
7.49
7.3
7.66
7.37
7.41
7.62
Date
Alert Limit
Jan
Feb
Mar
April
May
June
July
Aug
Sept
Oct
Nov
Dec
500
500
500
500
500
500
500
500
500
500
500
500
6
6
6
6
6
6
6
6
6
6
6
6
Alert
Limit
Date
Alert Limit
Temp
Stream oC
Date
Alert
Limit
9
9
9
9
9
9
9
9
9
9
9
9
Jan
Feb
Mar
April
May
June
July
Aug
Sept
Oct
Nov
Dec
25
25
25
25
25
25
25
25
25
25
25
25
7.7
12.3
11.2
14.9
15.6
21.2
15.6
19.4
15.7
16.2
19.3
14.3
Jan
Feb
Mar
April
May
June
July
Aug
Sept
Oct
Nov
Dec
250
250
250
250
250
250
250
250
250
250
250
250
Date
Alert
Limit
Peroxide
Stream
mg/l
0
0
0
0
0
0
0
0
0
0
0
0
Date
Alert
Limit
Jan
Feb
Mar
April
May
June
July
Aug
Sept
Oct
Nov
Dec
0.001
0.001
0.001
0.001
0.001
0.001
0.001
0.001
0.001
0.001
0.001
0.001
Hg
Stream
mg/l
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
COD
Stream
mg/l
62
46
39
10
24
10
24
16
30
38
35
19
ot
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
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ns
en
Jan
Feb
Mar
April
May
June
July
Aug
Sept
Oct
Nov
Dec
Co
Conductivity
Stream
uS/cm
679
420
469
528
462
472
462
442
447
513
425
444
he
ru
se
.
Jan
Feb
Mar
April
May
June
July
Aug
Sept
Oct
Nov
Dec
Limit
1
1
1
1
1
1
1
1
1
1
1
1
EPA Export 26-07-2013:00:39:36
Allergan IPPC Licence Application
Attachment F.1.D
Allergan
IPPC Licence Application
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Attachment F.1.D – Drawing showing overall wastewater system
EPA Export 26-07-2013:00:39:36
EPA Export 26-07-2013:00:39:36
Co
en
t
ns
of
co For
py in
rig sp
ht ect
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
he
ru
ot
se
.
Allergan IPPC Licence Application
Attachment F.2
Allergan
IPPC Licence Application
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Attachment F.2 – Standard Operating Procedures for
Surface water and effluent monitoring
EPA Export 26-07-2013:00:39:36
EPA Export 26-07-2013:00:39:36
to
f c Fo
op r i
yr ns
ig pe
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eq os
ui es
re o
d nl
fo y.
ra
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ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:37
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
Co
en
t
ns
of
co For
py in
rig sp
ht ect
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
he
ru
ot
se
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:38
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
Co
en
t
ns
of
co For
py in
rig sp
ht ect
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
he
ru
ot
se
.
Allergan IPPC Licence Application
Attachment F.3
Allergan
IPPC Licence Application
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Attachment F.3 – Tabular Data on Monitoring and
Sampling Points
EPA Export 26-07-2013:00:39:39
EPA Export 26-07-2013:00:39:39
PT_CD
A1-1
A1-2
A1-3
SE1
SW1
SW2
SW3
GW1
GW2
GW3
GW4
N1
N2
N3
N4
N5
N6
NSL1
NSL2
NSL3
PT_TYPE
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
EASTING
NORTHING
100490
100490
100490
100489
100586
100491
100446
100656
100659
100620
100415
Co
100500
ns
en 100530
to
f c Fo
100563
op r i
yr ns
100685
ig pe
ht ct
100551
o io
100346 wne n pu
r r rp
100395
eq os
ui es
100504
re o
d nl
fo y.
100478
ra
ny
se
ru
he
ot
.
285003
285011
284995
285143
285178
285176
285174
285009
285120
285177
285157
284973
284956
284829
285043
285151
285070
284962
284942
284832
VERIFIED
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
EPA Export 26-07-2013:00:39:39
Co
en
t
ns
of
co For
py in
rig sp
ht ect
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
he
ru
ot
se
.
Allergan IPPC Licence Application
Attachment G
Allergan
IPPC Licence Application
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Attachment G
Resource Use & Energy Efficiency
EPA Export 26-07-2013:00:39:39
Allergan IPPC Licence Application
Attachment G
Contents
Attachment G.2 – Energy Efficiency
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Attachment G.2.A – Base Energy Audit 2001
Attachment G.2.B – Greenhouse Gas Permit Application
Attachment G.2.C – Greenhouse Gas Emissions Permit
Attachment G.2.D – Westport Energy Audit Report, 2003
EPA Export 26-07-2013:00:39:39
Allergan IPPC Licence Application
Attachment G.2.A
Allergan
IPPC Licence Application
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Attachment G.2.A – Base Energy Audit 2001
EPA Export 26-07-2013:00:39:39
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:39
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
Allergan IPPC Licence Application
Attachment G.2.B
Allergan
IPPC Licence Application
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Attachment G.2.B – Greenhouse Gas Permit Application
EPA Export 26-07-2013:00:39:40
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:40
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:41
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:42
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:42
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
EPA Export 26-07-2013:00:39:42
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ns
en
Co
se
ru
he
ot
.
Allergan IPPC Licence Application
Attachment G.2.C
Allergan
IPPC Licence Application
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Attachment G.2.C – Greenhouse Gas Emissions Permit
EPA Export 26-07-2013:00:39:42
.
se
ru
he
ot
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
Headquarters,
Johnstown Castle Estate,
County Wexford, Ireland
Co
ns
en
GREENHOUSE GAS EMISSIONS PERMIT
Permit Register Number:
IE-GHG153-01
Operator:
Allergan Pharmaceuticals (Ireland)
Limited
Castlebar Road
Westport
County Mayo
Site Name:
Allergan Pharmaceuticals Ireland
Location of Site:
Castlebar Road
Westport
County Mayo
EPA Export 26-07-2013:00:39:42
Environmental Protection Agency
GHG Permit No. IE-GHG153-01
Explanatory Note
This explanatory note does not form a part of the Greenhouse Gas Emissions Permit.
This Greenhouse Gas Emissions Permit authorises the holder to undertake named activities resulting
in emissions of carbon dioxide from the listed emission points. It also contains requirements that must
be met in respect of such emissions, including monitoring and reporting requirements. Allowances for
emissions to air of greenhouse gases are allocated through the National Allocation Plan. This
Greenhouse Gas Emissions Permit places an obligation on the Operator to surrender allowances to the
Agency equal to the annual reportable emissions of carbon dioxide equivalent from the installation in
each calendar year, no later than four months after the end of each such year. The holders of
Greenhouse Gas Emissions Permits may buy and/or sell such allowances subject to the proper
he
ru
se
.
notification to the Registry Administrator.
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
Contact with Agency:
If you contact the Agency about this Greenhouse Gas Emissions Permit please quote the following
reference: Greenhouse Gas Emissions Permit No IE-GHG153-01.
All correspondence in relation to this permit should be addressed to:
Email: GHGPermit@epa.ie
ns
en
By Post:
Co
Emissions Trading Unit
Environmental Protection Agency
Regional Inspectorate, McCumiskey House,
Richview, Clonskeagh Road, Dublin 14
Updating of the permit:
This Greenhouse Gas Emissions Permit may be updated by the Agency, subject to compliance with
Condition 2. The current Greenhouse Gas Emissions Permit will normally be available on the
Agency’s website at www.epa.ie.
Surrender of the permit:
Before this Greenhouse Gas Emissions Permit can be wholly or partially surrendered, a written
application must be made to, and written permission received from, the Agency.
Transfer of the permit or part of the permit:
Before this Greenhouse Gas Emissions Permit can be wholly or partially transferred to another
Operator a joint written application to transfer this Greenhouse Gas Emissions Permit must be made
(by both the existing and proposed Operators) to, and written permission received from, the Agency.
Explanatory Note
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Environmental Protection Agency
GHG Permit No. IE-GHG153-01
Licence held pursuant to Directive 1996/61/EC (as of the date of this permit):
IPC/IPPC Licence Register Number
126
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End of Explanatory Note
Explanatory Note
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Environmental Protection Agency
GHG Permit No. IE-GHG153-01
Glossary of Terms
For the purposes of this permit the terms listed in the left hand column shall have the meaning given in
the right hand column below:
Code number assigned to the categories of activity in Schedule 1 to the
Regulations.
The Agency
Environmental Protection Agency.
Agreement
Agreement in writing.
Allowance
Permission to emit to the atmosphere one tonne of carbon dioxide equivalent
during a specified period issued for the purposes of Directive 2003/87/EC by
the Agency or by a designated national competent authority of a Member State
of the European Union.
Annual
Reportable
Emissions
Reportable Emissions made in any calendar year commencing from 1 January
2005 or the year of commencement of the activity, whichever is the later.
The Directive
Directive 2003/87/EC of the European Parliament and of the Council of 13
October 2003 establishing a scheme for greenhouse gas emission allowance
trading within the Community and amending Council Directive 96/61/EC.
Emissions
The release of greenhouse gases into the atmosphere from sources in an
installation.
EPA
Environmental Protection Agency.
GHG
Greenhouse gas.
GHG Permit
Greenhouse gas emissions permit.
Greenhouse Gas
Any of the gases in Schedule 2 of the Regulations.
IPC/IPPC
Integrated Pollution Control/Integrated Pollution Prevention and Control.
Installation
Any stationary technical unit where one or more activities listed in Schedule 1
to the Regulations are carried out. Also any other directly associated activities
which have a technical connection with the activities carried out on that site
and which could have an effect on emissions and pollution. References to an
installation include references to part of an installation.
The Operator
(for the purposes
of this permit)
Allergan Pharmaceuticals (Ireland) Limited.
“operator”
Any person who operates or controls an installation or to whom decisive
economic power over the functioning of the installation has been delegated.
Person
Any natural or legal person.
Reportable
emissions
The total releases to the atmosphere of carbon dioxide (expressed in tonnes of
carbon dioxide equivalent) from the emission points specified in Tables 2 and
Co
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Activity Code
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Environmental Protection Agency
GHG Permit No. IE-GHG153-01
3 and arising from the Schedule 1 activities which are specified in Table 1.
European Communities (Greenhouse Gas Emissions Trading) Regulations
2004 to 2005, (S.I. No. 437 of 2004 and S.I. No. 706 of 2005).
The Verifier
A competent, independent, accredited verification body with responsibility for
performing and reporting on the verification process, in accordance with
detailed requirements established by the Agency pursuant to Schedule 5 to the
Regulations and contracted by the Operator for this purpose.
The Registry
The Irish National Registry established pursuant to Article 19 of S.I. No. 437
of 2004.
The Registry
Administrator
The person so designated by the Agency in accordance with the requirements
of Commission Regulation (EC) No. 2216/2004 of 21 December 2004 for a
standardised and secured system of registries pursuant to Directive
2003/87/EC of the European Parliament and of the Council and Decision No.
280/2004/EC of the European Parliament and of the Council.
Schedule 1
Schedule 1 to the Regulations.
he
ru
se
.
The Regulations
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⎯⎯⎯⎯⎯⎯™⎯⎯⎯⎯⎯⎯
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Environmental Protection Agency
GHG Permit No. IE-GHG153-01
Reasons for the Decision
The Agency is satisfied, on the basis of the information available, that subject to compliance with the
conditions of this permit, the Operator is capable of monitoring and reporting emissions in accordance
with the requirements of the Regulations.
⎯⎯⎯⎯⎯⎯™⎯⎯⎯⎯⎯⎯
Activities Permitted
se
.
Pursuant to Articles 4 and 6 of the Regulations the Agency issues this Greenhouse Gas Emissions
Permit, subject to any subsequent revisions, corrections or modifications it deems appropriate, to:
ot
he
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The Operator:
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Allergan Pharmaceuticals (Ireland) Limted
Castlebar Road
Westport
County Mayo
to carry out the following
ns
en
Categories of activity:
Co
Combustion installations with a rated thermal input exceeding 20 MW (except hazardous or municipal
waste installations)
at the following installation:
Allergan Pharmaceuticals Ireland- Installation number: AL 1
located at
Castlebar Road
Westport
County Mayo
subject to the five conditions contained herein, with the reasons therefor and associated tables attached
thereto.
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Environmental Protection Agency
GHG Permit No. IE-GHG153-01
Conditions
Condition 1.
1.1
The Permitted Installation
The Operator is authorised to undertake the activities and/or the directly associated activities
specified in Table 1 below resulting in the emission of carbon dioxide:
Table 1 - Activities which are listed in Schedule 1 of the Regulations and other directly
associated activities carried out on the site:
Activity Code
Activity Description
AL 1
E1.1
Combustion installations with a rated thermal input
exceeding 20 MW (except hazardous or municipal waste
installations)
se
.
Installation
No.
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1.2
ru
Directly Associated Activity Description
Not Applicable
Subject to Condition 1.3 of this permit, carbon dioxide from Schedule 1 activities shall be
emitted to atmosphere only from the emission points as listed in Table 2 below:
Table 2
Part A – Existing Emission Points and Capacities:
Thermal Input
Capacity
Capacity Units
Boiler #1 Stack
3.82
MW
A2-2
Boiler #2 Stack
3.82
MW
A2-3
Boiler #3 Stack
3.82
MW
A1-1
Diesel Generator #1 Exhaust
1.26
MW
A1-2
Diesel Generator #2 Exhaust
2.09
MW
A1-3
Diesel Generator #3 Exhaust
1.66
MW
ns
en
A2-1
Emission Point Description
Co
Emission Point
Reference
Part B – Future Planned Emission Points:
Emission
Point
Reference
Emission Point
Description
Thermal Input
Capacity
Capacity
Units
Proposed
commencement
date Note 1, 2
A1-4
Diesel Generator #4 Exhaust
5.26
MW
20 May 2006
Note 1: The commencement date may be changed with the prior written agreement of the Agency.
Note 2: The activity is not deemed to have commenced until the relevant capacity threshold has been
reached or exceeded.
1.3
Carbon dioxide from Schedule 1 activities may also be emitted to atmosphere from the
minor emission points listed in Table 3 below. Amendments to the number and capacity of
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Environmental Protection Agency
GHG Permit No. IE-GHG153-01
minor emission points in Table 3 shall be notified in writing to the Agency and once
approved by the Agency become part of the emissions allowed under this permit.
Table 3 – Minor Emission Points
Emission Point
Reference Note 1
Emission Point Description
Thermal
Input
Capacity
Capacity Units
A3-1
Kitchen (various)
< 0.5
MW
#1 Diesel Engined Fire Pump Exhaust
< 0.5
MW
#2 Diesel Engined Fire Pump Exhaust
< 0.5
MW
A3-2
A3-3
A3-4
Note 1: An emission point in this table does not necessarily have the same meaning as "minor sources" as defined
in section 4.2.2.1.4 of the Commission Decision 2004/156/EC. In all cases the monitoring and reporting
tiers shall be approved in writing with the Agency in accordance with Condition 3.
The activity shall be controlled, operated and maintained so that emissions of carbon dioxide
shall take place only as set out in this GHG Emissions Permit. The permit does not control
emissions of gases other than carbon dioxide. All agreed proposals, programmes and
methodologies required to be carried out under the terms of this permit, become part of this
permit.
1.5
This GHG Permit is for the purposes of GHG emissions permitting under the European
Communities (Greenhouse Gas Emissions Trading) Regulations (S.I. No. 437 of 2004) and
any amendments to the same only and nothing in this permit shall be construed as negating
the Operator’s statutory obligations or requirements under any other enactments or
regulations unless specifically amended by the Regulations.
1.6
Any reference in this permit to ‘installation’ shall mean the installation as described in the
Greenhouse Gas Emissions Permit application and any amendments approved by the
Agency.
Reason:
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1.4
To describe the installation and clarify the scope of this permit.
Condition 2.
2.1
Notification
No alteration to, or reconstruction in respect of, the activity or any part thereof which would,
or is likely to, result in a change in:
2.1.1
the nature or functioning of the installation;
2.1.2
the capacity of the installation as detailed in this permit;
2.1.3
the fuels used at the installation;
2.1.4
the range of activities to be carried out at the installation
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Environmental Protection Agency
GHG Permit No. IE-GHG153-01
that may require updating of the GHG permit shall be carried out or commenced without
prior notice to and without the prior written agreement of the Agency.
