Fluid Bed Dryer Urs

JETT
USER REQUIREMENTS
SPECIFICATION
BATCH FLUID BED SYSTEM
Page 1 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
USER REQUIREMENTS TEMPLATE

FOR A
BATCH FLUID BED
SYSTEM
JOINT EQUIPMENT TRANSITION TEAM
JETT
USER REQUIREMENTS
SPECIFICATION
Page 2 of 29
September 2003
NOTES for use of the User Requirements Template:

Upon completion of the template, delete this page prior to updating the Table of
Contents and printing.
1. Many areas of this template have selections or tables that have been prepared
for guidance and ease of template completion. Text in italics is intended to be
used as notes to the User and should be deleted prior to printing. Any options
and/or examples that are not applicable to the specific document being created
should be deleted as well.
2. To update the final Table of Contents, place the cursor inside the shaded area,
press the Right mouse key, and select Update Field.
3. Where possible, the User should identify the source (e.g. studies, standards, etc.)
for the acceptable ranges of variables or other critical requirements that have
been derived.
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USER REQUIREMENTS
SPECIFICATION
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September 2003
REVISION HISTORY
Rev.
Date
Approval
09/15/03
Miller
Revision Summary
Initial Release
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USER REQUIREMENTS
SPECIFICATION
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September 2003
TABLE OF CONTENTS
1.0
INTRODUCTION..............................................................................................5
2.0
OVERVIEW........................................................................................................8
3.0
OPERATIONAL REQUIREMENTS...............................................................9
3.1
CAPACITY.........................................................................................................9
3.2
PROCESS REQUIREMENTS...............................................................................9
3.3
PROCESS CONTROL.......................................................................................10
3.4
FUNCTIONS.....................................................................................................10
3.5
DATA AND SECURITY.....................................................................................12
3.6
ENVIRONMENT...............................................................................................15
4.0
CONSTRAINTS...............................................................................................18
4.1
MILESTONES AND TIMELINES.......................................................................18
4.2
EQUIPMENT CONSTRAINTS...........................................................................19
4.3
COMPATIBILITY AND SUPPORT.....................................................................19
4.4
AVAILABILITY................................................................................................21
4.5
PROCEDURAL CONSTRAINTS.........................................................................22
4.6
MAINTENANCE...............................................................................................23
5.0
LIFE-CYCLE....................................................................................................23
5.1
DEVELOPMENT...............................................................................................23
5.2
TESTING..........................................................................................................24
5.3
DELIVERY.......................................................................................................24
5.4
SUPPORT.........................................................................................................25
6.0
GLOSSARY......................................................................................................27
7.0
REFERENCES.................................................................................................28
8.0
APPROVAL.......................................................................................................29
USER REQUIREMENTS
SPECIFICATION
JETT
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Project No.:
Insert the unique project number associated with this particular URS.
Document No.:
Insert the Document Identification Number and Revision.
Document Description:
Insert description of document, e.g. FLUID BED DRYER, JETT Example User
Requirements Specification.
1.0 INTRODUCTION
Fluid Bed systems vary in function and purpose. There are several uses of Fluid
Bed systems, such as:
Drying
Agglomeration
Bead Forming
Adding Active Drug Ingredients
Flavor Masking
Time Release
Making Product Easier to Flow
Making Product Easier to form into tablets
These systems range from simple systems that act as a drier column to those
with sophisticated controls and devices that protect against explosions, provide
metered sprays, rotors for bead forming and Wuster columns for more effective
coating of various substances.
Aqueous systems typically have less complexity, with less of a need to protect
against vapors. Solvent based systems employ more instrumentation and
controls required primarily for safety reasons (explosion protection). Systems
that spray actives, protective or timed release components onto the product
require more sophistication to guarantee the proper amount has been added to
the product.
The term Fluid Bed is used because air is forced up underneath the powders
or products in the product chamber. The resultant appearance is much like the
surface of water being disturbed by waves, hence the term fluidization of the
product. This action can be gentle or quite high and focused, depending upon
the needs of the process.
Fluid Beds inherently create explosive environments within their chambers.
Dry powders can ignite with sparks created by electrostatic discharges that
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USER REQUIREMENTS
SPECIFICATION
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September 2003
naturally occur within moving air and powder masses. Therefore, most Fluid
Beds have explosion vents that are designed to dissipate the pressure waves
created by explosions to a safe area before the pressure becomes too great for
containment. Some processes require total containment of the system (those
which deal with highly active pharmaceutical and/or chemical products that are
dangerous if not contained). For those systems, closed loop nitrogen purging
may be necessary to reduce the possibility of explosion, or a total containment
system with construction robust enough to contain the explosion (10 Bar
construction) may be used.
Filtration of the supply air to the fluid bed dryer using pre-filters and HEPA
filters is required to ensure only clean air comes in contact with the product.
These filter systems are located in the supply air unit along with the heating and
cooling coils, supply fan and humidification system if required. This unit can
be located in a technical area separate from the fluid bed dryer, which will be
located in a cGMP area.
In cases where there are highly reactive products used in the machine,
containment of waste materials from filtering, cleaning and processing must be
addressed, with proper handling to prevent contamination of the environment
and operators.
Filtration of the air in the fluid bed serves two purposes: to prevent loss of
product up the stack, and to protect the external environment from
contamination. The two most popular methods of filtering are bag systems (a
system of cloth mesh suspended from the filter chamber and shaken periodically
to dislodge powders) and cartridge filters of various constructions (metal mesh
or polyester type cloth, etc.). Some processes, such as bead formation, may not
require filtration at the fluid bed at all.
Filtration of the air exiting the fluid bed after the filter chamber is usually done
to prevent contamination of the local environment. Such systems can involve:
o Dust Collectors
o Scrubbers
o Incinerators (thermal oxidizers that literally burn the contaminants
away)
o HEPA systems with bag-in, bag-out feature for operator exposure
protection
o Closed loop recovery systems (Design to recycle and/or capture the
fluids and products for disposal or possible re-use)
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Charging (loading of product to the fluid bed) can be as simple as dumping

