Order Confirmation
September 7, 2001
Aspire Pharmaceuticals, Inc.
2915 Weston Road
Weston, FL 33331
ATTENTION: Saul Bautista
ASPIRE PHARMACEUTICALS, INC.
&
NIRO PHARMA SYSTEMS
FLUID BED MULTI-PROCESSOR SYSTEMS
400 liter
Order Confirmation 01113.1520
Rev 01
REGIONAL SALES MANAGER: Joseph S. Voss
Niro Pharma Systems (NPS)
Aspire
TABLE OF CONTENTS
1
EXTENT OF DELIVERY .......................................................................................... 3
2
PRICING .................................................................................................................. 3
3
TERMS OF PAYMENT ............................................................................................ 4
4
DELIVERY ............................................................................................................... 4
5
CANCELLATION OR DELAYS ................................................................................ 4
6
TERMS AND CONDITIONS .................................................................................... 4
7
400 LITER MP EQUIPMENT DESCRIPTION .......................................................... 5
8
TECHNICAL DATA SHEETS ................................................................................. 16
9
VALIDATION-SUPPORT PROGRAM & ENGINEERING SERVICES .................. 18
10 ITEMS NOT INCLUDED IN OUR ORDER ............................................................. 21
11 NIRO INC. - STANDARD, FIELD-SERVICE TERMS & RATES ............................ 22
APPENDICES
A.
APPROVAL SIGNATURES
B.
NIRO TERMS AND CONDITIONS
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1 EXTENT OF DELIVERY
Niro Pharma Systems, Fluid Bed Multi-Processor Systems
 400-liter MP as described in this Order Confirmation.
The Niro Pharma Systems proposal number 2001.0061 date printed 15-MAR-01
and Aspire RFQ, Rev.01 date printed 26-FEB-01 are the basis for this Order
Confirmation.
2 PRICING
400 liter MP Base System Price
$
431,000.00
2.1.1 Solution Delivery System
Added to the Base Price
$
24,040.00
2.1.2 Dehumidification and Humidification (future) of Inlet Air
Added to the Base Price
$
25,735.00
2.1.3 Exhaust HEPA Housing/Filters
Added to the Base Price
$
6,200.00
2.1.4 Un-interuptable Power Supply (UPS)
Added to the Base Price
$
5,106.00
2.1.5 Post Hoist Bowl Inverter
Add to the Base Price
$
58,500.00
2.1.6 Installation Inspection
Added to the Base Price
$
6,107.00
2.1.7 Start-up Assistance
Added to the Base Price
$
9,031.00
2.1.8 Training
Added to the Base Price
$
10,756.00
2.1
Optional Equipment
All prices are U.S. Dollars.
All equipment is CIP Aspire Pharmaceuticals, Weston Florida
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3 TERMS OF PAYMENT
30% of the contract will be invoiced upon receipt of the purchase order.
60% of the contract will be invoiced upon shipment of the main components of
the system.
5%
of the contract will be invoiced upon submittal of all documentation
required by the contract.
5%
of the contract will be invoiced upon mechanical start-up of the system or
four months after delivery of the equipment, whichever comes first.
Finance charges will be assessed monthly at the rate of 1.5% on the outstanding
amount due to Niro Inc. by terms of payment stated above.
4 DELIVERY
Delivery is anticipated as February 20, 2002 based BASED on customerapproval of P&ID, General Arrangement and Processor Outline Drawings (i.e all
technical details – enabling us to commence manufacture by September 7,
2001.
5 CANCELLATION OR DELAYS
If the work involved in this contract is cancelled or deferred until a later date, it is
understood that Niro Inc. will be paid in full for the part of the contract then
completed with no percentage to be retained.
6 TERMS AND CONDITIONS
Niro Inc.’s Terms and Conditions are made a part of this Order confirmation in
the Appendix.
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7 400 liter MP EQUIPMENT DESCRIPTION
7.1
Air Preparation Unit (APU)
The Air Preparation Unit is constructed for remote, interior installation and has a
horizontal configuration. The assembly has double-walled, insulated construction
with 304 stainless steel interior and painted steel outer cladding. For ease of
installation, the unit is mounted on a carbon-steel channel base.
Inlet Pre-Filter Section
This section includes 30% pre-filters and 85% medium-efficiency filters. Both sets
of filters are side-loading and are accessible by removing access panels on one
side of the housing. Monitoring of the pressure drop across the inlet filters is by
differential pressure switch, and visible notification is incorporated into the control
system.
Pre-Heating Section – Future
A section has been reserved in the air preparation unit for the future addition of a
pre heating coil. No coil is included.
Humidification Section – Future
A section has been reserved in the air preparation unit for the future addition of a
moisture addition spray bar. Section comes complete with a drain and sight
window. No spray bar is included.
Dehumidification Section
This section includes a cooling coil and mist eliminator screen as well as a drain.
The control system will modulate the chilled water supply to the coil.
Heating Section (Hot Water)
This section includes a hot water heating coil. The hot water is used to bring the
air temperature up from ambient. Control will be via modulating control valve.
Final Heating Section (Electric)
A final electric heating section is provided to heat the incoming air up to the
desired process temperature.
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Inlet HEPA Section
A HEPA filter section with a gel-sealing mechanism is provided on the air
exhaust side of the system. The 2 HEPA filters are 99.97% DOP efficiency,