The Operator shall notify the Agency in writing of the cessation of all or part of any activity
listed in Table 1 of this permit no later than one month from the date of cessation.
2.3
For installations or parts of installations which have not come into operation when the
application for this permit was made the Operator shall notify the Agency of the date of
commencement of the activity within seven days of commencement.
2.4
Any variation to the proposed commencement date of the Future Planned Emission Points or
Capacities listed in Table 2 above shall be notified to the Agency in writing before the
commencement date in Table 2.
2.5
The Operator shall notify the Agency in writing within three days of becoming aware of any
factors which may prevent compliance with the conditions of this permit.
2.6
All notifications required under Conditions 2.1 to 2.5 above shall be made to the address
given in the Explanatory Note included with this permit.
Reason:
to
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eq os
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.
2.2
To provide for the notification of updated information on the activity.
Condition 3.
Monitoring and Reporting
The Operator shall, within one month of the date of issue of this permit, submit a written
proposal for approval, in the format required by the Agency, describing in detail the
methodology for monitoring and reporting of greenhouse gas emissions to be carried out
from the date of commencement of operation and thereafter. The proposal shall be in
accordance with Commission Decision 2004/156/EC establishing guidelines for the
monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of
the European Parliament and of the Council or any amendment or revision of the same and
comply with any other guidance approved by the Agency for the purposes of implementing
the Directive and/or the Regulations. Once approved by the Agency the methodology shall
be applied from the date of commencement of operation and thereafter, subject to any
approved changes made in accordance with Condition 3.2 below.
3.2
The Operator shall without undue delay propose changes to the monitoring methodology
when:
Co
ns
en
3.1
3.2.1
data availability has changed, allowing for higher accuracy in the determination of
emissions;
3.2.2
a previously non-existent emission is to be commenced;
3.2.3
the range of fuels detailed in the approved monitoring and reporting proposal has
changed;
3.2.4
errors are detected in data resulting from the monitoring methodology;
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Environmental Protection Agency
3.2.5
GHG Permit No. IE-GHG153-01
the Agency has requested a change.
Where approved these changes shall be implemented within a timeframe agreed by the
Agency.
Temporary non-compliances with the approved monitoring and reporting proposal:
3.3.1
In the event of the breakdown or malfunction of the equipment used to monitor or
record the emissions of greenhouse gases or any other failure to comply with the
monitoring and reporting methodology as approved under Condition 3.1, the
Operator shall put into place an interim monitoring and reporting methodology (to
the highest tier achievable) and inform the Agency in writing if a return to normal
operations is not achieved within 24 hours. This notification shall be made within
three days of commencement of the breakdown or malfunction or failure to comply
with the monitoring and reporting methodology and shall include details of the
interim monitoring and reporting methodology and shall explain the measures
which have been or which will be taken to enable a prompt restoration of
compliance. Any use of alternative equipment, other than in emergency situations,
shall be agreed in writing with the Agency prior to use.
3.3.2
A record of all non-compliances with the approved monitoring and reporting
proposal, including non-compliances lasting less than 24 hours, shall be maintained
on-site and shall be available on-site for inspection by authorised persons of the
Agency and/or by the Verifier at all reasonable times.
to
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op r i
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eq os
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.
3.3
The Operator shall appoint a Verifier to ensure that, before their submission, the reports
required by Condition 3.5 below are verified in accordance with the criteria set out in
Schedule 5 of the Regulations and any more detailed requirements of the Agency.
3.5
The verified annual reportable emissions in respect of each calendar year, commencing 2006
shall be reported to the Agency by the Operator no later than 31 March of the following year.
The report shall be in the format required by the Agency. The Operator shall submit a signed
copy of the Verifier’s recommendations for improvement in the monitoring and reporting
plan and the Verifier’s final conclusions at the same time as submitting the verified report.
3.6
The Operator shall enter the verified annual reportable emissions figure for the preceding
year into the Registry no later than 31 March of the following year, commencing in March
2007. This figure shall be electronically approved by the Verifier in the Registry no later
than 31 March of each year, commencing in March 2007.
3.7
The Operator shall make available to the Verifier and to the Agency any information and
data relating to emissions of carbon dioxide which are required in order to verify the reports
referred to in Condition 3.5 above or as required by the Agency to facilitate it in establishing
benchmarks and/or best practice guidance.
3.8
Provision shall also be made for the transfer of environmental information, in relation to this
permit, to the Agency’s computer system, as may be requested by the Agency.
3.9
The Operator shall retain all information as specified in the Commission Decision
2004/156/EC establishing guidelines for the monitoring and reporting of greenhouse gas
emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council
Co
ns
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Environmental Protection Agency
GHG Permit No. IE-GHG153-01
or any amendment or revision of the same for a period of at least 10 years after the
submission of the relevant annual report.
3.10
A record of independent confirmation of thermal input capacities listed in this permit or
agreed with the Agency in writing as minor emissions shall be available on-site for
inspection by authorised persons of the Agency at all reasonable times.
3.11
The Operator shall establish a programme within one month of the date of this permit to
ensure that members of the public can view a copy of this permit and any reports submitted
to the Agency in accordance with this permit at all reasonable times. This requirement shall
be integrated with the requirements of any public information programme approved by the
Agency in relation to any other permit or licence held by the Operator for the site.
Reason:
To provide for monitoring and reporting in accordance with the Regulations.
Allowances
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Surrender of Allowances
4.1.1
The Operator shall, by 30 April in each year, commencing on 30 April 2007,
surrender to the Agency, or other appropriate body specified by the Agency,
allowances equal to the annual reportable emissions in the preceding calendar year.
4.1.2
From April 2008 and each year thereafter the number of allowances to be
surrendered shall be the annual reportable emissions for the preceding calendar
year plus such allowances as may be necessary to cover any earlier calendar year in
respect of which allowances remain outstanding and due. This includes allowances
to cover the amount of any annual reportable emissions in respect of which
allowances were not surrendered in accordance with Condition 4.1.1 in the
previous year, and the amount of any reportable emissions which were discovered
during the previous year to have been unreported in reports submitted under
Condition 3 in that or in earlier years.
4.1.3
In relation to activities or parts of activities which have ceased to take place and
have been notified to the Agency in accordance with Condition 2.2 above, the
Operator shall surrender to the Agency allowances equal to the annual reportable
emissions from such activities in the preceding calendar year or part thereof,
together with such allowances as may be necessary to cover any earlier calendar
year in respect of which allowances remain outstanding and due as described in
Condition 4.1.2 above.
Co
ns
en
4.1
he
ru
se
.
Condition 4.
4.2
The holding, transfer and cancellation of allowances shall be in accordance with the
requirements of Commission Regulation (EC) No. 2216/2004 of 21 December 2004 for a
standardised and secured system of registries pursuant to Directive 2003/87/EC of the
European Parliament and of the Council and Decision No. 280/2004/EC of the European
Parliament and of the Council, any amendment or revision to the same and any guidance
issued by the Agency or the Registry Administrator.
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Environmental Protection Agency
4.3
Reason:
The Operator shall provide the Registry Administrator with all the necessary information for
the opening of an operator holding account for the installation described in Condition 1 of
this permit within one month of the date of issue of this permit, unless such an account is
already open.
To provide for the surrendering, holding, transfer and cancellation of allowances in
respect of reported emissions.
Condition 5.
5.1
Penalties
Any Operator who fails to comply with Condition 4.1 above shall be subject to the
provisions of Article 16 of the Regulations, including, but not limited to the payment of
penalties, laid down in Article 16 (3) for the relevant trading period.
To provide for the payment of excess emissions penalties as required under the
Regulations.
Date of issue of permit:
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Reason:
GHG Permit No. IE-GHG153-01
Signed on behalf of the Agency:
__________________________
__________________________
Authorised Person
Seal of the Agency
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Allergan IPPC Licence Application
Attachment G.2.D
Allergan
IPPC Licence Application
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Attachment G.2.D – Westport Energy Audit Report, 2003
EPA Export 26-07-2013:00:39:42
ENERGY AUDIT
to
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.
Allergan Pharma
Westport
Co
ns
en
April 2003
Systems Optimisation Ltd
Auriga
Islandkeane
Fenor
County
Waterford
Ph: +353 51 386844
e-mail :gmcnulty@iol.ie
Prepared by: Gerard McNulty – Systems Optimisation Ltd
EPA Export 26-07-2013:00:39:42
Allergan Pharma Westport
Energy Audit-Year 2003
Action Plan and Executive Summary
(i) Report Objective
This report represents the results of a short energy audit conducted at Allergan
Pharma (Ire) in Westport on 19th/20th March-03. The report details the findings of the
audit and the consequential recommendations.
(ii) Nature of the energy audit
The audit took the form of an overview of the manufacturing facilities, the main
energy sources and energy users including auxiliary systems and the main process
plant. It also evaluated the status of energy efficiency and energy management within
he
ru
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.
the company.
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(iii) Present Energy usage and costs
ns
en
Allergan used over 77.4 GWh of energy in 2002 costing €3,338,995 of which 35.5
GWh was electricity costing €2,101,395 per year. The annual load factor for the
electricity consumption used is 69%. The cost of diesel oil –used mostly for space
heating was €1,237,600 per year or 31% of the total energy bill.
Co
(iv) Overview of energy audit results
The energy audit showed that large energy savings should be possible at Allergan by
implementation
of
a
range
of
energy
saving
measures.
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Allergan Pharma Westport
Energy Audit-Year 2003
The main areas where energy savings have been identified in the audit are:
1.
2.
3.
4.
5.
6.
The compressed air plant
The Chiller Plant
The HVAC System
The Boiler Plant and Steam distribution System
The Lighting Plant
The Blow Moulding and Injection Moulding System
.
The initial audit identified potential energy savings mainly through the overall design
and control of these systems. The assessment of the actual energy savings can only be
achieved after more energy and flow monitoring is installed and past history data is
obtained. The monitoring required is covered in the report.
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The audit also showed that good energy practices are presently been implemented in
the design and specification of new plant and processes, although there are no formal
policy on this issue, and efficiency aspects are generally left to the engineering
department’s good judgement.
Systems Optimisation Ltd
3
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Allergan Pharma Westport
Energy Audit-Year 2003
(v) Key recommendation
1. The suggestions and ideas of this energy audit should be quantified with
measurements and analysis and recommendations made and implemented
where feasible
2. The energy manager position should be officially recognised and specific
responsibility assigned such as energy usage reductions targets
3. A budget should be assigned for energy improvement measures in order to
progress with the low cost opportunities identified
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se
.
4. Energy efficiency guidelines for the design and specification of new plant
should be set as described in report.
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5. There is a requirement for more energy usage monitoring within the plant so
that key performance indicators can be set for major plant energy users
Co
ns
en
6. Key staff should be trained in energy efficiency identification
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Allergan Pharma Westport
Energy Audit-Year 2003
(vi) Action Plan (see appendix 3 )
A three year energy plan was developed for Allergan to improve the energy utilisation
and procedures in the plant (see Appendix 3). The main objectives of the plan are to
develop a programme to implement energy improvements, to sustain these
improvements and provide a means to record improvements as they occur. The focal
point for the energy savings measures will be the improved monitoring system that
will track energy savings and usage. The main components of the plan are:
1. The provision of a budget mechanism to implement energy efficiency
measures
to
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.
2. The suggestions and ideas of this energy audit should be quantified with
measurements and analysis and recommendation made for implemented where
feasible
3. Upgrade the BEMS so that key performance indicators for key plant can be
established and tracked on a regular basis.
ns
en
4. The purchase of efficient process and utility plant using energy efficiency
guidelines for new plant as per specifications (see appendix 2)
Co
5. The provision of energy efficiency maintenance criteria that include energy
usage as a maintenance criteria
6. Staff training of energy efficiency in the process and production plant to help
sustain any energy improvement measures obtained.
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Allergan Pharma Westport
Energy Audit-Year 2003
TABLE OF CONTENTS
1
INTRODUCTION AND BACKGROUND
9
1.1.
AUDIT DETAILS
1.2.
ENERGY CONSUMPTION
10
1.3.
ENERGY SAVING ACHIEVEMENTS TO DATE
10
2.
9
ENERGY MANAGEMENT AND REPORTING SYSTEMS
11
POLICY
11
2.2.
RESPONSIBILITIES FOR ENERGY MANAGEMENT
11
2.3.
REPORTING/PERFORMANCE MANAGEMENT
11
2.4.
MONITORING AND TARGETING
2.5
POTENTIAL FOR MONITORING AND TARGETING
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2.1.
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11
2.5.1.
PROPOSAL FOR M&T
16
2.5.2.
PROPOSED KPI (KEY PERFORMANCE INDICATORS)
16
2.5.3
COST OF M/T SYSTEMS
17
2.5.4
POTENTIAL SAVINGS
17
RECOMMENDATIONS
2.7.
STAFF INVOLVEMENT AND TRAINING
18
2.8.
ENERGY MANAGEMENT MATRIX ASSESSMENT
18
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18
2.8.1
ENERGY POLICY AND ORGANISATION
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2.8.2
MOTIVATION
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2.8.3
INFORMATION SYSTEMS
19
2.8.4
MARKETING
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2.8.5
INVESTMENT IN ENERGY MANAGEMENT
20
2.8.6
RECOMMENDATIONS
20
3
ELECTRICAL DISTRIBUTION SYSTEM
3.1
3.1.1.
ELECTRICAL METERING AT PRESENT
22
MAIN POINTS IDENTIFIED DURING STUDY
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3.1.2
4
Energy Audit-Year 2003
RECOMMENDATIONS
22
COMPRESSED AIR SYSTEMS
23
4.1.1.
DETAILS OF AIR COMPRESSOR INSTALLATIONS
23
4.1.2
PRESSURE LEVELS
24
4.1.3
DRYING AND AIR TREATMENT
24
4.1.4
AIR DISTRIBUTION
25
4.1.5
ENERGY EFFICIENCY OPPORTUNITIES
25
4.1.6
RECOMMENDATIONS
26
28
5.1
CHILLER DETAILS
28
5.2
CHILLED WATER DISTRIBUTION PUMPS
28
5.3
COOLING TOWERS
5.4
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OVERALL SUMMARY
AIR HANDLING AND AIR CONDITIONING
6.1
DESCRIPTION
RECOMMENDATION
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30
31
32
32
34
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OBSERVATIONS AND RECOMMENDATIONS
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5.3.1
.
CHILLER SYSTEMS
5
7
STEAM GENERATION AND DISTRIBUTION SYSTEMS
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7.1.1
BOILER EFFICIENCY
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7.1.2
STEAM AND HOT WATER HEAT LOSSES
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7.1.3
STEAM TRAPS
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8
LIGHTING
8.1
39
LIGHTING DESIGN FOR THE PACKAGING AREA
40
8.1.1
OBSERVATION ON LIGHTING SYSTEM
40
8.1.2
ENERGY EFFICIENT LIGHTING SYSTEMS
41
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8.1.3
GENERAL ENERGY SAVING SUGGESTIONS
41
8.1.4
LIGHTING CONTROL TYPES
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8.1.5
RECOMMENDATIONS
44
9
BLOW MOULDING AND INJECTION MOULDING PROCESSES
9.1.1
45
PROCESS PARAMETER CONTROL:
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9.2
INJECTION MOULDING MACHINES
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10
DOMESTIC ENERGY USAGE
48
10.1.1
48
MAINTENANCE OF PLANT AND ENERGY EFFICIENCY
50
.
11
RECOMMENDATIONS
ENERGY SAVING OPPORTUNITIES
50
11.1.2
MAINTENANCE SERVICE CONTRACTS
11.1.3
INTEGRATING MAINTENANCE WITH THE MONITORING AND TARGETING SYSTEM
52
11.1.4
RECOMMENDATION
53
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APPENDIX 1 – ENERGY MANAGEMENT MATRIX
13.
APPENDIX 2- NEW PLANT ENERGY EFFICIENCY SPECIFICATIONS
55
14.
APPENDIX 3– ACTION PLAN
74
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14.1
ENERGY REDUCTION PLAN – YEAR 1
75
14.2.
ENERGY IMPROVEMENT PLAN – YEAR 2
76
14.3.
ENERGY IMPROVEMENT PLAN – YEAR 3
76
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1 Introduction and Background
1.1. Audit details
This report details the finding of an energy audit conducted at Allergan in March-03.