product into the product container or as sophisticated as a totally contained
vacuum system.
Similarly, discharging can also be as simple as dumping the product into
awaiting barrels to vacuum discharging of product to other systems for further
processing. While not part of the actual process of fluidizing, charging and
discharging are integral to the machines safe operation and may affect product
quality, batch yields and integrity if not properly considered and carried out.
Lastly, the utilities and space involved needs to be discussed prior to purchasing
the equipment. Obviously, the actual equipment size is but a small part of the
entire scope of work necessary to implement a larger fluid bed operation. Small
fluid beds can be self-contained, depending upon the application. The unit and
its support equipment must be able to be installed in current building facilities.
This document encompasses the normal range of fluid bed operations. Fluid
bed technology is constantly improving. Obviously, technology improvements
and new applications may require deviation from this template. This is to be
utilized as a guide for the user to answer the majority of questions involved in
specifying and using the equipment. Addendums may be used to round out the
requirements.
A typical Dry Process involves the following steps:
1.
2.
3.
4.
5.
Preheat (to prevent product from sticking to sides of fluid bed)

Loading
Drying (Fluidizing)
Cool down (Heat off)
Unloading
A typical Spray Process involves the following steps:

1. Preheat
2. Attainment of a preset exhaust temperature indicating fluid bed
is warm
3. Loading
4. Top Spray
5. Sub-dry
6. Repeat of steps 4 and 5
7. Drying (fluidizing)
8. Cool down (Heat off)
9. Unloading
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NOTE: Spraying may be done using: Top Spray, Side Spray

and Wurster Column.
A typical Rotor Process involves the following steps:
1. Pre-heat
2. Attainment of a preset exhaust temperature indicating fluid bed
is warm
3. Loading
4. Fluidizing
5. Rotor start-up
6. Spraying
7. Sub-dry
8. Repeat of steps 6 and 7
9. Drying
10. Cool down
11. Unloading
NOTE: There are many types of rotor systems available, and
some may use seed pellets to provide a core and build
these seeds into bigger granules with multiple layers. It
is vital that the user specify the intended process to the
machine manufacturer so that the equipment may be
designed accordingly.
2.0 OVERVIEW
Use:
The fluid bed dryer shall be used primarily for:
Drying
De-dust/flavor mask
Ease of powder flow
Ease of making powder into tablets
Active drug coats
Protective
Timed release
All of the above (Full flexibility)
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USER REQUIREMENTS
SPECIFICATION