separatorless type, with galvaneal outer frames. Monitoring of the pressure drop
across the filters is by differential pressure switch and visible notification is
incorporated into the control system.
General
Note: See “Technical Data” later in this Order Confirmation for more information.
Access sections with doors are provided as necessary on one side of the APU. A
304 stainless steel transition is provided on the inlet and outlet to connect the
APU to customer-supplied ductwork. . Mating flanges are provided by NPS.
The total length of ductwork between the air preparation unit outlet transition
cone and the FBD inlet plenum mating flange must be a maximum of ten (10)
meters to minimize heat losses.
All ductwork (inc. supports and insulation) connecting the air preparation unit to
the FBD’s inlet plenum is furnished and installed by others. Nuts, bolts and
washers connecting the inlet ductwork, inlet air damper, inlet airflow element,
inlet deflagration containment valve (opt) and other ductwork related hardware
will be furnished and installed by others.
7.1.1 Air Bypass
Air Bypass is included in the design and will include one (1) butterfly-style,
modulating valve and one (1) airflow element to be installed in the customersupplied ductwork. Modulating the by-pass airflow allows the incoming air to
partially or fully by-pass the fluid bed processor. This feature can be used for preconditioning of the incoming air to process conditions before it enters the product
container, or to allow for reduced air volume. In Bypass Mode, this will maintain
high-efficiency operation of the APU coil(s) at maximum airflow during extended
“turndown” (typically required for most PC - bottom-spray coating - applications).
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7.2
Aspire
Fluid Bed Multi-Processor
One (1) 400 liter Fluid Bed Multi-Processor constructed in 10 bar deflagration,
shock pressure resistant (SPR) execution – separate deflagration relief venting is
not required resulting in a significant cost savings to the customer
Note: See “Materials of Construction and Finish Configuration” later in this Order
Confirmation for more information.
The processor body has a welded construction design, free of ledges and sills
where the product can collect. The Niro-Pharma Systems’s fluid bed processor
design meets current Good Manufacturing Practices (cGMP).
7.2.1 Inlet Plenum
The inlet plenum is positioned below the product container to receive conditioned
inlet air. It is supported by a welded connection to the two main support
stanchions on either side of the processor at the back of the unit. Pneumatic
connections plate(s) are mounted on the rear of a stanchion. Fittings and tubing
are Metric. Additional support is provided by smaller support legs at the front of
the plenum.
The inlet plenum has a low profile design free from ribs or channels and is raised
off the floor for easy cleaning beneath the unit. To provide for complete drainage
during wash down, the bottom of the plenum is pitched toward a flush-mounted,
pop-up drain. An inflatable pneumatic gasket is used to seal the inlet plenum to
the product container.
A transition duct with an on/off damper is supplied to isolate the inlet ductwork
from the processor when the system is not running and to prevent contamination
of the inlet ductwork by product and wash water.
7.2.2 Product Container Assembly
The Product Container Assembly incorporates a conical shape that promotes
optimum fluidization and a low profile that provides for easy operator handling.
Two sections make up the product container assembly. To maximize fluidization,
the upper section includes a conically shaped bowl. One (1) oval sight port, one
manual stainless steel sample port and one temperature probe well are mounted
in the product container wall. A heavy duty insulated grounding cable is provided
to ground the container to the stanchion assembly.
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An RTD-style temperature probe is used to detect the temperature of the product
in the product container during processing. This component works in conjunction
with a temperature transmitter and can be used as a process variable.
When in use, the temperature element is inserted into a port on the product
container and clamped securely in place. When not in use, the element is taken
out of the product container port and placed in a temperature element holder
located on the stanchion assembly of the fluid bed processor.
The product container lower section is a spool piece that connects the inlet
plenum to the product container.
A heavy-duty, product container trolley constructed of 304 stainless steel is also
provided. The trolley is a separate item and is equipped with two fixed and two
swivel casters of conductive urethane.
7.2.3 “Split-Shake” Filter Housing
The “Split-Shake” filter housing contains the exhaust air filter system and is
exhausted through the customer-supplied exhaust air ductwork. Three (3) sight
ports for observation of the process are included. A port for a chamber light is
also supplied.
Two open/close valves (one for each “Split-Shake” exhaust outlet) are provided
to isolate airflow through the filter assemblies and prevent wash fluids from
entering the exhaust ductwork. A “Y-shaped” transition piece(s) of ductwork
(furnished and installed by the customer) will be required to connect the valves to
the customer-supplied exhaust air ductwork.
7.2.4 “Split-Shake” Exhaust Air Filter System
The “Split-Shake” Exhaust Air filter system consists of (2) pneumatic shaker
cylinder/filter assemblies. The filters are mounted on individual stainless steel
frames by means of the Niro Pharma Systems exclusive filter clip. For effective