The audit covered mainly electrical systems and processes including utility plant and
present energy management practices on the site. The audit work was conducted by
Gerard McNulty – energy specialist with Systems Optimisation Ltd – A company that
specialises in Industrial energy efficiency work and partners with ESB Independent
Energy to assist their Customers reduce their energy costs.
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1.1 Company Information
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Allergan in Westport became the Company’s world centre for producing tablet
formulations. Over the years the site has expanded – most recently with the addition
of special areas for production of the neuromuscular toxin Botox. The production
process requires high specifications clean rooms and environmental conditions, which
are all energy intensive. This requirement has results in a large standing use of energy
within the plant. This high standing energy usage has costs problems in controlling
energy usage in the plant when production levels are low.
The site has two separate production buildings. The main production area covers an
area of 24,000 M² with an associated office area of over 8,000 M². The plant operates
24hrs/5days per week for 48 weeks per year. In general, the factory has a number of
manufacturing areas designated according to the final product. These are
x
x
x
x
x
The Lens Care Unit
Prescription Unit
The Dose Unit
Packaging
Blow Moulding and Injection Moulding Processes
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The Botox production is located in a separate building and uses separate utility plant.
1.2. Energy Consumption
Table 1– Energy usage and cost for year 2002
Annual Energy Usage and Cost - 2002 Estimates
Fuel
Average Unit Supply Level Demand Annual Usage Annual LF
Cost c/kWh
kV
kW
kWh
%
Electricity
5.91
20
5,152
35,556,606
78.8%
Oil
2.96
41,860,000
Totals
77,416,606
Annual Cost
€
€2,101,395
€1,237,600
€3,338,995
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The total energy bill for the year 2002 was €3,338,995. The total energy units used in
the year 2002 was 77.4 GWh. Electricity accounts for 63% of the total energy bill as
Oil 37%.
1.3. Energy Saving Achievements to date
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Allergan has been active in improving energy efficiency at the Westport site. Below is
a list of energy saving projects implemented in the last 5 years.
1. Efficient high frequency fluorescent fittings in the new production plant areas
2. The installation of a Trend Energy Management System for the utility plant
3. The installation of electrical sub-metering on main boards 1 to 10
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2. Energy Management and Reporting Systems
2.1. Policy
No official or company wide written energy management policy exists in the plant.
2.2. Responsibilities for Energy Management
Overall responsibility for energy reporting is assigned to the Engineering Department.
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2.3. Reporting/Performance Management
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At present, no key performance indicators are determined for either individual plant
items, such as chillers or air compressors. This is mainly due to lack of separate
energy and flow metering for individual process and utility plant.
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2.4. Monitoring and Targeting
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Although there is some sub-metering presently conducted on site at present this is
only at main board or sub distribution board level.
2.5 Potential for Monitoring and Targeting
Monitoring & targeting is the concept of applying cost management techniques to
energy usage in a plant. It is a structured system for implementing and maintaining
energy efficiencies in a company.
Most companies could reduce energy costs by implementing cost-effective energy
efficiency measures ranging from good housekeeping activities such as turning off
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lights in empty offices, switching off idling motors, etc and more by investment in
projects involving a range of energy technologies. Many companies launch in-house
energy awareness programmes to achieve efficiency improvements. These savings
although worthwhile from an energy awareness point of view rarely last. Loss of
interest, changes in company objectives, staff transfers, changes in processes, etc
mean that savings are often not maintained.
An energy management system via monitoring and targeting can help overcome these
problems by providing both energy information and the incentive to attain lower
levels of energy use. The first step to controlling energy costs effectively is to obtain
detailed consumption data to find out how energy is been used, where it is been used
and maybe even why is it been used. An energy monitoring and targeting system
achieves this by:
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1. Using meters to measure consumption of energy usage by utilities such as
water, steam, air, etc and some main process plant as well. The user identifies
energy account centres (EACs) and/or key performance factors.
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2. Typically, these are departments, processing lines or existing cost accounting
units where energy usage can be easily measured and related to a variable such
as production throughput, occupancy hours, etc. Ideally, each EAC will
correspond to an existing organisational unit on the site whose manager can
take responsibility for the energy usage
3. Automatically downloading and processing this raw energy usage and other
data into concise reports showing energy consumption and cost information in
a format which managers can use immediately to improve energy management
and reduce costs.
In this way, an energy monitoring and targeting systems makes it possible for energy
staff to:
1. Account for energy usage in the same way as other controllable costs rather
than treatment as a fixed overheads.
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2. Devolve responsibility to line managers to control energy consumption and
costs in their individual work areas.
3. Provide managers with regular, high quality reports on their performance
against specified energy targets. The need to meet these targets provides the
incentive for managers to look for energy savings in their own areas and
identify and correct adverse trends such as incorrect control settings, excessive
wear, maintenance problems etc.
4. Provide data to plan ahead for the design and specification of new plant and
processes when they are required. The present of annual data will help specify
requirements of say chillers more accurately saving of the capital costs that are
incurred with high design safety margins.
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It is possible to tailor reports to suit the specific requirements of individuals. They can
focus on the energy performance of the overall site as well as that of individual areas
on the site. They can also be used to compare different sites. Using these reports
management can track energy consumption and costs over time throughout a site and
identify and eliminate energy wastage.
For example, individual reports can be customised to show:
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1. How much electricity is been used by a department and its cost?
2. The percentage of total electricity costs accounted for by this department.
3. How actual consumption varies over each day and how it compares to target
consumption or high/low limits
4. How a department's electricity consumption and costs in any period compare
with those in previous periods this year or last.
5. How a department's consumption and costs compare with consumption and
costs in similar departments on this or other sites.
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6. Deviations from normal patterns of consumption so managers can take
corrective action immediately.
7. An energy league table of different shifts, production lines, buildings or sites.
8. All this information can be presented graphically in pre-defined formats to
give the numbers real meaning so users can readily identify and secure savings
opportunities. In particular, users can identify projects to improve energy
efficiency, estimating both the investment required and the potential payback
9. Verify that, after implementation, these actions are actually reducing costs.
.
10. Allocate costs and generate accurate departmental energy bills based on
energy consumption.
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11. Forecast future levels of energy consumption and energy costs- important for
utility tariff reviews.
12. Study energy usage patterns to make optimum use of a particular electricity
tariff.
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13. Provide information for future utility planning.
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In many cases it will require a wider programme of energy management to fully
realise the savings potential highlighted by an energy monitoring and targeting
system.
In addition to the benefits outlined above a successful energy management
programme will encourage staff to become more aware of factors that can affect
energy costs and provide a strong incentive to improve work practices to control
energy consumption in their areas to meet future targets. Since factors that affect
energy usage are associated with good operational practice, the operators also
benefit from better process understanding as well.
In summary to set up an Energy Monitoring and Targeting system first establish EAC
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and Key Performance Indicators for all major processes.
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In the case of Allergan, production variations have less effect of overall energy usage
then many other industries, due to the use of high energy users such as air
conditioning and handling systems. This implies that the best way of monitoring the
performance of individual plant is via Key Performance Indicators or KPI’s.
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2.5.1. Proposal for M&T
The plant would be divided into Energy Account Centres. These are proposed below.
The Lens Care Unit
Prescription Unit
The Dose Unit
Packaging
Blow Moulding and Injection Moulding Processes and Dakin Chiller
HVAC System
The compressed air Systems
The York Chillers, Cooling towers and pumps
The Offices and Canteen
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3.
4.
5.
6.
7.
8.
9.
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Along with the energy accounts centres above, individual plant items that expand a
large amount of energy should have Key Performance Indicators as shown below.
2.5.2. Proposed KPI (key performance indicators)
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Table 2- Key performance indicators
Energy Account Centre Metered Data
Key
Performance
Indicators
Auxiliary Plant
Boiler Plant
kWh thermal out/kWh gas in
Boiler Thermal efficiency
Air Compressors
kWhe and Air Flow
kWeh/1000NM3
Lighting In production
kWhe and Production Hours
kWh/unit production
Chilled medium
kWht/kWhe (or kWht/production)
COP or other
Process Plant
kWhs and kWht per ton product
kWh/Ton Product
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2.5.3 Cost of M/T Systems
Table 3 – Monitoring and targeting costs
Area
Measured Parameter Number Unit
Total Cost
Meters Costs
Chillers
Heat Meters
4
Air compressors
Electricity Pulse Meter 3
€3,500 €14,000
€500
€1,500
Air Flow Meter
€3,000 €3,000
1
Electricity Pulse Meter 4
Botox Plant
Electricity
€500
€2,000
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Pulse 1
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Production
Existing
Meters
Offices
Electricity Pulse Meter 1
€500
€1,500
Canteen
Electricity Pulse
€500
€500
1
M/T Software and wiring up above meters to 1
computer
€38,500
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Total
€15,000 €15,000
2.5.4 Potential Savings
The total utility bill is about €3,338,995. A saving of just 1% would save €33,500 is
therefore within reason. The capital cost €38,500 would have a simple payback period
of just 1 year.
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2.6 Recommendations
An energy monitoring and targeting system should be installed in the plant before any
other energy improvement projects take place.
2.7. Staff Involvement and Training
At present many operational staff may not be fully aware of the importance of
controlling energy usage and costs. The maintenance and engineering staffs have the
responsibility to ensure that the utility plant runs effectively. Operators should be
given training in energy awareness.
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2.8. Energy Management Matrix assessment
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The energy management matrix (see appendix 1), is an attempt to establish to what
degree good energy management practices are established and integrated into the
corporate culture of the business. In general it looks at several key areas of energy
management within the site including:
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2. Organisation
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1. Energy policy
3. Motivation
4. Information Systems
5. Marketing
6. Investment in energy management
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2.8.1 Energy Policy and Organisation
There is no formal corporate energy policy and energy management is not an assigned
management post. The site would be classified as a level 1 in regard to energy policy
and level 1 with respect to the organisation of energy management.
2.8.2 Motivation
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There is informal motivation to ensure that energy efficiency is considered in aspects
of design, but less so in day to day operations. It is strategically considered for new
plant as can be identified by the plant is use. Energy management is also considered in
the day to day operational procedures of the plant. The site is classified as a level 2 in
both these areas.
2.8.3 Information Systems
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2.8.4 Marketing
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Energy information systems are advanced and a good energy management system
exists. The site falls into level 2 in this regard.
There is no formal promotion of energy management on the site but informal methods
are used. The site falls into a level 2 site in this regard.
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2.8.5 Investment in energy management
Investment in energy management and efficient retrofits are made on merit basis
using simple payback and other benefits, similar to the criteria that would apply to
other investment decisions. The site ranks a level 3 in this regard.
2.8.6 Recommendations
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To improve the potential for energy management on the site and optimise the chance
of making regular energy savings it is recommended that the following actions be
undertaken
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1. Officially recognise the important role of Energy Manager either as a
separate job or as part of a job description, with specific responsibility for
energy costs reduction reporting to General Manager.
2. Establish an energy management committee reporting to energy manager
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3. Establish a formal structure for energy recording and reporting and
target setting for energy usage reduction – like an monitoring and
targeting system as described earlier
4. Establish a monthly energy awareness newsletter for distribution to all
staff. Hold energy awareness training courses for key operational staff
5. Develop corporate guidelines for energy efficiency investments, energy
efficiency specification for new plant and tender assessment of equipment
tenders.
6. Develop energy performance related maintenance contracts for larger
plant items such as the chillers – where such maintenance is out-sourced
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or done in house.
7. Train key staff on energy awareness techniques
The savings that will derive from better energy management will be incurred from the
following sources.
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1) Reduced idling time of plant and utilities
2) Better control of set points and comfort margins in process and utility plant
3) Retrofitting of energy savings devices such as variable speed drives, high
frequency lights etc
4) Control of HVAC plant and equipment
5) Improved generation efficiency of new plant , through more tighter control of
equipment specification and maintenance
6) Improved operator awareness of the need for energy saving as applied to these
working environment
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3 Electrical Distribution System
There are 11 transformers on the site. 1- 630 kVa, 2-1,000 kVa and 8-1,600 kVa. The
distribution system operates on a ring and radial system. There is one 380 volt, 630
kVa standby generator on the site.
3.1 Electrical metering at present
There are 9 electrical sub-meters on the main boards at present. The Botox plant also
has an electrical meter that is manually read at present.
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3.1.1. Main points identified during study
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¾ HVAC and chiller units represents the main energy user in the plant
¾ There is sub-metering of the main distribution boards and some major plant like
chillers but only on electricity usage.
¾ The harmonic level within the system is presently unknown and as the percentage
of the induction load with variable speed drives is very high this implies the need
to investigate the total harmonic distortion levels.
3.1.2 Recommendations
1. Due to the high number of non-linear loads in the plant a harmonic survey
should be conducted to determine if sensitive electronic equipment and power
factor capacitors should be protected from digital interference and possible
resonance power surges.
2. All major loads should have separate energy meters, such as air compressors,
refrigeration compressors etc (see M/T section). This is the case for the
chillers at present but not so for electric humidifiers and HVAC units.
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4 Compressed Air systems
4.1.1. Details of air compressor installations
There are four air compressors serving the production plants. Three in the SE corner
and one 75kw Atlas Copco machine, all operating at 10 barg.
Compressor no.
2
3
4
1
Rating
kW
75
132
100
75
Air Compressor Details
Pressure Interstage
Run Hrs
Load Hrs % Time on Off Load
barg
Load
kW
AC ZR 75
7.5
2.5
46395
not available
16.5
AC ZR 132
9.6
0.1
45163
19794
30.5%
29.04
AC ZT 100
9.8
3.5
31321
23256
42.6%
22
AC ZR 75 Off
16.5
Make
Off load
kWh
0
77,519
82,121
Cost
€4,581
€4,853
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There is an indication that the compressors spend much of their time running off load.
Compressors 3 and 4 above show 30% and 40% off load running costing about
€9,435 per year. This off load running implies that there is too much installed
compressor power. It may be possible to control the off load running by using a
compressor sequence controller or by using a variable speed drive compressor. The
correct design and running arrangement would be best determined by plotting the
airflow over time. This would be possible if an air flow meter was installed as
suggested in the M/T section. The saving potential would be a least €9,435 as shown.
One efficient running arrangement might be for example a base load machine running
to service the
All the compressors operate on their own different pressure bands. This is probable a
high pressure band due to the large number of compressors. A good controller should
be able to reduce the pressure band and save energy by allowing a reduction in the
upper pressure limit.
The main advantages of a centralised control system include
a) Reduced pressure band and hence energy usage
b) Reduce off load running
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c) Reduced pressure swings
The potential to use different air pressure set points for nights and weekends-called
time based pressure bands should also be investigated.
4.1.2 Pressure levels
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At present, all the air is generated at near 10 barG but not all the air may be required
at 10 barg or over. The moulding machines require the highest pressures.
Instrumentation air is normally requires 7 barg. It takes 6% more power and energy to
generate at 7 barg then at 6 barg. It may be worth considering a two pressure tier
system with lower pressure compressors serving the low pressure requirements of
instrumentation air etc and the blow moulding processes been served at a higher
pressure. The economics of this depend on how much air is been required at different
pressure levels.
4.1.3 Drying and air treatment
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Similar comments to pressure and generation are applicable to drying. Don’t over dry
air that does not have to be dried to a high level. The control of dryers is also
important is air is not to be over dried. The lower the due point required then the
lower the refrigerant temperature required and the more energy will be used.
x
Treat the bulk of air to the minimum quality necessary, e.g. 40-micron
filters are usually sufficient. Specifying 5 micron will increase filter
purchase cost, replacement frequency, and pressure drop.
x
Test filters regularly to make sure pressure drop does not exceed 0.4
bars - if the pressure drop is higher than 0.4 bars, replace the filters,
since the cost of power to overcome this drop is usually greater than
the cost of a filter.
x
Manual condensate traps are often left open and act as leaks. Consider
fitting electronic traps to replace these.
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4.1.4 Air Distribution
The longer the compressed air pipeline, the greater the pressure loss over the pipeline
and the greater the cost of the system.
x
Make sure that pipework is not undersized, this causes resistance to
airflow and pressure drops.
x
Use a ring main arrangement in each building - air can converge from
two directions. This reduces the pressure drop and makes changes to
the system easier.
x
Avoid sharp corners and elbows in pipework as these cause turbulence
and hence pressure drops.
4.1.5 Energy efficiency opportunities
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Monitoring
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kWh/M3 of air generated for whole plant and for individual plants.
M3/kWh
Total M3 per week
Total kWh per week
Cost air /week
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2.