September 2003
The products being used on the equipment are of:

Low active (vitamins, supplements)
Medium active (aspirin)
Highly active (morphine)
Exclusive (penicillin)
The intended use of the Fluid Bed is for:

Aqueous low explosive potential of dust
Aqueous medium explosive potential of dust
Aqueous high explosive potential of dust
Solvent operated at 25% of the LEL of the solvent being

used
Solvent operated at above the UEL of the solvent being
used
Solvent operated as inert system with the oxygen content in
the fluidizing air controlled
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Capacity:
The capacity of the machine is to be:
Extremely small (1 liter to 10 liters)
Small (10 liters to 30 liters)
Medium (30 liters to 60 liters)
Large (60 liters to 100 liters)
Larger (100 liters to 150 liters)
Largest (150, 170 and above liters)
3.0 OPERATIONAL REQUIREMENTS

3.1
3.2
Capacity
Range of products
Commodities to be used to load and unload the dryer i.e.

bags, drums, etc.)
Processed Materials to be used or involved
Production rates
Process Requirements
Quality of products and concentrations
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USER REQUIREMENTS
SPECIFICATION
3.3
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Product limitations (i.e. temperature, humidity, pH, etc.)
Process Control
Measurement Range
Setpoint Range
Parameter Control Tolerance
Note: At a minimum, list the critical process parameters. Consider

documenting how each of the parameter requirements was
determined.
3.4
Functions
3.4.1
Operation
Enter your specific operational requirements here.
Cycles expected the system will operate at are
Recipes the system will contain are
Operator interaction with the system will

include
The following is an example:
The system shall operate with a minimum of operator involvement.
Operation shall be safe from an operator and environmental
standpoint.
The system shall be operated locally at the equipment itself.
Control system requirements:
3.4.2
Manual only
Manual/automatic
Power failure/Recovery
In the event of a power failure, the system shall protect product

against damage. The system will stop in a safe mode automatically
upon loss of electricity, air or other major utility and will require
operator intervention to re-start.
Depending upon the options chosen in the overview section, the
system will:
Manually re-start based on operator inputs

(Operator initiates power recovery sequence).
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SPECIFICATION
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Re-start based on last state before loss of power.

(System runs through power recovery sequence when
operator start signal is given)
If there is an automatic batch reporting system,

the information shall be retained in the event of a power
failure (A UPS is required for automatic batch reporting
systems for data retention).
3.4.3
Emergency Stop
Insert your specific Emergency Stop (E-Stop) strategy and

communication scheme here.
For example:
The system shall have an E-Stop mechanism designed to stop all
physical movement of the equipment immediately. The E-Stop
mechanism(s) shall be located in easily accessible areas around the
equipment as required by national and local safety standards.
3.4.4
Alarms and Warnings
Critical alarms shall take action automatically to shut the

fluid bed system down and notify the operator. The operator shall
be required to acknowledge the alarm before the alarm can be reset
and the system restarted. Once the alarm is reset, the operator may
restart the system.
Process Critical- shall notify the operator and place the system
in a hold state to prevent product damage. Process critical
warnings and shall sound the alarm horn, illuminate the alarm
indicator but allow the system to continue to operate. The operator
shall be required to acknowledge the warning in order to silence
the alarm horn, and the alarm indicator shall be extinguished when
the warning condition disappears.
Non Critical Warnings shall notify the operator and take no
further action. Non-critical warnings shall sound the alarm horn,
illuminate the alarm indicator but allow the system to continue to
operate. The operator shall be required to acknowledge the
warning in order to silence the alarm horn, and the alarm indicator
shall be extinguished when the warning condition disappears.
The Fluid Bed shall have the following alarms and warnings:
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USER REQUIREMENTS
SPECIFICATION
JETT
Alarm or Informational Message
Critical
Alarm
Emergency Stop
PLC-OIT Communication Watchdog
Control Power Fault
Main Air Fault

