Académique Documents
Professionnel Documents
Culture Documents
USER REQUIREMENTS
SPECIFICATION
Page 1 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
SYSTEM
JETT
USER REQUIREMENTS
SPECIFICATION
Page 2 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
JETT
USER REQUIREMENTS
SPECIFICATION
Page 3 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
REVISION HISTORY
Rev.
Date
Approval
09/15/03
Miller
Revision Summary
Initial Release
JETT
USER REQUIREMENTS
SPECIFICATION
Page 4 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
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
Page 5 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
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
JETT
USER REQUIREMENTS
SPECIFICATION
Page 6 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
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)
USER REQUIREMENTS
SPECIFICATION
JETT
Page 7 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
JETT
USER REQUIREMENTS
SPECIFICATION
Page 8 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
2.0 OVERVIEW
Use:
The fluid bed dryer shall be used primarily for:
Drying
De-dust/flavor mask
Protective
Timed release
JETT
USER REQUIREMENTS
SPECIFICATION
Exclusive (penicillin)
Page 9 of 29
Capacity:
The capacity of the machine is to be:
3.2
Capacity
Range of products
Production rates
Process Requirements
JETT
USER REQUIREMENTS
SPECIFICATION
3.3
Page 10 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
Process Control
Measurement Range
Setpoint Range
Functions
3.4.1
Operation
3.4.2
Manual only
Manual/automatic
Power failure/Recovery
JETT
USER REQUIREMENTS
SPECIFICATION
Page 11 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
Emergency Stop
Page 12 of 29
USER REQUIREMENTS
SPECIFICATION
JETT
Critical
Alarm
Emergency Stop
Process
Critical
NonCritical
Alarm
Motor Faults
3.5
User Interfaces
JETT
USER REQUIREMENTS
SPECIFICATION
Page 13 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
Inlet Temperature
Exhaust Temperature
Inlet Airflow
o Optional
Product Temperature
Nozzle airflow
Nozzle Pressure
Solution Pressure
Rotor RPMs
JETT
USER REQUIREMENTS
SPECIFICATION
Page 14 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
Security Configurations
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
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:
JETT
USER REQUIREMENTS
SPECIFICATION
Page 15 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
Security Levels
Data Collection
None
Recorder
Process Printout
3.6
Inlet Temperature
Exhaust Temperature
Inlet Airflow
Nozzle airflow
System status
Product Temperature
Environment
Provide details of the physical environment in which the
[equipment/system] will be operated.
JETT
USER REQUIREMENTS
SPECIFICATION
Page 16 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
Layout
For example:
Physical Conditions
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
JETT
USER REQUIREMENTS
SPECIFICATION
Page 17 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
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
JETT
USER REQUIREMENTS
SPECIFICATION
Page 18 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
4.0 CONSTRAINTS
4.1
USER/(CONSULTANT if applicable)
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)
Approval
Approva
l
System Acceptance
Testing and Results
(User Witness Optional)
Maintenance & Support
Documentation
JETT
4.2
Page 19 of 29
USER REQUIREMENTS
SPECIFICATION
Environmental Conditions
Indoor Temperature:
Outdoor Temperature:
Minimum:
Maximum:
Climatic conditions:
4.2.3
JETT
USER REQUIREMENTS
SPECIFICATION
Page 20 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
Utilities
USER REQUIREMENTS
SPECIFICATION
JETT
Page 21 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
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
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].
JETT
4.5
USER REQUIREMENTS
SPECIFICATION
Page 22 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
Procedural Constraints
4.5.1
USER REQUIREMENTS
SPECIFICATION
JETT
Containment
4.5.5.1
Explosion Protection
Page 23 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
4.5.6
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.
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.
Page 24 of 29
USER REQUIREMENTS
SPECIFICATION
JETT
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
Project Plan
Functional Specification/Requirement
Design Specifications
Page 25 of 29
USER REQUIREMENTS
SPECIFICATION
JETT
Controls Test
Operational Test
Instrument Listing
Control Schematics
Bill of Materials
5.4 Support
Describe what support activities are required after acceptance. The
paragraphs outlined below provide some areas for consideration.
5.4.1
5.4.1.1
5.4.2
5.4.2.1
Technical Support
Telephone (Voice or Modem)
Replacement Parts Availability List (Normal lead times
shall be listed)
JETT
USER REQUIREMENTS
SPECIFICATION
Page 26 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
USER REQUIREMENTS
SPECIFICATION
JETT
Page 27 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
September 2003
6.0 GLOSSARY
Acronym
ASME
Definition
American Society of Mechanical Engineers
BL
Biohazard Level
Degrees Celsius
CFR
dB
Decibels
EMI
Electro-Magnetic Interference
ft
Feet
GUI
HEPA
HMI
HVAC
IQ
Installation Qualification
ISA
ISO
JETT
LEL
OIP
OIT
OQ
Operational Qualification
PO
Purchase Order
PSIG
RFI
RFQ
S.I.
UEL
URS
VAC
JETT
USER REQUIREMENTS
SPECIFICATION
Page 28 of 29
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
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
Doc ID: Batch Fluid Bed
System TEMPLATE Rev.0
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.