3.
4.
5.
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There is no flow meter on the compressors outlet lines. Each operating air
compressors (or pairs of duty and standby units) should have one air flow meter so the
following parameters should be measured:
Such a system can be used to track air leakage and overall system performance and
can be included in a plant wide monitoring and targeting system. A noticeable fall of
in performance as indicated by M3/kWh could indicate either an increase in air
leakages or compressor maintenance problems and should automatically produce a
job card for investigation by a maintenance technician. This is in effect integrating
energy and maintenance strategies together and will provide many other benefits
including decrease plant variability and improved air availability and help towards
any Sigma 4 ambitions.
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The benefits of such a system would be
1. Ability to keep air leaks below 10%
2. Ability to keep plant performance high
3. Compliment plant maintenance systems
This information would form part of an energy monitoring and targeting system as
described earlier in this report. Air leaks normally account for up to 30% of running
costs of compressors.
Other observations on the compressed air usage
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1. Check the pressure drop in the connecting pipework from the air receiver at
the compressors to the worst end user. It should be less then ½ bar, else there
is unreasonable pressure loss occurring.
2. Buy a good compressor sequencing unit to ensure that off-load running is
minimised
3. Install solenoid valves on all air lines to machines to ensure that air supply is
isolated when machines are off. This will reduce unnecessary air leakage. This
is particularly important for the moulding machines, which use a lot of air at
10 barg and are often off for maintenance but with the air still connected with
consequence air leaks.
4. Compressed air is often misused because everyone thinks it’s a cheap energy
source. With an overall efficiency of just 10% and the cost per unit of energy
of nearly 6.5 cents, air is costing 65 cents per kWh of energy. Compressed air
should only be used in applications where no other energy source would be
safe to use.
4.1.6 Recommendations
1. Install air flow meters for monitoring of compressed air (also in M/T section)
2. Install compressed air controller
3. Check pressure loss from receiver to machines
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4. Install solenoid valves on air lines to machines and interlocked with machines.
5. Try using time based pressure bands to accommodate the existing working
patterns.
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5 Chiller Systems
There are three main chilled water plants each serving the production plant AIR
Handling Units as shown below. There is also one smaller air cooled Daikin Chiller
which is situated outside the building used for cooling the moulding machines. The
larger York chillers are used for space cooling via the air handling units.
5.1 Chiller Details
Table 4–Chiller Description
Ambient Temp
Off
Off
On
On
On
11 degc
Cond
°C
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York Millennium
York Millennium
York Millennium
York Millennium
Daikin Chiller
Chiller Plant Description ( All Refrigerant R134A)
Rating each Est. Cooling Condenser Chilled water out Chilled Water In Capacity Evap
°C
°C
°C
….kw
load..kw
%
450
1,575
Water Cooled
Off
450
1,575
Water Cooled
Off
450
1,575
Water Cooled
4.9
6
54%
-5.5
450
1,575
Water Cooled
4.9
6
250
875
Air Cooled
3.6
7
37%
he
10
11
12
13
On/OFF
20
ot
Inside Units
Inside Units
Inside Units
Inside Units
Outside Unit
Type
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Unit Location Chiller
5.2 Chilled Water Distribution Pumps
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The chillers are served by one 45kW primary pump each and 12 secondary pumps, of
various ratings from 4kW to 22kW. There is no primary chilled water tank but the
primary line is of large length and a diameter of approximately 14 inch and hence has
a large volumetric capacity. There is however, a bypass loop from the primary side to
the secondary side, which is used to balance the flowrate from primary to secondary
as the demand for chilled water varies.
5.3 Cooling Towers
There are 4 cooling towers. They are all forced draught cooling towers and mainly
used for the cooling of the chiller condensers. Two cooling towers are 4 of 30kW two
speed fans and two have 2 of 30kW fans. There is also a 4 kW water re-circulation
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pump for each cooling tower. This gives a total load of 196kW of fan and pump
power associated with the cooling towers. The cooling water distribution pumps that
transmit this water to the chillers have an installed load of 400kW. Overall, the load
associated with just cooling the condensers of the chillers is nearly 600 kW – a very
large standing load.
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5.3.1 Observations and recommendations
1. The condensing temperature of chiller 12 was 20°C on the water cooled
machines even though the ambient temperature was less then 11°C a
difference of just 9°C. This is good indication and would be difficult to
improve upon.
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2. There is a high electrical load of 600 kW associated with the cooling water
pumps and cooling tower fans for the York chillers. This high load is resulting
in a large standing power requirement. If may be worthwhile considering the
replacement of the existing shell and tube condensers with evaporative
condensers. This would save of cooling water pumping costs and fan running
cost and free up wet cooling tower capacity. As a rough estimate, this would
save between €150,000 and €200,000 per year.
ns
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3. The evaporating temperature of chiller 12 was -5°C to give a chilled water
outlet temperature of 4.9°C a difference of nearly 10°C. If this could be
reduced by increasing the evaporating temperature by just 2 °C then a saving
of 5% - 6% of the running costs could be made, providing that efficient
capacity control is available.
Co
4. The two York chillers that were running at low capacity of just 54% and 37%.
It would be better to have one chiller running at 100% or as close as possible
to it from an efficiency point of view but this needs consideration as the
reduce condensing and evaporating surfaces may result in high condensing
and lower evaporating pressures in winter. The option of running in series for
low loads should also be considered. Here the condensing temperature of the
first chiller is the evaporating temperature of the second, resulting in overall
improved efficiencies.
5. The actual efficiencies of the chillers are unknown and need to be established
through measurement and analysis.
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6. The outside chiller serves the production processes and it’s efficiency is also
unknown
7. The chiller maintenance routines should take into account the need to keep the
efficiency as high as possible
8. There may be benefits in using variable speed drives on the chilled water
distribution pumps in the primary and secondary circuits as an alternative to
the present balancing arrangement.
9. The Daikin Chiller normally only operates at 50% capacity. It produces water
at about 3.6°C. It is probably worth investigating the potential to either use
well water for this purpose (available at less then 10°C most of the year).
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5.4 Overall summary
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This initial report shows that there is considerable scope for improvement to the
energy efficiency of the chilled water plant. Measurements and analysis are required
to determine the level of saving and investments required. The main area of energy
savings is associated with improvements to the chiller cooling water system and
chiller controls of evaporating and condensing conditions.
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6 Air Handling and Air Conditioning
6.1 Description
There are 44 air handling systems. Most of the HVAC systems have supply and return
fans, heating and cooling coils and air filtration. The normal arrangement is for 90%
re-circulation air and 10% fresh air make up. Some AHU operate at 50% recirculation and 50% fresh air. HVAC unit 23 serving the dose lines 5, 6, &7 operates
on 100% make up and no re-circulation. Three HVAC units have desiccant dryers
units also to provide dry air to production spaces. The HVAC system accounts for
much of the energy usage. This is due to the following:
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1. High air quality standard in clean rooms and production (Class 10,000)
2. The requirement for temperature and humidity control
3. The large room volumes and high air change rates (20 air changes per
hour)
4. The large production surface areas of 24,000 M2.
5. Office and other area of 8,000 M2
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These requirements have lead to the need for large chillers, supply and return fans,
filters and dehumidification / humidification equipment.
The air handling units, chillers, and hot water boilers, associated distribution pumps
and control valves are all controlled using the Trend BEMS. This system provides set
point and timer control based on simple feedback control loops.
Of the 44 AHU only half have variable speed drives on the supply and return fans.
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There are also 3 desiccant type air dehumidification units. These units operate with
steam regeneration element. This heater heats outside air and used it to purge the wet
side of the wheel as it rotated. The hot wet air produced was then expelled to
atmosphere but preheats the incoming cold air used for regeneration. This is a good
energy saving feature of the desiccant system.
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The typical AHU uses 10% make-up with 90% re-circulation. This is normally fixed
from summer to winter. There is no enthalpy control system to vary the ratio between
outside air and re-circulation air. The AHU are also set up to provide appropriate
pressure differentials between rooms and corridors and other rooms.
6.1.1 Recommendation
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1. Investigate the potential to use VSD on those with fixed speed drives at
present. Even if air volumes are fixed it is likely that variable speed drives
could save energy. A partially closed damper at the outlet of a fan is an
indication that a drive could be used in lieu of the damper to achieve the
same result but at reduce energy input. A partially closed damper that is
reducing the air flow by 30% will require 80% of the full load power as
opposed to a VSD that would only require (0.7*0.7*0.7) or 0.34 of the full
load power. The pressure developed by the fan will reduce also by 0.5 of
the full load pressure by the head losses would be reduced due to the
reduce flow.
Co
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2. There will be times during the night and in winter when it may be feasible
to use the colder outside air with less re-circulation air saving on cooling,
heating and re-cooling, humidification and de-humidification in the AHU.
This would require an outside and inside enthalpy control and RH system
monitored by the BEMS system. A control algorithm would then
determine the optimum percentage of outside air to inside air. Large
savings in chiller plant running could then be achieved.
3. The 20 split air conditioning outside compressor units should of about
7kW. These should be controlled by the Trend BEMS system so that they
can be isolated off during weekends and other times such when they are
not required. This might require wiring of the outside compressors controls
to the BEMS. The local temperature set points should also be adjusted for
winter and summer operation. With better control, then it would also be
possible to re-heat or pre-cool spaces as required in anticipation of a colder
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or hotter day using cheaper night-time electricity. The success of this
would be depending on the thermal mass of the offices/buildings in
question. The ability to ensure that the units are off when not required
would produce good savings.
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All the above suggestions require further analysis before an investment decision can
be made. The success of any BEMS is also depending upon the accuracy of the
system sensors. Sensor validation can help minimise energy usage and optimise
control by the BEMS. This function is requires more advanced data analysis using
systems that can learn from past data and compare readings over time and associate
with other parameters. Neural network can provide such a platform.
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7 Steam Generation and Distribution Systems
There are three boilers rated at 12,000lbs/hr at a FA of 100°C. This is the rated steam
production under standard conditions with condensate returning at 100°C. The actual
steam output will depend more on the boiler outlet pressure. The boilers produce
saturated steam at 7 barg. There are two main steam headers. One for 7 barg steam –
used in the laboratory area and the Botox Plant and another steam header at 5 barg for
the AHU, desiccant de-humidification unit’s regeneration coils. The steam from the 7
barg units is throttled via a steam-throttled valve from 7 barg to 6 barg. All the
boilers have modulating burners. The throttling arrangement is in itself an energy
inefficiency due to the energy across the throttle valve (similar to an expansion
turbine but with energy recovery).
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The fuel oil usage in 2002 is estimated at 3,640,000 litres or 41,860kWh of energy
costing €1,237,600 per year or 2.96 c/kWh. Oil is half the cost per kWh (purchased).
With a nominal boiler efficiency of 80% and overall distribution efficiency of 70%
the cost per useful unit of heat would be 4.22c/kWh or 71% the cost of electricity.
This cost for fuel oil makes the cost of self-generation of electricity at 7.8c/kWh. Add
to this maintenance at 1 c/kWh the cost to generate one kWh of electricity by a good
and efficient CHP plant would be 8.8 c/kWh. Even using all the heat all the time
would not make such a unit economical. If gas was available then the economics
might look better.
The main areas for concern in the steam generation and distribution areas are:
1.
2.
3.
4.
The Overall input/output efficiency of the boilers
The boilers combustion efficiency
Steam and hot water pipe heat losses and costs
The condition of steam traps
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7.1.1 Boiler efficiency
The overall input/output efficiency of the boilers is a key performance factor that
should be continuously logged. This will give when converted on the BEMS and input
output percentage efficiency or if preferred a ratio of pounds of steam produced by
litre of oil used. This can be done is separate gas and steam meters were installed as
recommended in the section concerning monitoring and targeting above.
7.1.2 Steam and Hot Water Heat Losses
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7.1.3 Steam Traps
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The insulation levels on all steam and hot water pipes should be analysed. This is
done by comparing heat losses and resulting energy costs of wasted heat with the
present level of insulation over bare pipe insulation. The measure of improvement
over bare pipes will give an efficiency figure for the insulation. This requires the
measurement of line lengths, diameters and insulation levels. Then this information is
analysed using insulation software to determine heat losses with and without
insulation to give results required. This will enable investment decisions to be made
of the need or not to improve insulation levels.
When a mechanical steam traps passes and fail to block the steam, then the steam will
pass into the condensate return lines, wasting steam unnecessary as well as causing
unsightly plumes of steam either at the de-aerator vent to atmosphere or the
condensate return vent line where it exist.
Evidence of steam traps leaking can be easily identified as steam bellowing from
condensate return stations atmospheric lines. This is the steam that should have been
stopped by the steam trap – hence the name, but has passed into the condensate return
lines.
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There is also another source of energy wastage using steam traps. As well as steam
leaking from faulty traps, all mechanical steam traps use steam as a motive force to
force the condensate out of the trap. This requires 12% of the steam that enters the
heat transfer apparatus to be used as this motive force. A new type of trap is available
that is in effect a two phase flow inhibitor. It allows the condensate through but not
the steam saving about 12% of the steam usage. These are called venturi – orifice
traps. One good example of such a trap can be found at http://www.gemtrap.com
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8 Lighting
The main items that concern lighting efficiency include:
1.
2.
3.
4.
5.
6.
Type of Lighting Source
The light fitting type
Suitability of lighting type for particular area
Light Levels in various locations
The use of natural light where available
Occupancy levels
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1. Packaging –Mains frequency fluorescent fittings
.
The dominant fluorescent fitting is the 58-watt fluorescent fittings.
2. Newer production areas – High Frequency fittings
3. Offices- New areas use high frequency/ high efficiency fittings
Co
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4. Other areas – All mains frequency
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8.1 Lighting Design for the packaging area
The packaging area uses 85 - 1.2M*0.6M three tube fittings using 58 watt dull
fluorescent fittings in 11 rows of 8 fittings per row. The present arrangement gives a
lighting level of between 760 Lux and 890 Lux. One proposal would be to replace
these fittings with fittings containing just two high frequency fluorescent lamps in a
polished reflector that would produce the same light levels or more and with
considerable energy saving. The analysis of the energy savings is shown below.
Table 5-Savings by replacing existing 3 lamp fittings in packaging area with 2 tube
high frequency fittings
255
High Frequency 2 tube fittings
170
Saving
kW Control
Total kW
15
3.06
17.9
9
1.02
9.5
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Existing Main Frequency 3 tube fittings
kW/tube
he
No. Tubes
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se
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Saving with high frequency fittings
8.3
kWh/yr
72,971
€/yr
€4,313
€12,750
3.0
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Simple PBP..Yrs
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Cost
8.1.1 Observation on lighting system
1. The occupancy pattern in the production areas is continuous
2. The low occupancy rooms such as toilets and washrooms are normally
candidates for occupancy detector controls
3. Offices are normally only occupied during the day time (8am to 5pm)
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8.1.2 Energy efficient lighting systems
Table 6- relative efficiency of various artificial lighting sources
Lm/W
Tungsten filament incandescent 9-16
Tungsten halogen (linear types)
16-22
T12 fluorescent tubes
46-75
T8 fluorescent tubes
58-89
Mercury fluorescent 45-56
Metal halide
60-80
High-pressure sodium
57-125
Low-pressure sodium
68-173
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LAMP TYPE
60-70
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Induction
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The table shows that the standard household incandescent light gives out the least
lumens per watt of electrical energy consumed - at only 9 to 16 Lumens per watt. The
alternative to the standard is the compact fluorescent giving 45 to 74 lumens per watt
an improvement of over 500%. This is the kind of energy utilisation improvement that
can be achieved with modern fittings.
8.1.3 General energy saving suggestions
x
Establish an effective lighting usage programme: - a planned programme to
turn on lights only when and where they are needed. The essential element of
this type of programme is to develop a lighting schedule related to occupant
usage patterns. Define the exact nature of occupancy for each period.
Determine the amount of lighting need for safety and security taking into
account the contribution from natural light where such is available. Provide
detailed instructions for system operation by responsible employees by means
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of charts, and / or colour coding of switches.
x
Rewire lighting circuits to provide more flexibility in switching individual
banks of lighting especially in open plan office areas. Plant 2 for example has
the lights wired at 90 degrees to the production lines. This would be required
to take advantage of an opportunity exist to turn off lights if a production line
is off.
x
Post a small sign or chart near each bank of switches that identifies which
lights are controlled by which switch.
x
Reduce the lighting levels in corridors and partially occupied areas.
x
Lamps should be wiped regularly at regular intervals to assure maximum
efficiency.