cleaning, the filters are designed to stay open (continuous airflow) during
shaking.
So the filters are properly sealed and grounded to the filter housing, the exhaust
air filter system is equipped with a filter-sealing ring. An inflatable gasket is
installed on the filter-sealing ring to prevent product “blow-by”.
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Filter cleaning is accomplished by a shaker cylinder that lowers the exhaust air
filter assembly, then quickly snaps it upward to dislodge product particles and
return them to the product container. Duration and dwell of filter shaking are
adjustable from the operator’s control panel. Due to the “Split-Shake” (dual,
independent piston) design, continuous processing of the batch can be achieved.
Removal of the filters for cleaning is accomplished by first removing the product
container assembly. The complete filter assembly can then be lowered to the
vacant container area where a quick release pin is used to ease fast removal of
the filter and frame assembly. When the filter system is removed, the inside of
the housing is fully presented - free from channels or ledges where product can
collect - leaving only an easy to clean, smooth surface.
7.2.5 Top-Spray Granulation
The fluid bed processor will be equipped with the ability to top-spray a solution
onto the product in the product container to perform top-spray granulations. For
the additional space (above the fluidized product bed) required to properly dry
top-sprayed granulations, a “Filter Housing Extension” (increasing the distance
from the bottom of the filter housing to the filter stop) will be provided.
Also included with top spray granulation is a 316SS spray lance assembly
consisting of one single-headed, two-fluid nozzle with three (3) spare nozzle tips
and one (1) additional granulation port with blanking cover for insertion of the
spray lance through the filter housing. An option has also been purchased for a
peristaltic pump and solution flow meter. Atomizing air pressure and pump on/off
control is incorporated into the control system.
7.2.6 Product In-Feed Assembly
The Product Inlet Assembly is attached to a flange mounted on the side of the
filter housing above the product container. It includes a sanitary-design,
butterfly-type valve. It is used to load product (from upstream equipment) into
the processor without removing the product container assembly. A slight negative
pressure within the processor (created by the system fan) helps “pull” the
material from upstream equipment through the open Inlet Assembly plug/valve
and into the fluid bed processor. To control the amount of air available to aid
product in-feed, a modulating valve replaces the std open/close valve in the inlet
plenum. When closed, the pneumatically-actuated, butterfly-type valve isolates
the processor from other equipment when product is not being loaded and during
processing. All necessary controls are integrated in the standard control system.
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NOTE: Custom ductwork, a.k.a. product transfer chute, connecting the Product Inlet
Assembly to upstream equipment is not included. WIP nozzles are not included.
7.3
Exhaust Fan/Motor Assembly
A remote-mounted, centrifugal fan is provided in AMCA “spark-resistant”
construction. The fan/motor assembly will include inspection opening, drain,
unitary base, V-belt drive with OSHA approved guard, flanged inlet and outlet
connections, totally enclosed shaft and bearing guards, and 480V/3Ph/60Hz,
TEFC motor, balanced both statically and dynamically. The entire assembly is
mounted on a painted, carbon-steel C-channel base supported by spring-type
vibration isolators. A switch-type vibration detector is included.
A modulating (percent open or closed) damper is provided to control airflow
through the system and is to be installed in the customer-supplied exhaust
ductwork. A noise attenuator is also suppled. The attenuator will be installed on
the outlet of the exhaust fan. Installation is by others.
All ductwork upstream and downstream of the Fan/Motor Assembly is by others.
Fan motor starter is by others.
7.4
Deflagration Containment Valves
10 bar design for Aqueous/Solvent formulations
Deflagration Containment Valves (DCVs, also known as Explosion
Protection Valves - EPVs) are constructed of 304 stainless steel internals with
painted mild steel housings, and are to be installed in the inlet and exhaust
ductwork. If a deflagration occurs, DCV’s prevent the propagation of the pressure
wave and the flame front beyond the valve to protect non-reinforced equipment.
The inlet DCV (Ventex-ESI-R) is a passive-style, normally-closed check valve
which is operated when sufficient air flow “pushes” the valve to the open position.
The valve has good air flow characteristics, is technically simple and functionally
very reliable. This valve can be purchased for either vertical or horizontal
installation, and requires little service attention.
The outlet DCV (Ventex-ESI-E) is a passive, single-acting (one direction) valve
actuated by the pressure wave. The pressure wave proceeds the flame front and
closes the poppet into the rubber seal. A mechanical shutoff device retains the
poppet in the closed position until manually reset. This valve can be purchased
for either vertical or horizontal installation, are requires little service attention.
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Two (2) Deflagration Containment Valves are provided. All necessary controls
are integrated into the standard control system.
7.5
ICS-200”LT”: PLC/PC-based Integrated Control System
The control instrumentation will be supplied suitable for a Class 1, Division 1,
Group D rated Process area. This will include, but is not limited to;



