Union
New Jersey
Prepared by
E. Ferguson
EXTRACT
TECHNOLOGY
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
CLS Ref: Q16399 (Rev IV)
10 February, 2004
For the attention of Tracee Wright
Schering Plough
1700 Galloping Hill Road
Rondell Building -20
Kenilworth, NJ 07033
Telephone 908 298 5546
Dear Tracee,
RE:
Solvent Booth Package
Drum Storage Building in Union, NJ
Thank you for your continued interest in Carlisle Life Sciences. Extract is pleased to provide
you with our revision 4 Proposal Q16399 for your review and consideration.
Please refer to layout drawing Q16399-(GA2). This drawing illustrates the dimensions and
arrangement of our Downflow booth, sliding doors, conveyors, turntable and raised internal
flooring.
We trust we have interpreted all your requirements correctly and we look forward to further
discussions in the very near future.
Should you have any questions or require additional information, please do not hesitate to
contact us.
Very truly yours,
Joseph W. Schirmer, CSE
CLS
Main Office: 618 State Street, New Lisbon, WI 53950 Tel.: 800-356-5734 Fax: 608-562-5956
East Coast Office: 79 Veronica Avenue, Somerset, NJ 08873 Tel.: 732-873-4100 Fax: 732-873-4111
E-mail: Info@carlislelifesciences.com Internet: www.carlislelifesciences.com
-1-
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
EXTRACT TECHNOLOGY LIMITED
DOWNFLOW SINGLE PASS SOLVENT BOOTH
TECHNICAL SPECIFICATION
Client:
Schering Plough
Site:
Union, NJ
ETL Ref No.:
Q16399 (Rev4)
Qty
Description
Building
1
2.5m wide DX 6/9/12B
Single Pass Downflow Solvent Booth
W/ Sliding Doors, Conveyors and Turntable
Drum Storage Building
Union, NJ

Dust in Air Level:- Operator Exposure Level (OEL) 50 - 100 µg/m³ TWA over operation
period. All OEL’s are dependent upon the operators following Carlisle Life Sciences
operator training practises and safe working methods.

Airflow Management:- Single pass airflow with Downflow velocity of
0.5m/s (98 fpm) +/- 10%, circa 750 ACH (Air Changes per Hour)

Noise Levels:- Below 78dBA (free field subject to building / surrounding area) within the
booth work area, 1.0m away from rear bulkhead.

Lighting Levels:- Lighting levels 1.0m above floor level within the working area would be
250 Lux. A standard safety feature ensures that the lights do not operate without the fan
running.

Booth Air Temperature Control:- Due to the single pass system, no control systems are
required to offset the temperature and humidity.
-2-
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
Typical airflow movement
within downflow booth or
workstation. Excellent
containment levels achieved
by combining downflow over
operation with rear exhaust
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Guaranteed operator
exposure levels (O.E.L).
Flexibility to individual client
needs.
Potential dust sources
suppressed by downflow air.
Integrated mechanical
handling devices.
Proven solutions worldwide.
Dispensing, Sampling,
charging operations.
Personnel/material airlock
integration.
Designed and manufactured
to latest cGMP standards.
Complimented with full
DQ/IQ/OQ validation package.
Fully integrated with surrounding
environment.
Temperature controlled work area.
On board filtration package,
including safe change.
Low operating maintenance costs.
-3-
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
EQUIPMENT PROVIDED
One 2.5m DX Single Pass Solvent Booth
Special Features
The following special features have been incorporated within the booth design to provide a
purpose designed system:A
“Closed loop” control system automatically increases fan speed to compensate for filter
blockage.
B
Base plinth, 100mm (4") high in stainless steel below technical stack and sidewalls.
10mm (3/8") recess around internal faces to allow for coving. Coving supplied and
fitted by client
C
Sprinkler penetration through ceiling plenum c/w sealed tube welded in place. All
pipes and nozzles by client
D
Rear Bulkhead, Interior and Exterior walls in 304 grade Stainless Steel
E
Code 12B Filtration, which incorporates Fine Dust Filters in Safe Change Housings, midstage HEPA filters in Safe Change Housings and ceiling mounted HEPA Filters
F
Exhaust Fan and Motor
G
Supply air (4964 CFM) duct work to ceiling plenum excluded from Carlisle Life Sciences
scope of supply
H
Internal ceiling height of 8’-6” to accommodate sliding doors
I
All internal electrics, RHS roller conveyor and booth motor to be Class I Div 2 rated
J
Two, (2) electrically automated St. St. sliding doors vision panel. Door on RHS –
looking in- to be class 1 div 2 rated. Door on LHS- looking in, to not be electrically
rated as motor will be outside of booth in safe area.