Disconnect old luminaries where the control gear may be energised but the
lamps not working.
x
Finally, lamp replacement should be on a planned basis taking into account the
lumen decay characteristics rather than when the lamp fails. This is
particularly important in the production areas where light intensities are
higher.
x
Replace incandescent in exit signs with light emitting diodes (LEDs)
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8.1.4 Lighting Control Types
Characteristics of the most common lighting controls for offices and other public
buildings are outlined below:
Occupancy Sensors
Occupancy sensors are the most common lighting control used in buildings today.
Two technologies dominate: infrared and ultrasonic. Infrared sensors detect
temperature changes in a room, and work well where the entire room is within the
sensor's field of view. Ultrasonic sensors use high frequency sound, much like bats
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do, to detect motion (even around corners).
Dual-technology sensors use both methods, increasing accuracy and flexibility, but at
a higher price. Even though lamp running life may be somewhat shortened by
increased switching due to occupancy sensors, the overall chronological life of lamps
is usually extended by the reduced daily burn hours.
Time Scheduling
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Large open office areas work well with simple time scheduling - automatic switching
at fixed hours of the day. Overrides allow users to turn on the lights after hours (using
wall switches or telephone dial-up codes). Time scheduling can be accomplished with
simple time clocks or more sophisticated computer controls. To save more energy,
time scheduling systems can be designed so that lights are turned on manually rather
than automatically at the beginning of the day, but are turned off automatically at 1or 2-hour intervals after close.
Bi-level Switching
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Some people prefer lower overhead lighting levels (especially if daylight is available).
Lower light levels are often preferred for computer use, meetings or tasks that are not
visually demanding. Bi-level switching can provide simple manual control. For
example, in a typical 3-lamp fluorescent fixture, the outer lamps are switched
separately from the middle lamp, allowing the user to switch on one, two, or all three
lamps.
Manual Dimming
In rooms where different light levels are needed at different times, such as conference
rooms and some private offices, the use of manually operated dimming controls is a
common solution.
Automatic Daylight Dimming
Automatic daylight dimming, or "daylighting," uses a light sensor to measure the
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amount of illumination in a space. Then, light output from dimming ballast is adjusted
to maintain the desired level of illumination. The combination of daylight dimming
with appropriate task lighting is often very effective.
Corridors and open cubicles near windows, particularly those with task lighting, are
good candidates for daylighting controls. Private offices with windows can also be
equipped with individual daylight sensors. Initial commissioning and calibration of
light sensors and controls is critical for effective daylighting, however; poorly
calibrated daylight sensors can result in little or no savings, and may annoy occupants.
8.1.5 Recommendations
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1. Replace 58-watt mains frequency fluorescent lamps with high frequency 58watt fittings in production areas
2. Use occupancy detectors in low occupancy areas such as toilets and change
rooms
3. Disconnect ballasts in unoccupied mains frequency fluorescent luminaires
4. Use LED exist signs
5. Take full advantage of natural daylighting by using daylighting control
strategies.
6. Replace any older tungsten fittings with equivalent light, lower wattage
compact fluorescent fittings (CFL’s)
There suggestions require a full light survey and analysis before energy saving
benefits can be determined.
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9 Blow Moulding and Injection Moulding processes
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10 Domestic Energy Usage
Domestic energy usage is often overlooked in energy efficiency drives. This is
because it is assumed small in comparisons to industrial energy usage. In many
industries, it can account for 10% of the energy used.
Kitchen equipment can be operated efficiently and wastage reduced. Electric cookers
and other appliances can be replaced with gas ones (Propane) and cooking activities
restricted during peak tariff periods.
10.1.1 Recommendations
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1. Morning cooking should be done before 8 am (if possible) so advantage can be
taken of cheap night rate and reduce demand charges.
2. Ventilation fans should be run on timers and controlled by the Trend systems to
ensure they are not left running unnecessarily.
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3. Dishwasher machine should do it’s last wash at night to take advantage of cheaper
night rate electricity
4. Fully load the washing machine for each cycle. A partial load will use almost as
much energy as a full load.
5. Seal off unused non-food storage areas. Don't use unneeded heating and cooling
energy.
6. Purchase the most energy efficient equipment possible. Consider a new gas
cooker. Chiefs prefer them.
7.
Develop a set procedure for having equipment routinely cleaned and maintained.
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8. Lower Lids on Pans during simmering
9. Canteen lights are normally left running and can benefit from local control options
but are best controlled by the Trend system timer functions.
10. Convert electric cookers, grills, and hot plates to gas. Propane gas is 2 times less
expensive per kWh of energy used then electricity.
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These sound practices can save a lot of energy. An energy saving of 10% is estimated
and is considered a reasonable obtainable objective.
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11 Maintenance of plant and energy efficiency
Maintenance strategy does not normally take into account energy efficiency aspects
that are important in an overall maintenance programme. This can be allowed for in
utility plant such as compressors, pumps, and boilers etc. using data collected from a
monitoring system as described earlier. By keeping an eye on energy usage,
maintenance intervals can be optimised to help reduce energy usage and running
costs. A good example of this can be found for a chiller. Maintenance is often only
done when either items fail or the recommended run hours have been logged. A better
reason for maintenance might be when the energy performance is reduced below a
pre-determined level.
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11.1.1 Energy saving opportunities
When the minimum efficiency of a plant item such as a compressor or boiler as
diagnosed by the KPI, deteriorates below a pre-determined level then maintenance
may be required on this item to bring it back to its target efficiency. This will also
improve its reliability and process plant / product variability.
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Table 7 - Maintenance and key performance indicators
Maintenance and Energy Efficiency *
Plant Item
Performance
Target
Actual
Indicator
Performance
Performance
Air Compressed
Kwh/M3
0.1
0.13
Boiler
kwhgas/tonne steam
760
800
Chiller
kWht/kWht
3
2.5
* example only –actual will depend on type equipment in use
To achieve the above would require that all main utility and larger energy consuming
process plant items have a minimum efficiency figure establish. These can be the key
performance indicators as described in the M/T section above.
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11.1.2 Maintenance Service Contracts
When maintenance is out-sourced then guidelines should be given to the contractor as
regards the energy efficiency aspects of the equipment that they are contracted to
maintaining:
When extra maintenance and materials are required to enhance energy performance
then this should be discussed with plant maintenance personnel to determine the cost
benefit of the extra improvement.
The purpose of maintenance of plant should be to improve both efficiency and
availability of the plant and its overall contribution to production rates and process
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Availability
Efficiency via improvements to KPI
Costs of maintenance
Effect on overall process variability
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2.
3.
4.
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The success of maintenance contract of a particular plant item should be judge on the
following:
It is well known that maintenance has a direct bearing on plant availability but not
generally realised that maintenance procedures and energy efficiency are also interlinked.
A well-maintained plant requires less energy per unit of output. This is true for all
utility plant from air compressors to effluent treatment plant.
For example when the monitoring system shows that the Key Performance Indices for
energy usage for a particular compressor has deteriorated below an acceptable norm
then this will be flagged as a maintenance requirement.
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11.1.3 Integrating maintenance with the monitoring and targeting
system
The maintenance data and the energy data from a monitoring and targeting system can
be useful in creating an improved platform for maintenance based decisions. Energy
efficiency of many machines such as air compressors can vary greatly depending on
the maintenance strategy adopted. Dirty filters, wearing valves, poor sensors and
leaking pipes can increase energy usage by over 30%.
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Schematic 6- Maintenance and energy usage monitoring
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11.1.4 Recommendation
Use energy efficiency indices and procedures in the maintenance criteria of all
process plant
Savings:
Improve Efficiency
Reduced Maintenance Costs
Increase in availability
Improve process variability
Reduce downtime
Reduce labour costs
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1.
2.
3.
4.
5.
6.
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Appendix 1 – Energy management Matrix
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12.
Energy Audit-Year 2003
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13.
Energy Audit-Year 2003
Appendix 2- New Plant energy efficiency specifications
Most Corporate Guidelines for new plant and machinery if they exist, mainly deal
with the specifications of process plant and utility plant as regards to minimum
outputs required. Although some mention may be given to energy efficiency it is often
not elaborated upon and left at the individual contractors involved to include
efficiency measures or quote an extra for them. In general, the onus is on the
contractor to suggest improvements to the energy performance of the plant they are
offering.
This is flawed for a number of reasons.
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1. The contractor may not be aware of the efficiency improvement potential
using all the latest technologies
2. Contractors are worried about adding onto the cost of a new project in case
they lose it on price.
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3. Where an improvement is given as an extra cost contractors may be exposing
shortfalls in there own basic offerings
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Improvements to existing guidelines
The following improvements should be included in any Corporate Guidelines for new
plant and machinery.
Design Criteria
The maximum acceptable specific energy consumption should be included in the
design guidelines. For example:
1. 300NM3/min of compressed air at specific energy consumption of no more
than 0.1.kwh/M3 of compressed air delivered at 110 psig. The actual values
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will depend on system design parameters such as outlet pressure.
2. Similar guidelines are needed for other process plant.
Capital Expenditure
Capital expenditure should take into account the life cycle operational cost of the
equipment – not just the once off capital cost. An electric motor will consume 100
times its initial purchase costs over its lifetime – but we attribute far more weight to
the initial purchase cost then the energy efficiency of the motor.
1. The life cycle cost of the equipment (Capital, Maintenance, energy, labour)
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2. The global warming potential (GWP) of new equipment should also be
compared as well as energy efficiency.
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Unless minimum efficiency targets are specified both for plant design and plant
specification it is unlikely that the best energy efficiency will be achieved.
Tender assessment
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The energy efficiency and fuel type need to be formal assessed when analysing and
comparing tenders for new plant and equipment. The benefits of using higher
efficiency over the life of the plant should also be analysed if the marginal cost of
these systems is to be justified.
General Energy Efficiency points
It is important that process and equipment are design to operate efficiency both at the
duty point – 100% load and under part load conditions. Many process plants only
operate at 100% design conditions for 10% of the time and probable operate at
between 50% to 80% for 80% of the time. A chiller plant is a good example of this –
yet many designers design for the maximum efficiency at the 100% full load point
only. The efficiency of the plant at 60% load is often much lower then at 100% load.
Example of this includes Screw compressors and large pumps.
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Hence the design of the process should be such that it can mimic a reduction in output
and energy usage to near a straight line i.e. half the output and you half the energy
input (this is ideal and hard to achieve). If this rule is adhered to as much as possible
then the overall energy efficiency curve for the production facility will also be as
close to a straight line as possible – minimising energy costs per unit of production.
This is particularly true for utility plant operations as well as production plants
Compressed air plant
The compressed air system and pipe work should be designed to minimise
pressure drops and a ring main system is best. Standard table are available to
help designers size pipe work for efficiency.
‰
The type and controls on the compressors need attention
‰
Multiple smaller compressors are easily controlled for efficiency rather then a
couple of larger units.
‰
Be careful with variable speed controls on compressors
‰
The “off-load” running time should be as low as possible and the off load
running power in kW should be less then 20% of “on load” power in kW
‰
The overall specific energy consumption along with maintenance costs etc.
need to be evaluated
‰
The need to use compressed air in the first place needs attention. Direct drive
alternatives should first be considered
‰
All compressors should be fitted with high efficiency motors with slip speed
not greater then standard motors – else efficiency benefits will be lost
‰
The potential for a two tier pressure system and the use of high efficiency
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‰
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nozzles need attention
‰
The use of air amplifiers and high efficiency air nozzles should be considered
in place of open-ended pipes.
Electrical Distribution panels
1. All panels should be supplied with pulse kW and kWh meters to allow for
automatic monitoring of energy
2. Terminal points should be provided for energy monitoring purposes.
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.
3. Power factor correction capacitors should be fitted with tuned inductors to
avoid RCL resonance circuits forming where non-linear loads such as variable
speed drives produce sine wave with frequency components that are multiples
on the basic ESB frequency of 50Hz. In general if over 40% of the inductive
motor loads are feed with waveform distortion equipment such as variable
speed drives or frequency generators, then the total harmonic distortion
content of the system should be checked. This is an increasing problem in
Ireland and should be checked annually.
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Three Phase Industrial Transformers DOE Efficiency recommendations
Efficiency Level (%)
15
97.0
30
97.5
45
97.7
75
98.0
112.5
98.2
150
98.3
225
98.5
300
98.6
500
98.7
750
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Three Phase-kVa
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The following efficiency is based on 35% nameplate load and a temperature of 75 degc.
98.8
98.9
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1000
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Open drip proof motors
82.5 82.5 85.5 86.5 80.0 84.0 1.5 86.5 87.5 86.5 86.5 85.5 86.5 2
87.5 88.5 86.5 88.5 86.5 86.5 3
89.5 90.2 89.5 90.2 86.5 87.5 5
89.5 90.2 89.5 90.2 se
89.5 91.0 7.5 91.7 91.7 91.0 91.7 ru
89.5 90.2 10 91.7 92.4 91.7 91.7 90.2 91.7 15 92.4 92.4 93.0 93.0 91.0 91.7 20 92.4 93.0 93.0 93.6 92.4 93.0 25
93.0
93.6
93.6
94.1
93.0
93.0
30
93.6
93.6
94.1
94.1
93.0
94.0
40
94.1
94.5
94.1
94.5
93.6
94.5
50 94.1 94.5 94.5 95.0 93.6 94.1 60 95.0 95.4 95.0 95.4 94.1 94.5 75 95.0 95.8 95.0 95.4 94.5 95.4 100 95.0 95.4 95.4 95.8 94.5 95.8 125 95.4 95.8 95.4 95.8 95.0 95.4 150 95.8 95.8 95.8 96.2 95.4 96.2 200 95.4 96.2 95.8 96.2 95.4 96.2 250 95.4 95.8 96.2 96.2 95.8 95.8 300 95.4 95.8 95.0 96.2 95.4 96.2 Systems Optimisation Ltd
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.
1
he
1200 RPM
1800 RPM
3600 RPM
Motor
Size
Best
Best
(Horsepower) Recommended Best
Recommended
Recommended
Available
Available
Available
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350 94.5 96.2 95.4 96.2 95.0 96.2 400
94.1
96.2
95.8
96.5
95.0
96.2
450
94.5
96.2
95.4
95.8
95.4
96.2
500 94.5 96.2 94.5 95.8 94.5 96.5 1.
Energy-efficient motors usually have higher inrush current than equivalent standard efficiency
models. In older buildings, make sure that existing motor circuits and protection equipment
are adequate to handle this higher initial current
2. . This Recommendation is for general-purpose, single-speed, polyphase induction motors.
Some applications require definite-purpose, special-purpose, special frame, or special
mounted polyphase induction motors. A motor meeting the Recommended efficiency level is
usually available for these applications also.
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.
3. Motor efficiency is identified on the nameplate by "nominal" efficiency, which represents the
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average efficiency of a large population of motors of the same design. It is measured in
accordance with NEMA MG 1-1993, "Motors and Generators," and IEEE 112 Test Method
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Fan cooled motors
1200 RPM
1800 RPM 3600 RPM Motor
Size
Best
Best
(Horsepower) Recommended Best
Recommended
Recommended Available
Available
Available
1
82.5 85.5 85.5 86.5 78.5 80.4 1.5 87.5 87.5 86.5 87.5 85.5 87.5 2
88.5 88.5 86.5 86.5 86.5 87.5 3
89.5 90.2 89.5 89.5 88.5 89.5 5
89.5 90.2 89.5 90.2 89.5 89.5 7.5 91.7 91.7 91.7 91.7 91.0 91.7 Systems Optimisation Ltd
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91.7 92.4 91.7 91.7 91.7 91.7 15 92.4 92.4 92.4 93.0 91.7 91.7 20 92.4 93.0 93.0 93.6 92.4 92.4 25 93.0 93.0 93.6 94.1 93.0 93.6 30 93.6 93.6 93.6 94.5 93.0 93.6 40 94.1 94.5 94.1 94.5 93.6 94.1 50 94.1 94.5 94.5 95.0 94.1 94.1 60 94.5 95.0 95.0 95.4 94.1 94.5 75 95.0 95.0 95.4 95.4 94.5 95.0 100 95.4 95.4 95.4 95.4 95.0 95.8 125 95.4 95.8 95.4 96.2 95.4 95.8 150 95.8 96.2 95.8 96.2 95.4 96.2 200 95.8 95.8 96.2 96.5 95.8 96.2 250 95.6 95.8 96.2 96.5 se
95.9 96.5 300 95.4 96.2 96.1 96.5 95.8 96.2 350 94.5 95.0 96.2 96.3 94.8 95.8 400 94.5 95.0 95.8 96.2 94.5 95.8 450 94.5 95.4 94.5 95.0 94.5 95.4 500 94.5 95.4 94.5 95.4 94.5 95.4 1.