Intrinsic safety barriers on electrical devices in the process area such as
drain valve limit switches, temperature transmitter and Product in-feed
valve limit switches,
the Operator Interface Terminal (OIT) enclosure will be provided with an
“X-type” purge, which will shut down power to the enclosure on loss of
pressure, and
equipment supplied by Niro for use in the process area such as (opt)
spray pumps and (opt) sizing mills, which will be suitably protected by
construction, pressurization or design methods.
NOTE: There will be an additional charge for IS barriers OR EXP construction, for nonprocess room electrical devices required BY THE CUSTOMER. The choice of
barrier or EXP construction is dependent on the actual device and the hazard
classification where the devices are installed.
NPS’ ICS-200LT Control System integrates an Allen-Bradley Programmable
Logic Controller (PLC) and a Personal Computer (PC) using "InTouch" graphical
operator interface software by Wonderware, running on the Windows 2000
platform.
The Allen-Bradley PLC and other control devices are mounted in a NEMA 12
Electro-Pneumatic control panel with terminals and bulkheads for easy
connection to field devices. This enclosure is designed to be outside the process
area. An optional stainless steel NEMA 4 enclosure is available at additional
cost if process room location is necessary.
Typical types, brands, and model numbers of Electro-Pneumatic Control Panel
instruments and devices used are:
PLC CPU
PLC Analog Inputs
PLC Analog Outputs
PLC Digital Input
PLC Digital Output
Allen Bradley 5/X0
Allen Bradley 1771-IFE
Allen Bradley 1771-OFE2
Allen Bradley 1771-IBD
Allen Bradley 1771-OBD
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DC Power supplies
Pressure Switches
Solenoid Valves
Regulator and Filter
Terminal Blocks
Panel (enclosure)
Aspire
Acopian, Sola, or equal
United Electric
SMC NVFR2000 series
SMC NAC series
Weidmuller WDU2.5 or equal
Hoffman, Rittal or equal
Operator interface PC hardware will consist of, at a minimum, an office-type
Pentium processor, 64 MB of Ram, 6 GB hard drive, CD-ROM drive, a 3.5”
(1.44 MB) “floppy” drive, a 17” SVGA color monitor drive, industrial keyboard and
pointing device (mouse), and a printer. Due to the rapid changes in available PC
hardware, the PC supplied may deviate from these specifications.
For rear access in a non-process area, the operator interface PC is in a NEMA
12 enclosure designed for mounting through a wall. The back of the enclosure
facing the process area will have a stainless steel plate, a wash-down rated
window for viewing the operator interface monitor and an industrial mouse.
General description of modes of operation
The control system will be developed using current versions of vendor authorized
development programs. The basic package includes a fully programmed,
tested, and documented PLC and OIT, however the development software
for the PLC and OIT is not included.
When automatic mode of operation is selected the user can enter the desired
operating set points for critical process critical parameters; airflow, air
temperature, filter cleaning interval time, and length of run. The machine will
start upon command and run until either the length of run is satisfied or a stop
command is initiated. The operator can change the entered set points at any time
during the run, and those new set points will be effective immediately.
A manual mode of operation is also provided. This mode permits the operator
to manually set the output of each controller and device. The expected primary
use for this mode is for maintenance and calibration service.
Whenever the exhaust fan is running, the values of the critical process
parameters are collected and displayed on the trend pages. There is a multiple
trend page that simultaneously shows the critical process parameters. This trend
page is like an electronic chart recorder, and the page can be printed, if a printer
is included, or viewed for abnormal conditions.
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When the machine is running in automatic mode and started from the start-up
sequence, critical data is collected at one minute intervals and stored on the