K
Extended and structurally reinforced side panels to accommodate weight and size of
sliding doors
L
XP rated Audible and Visual Alarm panel for all gauges inside the booth
Optional Features
The following Optional features are priced out separately in the cost section:1
Electrically automated rollers to aid manoeuvre of pallets entering and exiting the
booth. Electrically automated pallet turntable with automated rollers to rotate and
position the pallets within the booths work area. Also includes raised flooring to
elevate operator allowing ergonomic access to the drums on the pallet.
-4-
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
STANDARD SPECIFICATION
DOWNFLOW BOOTH CONSTRUCTION : CODE 6S
Item
No.
MATERIAL
COMPONENT
Zintec - Epoxy
Powder Coated
White
304 Stainless
Steel - 240S Finish
1
Wall Panels
Yes
2
Infill Skins
Yes
3
Rear Bulkhead
Yes
4
Downflow Workbench
N/A
5
Spillage Trays
Exhaust Plates
(Magnetic Fixing)
Exhaust Plates
(Bolted Fixing)
Exhaust Plenum
N/A
6
6
7
8
9
10
11
Filter Housings
Return Air Duct c/w Internal
Acoustic Foam
Overhead Supply
Plenum/Panels
Floor Plinth
Yes
N/A
Yes
Yes
Yes
Yes
Yes
-5-
316L Stainless
Steel - 240S Finish
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
STANDARD SPECIFICATION
DRIVE AND ELECTRICAL CODE 9 : 460V 60Hz 3ph +E
FAN TYPE
Construction: Fan
: Housing
Duplex double inlet double width centrifugal directly driven
Galvanised sheet steel with anti-spark copper end plates
Epoxy coated aluminium frame complete with epoxy coated
zintec sheet enclosure panels.
MOTOR
Motor 460V 4 pole. TEFC Explosion Proof Class I Group C
& D, Class II Group F & G T3 complete with thermal
protectors. Inverter Duty for variable torque application.
FAN SPEED
CONTROL
Fan speed can be adjusted to suit filter condition via the
frequency inverter located in main control panel.
LIGHTS
Location
120v Twin fluorescent (PL tube) fitting for hazardous
locations Class I Div.1/2 - Groups C + D
Class II Div.1/2 - Groups E, F + G
Mounted behind acrylic diffuser in rear bulkhead
MAIN CONTROL PANEL
Location
Electrical control panel rated
NEMA 12
Remote sited in Safe Area. Not on booth chassis.
LOCAL OPERATOR STATION
The local operator station consists of : Explosion proof
surface mounted unit complete with stop / start pushbutton.
UL approved Class I Div 1 and DW2. Class II Div 1 and Div
2. Class III NEMA 4 X. Extended operator functions are
available - see special features section if applicable.
POWER RECEPTACLES
None included
MOTOR DISCONNECT SWITCH
Location
Adjacent to motor
INSTRUMENTATION
Pressure transmitter / pressure switches - for inclusion see
special features section if applicable.
WIRING HARNESS
Located 25 feet or less away
from booth
The booth will be wired from the ETL control panel to all
electrical components supplied by ETL, this includes:
Lights, motor and local operator station. Site reconnections
by Extract Technology.
The above electrical equipment requires a supply of:
460V, 3 phase, 60Hz, earth.
Mains connection to the booth control panel is
excluded from our scope of supply
-6-
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
STANDARD SPECIFICATION
FILTRATION CODE 12B
Three stage filtration with “safe change” Fine Dust & HEPA filters, and ceiling
mounted HEPA Filters for Recirculatory airflow
SUPPLY AIR
Volume:
By Client’s System
8434 m3/hr (4964 CFM)
SUPPLY AIR FILTER
Ceiling HEPA Filter
Efficiency :
- EN1822
- IES-RP-CC001.3 (HEPA & ULPA)
Classification:
- EN1822
- IES-RP-CC001.3
FIRST STAGE
Efficiency :
- Ashrae 52.76 & EN779
Classification :
- EN779
Case Construction :
SECOND STAGE
Efficiency :
- EN1822
- Sodium Flame to Ashrae 52.76
Classification :
- EN1822
Case Construction :
On site testing :
EXHAUST AIR
Volume:
INSTRUMENTATION
Option for Visual and Audible
Alarms on all Gauges
99.995% minimum to MPPS
99.999% minimum on 0.3 micron
H14
Type 'D'
Anodised aluminium with gel seal location
Epoxy coated to both sides of filter
Filter integrity may be tested on site to 0.01% penetration
High capacity Fine Dust Filter
safe change type : bag-in / bag-out
93%
F8
Galvanised Steel case complete with EPDM seal.