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.
10 he
Energy Audit-Year 2003
Energy-efficient motors usually have higher inrush current than equivalent standard
efficiency models. In older buildings, make sure that existing motor circuits and
protection equipment are adequate to handle this higher initial current.
2. This Recommendation is for general-purpose, single-speed, polyphase induction
motors. Some applications require definite-purpose, special-purpose, special frame,
or special mounted polyphase induction motors. A motor meeting the Recommended
efficiency level is usually available for these applications also.
3. These efficiency levels, up to 200 hp, are the same as those recommended by the
Consortium for Energy Efficiency (CEE) to their member utilities.
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4. Motor efficiency is identified on the nameplate by "nominal" efficiency, which
represents the average efficiency of a large population of motors of the same design.
It is measured in accordance with NEMA MG 1-1993, "Motors and Generators," and
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IEEE 112 Test Method B
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Lighting plant
1. The lighting should be designed for lighting requirements for task on hand as
per CIBS guides
2. Natural lighting should be used when possible
3. The lighting plant should controlled for both natural light levels and
occupancy levels during all shifts and out of work hours
4. The potential to use more natural lights / and skylights should always to
addressed.
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.
5. High frequency fittings should always be used in production areas.
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6. Outside lights should be high efficiency and controlled with low lumen
photocells
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Fluorescent Light Fixtures Energy Efficiency
Luminaire[1]
Type No.
(NEMA designation)
Lamps
of Recommended
LER
Best
LER
Available
2' x 4' Recessed
Lensed
(FL)
VDT[3]-preferred[4]
Louvered
(FP)
Systems Optimisation Ltd
2
62 or higher
77
3
61 or higher
77
4
61 or higher
77
2
50 or higher
62
3
51 or higher
68
4
54 or higher
68
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Plastic Wraparound
Four-Foot
(FW)
2
63 or higher
88
4
62 or higher
100
1
70 or higher
86
2
70 or higher
92
Four-Foot (FI) 2
67 or higher
91
Eight-Foot (FI)
2
68 or higher
86
Strip Lights
Four-Foot
(FS)
Industrial
2' x 2' Recessed, for U-Tube Lamps
2
41 or higher
63
Lensed
2
49 or higher
78
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Luminaire is a complete lighting unit consisting of a fixture along with one or more
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.
VDT-preferred
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ballasts and lamps.
2. Luminaire Efficacy Rating (LER) describes the efficiency of a luminaire in terms of
rated light output (in lumens) per watt of electricity use. (Lumen is a measure of light
output)
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3. VDTs, or video display terminals (computer monitors), may be obscured by direct or
reflected glare from overhead luminaires that emit light at wide angles.
4. "VDT-preferred" luminaires meet IESNA recommendations for glare reduction
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Energy Audit-Year 2003
DOE Fluorescent Lamp Ballast
Lamp Type
Recommended
BEF[1][2]
Best
BEF
1
2.54 or higher
3.00
2
1.44 or higher
1.54
3
0.93 or higher
1.06
4
0.73 or higher
0.79
1
2.64 or higher
3.05
2
1.41 or higher
# of Lamps
Available
3
Eight-Foot Lamps
2
T12, 60 Watts
2
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0.93 or higher
0.95
0.80 or higher
0.81
0.80 or higher
0.80
Ballast Efficacy Factor (BEF) is the ratio of the ballast factor (BF) to input watts; it measures the
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T8, 59 Watts
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T12, 34 Watts
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T8, 32 Watts
.
Four-Foot and U-Tube Lamps
efficiency of the lamp/ballast system relative to others using the same type and number of lamps.
6. (2)Ballast Factor (BF), also called Relative Light Output (RLO), is the ratio of the light output of a
lamp(s) operated by a ballast, to the light output of the same lamp(s) operated by a reference
ballast at rated current and voltage.
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High Intensity Discharge Lamps
Lamp
Wattage
Recommended
Best
Available
Recommended
Best
Available
150-399
41 or higher
64
(insuff. data)
63
400-999
53 or higher
67
59 or higher
69
>1000
77 or higher
83
(insuff. data)
110
150-399
56 or higher
70
(insuff. data)
53
400-999
62 or higher
67
64 or higher
70
>1000
insuff. data
99
88 or higher
108
150-399
57 or higher
69
(insuff. data)
67
400-999
65 or higher
73
69 or higher
75
>1000
insuff. data
87
(insuff. data)
118
150-399
62 or higher
73
77 or higher
90
400-999
ns
en
Upward
Efficiency[1]
Closed Fixture (HC) LER[2] Open Fixture (HO) LER[2]
65 or higher
74
(insuff. data)
75
insuff. data
96
(insuff. data)
96
150-399
58 or higher
76
68 or higher
76
400-999
63 or higher
87
84 or higher
96
>1000
insuff. data
94
(insuff. data)
95
150-399
64 or higher
78
63 or higher
84
400-999
82 or higher
101
89 or higher
111
>1000
(insuff. data)
92
109 or higher 121
150-399
(insuff. data)
89
78 or higher
11%-20%
>20%
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1%-10%
Co
0%
.
Metal Halide Lamps
>1000
High Pressure Sodium Lamps
0%
1%-10%
11%-20%
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>20%
5.
Energy Audit-Year 2003
400-999
(insuff. data)
91
94 or higher
100
>1000
(insuff. data)
79
(insuff. data)
122
150-399
75 or higher
80
77 or higher
90
400-999
(insuff. data)
102
(insuff. data)
103
>1000
(insuff. data)
116
(insuff. data)
121
Upward efficiency is the portion of light directed up. Both high-bay and low-bay
luminaires are available with opaque reflectors, which direct all or most of the light
downward, and with transparent refractors, which direct some light up.
6. LER, or luminaire efficacy rating, describes the efficiency of a luminaire in terms of
rated light output (in lumens) per watt of electricity use. A lumen is a standard
measure of light output.
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.
Exit Signs
Recommended
Best Available
Single Face
5 watts or less
1 watt
Double Face
10 watts or less
1 watt
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Product Type
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Process plant
1. Process plant should include high efficiency motors where economics are
favourable. Motors operating over 5,000 hours per year and over 15kW should
be the high efficiency types.
2. Large energy process plant should have kW/kWh pulse meters installed
3. The use of compressed air as motive power should always be avoided if
possible as compressed air as an energy source cost 60 c/kWh.
4. The use of compressed air open pipe ends should be avoided
he
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.
5. When low pressure air is required then a blower should be considered
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6. The use of electric heaters for water or steam should be avoided except in
special cases where the economics allow.
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7. The use of electric fans heaters and stand-alone space heating equipment
should be avoided
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Energy Audit-Year 2003
USA DOE Guide for personal computer
Maximum
Continuous
Power Recommended
Supply Rating (or system type)
"Sleep" Mode[1] Power[2]
15 watts or less
201 - 300 watts
20 watts or less
301 - 350 watts
25 watts or less
351 - 400 watts
30 watts or less
> 400 watts
<= 10% of max. power supply rating
PC/Monitor ("all in one")
35 watts or less
All personal computers with the
label
he
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.
<= 200 watts
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meet this efficiency recommendation. Click on
the button below, "Complying Models," to view the list of products that carry the
1.
label.
"Sleep" mode refers to a low-power standby condition, which is entered automatically after a
set period of inactivity. The computer's active mode is restored when the user touches the
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mouse or the keyboard, or in response to a network signal.
2. For computers shipped with networking capability that require the processor or memory to be
involved in maintaining the network connection during sleep mode, the recommended sleep
mode is 15% of the maximum power supply rating.
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Energy Audit-Year 2003
USA DOE Guide for colour computer monitors
Product Type
Recommended
"Sleep Mode"[1]
Best
Available
"Sleep Mode"
14" - 15" Colour
15 watts or less[2]
1 watt
17" Colour
15 watts or less[2]
1 watt
20" - 21" Colour
[2]
15 watts or less 2 watts
Recommended
Mode[1]
Best Available
in Watts in Watts
Off
"Sleep"
Mode Mode
N/A
21-44 cpm
5 + (cpm *
cpm *
3.85)
15 or less
or less
or less[2]
> 44 cpm
5 + (cpm *
cpm *
3.85)
20 or less
or less
or less
Co
<= to 20 cpm
1.
in
ns
en
Copier
Type Watts
(copies/minute) "Sleep"
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USA DOE Guide for Photocopiers
5 or less 0
3.0
1.3
Automatic
Watts
in Copying
Off Mode
0
N/A
0
Default
Setting
0
Default
Setting
Duplex
"Sleep" mode refers to a low-power standby condition, which is entered automatically after a
set period of inactivity. The copier's active mode is restored when the user touches a control
button, or by a motion sensor.
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2.
Energy Audit-Year 2003
For example, a 30 cpm copier can only use 120.5 watts (5 + (30 * 3.85)) in sleep mode.
USA DOE Computer Printers Efficiency Recommendations
Printer Speed
Recommended "Sleep" Mode*
Laser Color [b] <10 pages/min.
10 watts or less
35 watts or less
11-20 pages/min.
20 watts or less
45 watts or less
21-30 pages/min.
30 watts or less
70 watts or less
31-44 pages/min.
40 watts or less
70 watts or less
> 44 pages/min.
75 watts or less
70 watts or less
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Laser B/W + All Inkjet [a] to
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All computer printers with the
label
meet this efficiency recommendation.
Click on the button below, "Complying Models," to view the list of products that carry the
label.
*"Sleep" mode refers to a low-power standby condition, which is entered automatically after a set
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period of inactivity. The printer's active mode is restored when a print command is received
[a] Includes both black-ink and color inkjets, and printer/fax combinations.
[b] Also includes LED and thermal transfer color printers. Note that higher speed colour printers are
digital, network-capable copier-printer combinations.
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Energy Audit-Year 2003
USA DOE Office Fax Machine Efficiency Recommendations
Recommended
"Sleep" Mode *
Best
"Sleep" Mode
All Types [a] Inkjet Laser, LED < 10 pages/min. 10 watts or less
1 watt
2 watts
> 10 pages/min. 15 watts or less
2 watts
2 watts
Fax Speed
Available
se
.
All fax machines with the
label
meet this efficiency recommendation.
Click on the button below, "Complying Models," to view the list of products that carry the
to
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label.
* "Sleep" mode refers to a low-power standby condition, which is entered automatically after a set
period of inactivity. The active mode is restored when the user touches the keypad to send a fax or
when an incoming fax is received.
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Building Fabric and Design
The energy efficiency aspects of the building fabric should be as per the UK
government’s guides for energy efficiency design of industrial buildings or
equivalent. Contractors should be made aware of this guide and ensure that the
recommendations are out to use in the design of the plant
Remember to use building standards relevant to Ireland’s climate. Standards designed
for another country such as USA will have different emphasis to minimise energy
usage during seasonal changers in wet and dry bulb temperatures, prevailing wind, air
conditioning requirements etc. For example, the use of desiccant cooling equipment is
depending on low wet bulb depression (low RH).
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14.
Energy Audit-Year 2003
Appendix 3– Action Plan
A three-year energy plan was developed to improve the energy utilisation and
procedures in the plant. The main objectives of the plan are to develop a programme
to implement energy improvements and provide a means to record improvements as
they occur. The focal point for the energy savings will be the monitoring system that
will track energy savings and usage.
The main components of the plan are:
1. The provision of a budget mechanism to implement energy efficiency
measures
ru
se
.
The improvements to the corporate aspects of energy management as detailed
in this report.
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2.
3. Installation of an energy monitoring system to monitor energy usage and to
allow for estimates of energy savings measures to be made.
Co
ns
en
4. The purchase of efficient process plant using energy efficiency guidelines for
new plant as per specifications
5. The provision of energy efficiency maintenance criteria
6. Staff training of energy efficiency in the process and production plant
Systems Optimisation Ltd
74
27/05/08
E-mail:gmcnulty@iol.ie
EPA Export 26-07-2013:00:39:46
Allergan Pharma Westport
Energy Audit-Year 2003
14.1 Energy Reduction Plan – Year 1
This involves proceeding with the energy improvements under the following
elements
1. Appoint and energy manager or part thereof with specific responsible for
energy management
2. Launch an energy efficiency campaign – enlist the support from the top
management down.
ru
se
.
3. Have a detailed audit carried out to quantify the savings and grade the
opportunities.
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4. The driving force should be the environmental savings rather then just energy
cost savings.
5. Have talks and seminars presented to key staff in various areas concerning
energy usage and saving opportunities
Co
ns
en
6. Consider a separate staff suggestion scheme for development of energy saving
ideas
7. Participate in energy awareness week – around September of each year.
8. Implementation of the Monitoring and targeting systems so that savings that
are achieved throughout the 3-year plan can be logged and verified to
management and funding will continue for further projects. This will be the
first expenditure that needs to be approved.
9. Monitor the energy consumption of the plant for one month before any energy
efficiency improvements take place. This is required to find the existing
energy benchmarks for the plant so comparisons can be made latter as
Systems Optimisation Ltd
75
27/05/08
E-mail:gmcnulty@iol.ie
EPA Export 26-07-2013:00:39:46
Allergan Pharma Westport
Energy Audit-Year 2003
improvements are made.
10. Proceed with low cost measures as identified in the report or through better
monitoring of energy and key performance factors of major plant items
14.2.
Energy Improvement plan – Year 2
1. Ensure that corporate guidelines take into account energy efficiency in plant
design, procurement and operations as detailed in the report
2. Draw up energy efficiency guideline for maintenance contractors to adhere
too. Include key performance factors.
ru
se
.
3. Ensure that all energy suppliers are selected on a bid basis.
14.3.
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Implement the next phase-the medium cost projects using the money saved in Year
one.
Energy Improvement plan – Year 3
Co
ns
en
1. The higher cost projects can be implemented next. Some of these projects
provide faster paybacks and should be implemented first.
2. Evaluate effects of efficiency drive
Systems Optimisation Ltd
76
27/05/08
E-mail:gmcnulty@iol.ie
EPA Export 26-07-2013:00:39:46
Allergan IPPC Licence Application
Attachment H
Allergan
IPPC Licence Application
Co
ns
en
to
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op r i
yr ns
ig pe
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ne pu
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eq os
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.
Attachment H – Materials Handling
EPA Export 26-07-2013:00:39:46
Allergan IPPC Licence Application
Attachment H
Contents
Attachment H.1 – Raw Materials, Intermediates, Products Handling
Attachment H.1.A – Details of Raw material, Intermediates and Product Handling
Attachment H.1.B – Bund Location Plan
Attachment H.1.C – Bund Testing Report
Attachment H.1.D – Balancing Tank Integrity
Attachment H.2 – Waste Handling
Co
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.
Attachment H.2.A – Details of Waste Handling
EPA Export 26-07-2013:00:39:46
Allergan IPPC Licence Application
Attachment H.1.A
Allergan
IPPC Licence Application
Attachment H.1 – Raw Materials, Intermediates, Products Handling
Co
ns
en
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.
Attachment H.1.A – Details of Raw material, Intermediates and Product Handling
EPA Export 26-07-2013:00:39:47
Allergan IPPC Licence Application
Materials Handling
Attachment H1 –Raw material, Intermediates and Product Handling.
Materials on site are stored both internally and externally in designated
storage area as per hazardous classification.
All materials are transported across the site by either forktruck, pallet truck or
trolley. All personnel operating forktrucks are trained and certified. All
personnel handling chemicals are trained in chemical handling.
H1.1 Internal Storage
Internal storage is located in the Warehouse Area of the facility. Raw
materials, active pharmaceutical ingredients, and final products are stored in
the Warehouse. Initially, raw materials and API’s undergo QC testing prior to
being released to the various Departments. Production raw materials and
API’s are then stored in designated areas on the warehouse or in certain
cases in storage areas in specific Departments.
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.
Intermediate packaged product may be transferred to the warehouse for
storage as work in progress (WIP). Thereafter it is transported to the required
departments as needed for further packaging.