computer hard disk as a “CSV” file format. This is a coma-separated format that
can be imported into many other Customer-supplied software packages, like a
spreadsheet or data analysis program. The data values collected are: time,
airflow, inlet air temperature, product temperature, and outlet air temperature.
The following Processor/field-mounted instrumentation has been selected to
provide reliable service and accurate performance in an industrial environment
(installation is by others):
Parameter
Manufacturer/Model
Air Flow:
Brandt NZP pitot array with Rosemount 3051C
Differential Pressure (DP) transmitter
FBD Inlet air and Outlet air
Temperature:
Pyromation RTD’s, Rosemount 3144C transmitters
7.6
Product Bed and
FBD Filter DP:
Rosemount DP Transmitter 3051C
Air Prep pre-filter(s) and
HEPA Filter(s):
Dwyer DP Switches
Extended Warranty
An extended warranty has been included in the base price. This warranty
extends the period to “eighteen months after delivery or twelve months after
commissioning. This is an extension of the base warranty described in the Niro
Terms and Conditions.
7.7
Optional Equipment Description
7.7.1 Solution Delivery System
A wall mounted Solution Delivery System is offered with a variable- capacity
spray feed pump with controller, “Micro Motion, Endress-Hauser or equal” mass
flow element and transmitter, and the complete system is mounted in an “x
purged” NEMA 4 stainless steel enclosure.
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This system meters and distributes the flow of spray solutions from the customersupplied batching tank to the spray nozzles on the processor. The system is
designed to allow precise control of the quantity of delivered solution.
7.7.2 Dehumidification and Humidification (future) of Inlet Air
One (1) Dehumidification section is provided to reduce inlet air moisture
(humidity). Cooling coil is copper tubing with aluminum fins. Coil is sized for
approx. a 10°C (50°F) air stream dew-point temperature based on customer’s
cooling liquid (chilled water) supplied to the coil. A drip pan is also provided for
collection and drainage of the condensate. Niro supplies one temperature
element with transmitter in addition to the cooling liquid control valve with
actuator and positioner. Chilled water, supply/return piping and other valves/local
gauges are by others. A moisture separator downstream of the dehumidification
coil with stainless steel pan and a drain connection is included. The separator
mesh is constructed of stainless steel, slides in filter tracts and has a side access
for cleaning.
One (1) Humidification section is provided in the air preparation unit. This
section is supplied with room to add a Pre-heat coil for raising the process air
stream temperature so controlled humidification can occur. The section also
contains room to add a stainless steel steam humidification bar. This section is
reserved in the air preparation unit should humidity addition be required in the
future.
7.7.3 Exhaust HEPA Housing/Filters
One (1) Exhaust HEPA Unit designed for indoor installation shall be BagIn/Bag-Out including inspection/access doors, transition from flanged inlet, prefilters, HEPA filters, pressure taps, drain, DOP test ports and transition to a
flanged outlet.
HEPA filters are side-loading, 99.97% DOP-efficiency separatorless-type with a
gel-seal mechanism. Housing will be provided in 18 gauge- 304 stainless steel
construction with test ports, lifting lugs, a structural channel base and designed to
withstand 50” WG negative pressure. Monitoring of the pressure drop across the
filters is by differential pressure switch and visible notification is incorporated into
the control system.
7.7.4 Un-interuptable Power Supply (UPS)
30-minute backup for controls system only. Not intended to provide sufficient
power to operate the complete system.
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7.7.5 Post Hoist Bowl Inverter
A Discharge Post-Hoist is included to aid in reducing time-consuming, manual
discharge of the product container. For discharge, the fluid bed product container
is lifted from its trolley, inverted up to 180° and lowered to the correct height to