Mid Stage HEPA Filter – safe change type : bag-in / bag-out
99.995%
99.997%
H13
Galvanised Steel case complete with EPDM seal.
Ability to carry out filter integrity testing after HEPA Filter to
0.03% penetration.
To be exhausted to Client’s System
8855 m3/hr (5212 CFM)
Magnehelic differential pressure gauges. Easy to read 120mm
gauges marked up with red and green safe work segments to
monitor:
(i)
Supply airflow
(i)
Exhaust airflow
(ii)
Fine dust filter condition
(iii)
HEPA filter condition
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Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
POWERED, AUTOMATED ROLLER CONEYORS AND TURNTABLE
Product Flow through
Conveyors and
Turntable
The proposed line comprises of one LHS infeed conveyor to a booth
conveyor. This is positioned directly before the turntable. After sampling,
discharge is directly to an outfeed conveyor to the warehouse.
Support Floor
Due to the height of the conveyors, a 2415mm x 3310mm floor elevates the
operator to allow ergonomic access to the drums. Floor is manufactured
using aluminium chequer plate for the decking and 304-grade stainless steel
for the support frame
Pallet Size
The pallets have been considered as 1200 mm x 1200 mm with a maximum
load of up to 1000 kg.
Roller Dimensions
The rollers would be 76.2 mm (3") diameter on a 303.2 mm (8") pitch.
Length
Infeed Conveyor - Nominally 4 foot 8 inch powered section
Booth Entry Conveyor - Nominally 2 foot powered section
Turntable - Nominally 6 foot diameter with powered deck
Discharge Conveyor - Nominally 4 foot 8 inch powered section
Other Dimensions
Width: Nominally 4' 2" inside frame
Rollers: 3" diameter on a 8" pitch
Height: 16" to top of roller
General Construction
304-grade stainless steel for all internal conveyors and turntable.
LHS infeed and RHS discharge conveyors to be coated, mild steel
Finish: Dull polished
Drives
Suitably rated, Leeson/Motovario, geared motor units to NEMA standard and
US electrical specification Class 1, Div. 1, Groups C& D and Class 2, Div. 2,
Groups F & G within the booth and on the RHS discharge conveyor.
Non hazardous area motor on LHS infeed conveyor
Supply: 480 V, 3 phase, 60 Hz - to be confirmed
Speed: 36 feet per minute - to be confirmed
Controls: Included
Notes
Includes covers over any foot adjustment studding within booth.
Includes covers over motors within booth.
Turntable designed with slip-ring arrangement to enable continuous rotation
by 90-degree increments. However due to the nature of this design, hose
down of turntable is not permissible.
-8-
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
POWERED, AUTOMATED SLIDING DOORS (2 TOTAL)
Product Flow through
Sliding doors
A pallet on the infeed conveyor will pass though a sensor on the LHS Sliding
door, causing the door to open. Once the pallet in passed to the Booth entry
conveyor and then onto the turntable, the LHS sliding door will shut. When
all sampling operations are finished with the drums inside the booth, the
pallet on the turntable will activate the RHS sliding door to open. Once
though to the Discharge conveyor, the RHS sliding door will close. Doors
may be manually activated by push to open/close switches. Note: door
control panels to be remotely located in safe area.
Door Opening
5’ 5”W x 8’ 0” H
Electrical
Classification
RHS Sliding (looking into booth) door will have Class 1 Div 2 rated motor,
sensors and switches
LHS Sliding (looking into booth) door will have Class 1 Div 2 rated sensors
and switches only. Door motor will not be electrically rated.