Final packaged product is held on racking in the Warehouse until it is released
by the QA Department and ready to be shipped off site. It is then stretch
wrapped and loaded onto containers in the Shipping Dock.
ns
en
All raw materials, W.I.P. and finished goods are stored in shippers or outer
containers, which clearly identify the contents by material number, batch, and
the quantity there in.
Co
All non–production chemicals are taken to the Chemical Store (Pharma) for
intermediate storage. Laboratory solvents are taken directly to the relevant
Laboratory where they will be stored in designated solvent storage areas.
H1.2 External Storage
External Storage Locations and the varying materials stored in these areas
are outlined in Table A below.
1
EPA Export 26-07-2013:00:39:47
Allergan IPPC Licence Application
Co
Botox
Hazardous
waste store
Bund Details
Neutralisation
tank
Sulphuric acid
holding tank
Caustic
Holding tank
Mercury tank
Brine Tank
Botox Core 3
generator oil
tank
2 X 66000L oil
tanks
Sodium
Hydroxide
Mercury
containing
materials
Brine for
Water System
Diesel oil
Diesel oil
Bund integrity
test details
Pass – December
2007
Bunded
Cabinet
Bund integrity
test details
Pass – December
2007
Bunded
Cabinet
Pass – December
2007
Bunded
Cabinet
Pass – December
2007
Bunded
Cabinet
Pass – December
2007
Tank
Bunded area
March 2008
Double lined
tank
Double lined
tank
Tank
Bunded area
Under test
Bunded area
Under test
Bunded area
January 2008
Tank
Bunded area
January 2008
Tank
Bunded area
January 2008
Tank
Bunded area
January 2008
.
se
Hazardous
Chemical
store 4
Storage
Conditions
Designated
containers in
flameproof
cabinet
Designated
containers in
flameproof
cabinet
Designated
containers in
flameproof
cabinet
Designated
containers in
flameproof
cabinet
ru
Hazardous
Chemical
store 3
Material
Stored
Mainly
oxidiser waste
from lab
activities
Storage of
waste drums
awaiting
collection.
Storage of
waste drums
awaiting
collection.
Mainly waste
solvents Botox
labs. Also
includes
corrosive
waste, HPLC’s
and wipes.
Wastewater
effluent
Sulphuric acid
Bunded
Cabinet
he
Hazardous
Chemical
store 2
Bund Details
ot
Storage Area
Storage
Conditions
Designated
drums in
flameproof
cabinet
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Hazardous
Chemical
store 1
Material
Stored
Mainly waste
solvents for
the ETC/
Chemistry
labs. Also
includes
corrosive
waste, HPLC’s
and wipes.
ns
en
Table A
Storage Area
Materials Handling
2
EPA Export 26-07-2013:00:39:47
Allergan IPPC Licence Application
Materials Handling
Disinfectants
3 x 400L
tanks
Bunded area
N/A
1000L oil tank
Forklift oil tank
Gas
compound
(ETC/
Chemistry)
Gas
compound
(Botox)
Storage Area
Diesel oil
Diesel oil
Propane,
butane gas
Tank
Tank
Cylinders
Bunded area
Bunded area
N/A
December 2007
December 2007
N/A
Propane,
butane gas
Cylinders
N/A
N/A
Material
Stored
Oils and
lubricants
Nitrogen
Storage
Conditions
Original
container
Tank
Bund Details
Bunded pallet
Bund integrity
test details
N/A
N/A
N/A
se
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Maintenance
oil store
Nitrogen Plant
.
Cooling
towers
chemical
storage and
dosing unit
Table B : Internal Storage Locations
Storage
Conditions
Flammable
cabinet
Bund Details
N/A
Bund integrity
test details
N/A
Segregated
based on
compatibility
Cabinets
N/A
N/A
Toxic
materials
Cabinet
N/A
N/A
ns
en
Laboratory
flammable
storage
cabinets in
Botox and
Pharma
Laboratory
(ETC, PSR,
Chemistry,
Micro) –
storage of
chemicals
under
fumehoods
and in weigh
rooms
Warehouse Toxic/
Corrosive &
Oxidiser
storage
cabinet
Material
Stored
Flammable
materials
Co
Storage Area
3
EPA Export 26-07-2013:00:39:47
Allergan IPPC Licence Application
Bunded
cabinets
N/A
ETC/Chemistr
y chemicals x
3
Maintenance
cabinet x 1
EHS cabinet x
2 - interim
storage of
waste prior to
removal from
site.
Unit Dose
Packaging
inks
Flammable
cabinets
Bunded
cabinets
December 2007 Pass
Flammable
cabinet
N/A
N/A
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Flammable
cabinets
ns
en
Plastics –
Flammable
storage
cabinet
Raw material
retains
Co
Warehouse –
raw materials
retains area
Pharma
Chemical
Store – 6 x
Flammable
cabinets
Materials Handling
4
EPA Export 26-07-2013:00:39:47
Allergan IPPC Licence Application
Attachment H.1.B
Allergan
IPPC Licence Application
Co
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Attachment H.1.B – Bund Location Plan
EPA Export 26-07-2013:00:39:47
EPA Export 26-07-2013:00:39:47
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Allergan IPPC Licence Application
Attachment H.1.C
Allergan
IPPC Licence Application
Co
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Attachment H.1.C – Bund Testing Report
EPA Export 26-07-2013:00:39:47
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EPA Export 26-07-2013:00:39:48
Allergan IPPC Licence Application
Attachment H.1.D
Allergan
IPPC Licence Application
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Attachment H.1.D – Balancing Tank Integrity
EPA Export 26-07-2013:00:39:48
31st January 2008
Mr. P.J. Griffin,
Senior Engineer,
RPS Consulting Engineers,
Lyrr Building,
IDA Business & Technology Park,
Mervue,
Galway.
Re: Allergan Tank, Westport, County Mayo
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
On Site Inspection & Maintainence:
ot
he
ru
se
.
Structural Report on Tank
Evidence: Site Inspection & Photographic
Report:
Internal Diameter:
Wall Height:
Liquid Depth:
Co
Tank Details:
ns
en
Introduction: This waste tank was constructed in 1998. The tank is constructed of pre-cast,
prestressed and postensioned concrete to the following dimensions and details.
19.10m
4.00m
3.50m
The tank is circular in geometry and consists of modular precast and prestressed concrete
wall panels that are erected on a flat reinforced concrete foundation base. The base of this
tank was constructed on a piled foundation and these piles and foundation base was
constructed by the main contractors “ MJ Conroy & Sons Ltd”. The wall panels are then
postensioned horizontally. A reinforced concrete up-stand beam is cast at the joint between
the wall and the foundation base performing a watertight seal. The roof structure consists of
a series of precast concrete columns, beams and prestressed concrete deck units. These
deck units are then covered with a reinforced concrete roof screed placed to falls to
facilitate rainwater run-off from roof.
SHAY MURTAGH LTD
Raharney, Mullingar, Co. Westmeath Ireland
Telephone: (044) 9374108 Fax: (044) 9374552
Directors: J. Murtagh (Managing), D. Murtagh, B. Murtagh, L. McGovern, B. Surv, C. Murtagh B. Civ Eng., G. Murtagh
Company Registered in Ireland – Rgd. No. 54976
EPA Export 26-07-2013:00:39:48
Site Inspection:
On Monday 28th January 2008 our Engineer Mr. Sean Kennedy and an operative attended
the above site at Allergen, Westport, County Mayo. The purpose of this visit was to
undertake a visual structural assessment of the tank and to undertake any obvious
maintenance. The following report has been compiled following this site visit.
Tank Lining System:
he
ru
se
.
This tank is lined with 2.50mm Butyl Liner. This liner is to protect the concrete from the
variable nature of the process effluent that is been stored within the tank. This lining
system was specified by the Consultant Engineers and installed by a third party specialist
contractor. It would not be possible for our company to comment on the lining system.
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
Year of Construction: 1998
Purpose of Tank: The tank was constructed to store process effluent. The tank serves the
double purpose of Equalization and Balance in the effluent system.
Site Status:
Co
Site Inspection evidence:
ns
en
The tank is partially backfilled for approximately one third of its height.
Roof:
A full visual inspection has been undertaken on tank roof structure. The roof structure
would appear to be in good condition and does not require any maintenance work.
Walls: (External)
From the photos the walls appear to be structurally fine with no signs of carbonation or
other deterioration. There were a few minor chipping of wall panels at junction with roof.
This would be caused by thermal movement of the roof structure during hot summer
periods. We did undertake a little cosmetic repair of concrete wall panels at this area.
SHAY MURTAGH LTD
Raharney, Mullingar, Co. Westmeath Ireland
Telephone: (044) 9374108 Fax: (044) 9374552
Directors: J. Murtagh (Managing), D. Murtagh, B. Murtagh, L. McGovern, B. Surv, C. Murtagh B. Civ Eng., G. Murtagh
Company Registered in Ireland – Rgd. No. 54976
EPA Export 26-07-2013:00:39:48
Postensioning:
From our site inspection we could see that a number of PVC protection caps that cover the
anchor housing in the postensioning anchor panel were missing. Following our inspection
we decided to re-grease all anchors and fit new PVC protection caps.
ru
se
.
Internal Inspection:
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
An internal inspection was not possible. The fact that the tank has an internal lining system
will also mean that an internal inspection of the tank is virtually impossible. However an
integrity test on the lining system may be an option and would be recommended, given the
nature of the tank effluent and the possibility of attack on the concrete from any leakage.
Summary:
Co
ns
en
From our site inspection we found the tank to be in a very sound structural state and fit for
the purpose intended.
Drawings:
We have attached drawings of tank for your attention;
This report has been compiled by:
______________________
Liam McGovern
Contracts Director
For Shay Murtagh Ltd
SHAY MURTAGH LTD
Raharney, Mullingar, Co. Westmeath Ireland
Telephone: (044) 9374108 Fax: (044) 9374552
Directors: J. Murtagh (Managing), D. Murtagh, B. Murtagh, L. McGovern, B. Surv, C. Murtagh B. Civ Eng., G. Murtagh
Company Registered in Ireland – Rgd. No. 54976
EPA Export 26-07-2013:00:39:48
Allergan IPPC Licence Application
Attachment H.2.A
Allergan
IPPC Licence Application
Attachment H.2 – Waste Handling
Co
ns
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Attachment H.2.A – Details of Waste Handling
EPA Export 26-07-2013:00:39:48
EPA Export 26-07-2013:00:39:48
ns
en
Waste Handling
1
Find below in Table B an outline of the arrangement for the storage of hazardous and non-hazardous wastes generated on site.
These waste streams are collected internally at the points of generation within the various Manufacturing areas such as Posurdex, Mementine,
Trivaris, Compounding, Botox manufacturing and laboratory areas and placed in UN approved containers suitable for the transportation and
shipment of this waste off-site for incineration at Indaver NV (Belgium) or AVG (Germany) facility.
H2.1 Hazardous Waste
ig pe
ht ct
ow ion
Disposal of each of these waste streams in terms of disposal or recovery
location and undertaker is addressed in the additional tables
ne method,
p
r r urp
inserted into IPPC application form. These additional tables include permit
and
licence
details for all waste contractors.
eq os
ui es
re o
d nl
fo yon
A copy of all waste licences and permits for each waste contractor is maintained
r a . site. Each hazardous waste shipment and the assigned waste
ny
container is audited for compliance with ADR requirements prior to sending hazardous
waste off site. Please find below in Table A: Names and
ot
he
permit/ licence of waste contractors.
ru
se
.
of F – Hazardous Waste Recovery/ Disposal, and Table H1(ii) Waste – Other
Each of the above waste streams are detailed in Table H1(i) Waste
co or
py in
Waste Recovery/ Disposal in the IPPC Application.
r s
t
Waste is generated within the facility on a continuous basis and can be broken down into :
- Hazardous waste for incineration
- Hazardous waste for recycling
- Non-hazardous waste to landfill
- Non-hazardous waste for recycling
Co
Attachment H2
Allergan IPPC Licence Application
EPA Export 26-07-2013:00:39:48
Hydrochloric acid
Other acids
Ammonium
Hydroxide
Sodium and potassium
hydroxide
Other bases
Wastes containing
mercury
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Description
Hazardous
Nature of waste
Disposal site
Waste contractor
2
AVG, Dr. Otte,
Indaver Irl, Tolka
Borigstrasse 2 DQuay, Dublin
22113, Hamburg,
Germany.
Co
ns
E2310/AVG-GENB
e
Incinerationnt o
AVG, Dr. Otte,
Indaver Irl, Tolka
f c Fo Borigstrasse 2 DQuay, Dublin
op r i
ns
yr 22113,
Hamburg,
ig pe
ht ct
Germany.
ow ion
E2310/AVG-GENB
n pu
Incineration
AVG,erDr.
Indaver Irl, Tolka
re rpOtte,
qu ose2 DBorigstrasse
Quay, Dublin
ire s o
d nl
22113, Hamburg,
fo y.
ra
Germany.
ny
E2310/AVG-GENB
o
Incineration
Indaver, B-2030 ther Indaver Irl, Tolka
us Quay, Dublin
antwerp, Belgium
e.
MLAVI/9800000485
Incineration
AVG, Dr. Otte,
Indaver Irl, Tolka
Borigstrasse 2 DQuay, Dublin
22113, Hamburg,
Germany.
E2310/AVG-GENB
Incineration
Indaver Relight NV,
Indaver Irl, Tolka
Molenweg - 9130
Quay, Dublin
Beveren, Belgium
46003/233/M/1/CH/av
Incineration
Disposal method
Table A : List of Waste Collection Permits and Waste Licences
Allergan IPPC Licence Application
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2 Indaver
Ireland/ Licence 36-2
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
EPA Waste Licence
Registration
Indaver Ireland/
Licence 36-2
CW029
CW029
CW029
CW029
CW029
Waste Collection
Permit
CW029
Waste Handling
EPA Export 26-07-2013:00:39:48
Aqueous washings
and other liquors
Organic halogenated
solvents
Other organic solvents
Solid wastes
containing dangerous
substances
Aqueous suspensions
containing paint or
varnish containing
organic solvents or
other dangerous
substances.
Hazardous
Hazardous
Hazardous
Hazardous
Description
Hazardous
Nature of waste
Allergan IPPC Licence Application
AVG, Dr. Otte,
Borigstrasse 2 D22113, Hamburg,
Germany.
E2310/AVG-GENB
Disposal site
Indaver Irl, Tolka
Quay, Dublin
Waste contractor
Incineration
3
Indaver, B-2030
antwerp, Belgium
MLAVI/9800000485
Indaver, B-2030
antwerp, Belgium
MLAVI/9800000485
Indaver Irl, Tolka
Quay, Dublin
Indaver, B-2030
antwerp, Belgium
MLAVI/9800000485
Co
Incineration
AVG, Dr. Otte,
Indaver Irl, Tolka
ns
en
Borigstrasse
2
DQuay, Dublin
to
f c Fo 22113, Hamburg,
op r i
ns
yr Germany.
p
igE2310/AVG-GENB
ht ect
i
o
w on B-2030
Incineration
Indaver,
Indaver Irl, Tolka
ne pu
antwerp,
Quay, Dublin
r r Belgium
rp
eq os
MLAVI/9800000485
ui es
re o
Incineration
AVG, Dr. Otte,
Indaver Irl, Tolka
d nl
f y.
Borigstrasse 2oDQuay, Dublin
ra
22113, Hamburg,ny
ot
he
Germany.
r
E2310/AVG-GENB use
.
Incineration
Disposal method
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
EPA Waste Licence
Registration
CW029
CW029
CW029
CW029
CW029
Waste Collection
Permit
Waste Handling
EPA Export 26-07-2013:00:39:48
Waste ink containing
dangerous substances
Other engine, gear and
lubricating oils
Other halogenated and
solvents and solvent
mixtures
Packaging
contaminated by
dangerous substances
Absorbants
contaminated by
dangerous substances
Hazardous
Hazardous
Hazardous
Hazardous
Description
Hazardous
Nature of waste
Allergan IPPC Licence Application
AVG, Dr. Otte,
Borigstrasse 2 D22113, Hamburg,
Germany.
E2310/AVG-GENB
Disposal site
Indaver Irl, Tolka
Quay, Dublin
Waste contractor
4
Indaver, B-2030
antwerp, Belgium
MLAVI/9800000485
ENVA. Clonminam
ENVA. Clonminam
Industrial Estate,
Industrial Estate,
Portlaoise, Co.Laois
Portlaoise, Co.Laois
Co
Incineration
AVG,
Dr.