discharge the product. Column design will be non rotational.
The following components are included:
 One (1) lifting column encased in 304 stainless steel. Maximum column height of
16’. Lifting height of 12’. The column is non rotating.
 One discharge “Angle Cone” of 316 stainless steel. Seal of white neoprene for
sealing the fluid bed product container to the Angle Cone.
 One (1) manual discharge valve with silicone seal, flange mounted to the Angle
Cone.
 Column mounted control panel with raise, lower, 180° tilt, emergency stop
buttons, and discharge valve open / close.
 Controls suitable for non-hazardous-rated process area.
7.7.6 Installation inspection – See Section 10 of this Order Confirmation
7.6.7 Start-up Assistance – See Section 10 of this Order Confirmation
7.6.8 Training – See Section 10 of this Order Confirmation
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8
TECHNICAL DATA SHEETS
8.1
Equipment Specifications and Utilities
400 liter MP
Metric
English
Air Preparation Unit (APU)
Maximum Air Flow into processor
3100CMH
Minimum Air Flow into processor w/ Air Bypass design
Maximum Air Prep Inlet conditions
(Summer Conditions must be verified by customer)
Minimum Air Prep Inlet conditions
(Winter Conditions must be verified by customer)
Max. Air Temperature into processor
90°C
Min. Air Temperature into processor
10°C
Max. controllable dewpoint into processor – OPT. Humidification
Min. controllable dewpoint into processor – OPT. Dehumidification
1825 SCFM
456 SCFM
95F db, 80F wb
37F db, 37 wb
194°F
50°F
75°F
50°F
Fluid Bed Filter Housing
Pressure Shock Resistance
10 Bar
150 psig
Exhaust Air Filter System
“Split-Shake” Filter Area
14.4 m2
155 sq.ft.
“J7” Standard Product Container
Pressure Shock Resistance
Gross Volume
Bottom Plate Area
10 bar
460 liters
0.48 m2
150 psig
Exhaust Fan/Motor Assembly
Total Pressure Rise
Power of Motor
 12450 N/m2
22.5 KW
 50" Water Gauge
30 Hp
Estimated Utilities required
Electrical
PLC Control Panel
Exhaust Fan Motor
OPT. Spray Pump Motor
120V/1 ph/60 Hz/40 amps
480V/3 Ph/60 Hz
120V/1 ph/60 Hz/20 amps
Compressed Air System
Instrument air - PLC Control Panel
Instrument air - Operator Int. Terminal (OIT)
Process grade air – Granulating/Coating
20 cfm @ 90 psig
10 cfm @ 90 psig
18-25 cfm @ 75-90 psig
APU (dependant on max/min inlet air conditions)
Heating to be by 140°F Hot water and supplemental Electric coil
Clean Steam at 10-15 psig
45-57 kg/hr
(optional Humidification)(future)
Chilled water @ 42°F
189 L/min
(optional Dehumidification)
Miscellaneous
OPT. Top-Spray Granulating, liquid
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5.14 sq.ft.
0.3-1.5 L/min
100-125 lbs/hr
50 gal/min
.08-0.4 gal/min
Niro Pharma Systems (NPS)
8.2
Aspire
Materials of Construction and Finish Configuartion
Processor – Finish Configuration “F2”
Internal Surfaces
Product Contact
316/316L SS
SF2 Mirror 1(0.1 µm max. Ra)
304 SS or other corrosion-resistant
SF7 Bright 1, (0.6 µm max. Ra)
Non-contact
External Surfaces
Production Area
Technical Area
SF9 Bright 3, (max. Ra N/A)
(welds are cleaned/polished but not ground smooth)
SF10 Bright 4
Air Preparation Unit
Outside of Housing (Cladding)
Inside of Housing
Dehumidification Coil (if supplied)
Heating Coil(s)
Humidification Device (Vapor Dispersion)
Base
Galvanized/Painted
304 SS
Copper tubes/Aluminum fins
Copper tubes/Aluminum fins
316 SS
carbon steel
Exhaust Fan
Housing
Wheel
Base
Painted mild steel
Aluminum, non-sparking
Carbon steel
Control Cabinets
PLC/Pneumatics
Thru-the-Wall OIT
Painted mild steel
304 SS facing Process Area
Mild steel in technical area
304 SS facing Process Area
Mild steel in technical area
Thru-the-Wall Pump Station
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9
VALIDATION-SUPPORT PROGRAM & ENGINEERING SERVICES
9.1
Documentation & Validation-Support Program
Niro Pharma Systems’ Documentation & Validation-Support Program is
specifically designed to provide the information required for a user to install,
operate and maintain an Niro Pharma Systems system. In addition, support
documentation is provided to assist the customer in their installation and
validation activities associated with the fluid bed processor system.
Standard documentation includes:

The Quality Assurance Plan (QAP) - The QAP defines the process for the
development of all activities required to design and implement the
equipment/system. This document also outlines the scope/sequence/integration of
project activities for all individuals (based on the customer’s/Niro’s specifications)
to insure the highest quality of the overall project.

The Functional DESIGN Specification (FDS) phase identifies the way in which
the control system will be realized for the project in terms of required hardware and
software products. The FDS will be assembled as directed by/from content
standards and guidelines defined in the Quality Assurance Plan. The FDS will
facilitate design reviews, aid in test document development and promote design
validation against the User’s requirements.
Niro will generate the FDS (aka Detailed Design Specification) as described in this
Proposal. Customer will have reasonable time (as determined by the project
schedule) to make one (1) revision to incorporate clarifications/changes. Additional
hardware/software functionality or other revisions to the FRS/DDS
initiated/requested by the Customer may affect schedule and incur additional cost.
Any and all provisions required by the Customer for Niro-compliance with 21CFR
part 11 must be discussed prior to order.

The Installation manual contains information for the customer to receive and
install the equipment. This manual includes utilities and civil interfaces.

The Operating and Maintenance manual contains information about the function
of the system, the description of mechanical operation, maintenance instructions,
major sub-supplier’s manuals and selected spare parts information.

The Component Literature Manual contains information about the primary
components of the system such as manufacturer, manufacturer’s part no., Niro
system tag no., Loop item/drawing number and associated documents.
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
Aspire
The Drawing manual contains standard equipment General Arrangements (GA),
Process Flow Diagram (PFD), Piping and Instrumentation Diagram (P&ID), loop
drawings, PLC ladder logic/layout, and assembly drawings in Niro Pharma
Systems format.
These manuals will be created concurrently with project execution and will follow
established, Niro procedures.
9.2
IQ/OQ Documentation
Certification and Validation Manual containing additional system documentation
are supplied with the standard documentation for the validation activities.
System descriptions and specifications, manufacturers’ letters of certification,
equipment qualifications and I.Q. and O.Q. protocols are included. Additionally,
P&I diagrams, support ladder logic information, loop diagrams, equipment
qualification protocols and results are included as part of the controls
documentation.
9.3
Installation Assistance
Installation Inspection, equipment set-up and checkout prior to start-up. The
optional price is for three (3), two-day trips PER SYSTEM, inclusive of
reasonable expenses.
Additional Installation assistance by one of our technical service representatives
is available at a daily rate as given in “Field Service Rates” later in this Proposal.
9.4
Start-Up Assistance & Control System tuning and sequence checkout
Start-up Assistance: Two (2), five-day trips PER SYSTEM, inclusive of expenses,
is included with this order.
Control System tuning and sequence checkout: One (1), five-day trip PER
SYSTEM, inclusive of expenses, is included with this order.
9.5
Operator and Maintenance Training
One (1), five-day trip PER SYSTEM, inclusive of reasonable expenses by a Niro
representative to perform operator and maintenance training.
Also, Three days, one trip by a Niro Control representative for the Automation
and Control System.
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9.6
Aspire
Implementation of IQ/OQ (Validation) Protocols
The Fluid Bed Processor system IQ/OQ protocol will be executed by NPS with
assistance from Aspire personnel.
The execution of the protocol will take place in conjunction with the startup of the
machine. An extra trip to Weston Florida will not be required.
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ITEMS NOT INCLUDED IN OUR ORDER