120 V or 220 V A.C., single phase with a 24 volt control circuit
Vision Panels
24” x 36” laminates safety glass
Construction
20 Ga., 304 #3/#4 Stainless Steel Door Panels with welded construction
Kraft honeycomb core or urethane foam core as selected
12 ga. Carbon steel tubular steel interior framing
14 gauge stainless steel capping channels
Track hood, header and jamb casing all stainless steel 304 #3/#4 finish
Full perimeter neoprene seals
-9-
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
Equipment Cost Schedule
Our price for the equipment proposed is set out below and this includes an English language
Operation Manual:One (1) 2.5m DX Single Pass Downflow Solvent Booth as per
Drawing: Q16399-GA2 including two automated sliding doors, all
controls and alarm panel for the internal gauges. Price excludes roller
conveyors, turntable and raised flooring
$ 117,488
Roller Track & Conveyors/Turntable and raised flooring including all
controls and integration costs
$ 91,332
Factory Acceptance Test Report Sent to Schering prior to Equipment
Shipment
$ Included
Packing of all equipment suitable for sea freight
$ 4,915
DDP delivery to site for all equipment
$ At Cost + 10%
Supervision of installation by one CLS Engineer charged at $1,200/day
including travel, accommodation and expenses but precluding airfare.
Estimated at 5 days total ($6,000 estimate)
$ Actual Days to
be Invoiced
On site commissioning and operator training by one CLS Engineer
charged at $1,200/day including travel and accommodation.
Estimated at 3 day total ($3,600 estimate)
$ Actual Days to
be Invoiced
IQ/OQ Documentation
$ 2,540
THE ABOVE PRICES ARE IN US DOLLAR AND ARE VALID FOR 60 DAYS
- 10 -
Client : Schering Plough
Site: Union, NJ
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
General Conditions of Contract
Documentation Schedule
The following documents have been included within the scope of the specified equipment:
Provided by
Carlisle Life
Sciences
Quantity
Yes
1
Equipment General Arrangement (GA) Drawings
Yes
1
Hardware Design Specification
Yes
1
Pneumatic & Electrical Schematic Drawings
Yes
1
Yes
1
Yes
1
Yes
1
Description
As Ordered Specification / Functional Requirement
Specification (FRS)
Quality Plan
Factory Acceptance Test (FAT) and FAT report
Installation Qualification (IQ) documentation and site
execution
Operational Qualification (OQ) documentation and site
execution (includes commissioning report)
Commissioning Report (Not required if IQ/OQ is ordered)
Equipment Data Book, including Operation and
Maintenance (O&M) Manual. (hard copy)
O&M manual (soft copy)
Site validation / Operator Exposure Level (OEL) proving
report
NOTE:
All documentation purchased will be to our standard format unless
specifically detailed within special features of quotation.
We will provide one equipment data book, which includes a section for the operation and
maintenance manual.
The equipment data book will contain all relevant material certification. Stainless steel mill
certificates will be provided for product contact parts only (if requested at purchase order
placement), these being hoppers, chutes, cones, etc.
- 11 -
Client : Schering Plough
Site: Union, NJ
1.
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
Delivery Date
Delivery dates will be agreed between ourselves and the client. Following order placement a
detailed programme will be issued highlighting key milestones within the contract schedule.
2.
Terms of Payment
Our standard terms of payment are as follows:
Equipment:
20% of equipment value due with order placement
20% of equipment value with GA drawing approval
60% of equipment value plus all packing and delivery charges due with goods ready for delivery
Site Services:
100% of installation charges due with completion of installation (or 30 days from delivery if
delayed by client)
100% of commissioning charges due with completion of commissioning (or 60 days from delivery
if delayed by client)
Note: Client requested delays to delivery, installation or commissioning will result in
invoices being issued on original programmed dates.
3.
Project Engineers Site Visits
We have included for 1 visit by our Project Engineer.
Additional visits will be changeable at the current rate
4.
Factory Acceptance Tests (FAT)
This quotation does not include for a witnessed FAT of the specified equipment. This may be
arranged at an additional price. If a full FAT is purchased then this would normally consist of the
following:
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GA drawing review/verification.
Functionality testing as required
Airflow velocity test
Smoke containment test
Light level check
Noise level check
Documentation status review
Site requirement review
Dust in air testing / verification - optional at extra cost
- 12 -
Client : Schering Plough
Site: Union, NJ
5.
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
Mechanical Site Installation
We can only commence site assembly when the work area is clean and dust free. Dust may
contaminate the equipment sealing systems and filters, which could necessitate additional parts /
filters, etc being required to ensure satisfactory operation. This would be chargeable. A preinstallation checklist will be issued prior to installation allowing you to confirm site readiness.
Supervision of Installation on site has been estimated for a total of 5 man days (8 hours per day)
depending on option taken. Should site condition delay the installation, we will charge lost hours
at the current rate.
Should we be unable to install the filters or ceiling screens due to site conditions, we reserve the
right to charge for a return visit. Alternatively we may charge for additional site time during the
commissioning / start up activities to carry out this work.