Otte,
Indaver Irl, Tolka
ns
en
Borigstrasse
2
DQuay, Dublin
to
f c Fo 22113, Hamburg,
op r i
ns
yr Germany.
p
igE2310/AVG-GENB
ht ect
i
o
Incineration
AVG,
Indaver Irl, Tolka
w o,n Dr. Otte,
ne pu
Borigstrasse
Quay, Dublin
r r rp 2 Deq os
22113, Hamburg,
ui es
Germany. red on
fo ly.
E2310/AVG-GENB
ra
Indaver, B-2030 ny
o
antwerp, Belgium the
MLAVI/9800000485 r us
e.
Incineration
AVG, , Dr. Otte,
Indaver Irl, Tolka
Borigstrasse 2 DQuay, Dublin
22113, Hamburg,
Germany.
E2310/AVG-GENB
Recovery
Incineration
Disposal method
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
EPA Licence W018401
Indaver Ireland/
Licence 36-2
EPA Waste Licence
Registration
CW029
CW029
CW029
CW030
CW029
Waste Collection
Permit
Waste Handling
EPA Export 26-07-2013:00:39:48
Lab. Chemicals,
consisting of or
containing dangerous
substances, including
mixtures of lab
chemicals
Discarded inorganic
chemicals
Discarded organic
chemicals
Peroxides
Hazardous
Hazardous
Hazardous
Hazardous
Gases in pressure
containers
Description
Hazardous
Nature of waste
Allergan IPPC Licence Application
Disposal site
Waste contractor
5
Chemogas,Die Heer
Indaver Irl, Tolka
Adamo Pia
Quay, Dublin
Westvaarblj 85
1850 Grimleirgen
Belgium Licence
D/PMVC/05F09/0393
3
AVG, Dr. Otte,
Borigstrasse 2 DCo
22113, Hamburg,
ns
Germany.
en
to
f F E2310/AVG-GENB
Incineration cop orAVG,
, Dr. Otte,
Indaver Irl, Tolka
yr ins
pe
2 DQuay, Dublin
igBorigstrasse
ht ct
22113,
ow ionHamburg,
ne pu
Germany.
r r rp
E2310/AVG-GENB
eq os
ui es
re o
d nl
fo y.
Incineration
AVG, , Dr. Otte,
Indaver Irl, Tolka
ra
Borigstrasse 2 DQuay, Dublin
ny
22113, Hamburg, oth
er
Germany.
u
E2310/AVG-GENB se.
Incineration
AVG, Dr. Otte,
Indaver Irl, Tolka
Borigstrasse 2 DQuay, Dublin
22113, Hamburg,
Germany.
E2310/AVG-GENB
Incineration
AVG, Dr. Otte,
Indaver Irl, Tolka
Borigstrasse 2 DQuay, Dublin
22113, Hamburg,
Germany.
E2310/AVG-GENB
Incineration
Disposal method
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
EPA Waste Licence
Registration
Indaver Ireland/
Licence 36-2
CW029
CW029
CW029
CW029
Waste Collection
Permit
CW029
Waste Handling
EPA Export 26-07-2013:00:39:48
Oxidising substances
Acids (Municipal
wastes)
Fluorescent tubes and
other mercury
containing waste.
Batteries
Discarded electrical
and electronic
equipment.
Hazardous
Hazardous
Hazardous
Hazardous
Description
Hazardous
Nature of waste
Allergan IPPC Licence Application
Disposal site
Waste contractor
6
AVG, Dr. Otte,
Indaver Irl, Tolka
Borigtrasse 2 DQuay, Dublin
22113, Hamburg,
Germany.
E2310/AVG-GENB
Incineration
AVG, Dr. Otte,
Indaver Irl, Tolka
Borigstrasse 2 DQuay, Dublin
22113, Hamburg,
Co
Germany.
ns
E2310/AVG-GENB
en
Recovery t of F 1.Claushuis Metal,
Irish Lamp Ltd,
co or3899AH Zeewolde,
Kilkenny Rd, Athy,
py in
sp
rigHolland
Permit
Co. Kildare
ht ect
MB/00.091030/A
ow ion
ne pu Scrap
2.Midland
r r rp
eq os
Metal, Montmellick,
Co. Laoisuire es o
d n
WMP005 fo ly.
r
Recycling
KMK Metals, any
Irish Lamp Ltd,
ot
Tullamore, Co.Offaly
Kilkenny Rd, Athy,
h
EPA Licence 113-2 er u Co. Kildare
se
Recovery
KMK Metals,
.Irish Lamp Ltd,
Tullamore, Co.Offaly/ Kilkenny Rd, Athy,
EPA Licence 113-2/
Co. Kildare
2.
Rehab recycling Ltd
TechRec Ltd, 110
Parkmore Ind. Estate,
Trewmount Rd,
Ballybrit, Galway
Killyman,
Dungannon, BT71
7EF, NI
Licence ref.
LN/04/07/A
Incineration
Disposal method
Permit WR/121.
Waste Permit
02/2000A
Waste Permit
02/2000A
Waste Permit
02/2000A
Indaver Ireland/
Licence 36-2
Indaver Ireland/
Licence 36-2
EPA Waste Licence
Registration
CW190
CW095
CW095
CW095
CW029
CW029
Waste Collection
Permit
Waste Handling
EPA Export 26-07-2013:00:39:48
Non-hazardous
Hazardous
Nature of waste
Cardboard
Waste chemicals for
recovery – Sulphuric
acid
Description
Allergan IPPC Licence Application
nt
Recycling
Co
ns
e
Recovery
7
se
ru
he
ot
ENVA, Shannon,
Co.Clare.
EPA Licence W004101
Disposal site
of F
co or
py in
rig sp
ht ect
ow ion
ne pu
r r rp
eq os
ui es
re o
d nl
fo y.
ra
ny
Disposal method
Environmental
Agency – Waste
Management licence
510/04
Roydon Granulation
Ltd, St Helens,
WA9 3NA, UK
.
WR03-02
Permit PER228
EPA Licence W004101
EPA Waste Licence
Registration
Connacht Waste
Recycling, Hanley
Building,
Claregalway,
Co.Galway
Feoil Freight,
Balloor, Castlebar,
Co. Mayo.
ENVA Ltd,
Smithstown Industrial
Estate,
Shannon,
Co.Clare.
Waste contractor
CW77
CW75
CW016
Waste Collection
Permit
Waste Handling
EPA Export 26-07-2013:00:39:48
Drinks cans (Quantity
estimated)
Municipal waste
Waste printing toner
other than those
mentioned in 08 03 17
– ink cartridges
Wastes not otherwise
specified - Metals
Non-hazardous
Non-hazardous
Non hazardous
Non hazardous
Paper
Description
Non-hazardous
Nature of waste
Allergan IPPC Licence Application
Used in making arts &
crafts
Connacht Waste
Recycling, Hanley
Building,
Claregalway,
Co.Galway
WR03-02
Disposal site
Recycling
8
Various
Galway Metal Co.,
Oranmore, Galway
Waste Permit WR 054
CP004
N/A
CW002
Waste permit PER109
N/A
CW50
CP004
N/A
CW77
Waste Collection
Permit
Waste Permit PER92
Waste Permit WR 054
N/A
Castlebar Creative
Resources Centre,
John Moore Rd,
Castlebar, Co.Mayo
Galway Metal Co.,
Oranmore, Galway
WR03-02
EPA Waste Licence
Registration
Connacht Waste
Recycling, Hanley
Building,
Claregalway,
Co.Galway
Waste contractor
Bourke’s Waste,
Westport, Co.Mayo
McGraths Ltd,
Gortnafolla,
Castlebar, Co.Mayo
Temple St. Childrens
r u Hospital, Temple St,
se Dublin 1
.
to
f c Fo
op r i
Recycling
n
yr Various
ig spe
ht ct
ow ion
Disposal to landfill
Mayo
ne County
p
r r uLandfill,
r
Council,
eq pos
u
Newport, Co.Mayo
ire es o
n
EPA licencedW0021fo ly.
r
02
an
y
Recycling
N/A
ot
he
ns
en
Co
Recycling
Disposal method
Waste Handling
EPA Export 26-07-2013:00:39:48
Absorbents, filter
materials, wiping
cloths and protective
clothing other than
those mentioned in 15
02 02
Glass
Wood
Non-hazardous
Non-hazardous
Non-hazardous
Plastics (Plastic sold
as raw material not
waste)
Description
Non-hazardous
Nature of waste
Allergan IPPC Licence Application
Recycling
Recycling
ns
en
Recycling t of
Co
Recycling
Disposal method
9
Bourkes Waste Ltd,
Westport, Co.Mayo
Rehab Recycling Ltd,
Parkmore Ind. Estate,
Ballybrit, Galway
JL Goor Ltd,
95 Seapoint Ave
Monkstown
County Dublin
Ireland
Roydon Granulation,
St Helens, WA9
3NA, UK
Waste contractor
Wood Systems,
se Kilmaine Rd,
.
Ballinrobe, Co. Mayo.
Feoil Freight,
Balloor, Castlebar,
Co. Mayo.
Roydon Granulation,
St Helens, WA9 3NA,
UK
N/A
co For
py in
rig sp
ht ect
ow ion
ne pu
r r rp
eq os
ui es
Rehab Recycling
re o
d nl
fo y.
Plant, Ballymount,
ra
Dublin
ny
ot
WPR004
he
ru
N/A
N/A
Disposal site
CW181
CW75
N/A
Permit PER228
N/A
CW50
CW190
N/A
Waste Collection
Permit
N/A
Permit PER 208
Waste Permit PER92
Permit WR/121
N/A
EPA Waste Licence
Registration
Environmental
Agency – Waste
Management licence
510/04
Waste Handling
EPA Export 26-07-2013:00:39:48
Other bases
Wastes containing
mercury
Aqueous washings
and other liquors
Organic halogenated
solvents – Chlorinated
waste
Other organic solvents
– Non-chlorinated
waste; HPLC vials
Solid wastes
containing dangerous
substances including
Botox contaminated
waste; tabletting waste
Aqueous suspensions
containing paint or
varnish containing
organic solvents or
other dangerous
substances.
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Other acids –
Corrosive waste
Ammonium
Hydroxide
Sodium and potassium
hydroxide
Description
Hydrochloric acid
Hazardous
Nature of waste
Hazardous
Table B : Waste Disposal Arrangements
Allergan IPPC Licence Application
Storage Location
Hazardous Chemical cabinet
3&4
Hazardous Chemical cabinet
3&4
Hazardous Chemical cabinet
3&4
Hazardous Chemical cabinet
3&4
UN Approved drum
10
Hazardous Chemical cabinet
3&4
C
UN Approvedondrum
Hazardous Chemical cabinet
se
nt
3&4
o
UN Approved drumf co ForHazardous Chemical cabinet
py in
rig3 s&
p 4
ht ect
UN Approved drum
Hazardous
Chemical cabinet
o io
3 &wn4 n p
er ur
re pChemical
UN Approved drum
Hazardous
cabinet
qu ose
ire s o
3&4
d nl
fo y.
ra
ny cabinet
UN Approved drum
Hazardous Chemical
ot
3&4
he
ru
se
.
UN Approved drum
Hazardous Chemical cabinet
3&4
UN Approved drum
UN Approved drum
UN Approved drum
Storage Container
UN Approved drum
08 01 19
07 05 13
07 05 04
07 05 03
07 05 01
06 04 04
06 02 05
06 02 04
06 02 03
06 01 06
EWC
06 01 02
Ongoing (Process
related)
Ongoing (Process
related)
Ongoing
Ongoing
Ongoing (Process
related)
Ongoing (Process
related)
Ongoing
Ongoing
Ongoing
Period of generation
Ongoing (Process
related)
Ongoing
Waste Handling
EPA Export 26-07-2013:00:39:48
Other engine, gear and
lubricating oils
Other halogenated and
solvents and solvent
mixtures
Packaging
contaminated by
dangerous substances
– Glass vials, caps and
stoppers
Absorbants
contaminated by
dangerous substances
– lab wipes, spill kits
Gases in pressure
containers – aerosols,
gas cylinders
Lab. Chemicals,
consisting of or
containing dangerous
substances, including
mixtures of lab
chemicals
Discarded inorganic
chemicals
Discarded organic
chemicals
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Waste ink containing
dangerous substances
Description
Hazardous
Nature of waste
Allergan IPPC Licence Application
UN Approved drum
UN Approved drum
11
Hazardous Chemical cabinet
3&4
Hazardous Chemical cabinet
3&4
16 05 08
16 05 07
16 05 06
16 05 04
15 02 02
15 01 10
Co drum
UN Approved
Hazardous Chemical cabinet
ns
3&4
en
to
f c Fo
op r i
yr ns
ig pe
ht ct
UN Approved drum
Hazardous
ow ion Chemical cabinet
3 & n4e pu
r r rp
eq os
ui es
re o
d nl
fo y. cabinet
UN Approved drum
Hazardous Chemical
ra
3&4
ny
ot
h
ru
UN Approved drum
Hazardous Chemical ecabinet
se
3&4
.
13 08 99
08 03 12
EWC
14 06 02
Maintenance Workshop
storage area
Hazardous Chemical cabinet
3&4
Storage Location
Hazardous Chemical cabinet
3&4
UN Approved drum
Bunded 200L UN
Approved drum
UN Approved drum
Storage Container
Periodic
Periodic
Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
Period of generation
Waste Handling
EPA Export 26-07-2013:00:39:48
Peroxides
Oxidising substances
Acids (Municipal
wastes)
Fluorescent tubes and
other mercury
containing waste.
Batteries
Discarded electrical
and electronic
equipment.
Cardboard
Paper
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Drinks cans (Quantity
estimated)
Municipal waste
Waste printing toner
other than those
mentioned in 08 03 17
– ink cartridges
Non-hazardous
Non-hazardous
Non hazardous
Non-hazardous
Non-hazardous
Hazardous
Description
Nature of waste
Allergan IPPC Licence Application
Hazardous Chemical cabinet
3&4
Hazardous Chemical cabinet
3&4
Final Storage Location
Designated container
in office areas and
then packed off
Bunded general waste
bins
Designated bins
12
Pallet/Truck shed (Pharma)
Botox Bin Storage Area
(Botox)
Pharma Chemical Store
Recycling centres – Botox &
Pharma
UN Approved drum
Hazardous Chemical cabinet
Co
3&4
ns
en
Lamp coffin
Pallet/ Truck shed
to
f c Fo
op r i
yr ns
ig pe
ht ct
Battery box
Maintenance,
Botox
ow ion centre, Pharma
recycling
ne pu
r r rcentre.
recycling
eq pos
WEEE storage
Pallet/ Truck
ui eshed
re s o
d nl
container/triwall
fo y.
ra
n
Bales
Pallet/Truck shedy o
th
er
Paper recycling bins
Pallet/Truck shed (Pharma)
us
e.
(Botox and Pharma)
Recycling centre (Botox)
UN Approved drum
UN Approved drum
Storage Container
08 03 18
20 01 40
20 01 01
20 01 01
20 01 35
20 01 33
20 01 21
20 01 14
16 09 04
16 09 04
EWC
Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
Periodic
Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
Period of generation
Waste Handling
EPA Export 26-07-2013:00:39:48
Wastes not otherwise
specified - Metals
Plastics (Plastic sold
as raw material not
waste)
Non hazardous
Wood
Non-hazardous
Non-hazardous
Absorbents, filter
materials, wiping
cloths and protective
clothing other than
those mentioned in 15
02 02
Glass
Non-hazardous
Non-hazardous
Description
Nature of waste
Allergan IPPC Licence Application
ns
en
Co
Truck shed
Near receiving/shipping
dock
Truck shed
Final Storage Location
13
to
f c Fo
o ri
n
Recycling wheely binspyr Truck
shed (Pharma)
ig spe
ht ct
Recycling
Centre (Botox)
ow ion
N/A
Truck
ne shed
p where loaded
r r urp
onto truck
eq os
ui es
re o
d nl
fo y.
ra
ny
ot
he
ru
se
.
Baled
Baled
Waste skip
Storage Container
20 01 38
20 01 02
15 02 03
n/a
12 01 99
EWC
Ongoing
Ongoing
Ongoing (Process
related)
Ongoing
Ongoing
Period of generation
Waste Handling