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

BATCH FLUID BED SYSTEM

Page 2 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 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

BATCH FLUID BED SYSTEM

Page 3 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

REVISION HISTORY Rev.

Date

Approval

0

09/15/03

Miller

Revision Summary Initial Release

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USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM

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 ...........................................................................................................29 8.0 APPROVAL.................................................................................................................30

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USER REQUIREMENTS SPECIFICATION

JETT

BATCH FLUID BED SYSTEM

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 naturally

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USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM

Page 6 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

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: Dust Collectors Scrubbers Incinerators (thermal oxidizers that literally burn the contaminants away) HEPA systems with bag-in, bag-out feature for operator exposure protection Closed loop recovery systems (Design to recycle and/or capture the fluids and products for disposal or possible re-use) 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.

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BATCH FLUID BED SYSTEM

Page 7 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

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 machine’s 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 NOTE: Spraying may be done using: Top Spray, Side Spray and Wurster Column.

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BATCH FLUID BED SYSTEM

Page 8 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

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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JETT •

•

•

BATCH FLUID BED SYSTEM

Page 9 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 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 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

Capacity • • • •

3.2

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

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JETT 3.3

USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM

Page 10 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

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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USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM

Page 11 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

• 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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Page 12 of 29

USER REQUIREMENTS SPECIFICATION

JETT

BATCH FLUID BED SYSTEM

Alarm or Informational Message

Critical Alarm

Emergency Stop

X

PLC-OIT Communication Watchdog

X

Control Power Fault

X

Main Air Fault

X

Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

Process Critical

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

NonCritical Alarm

Inlet Dew Point Low Warning

X

Motor Faults

X

PLC Battery Low Warning

3.5

X

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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JETT

USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM

Page 13 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

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

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:

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USER REQUIREMENTS SPECIFICATION

JETT

BATCH FLUID BED SYSTEM

Page 14 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003



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 User’s 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: • • • 3.5.4

All process variables Alarms and Warnings System status

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.).

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USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM 3.5.5

Page 15 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

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. 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.

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JETT

BATCH FLUID BED SYSTEM

Page 16 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

• 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 146442)  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 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)

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JETT

USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM

Page 17 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

 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 The Seismic Zone in the operating environment is .

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USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM

Page 18 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

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 RFQ

o op Pr

Proposal • Quality Plan • Project Plan

sal

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

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4.2

Page 19 of 29

USER REQUIREMENTS SPECIFICATION

Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

BATCH FLUID BED SYSTEM

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:

°C °C

Climatic conditions:

4.2.3

Winter dry bulb

°C

Winter wet bulb

°C

Summer dry bulb

°C

Summer wet bulb

°C

Equipment Generated Vibration

The maximum allowable equipment vibration generated during operation is . 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.

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JETT

USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM

Page 20 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

The Supplier shall provide documentation that the program (embedded software) was developed and coded utilizing program development and documentation software. 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 subvendors 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

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USER REQUIREMENTS SPECIFICATION

JETT

BATCH FLUID BED SYSTEM

Page 21 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

• 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 •

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

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USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM

Page 22 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

per week, __ continuous hours per week, __ days per month, __ weeks per year]. 4.5

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.

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USER REQUIREMENTS SPECIFICATION

JETT

BATCH FLUID BED SYSTEM 4.5.5

4.5.5.1

Page 23 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

Containment

Explosion Protection 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 User’s review.

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USER REQUIREMENTS SPECIFICATION

JETT

BATCH FLUID BED SYSTEM

Page 24 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 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 User’s 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. 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

Microsoft Word 97 (*.doc)

•

Functional Specification/Requirement

Microsoft Word 97 (*.doc)

•

Design Specifications

Microsoft Word 97 (*.doc)

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Page 25 of 29

USER REQUIREMENTS SPECIFICATION

JETT

Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

BATCH FLUID BED SYSTEM

•

Controls Test

Microsoft Word 97 (*.doc)

•

Hardware Installation Test

Microsoft Word 97 (*.doc)

•

Operational Test

Microsoft Word 97 (*.doc)

•

Factory Acceptance Test

Microsoft Word 97 (*.doc)

•

Operator, Maintenance and Service Manuals

Microsoft Word 97 (*.doc)

•

Process and Instrumentation Diagram (P&ID)

AutoCAD version 12.0 (*.dxf)

•

Instrument Listing

Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

•

Control Schematics

AutoCAD version 12.0 (*.dxf)

•

Control Panel Assembly Drawings

AutoCAD version 12.0 (*.dxf)

•

Equipment Assembly Drawings

AutoCAD version 12.0 (*.dxf)

•

Bill of Materials

Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

•

Spare Parts List

Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

•

Component Cut Sheets

Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

•

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)

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USER REQUIREMENTS SPECIFICATION

BATCH FLUID BED SYSTEM 5.4.2.2

Page 26 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 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)

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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

°C

Degrees Celsius

CFR

Code of Federal Regulations

dB

Decibels

EMI

Electro-Magnetic Interference

ft

Feet

GUI

Graphical User Interface

HEPA

HMI

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). 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

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BATCH FLUID BED SYSTEM

Acronym VAC

Page 28 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

Definition Voltage Alternating Current

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BATCH FLUID BED SYSTEM

Page 29 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.

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Page 30 of 29 Doc ID: Batch Fluid Bed System TEMPLATE Rev.0 September 2003

8.0APPROVAL 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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