6.
Equipment Commissioning
Commissioning is planned to take place following completion of all client / sub-contractor
interfaces with our equipment. A pre-commissioning checklist will be issued after installation
allowing you to confirm site readiness.
Commissioning on site has been costed for a total of 3 man-days (8 hours per day). Should site
conditions delay the commissioning, we will charge lost hours at the current rate.
7.
Operator Training
Operator and maintenance training would be carried out on the same visit as equipment
commissioning.
Special training such as Operator Exposure Limit (OEL) verification, is subject to an additional
price.
8.
Variation Orders
Variation orders that are agreed during the contract life cycle must be raised promptly to avoid
delay in delivery / completion. Failure to provide written acceptance may postpone release of
goods.
9.
Client Requested Design Changes
This quotation is based upon the specification and designs attached. Should the client request
layout or specification changes after placement of purchase order we reserve the right to make a
charge for additional design labour or materials associated with the required changes.
Where a mock-up is provided for design review this mock-up represents the concept developed
during our discussions with the project team. Where a purchase order has been placed for this
design and the resultant mock up is found to require changes (at the client's request) then we will
charge the additional materials and labour at the current rates.
- 13 -
Client : Schering Plough
Site: Union, NJ
10.
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
Delivery To Site
The goods will be packed in bubble film or crated and delivered generally to coincide with the
arrival of our installation engineers. This allows direct offloading and moving the equipment to
the final location.
11.
Hazardous Area Certification
All ETL designs are compliant to the EC Machinery Directive – (98/37/EC), Low Voltage
Directive (73/23/EEC) and EMC Directive (89/336/EEC). Also harmonized standards EN292
pt 1:1991, EN292 pt 2:1991 and EN60204-1:1998 outlined in our CE Declaration of
Conformity.
Non European designs/projects shall also be based on the above standards.
Alternatives can be accommodated for National technical standards/specifications and client
site standards upon request. (eg: UL, CSA)
12.
Dispersed Oil Particulate (DOP) Filter Integrity Testing
Filter integrity testing and certification to the relevant standard is available, and subject to an
additional price. Exclusions of DOP testing during the commissioning engineers visit invalidates
any claims regarding filter damage or leakage arising after our commissioning.
We reserve the right to charge for return visits to site and delivery of commissioning spares
should DOP be carried out by a third party after the main commissioning visit.
13.
Storage
In the event of goods being stored at our premises due to programme delays not of our making
we reserve the right to charge for storage at the current rate.
14.
Cancellation Charges
15.
In the event of order cancellation after order placement, we reserve the right to charge 10% of
order value or for all work carried out whichever is the greater amount, calculated on our
standard hourly rates and usage of materials.
Duty
The above costs include for duties and taxes.
- 14 -
Client : Schering Plough
Site: Union, NJ
16.
Q16399 (Rev4)
Date: 10 Feb 2004
ETL Engineer: Eric Ferguson
Exclusions : Work Not Included In ETL Scope Of Supply
a. Electrical connection to mains supply and all site wiring unless specifically
mentioned.
b. Building work, pipe fitters work or any other work not of our trade.
c. Overtime working or work carried out at premium rates.
d. Cranage and scaffolding unless specifically mentioned.
e. We exclude all validation services unless specifically detailed in our proposal. This
includes validation of computers, Programmable Logic Controller’s (PLC's) and
weighing systems. Please advise in writing specific requirements for additional
validation work required.
f. Verification of field “safe work loads” from vendors equipment unless specifically
mentioned.
g. Scale set up and testing on site. (Should be provided at owners cost using local
contractor unless specifically mentioned.)
If you require further clarification of our scope of supply or details of work to be carried out by a
third party contractor i.e. electrical / plumbing etc please contact our offices. Unless questions
are raised prior to order we will assume our offer has been accepted and third party contractors
have been organised by others.
17.
Validity
This quotation is valid for a period of 60 days from the above date.
18.
Conditions Of Sale
This offer is subject to our standard conditions of sale.
19.
Warranty
Should any defect or failure arise in the equipment supplied within 12 months of
commissioning or handover of the equipment or within 18 months from delivery, whichever is
the sooner, we will repair or replace the parts.
No guarantees are made regarding expected filter life.
The above guarantee is subject to the provision that no liability can be accepted for defects
caused by using the equipment outside the limits of specification for which it was designed.
We cannot accept any responsibility if failure of the equipment / component is due to neglect
or inadequate service work carried out by a third party.
- 15 -