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.
REVISION HISTORY
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
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.
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)
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.
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
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
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)
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:
Manual only
Manual/automatic
3.4.2 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.
The Fluid Bed shall have the following alarms and warnings:
Non-
Critical Process
Alarm or Informational Message Critical
Alarm Critical
Alarm
Emergency Stop X
PLC-OIT Communication Watchdog X
Control Power Fault X
Main Air Fault X
Inlet Air Temperature High Fault X
Inlet Air Temperature Low Fault X
Inlet Airflow Low Fault X
Plugged Gun (low flow or solution pressure high) X
Nozzle Airflow Low Fault X
Inlet Dew Point High Fault X
Inlet Dew Point Low Warning X
Motor Faults X
PLC Battery Low Warning X
3.6 Environment
Provide details of the physical environment in which the
[equipment/system] will be operated.
3.6.1 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
4.0 CONSTRAINTS
4.1 Milestones and Timelines
Based on the model outlined below, establish the project milestones with a
timeline:
Approval
Review Detailed Design System Acceptance Test
Specifications (IQ/OQ)
Hardware
Software
Review System
Approva
Acceptance Test Specifications l System Acceptance
Testing and Results
(User Witness Optional)
Integrate with Validation
Documentation (as appropriate) Maintenance & Support
Documentation
pH
Temperature
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
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)
4.4 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.
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. All sub-systems provided (Maintenance and operation manuals
of vendor equipment)
2. A comprehensive lubrication list and recommended lubrication
schedule
3. A comprehensive recommended maintenance (regular
recommended inspection intervals, wear points, recommended
spare parts list)
4. Supplier shall supply ______ Copies of Operation, Installation,
Maintenance and de-commissioning manuals
5. 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.
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 as-
built 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.
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.
6.0 GLOSSARY
Acronym Definition
ASME American Society of Mechanical Engineers
BL Biohazard Level
C 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
Acronym Definition
VAC Voltage Alternating Current
7.0 REFERENCES
List references that were used in preparing this document or that provide
additional details.
8.0 APPROVAL
This document has been reviewed by the User Project Manager and approved for use by the
Supplier.
This document has been reviewed by the User Quality Assurance Group and approved for
use by the Supplier.
This document has been reviewed by the Supplier Project Manager and approved for use by
the Supplier Project Team.
Other approvals as necessary may be included, such as the Technical Services Groups,
User Groups, Engineering, etc. as required.