September 2003
Process
Critical
Inlet Air Temperature High Fault
Inlet Air Temperature Low Fault
Inlet Airflow Low Fault
Plugged Gun (low flow or solution pressure high)
Nozzle Airflow Low Fault
Inlet Dew Point High Fault
Inlet Dew Point Low Warning
NonCritical
Alarm
Motor Faults
PLC Battery Low Warning
3.5
Data and Security

Controls provided with Data Collection systems intended for use in the
manufacture of pharmaceutical products shall be required to meet 21 CFR
Part 11 compliance. The supplier shall stipulate the methods by which this
criterion is met.
3.5.1
User Interfaces
This section should address the following issues:
Operator interface access levels
Frequency of data point collection
Hardcopy/electronic data collection requirements
Compliance with 21CFR Part 11 (for Europe EREC Guidelines)
Data retention time on the system
Data storage media
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SPECIFICATION
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Access to all Input/Output values and system status bits shall be

provided through a data-communication link. Security for data
and operator access is provided by (User ID/Password, Card
Reader, Biometric (Fingerprint, eye scan, voice recognition, etc.),
etc.).
3.5.2
User Interface with Supervisors and Operators
The CONTROL PLATFORM system shall include interfaces with

the Operator and Supervisor that ensures easy, safe, and reliable
operation.
An operator-interface panel shall be provided and mounted near
the equipment or on the equipment. This panel shall provide the
necessary switches, indicators, and devices to operate the fluid bed
system. The following shall be displayed:
o Recommended
Inlet Temperature
Exhaust Temperature
Inlet Airflow
Product Screen Delta Pressure
Filter Chamber Delta Pressure
Alarms and Warnings
System status (ready, running, etc.)
o Optional
Product Temperature
Solution Flow Rate
Total/Set point Spray amount
Nozzle airflow
Nozzle Pressure
Solution Pressure
Rotor RPMs
Inlet Dew Point
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USER REQUIREMENTS
SPECIFICATION
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The PLC/OIT system shall include interfaces with Supervisors to

ensure easy, safe and reliable configuration of the Fluid Bed
System. The following shall be accessible only to Supervisors:
Security Configurations
Control loop variables (i.e., PID terms)
Alarm setpoints
3.5.2.1
Language requirements
Specify language that information will be displayed in
(i.e. English, Spanish, German, Bilingual, etc.)
3.5.2.2
Displayed Requirements:
State the system of measurement that will be used
(English or Metric (S.I.)).
XXXXXXX
(###.#) units
Unit(s) of
measurement
units
YYYYYYY
(##)%
Parameter
3.5.3
Format
Interface with Other Equipment
The PLC/OIT system shall include interfaces with the Users

control system to facilitate automatic operation and configuration.
The control system shall include the interfaces necessary to
facilitate operation and configuration.
An RS-232 communications port shall be

provided.
A Modem communications port shall be provided.
A high-speed configuration/monitoring
connection shall be provided.
The port shall be capable of being configured to communicate the
following data to a supervisory control and data acquisition
(SCADA) node. Available shall be:
All process variables

Alarms and Warnings
System status
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USER REQUIREMENTS
SPECIFICATION

3.5.4
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Security Levels
List the total number of different access levels that will be

required. Provide a general description of the access rights for
each level (screen navigation, operational control, control loop
variable manipulation, alarm setpoint manipulation, etc.).
3.5.5
Data Collection
Consider any archiving and reporting requirements here.
None
Recorder
Process Printout
Electronic process printout, Historical Trending
Electronic process printout, Historical Trending

and interface to company network
The following shall be recorded:
3.6
Inlet Temperature
Exhaust Temperature
Inlet Airflow
Product Screen Differential Pressure
Filter Chamber Differential Pressure
Solution Flow Rate
Total/Set point Spray amount
Nozzle airflow
Alarms and warnings
System status
Product Temperature
Inlet Dew Point
Environment
Provide details of the physical environment in which the
[equipment/system] will be operated.
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USER REQUIREMENTS
SPECIFICATION