Building or alteration to buildings

Building structural design calculations

Foundations, grouting and/or anchor bolts for the APU, fluid bed processor,
exhaust fan/motor assembly or any other piece of equipment

Site preparation

Structural steel to support the system or “architectural/flashing” steel at floor,
wall or ceiling penetrations

Installation of the equipment

Product conveying system from discharge point

Interconnecting ductwork inc. floor supports, hangers, insulation

Electrical wiring between sub components

Motor Control Center (MCC) or Power distribution components such as motor
starters and/or electrical disconnects, unless otherwise noted in this Proposal.

Pneumatic tubing between sub components

Supply and piping of all utilities and services

State, local or other taxes and duty, present or future

Permits for installation of the equipment covered by this Proposal

Lighting fixtures

Freight, unless otherwise noted.

Any item not specifically mentioned as included in our Order
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NIRO INC. - STANDARD, FIELD-SERVICE TERMS & RATES
Niro Inc. offers the field-services of a qualified engineer or technician to advise
on the construction, start-up, commissioning/validation or equipment repair work
and/or to perform inspection services.
During the period that the engineer is engaged at the project site the purchaser
will be entitled to and invoiced for the engineer’s service for a five-day, forty-hour
week, Monday to Friday inclusive.
The purchaser of these services will place at the disposal of Niro representative
any necessary labor and equipment. Responsibility for all lighting, power, oil, fuel
and materials used during the service visit will not be charged to Niro.
The following table “2001 STANDARD SERVICE RATES” includes the
preparation of brief inspection reports where required. The preparation of
detailed engineering reports, drawings, or recommendations are not included in
this rate schedule and will be quoted separately.
To assume availability of personnel we request that Niro be given a minimum of
two weeks’ advance notice when an engineer is required. Service Rates are
subject to change without notice.
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2001 STANDARD SERVICE RATES
ON CALL
SUPPORT
Hourly Rate
Overtime
Sundays
Holidays
Travel Time
DAILY SUPPORT
TIME
FIELD
SUPPORT
CONSULTING
SUPPORT
8:00 a.m. - 5:00 p.m.
Monday through
Friday
5:00 p.m. - 8:00 a.m.
$ 100.00 /
hour
$ 120.00 / hour
$ 150.00 /
hour
$ 200.00 /
hour
$ 180.00 / hour
$ 200.00 /
hour
$ 240.00 / hour
$ 80.00 / hour
$ 80.00 / hour
12:00 a.m. Sunday
through
8:00 a.m. Monday
12:00 a.m. the day
before a
scheduled holiday to
8:00 a.m. the first
normal
working day
Monday through
Saturday
$ 240.00 / hour
MINIMUM BILLING
The minimum charge for Support Service is four (4) hours at the base rate, plus travel
time (portal to portal, 4 hours maximum), and reasonable living and incidental expenses
in connection with the service performed.
TRAVEL EXPENSE
Auto Mileage Rate
Public Transportation / Auto Rental
Lodging, Meals, Phone, Misc., Etc
TERMS are Net 30 days from date of invoice
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$0.345/ mile
At Cost
At Cost
Niro Pharma Systems (NPS)
Aspire
ORDER CONFIRMATION APPROVALS
Please sign this document for approval and return one signed copy to Niro Inc.
Aspire Pharmaceuticals, Inc.
Mr. Saul Bautista
Manufacturing Manager
Mr. Aldo Villaneuva
Process Engineeer
Niro Inc.
Pharma Systems Division
Mr. Chris Healy
Contracts Manages
Mr. Ray Beard
Project Engineer
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