3.6.1
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Layout
For example:
Allocated floor space for the equipment is _____

inches by ________ inches with at least a _______inch
corridor around the periphery for the equipment.
Vertical clearance is _________ inches.
See attached drawing

#________________________ (if applicable).
Layout is specific to the size equipment being used and system
requirements of the equipment.
3.6.2
Physical Conditions
Room Explosion Classification

List the critical explosion requirements for the room.
Room will be non-hazardous
Room will be Class I Div II (Zone 2) (explosive
atmosphere present at known times)
Room will be Class I Div I (Zone 1) (explosive
atmosphere present at all times)
Environmental Classification
List the critical air quality requirements for the environment.
Class 100, 10,000, or 100,000 (Federal Standard
209E)
ISO Class 5, 7, or 8 (ISO 14644-1 and ISO
14644-2)
Class A, B, C, or D (The Rules Governing
Medicinal Products in the European Union Annex
1)
Directional airflow
Airflow velocity
Number of air changes
Particle Ingress
Biohazard Level
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List the critical biohazard level requirements for the

environment.
BL-1
BL-2
Rating of enclosures
List the rating requirements for enclosures in the
environment.
NEMA 1 (Open)
NEMA 12 (Oil tight)
NEMA 4 (Wash down)
NEMA 4X (Wash down and non-Corrosive)
3.6.3
Cleaning Requirements
Hand-Wash
Auto-Wash
Steam Clean
3.6.4
Sterilization Requirements
Describe the type of sterilization that will be performed on or
within the [equipment/system] and the duration the
[equipment/system] will be exposed.
3.6.5
Intended Operating Environment:
Describe the type of operating environment that the

[equipment/system] will be exposed to following installation.
For example:
The [equipment/system] shall be mounted in a GMP environment
with a temperature range of 15 to 25 C, non-condensing humidity.
Vibration levels in operating environment are <Negligible, Slight,
or Severe>
The Seismic Zone in the operating environment is <Zone 1, Zone
2, Zone 3, Zone 4, or Zone 4A>.
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4.0 CONSTRAINTS
4.1
Milestones and Timelines

Based on the model outlined below, establish the project milestones with a
timeline:
BASELINE EQUIPMENT ACQUISITION MODEL

SUPPLIER
USER/(CONSULTANT if applicable)
User Audit of Supplier
Master Validation Plan

Equipment Validation Plan
Explanation to Supplier
(Living Document)
User Requirements Specification (URS)

(Living Document)
Proposal Analysis
User Initiates
RFQ
Proposal
RFQ
Quality Plan
Project Plan
l
o sa
p
o
Pr
P.O.
Approval
Review Functional Specification
Functional Specification
(Traceable to URS)
Detailed Design
Documentation
(traceable to Functional Specification)
Review Detailed Design

Review System
Acceptance Test Specifications
Integrate with Validation
Documentation (as appropriate)
Approval
System Acceptance Test

Specifications (IQ/OQ)
Hardware
Software
Approva
l
System Acceptance
Testing and Results
(User Witness Optional)
Maintenance & Support
Documentation
JETT
4.2
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USER REQUIREMENTS
SPECIFICATION

September 2003

Equipment Constraints
Describe the operating constraints that the [equipment/system] will be

required to meet.
For example:
4.2.1
Environmental Conditions
The [equipment/system] is to be used at the following

environmental conditions:
Altitude ________ ft above sea level
4.2.2
HVAC Equipment Constraints
Process air enters in from

C
Indoor Temperature:
Outdoor Temperature:
Minimum:
Maximum:
Climatic conditions:
4.2.3
Winter dry bulb
Winter wet bulb
Summer dry bulb
Summer wet bulb
Equipment Generated Vibration
The maximum allowable equipment vibration generated during

operation is <value>.
4.3
Compatibility and Support

Include any requirements for compatibility with other User systems. In
the examples provided below, fill in blanks with the appropriate
information. Delete areas that are not applicable to this application.
4.3.1
CONTROL PLATFORM Controllers
The Supplier shall utilize

Control Platform
Controllers that shall include a communications port.
The Supplier shall provide documentation that the program
(embedded software) was developed and coded utilizing
program development and documentation software.
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The supplier shall indicate the use of custom or bespoke code

within the equipment, and shall supply licensing of the custom
code for the life of the equipment.
An escrow agreement shall be required in the event the supplier
cannot support the supplied custom software any longer. In such
instances, the source code and all information regarding the source
code shall be given to the user in a timely fashion to prevent
downtime of the equipment.
4.3.2
Preferred Vendor List
If necessary attach any critical preferred vendors. Refrain from

driving the supplier into customizing his equipment package.
If the vendor wishes to deviate from the Preferred Instrumentation
List, a listing of the proposed components and instrumentation
sub-vendors indicating type and model numbers shall be submitted
with the quotation, along with an explanation of why the deviation
is recommended.
4.3.3
Utilities
The utilities and space involved needs to be discussed prior to

purchasing the equipment. Obviously, the actual equipment size is
but a small part of the entire scope of work necessary to implement
a larger system. The unit and its support equipment must be able to
be installed in current building facilities.
The User shall ensure that the following utilities are available and
that the utility supply lines and piping are terminated with fittings
or connections, which are compatible with those described on the
Customer Connection Drawings.
The Supplier shall specify utility data, which is marked with a
triangle. Utility data, which are not specified or marked with a
triangle, shall be brought to the attention of the User. These data
shall be specified (by the User or the Supplier) and shall be
approved by both the User and the Supplier before system design
begins.
Base Utilities Worksheet
Related Discharges
Volume
pH
Temperature
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Materials
Electricity
______ VAC ____ Hertz
Phases
Amperage
Uninterruptible Power Supply (Define Use)
Control Air
Pressure
For example:
_______ PSIG (must be clean, dry ISA instrument
quality air, capacity to be determined by size of
equipment). Recommend at least 90 PSIG
constant air pressure for all equipment, unless
specified.
Other Utility Requirements Grounding
4.4
Because of the static electricity normally created in a fluid bed

operation, static electricity protection may be required:
None (typical grounding machine only)
Ground Straps and Pins
Ground proving system (specifically
designed monitor and alarm if the
grounding systems are compromised)
Availability
The [equipment/system] is intended to be operated [Continuously,
Regularly, __ hours per day, __ hours per week].
The fluid bed dryer shall be capable of processing a batch in ______
hours.
Cleaning the Fluid Bed Dryer shall be accomplished in _______ hours
from start to ready for production.
Operation of the [equipment/system] shall be suspended, and the system
shall be available for preventative maintenance or routine service [__
hours per week, __ continuous hours per week, __ days per month, __
weeks per year].
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4.5
USER REQUIREMENTS
SPECIFICATION
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Procedural Constraints
4.5.1
Product Contact Materials
Describe any local procedural requirements such as local

standards, which must be adhered to if applicable.
All piping welds and product contact welds shall meet ASME and
3A specification requirements. Product contact metal to be (316L
Stainless Steel, 316 Stainless Steel, 304 Stainless Steel, etc.)
List critical requirements for surface finish, roughness, etc..
Other standards are attached. The Supplier shall adhere to the
indicated sections only.
4.5.2
Product in Contact with Materials
All product contact parts should be considered. The Fluid Bed

System will be used for:
Low active (vitamins, supplements)
Medium active (e.g. Aspirin)
Highly active (e.g. Morphine)
Exclusive (e.g. Penicillin)
4.5.3
Noise Level Constraints
Insert your own noise level constraint requirements here.

For example:
The noise level generated during operation of the
[equipment/system] will not exceed 85 dB from 3 feet away.
4.5.4
EMI / RFI levels are:
Insert your own electrical and radio noise immunity requirements

here.
For example:
The [equipment/system] [will/will not] be used in an area where
two-way radio communication devices are in operation. The
[equipment/system] shall meet CE requirements for electrical noise
immunity and emissions.
USER REQUIREMENTS
SPECIFICATION
JETT

4.5.5
Containment
4.5.5.1
Explosion Protection
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September 2003
Based on the application, explosion protection may be

required. This can take form of:
4.5.6
Total containment and isolation (10 bar construction

with quick acting valves) designed to ASME code,
stamped and registered.
Isolation and suppression (quick acting valves and
chemical flame suppressants to prevent propagation
of conflagration) designed to ASME code, stamped
and registered
Explosion venting to safe area through ducting (may
require special design of the duct to contain the
pressure build-up).
Labeling
All equipment and control wiring shall be labeled and identified.

4.6
Maintenance
System shall be maintained on a schedule as indicated by the supplier.
Supplier is to provide (at minimum) the following maintenance
instructions:
1.
2.
3.
4.
5.
All sub-systems provided (Maintenance and operation manuals

of vendor equipment)
A comprehensive lubrication list and recommended lubrication
schedule
A comprehensive recommended maintenance (regular
recommended inspection intervals, wear points, recommended
spare parts list)
Supplier shall supply ______ Copies of Operation, Installation,
Maintenance and de-commissioning manuals
Accessibility for operation and maintenance personnel.
5.0 LIFE-CYCLE
5.1
Development
The Supplier shall provide a Quality and Project Plan as part of their
proposal. The Supplier shall have a quality system in place. Internal
quality procedures shall be available for the Users review.
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September 2003
The Supplier shall provide a Project Manager for the project to provide a
single communication point with the User.
The project shall utilize the GAMP methodology when developing the
system and documentation.
5.2
Testing
In order to verify system performance, the User shall witness the
execution of the Factory Acceptance Test procedures. The Supplier shall
notify the User _______ weeks in advance of the start of this test.
The Factory Acceptance Test Specification shall be submitted to the User
for review and approval prior to execution. A minimum of _______
weeks shall be allowed for the User to review and to comment and/or
approve the Factory Acceptance Test Specification.
5.3 Delivery
The Fluid Bed System, with all options, equipment, and the
documentation listed below, shall be delivered to the Users receiving
dock.
5.3.1
Documentation
Installation, operation, and maintenance instruction documentation

for the system shall be developed to a level that is comprehensible
to a high school graduate.
The Supplier shall use the formats described in the GAMP
Supplier Guide, Current Version, to produce the documentation.
The Supplier shall provide the documentation for preliminary
review. The Supplier shall provide documentation reflecting asbuilt condition with final delivery.
All final documents shall be shipped with transmittals that identify
them as contractually required documents. All final documents
and drawings shall reflect as-built condition.
All documents shall in the language of the destination country and
supplied with hard copies and electronic versions supplied in the
format identified for each document:
Project Plan
Microsoft Word 97 (*.doc)
User Requirements Specification
Functional Specification/Requirement
Design Specifications
Page 25 of 29
USER REQUIREMENTS
SPECIFICATION
JETT

September 2003
Controls Test
Hardware Installation Test
Operational Test
Factory Acceptance Test
Operator, Maintenance and Service Manuals
Process and Instrumentation Diagram (P&ID)
AutoCAD version 12.0 (*.dxf)
Instrument Listing
Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
Control Schematics
Control Panel Assembly Drawings
Equipment Assembly Drawings
Bill of Materials
Spare Parts List
Component Cut Sheets
CONTROL PLATFORM Program Printout and Disk File
XXX Program Development format
OIP Configuration Printout and Disk File
XXX Program Development format
5.4 Support
Describe what support activities are required after acceptance. The
paragraphs outlined below provide some areas for consideration.
5.4.1
Start-up Support (list available options)
5.4.1.1
Training (list training options available)
5.4.2
Post Start-up Support (list post-startup support available)
5.4.2.1
Technical Support
Telephone (Voice or Modem)
Replacement Parts Availability List (Normal lead times
shall be listed)
JETT
USER REQUIREMENTS
SPECIFICATION

5.4.2.2
Page 26 of 29
September 2003
User Site Support

Preventative Maintenance (list maintenance contracts
available)
System Improvements (supplier shall notify user of any
improvements available on a regular basis)
USER REQUIREMENTS
SPECIFICATION
JETT
Page 27 of 29
September 2003
6.0 GLOSSARY
Acronym
ASME
Definition
American Society of Mechanical Engineers
BL
Biohazard Level
Degrees Celsius
CFR
Code of Federal Regulations
dB
Decibels
EMI
Electro-Magnetic Interference
ft
Feet
GUI
Graphical User Interface
HEPA
High Efficiency Particle Arrestance

HEPA filtered air is 99.97% free of all particulate down to 0.3 microns
(including bacteria, fungal and other opportunistic microbiological).
HMI
Human Machine Interface
HVAC
Heating, Ventilation, and Air Conditioning
IQ
Installation Qualification
ISA
International Society for Measurement and Control
ISO
International Organization for Standardization
JETT
Joint Equipment Transition Team
LEL
Lower Explosion Limit
OIP
Operator Interface Panel
OIT
Operator Interface Terminal
OQ
Operational Qualification
PO
Purchase Order
PSIG
Pounds per square inch gauge
RFI
Radio Frequency Interference
RFQ
Request for Quote
S.I.
International System of Units (Metric)
UEL
Upper Explosive Limit
URS
User Requirement Specification
VAC
Voltage Alternating Current
JETT
USER REQUIREMENTS
SPECIFICATION
Page 28 of 29
September 2003
7.0 REFERENCES
List references that were used in preparing this document or that provide
additional details.
JETT
USER REQUIREMENTS
SPECIFICATION
Page 29 of 29
September 2003
8.0 APPROVAL
This document has been reviewed by the User Project Manager and approved for use by the
Supplier.
Printed/Typed Name
Signature
Date
This document has been reviewed by the User Quality Assurance Group and approved for
use by the Supplier.
Printed/Typed Name
Signature
Date
This document has been reviewed by the Supplier Project Manager and approved for use by
the Supplier Project Team.
Printed/Typed Name
Signature
Date
Other approvals as necessary may be included, such as the Technical Services Groups,
User Groups, Engineering, etc. as required.

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JETT

BATCH FLUID BED SYSTEM

USER REQUIREMENTS TEMPLATE

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

NOTES for use of the User Requirements Template:

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

Charging (loading of product to the fluid bed) can be as simple as dumping

Preheat (to prevent product from sticking to sides of fluid bed)

A typical Spray Process involves the following steps:

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

NOTE: Spraying may be done using: Top Spray, Side Spray

Ease of powder flow

Ease of making powder into tablets

Active drug coats

All of the above (Full flexibility)

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

Doc ID: Batch Fluid Bed

The products being used on the equipment are of:

Medium active (aspirin)

Highly active (morphine)

The intended use of the Fluid Bed is for:

Aqueous medium explosive potential of dust

Aqueous high explosive potential of dust

Solvent operated at 25% of the LEL of the solvent being

Extremely small (1 liter to 10 liters)

Small (10 liters to 30 liters)

Medium (30 liters to 60 liters)

Large (60 liters to 100 liters)

Larger (100 liters to 150 liters)

Largest (150, 170 and above liters)

3.0 OPERATIONAL REQUIREMENTS

Commodities to be used to load and unload the dryer i.e.

Quality of products and concentrations

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

Product limitations (i.e. temperature, humidity, pH, etc.)

Parameter Control Tolerance

Note: At a minimum, list the critical process parameters. Consider

Enter your specific operational requirements here.

Cycles expected the system will operate at are

Recipes the system will contain are

Operator interaction with the system will

In the event of a power failure, the system shall protect product

Manually re-start based on operator inputs

JOINT EQUIPMENT TRANSITION TEAM

BATCH FLUID BED SYSTEM

Re-start based on last state before loss of power.

If there is an automatic batch reporting system,

Insert your specific Emergency Stop (E-Stop) strategy and

Alarms and Warnings

Critical alarms shall take action automatically to shut the

JOINT EQUIPMENT TRANSITION TEAM