URS saya isi halaman 1-16.doc

JETT

USER REQUIREMENTS SPECIFICATION

Wet High-Shear Granulator

Page 1 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

USER REQUIREMENTS TEMPLATE for a WET HIGH-SHEAR GRANULATOR FOR PHARMACEUTICAL PRODUCTS

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JETT

USER REQUIREMENTS SPECIFICATION

Wet High-Shear Granulator

Page 2 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

REVISION HISTORY Rev.

Date

Approval

Revision Summary

A1 A2

07/17/02 10/14/02

VRM VRM

A3

02/14/03

VRM

Initial Draft Incorporated comments by technical review team attended by P. Coury, D. Rosendale, D. Noteboom, and V. Miller on July 18, 2002. This revision will focus the template on specific granulator application, rather than providing general guidelines on several granulator application options. Edited to insert comments from review during October 2002 JETT meeting as noted by J. Lustri. Comments need to be evaluated against blank template format and current URS content guidelines.

A4

9/19/03

BAL

Reviewed during September, 2003 meeting by all present and incorporated comments

C1

09/25/03

MRR

Format Review

The revision history section should be utilized during development to provide information that will allow the reviewer/approver to understand what part/parts of the document are being revised. For an initial release, provide a note that the document is being routed for initial review/approval. This will ensure reviewers/approvers evaluate the entire document. In the revision summary include the revision number of the Blank Template used to create any equipment specific templates.

(Reminder of Page Intentionally Left Blank)

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USER REQUIREMENTS SPECIFICATION

Wet High-Shear Granulator

Page 3 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

TABLE OF CONTENTS 1.0 1.1 1.2 1.3 1.4

INTRODUCTION..............................................................................................4 PURPOSE...........................................................................................................4 SCOPE...............................................................................................................4 GENERAL DESCRIPTION..................................................................................4 VALIDATION PLAN...........................................................................................4

2.0

OVERVIEW........................................................................................................5

3.0

OPERATIONAL REQUIREMENTS...............................................................6

3.1 3.2 3.3 3.4 3.5 3.6 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 5.0 5.1 5.2 5.3 5.4

CAPACITY.........................................................................................................6 PROCESS REQUIREMENTS...............................................................................6 PROCESS CONTROL.........................................................................................7 FUNCTIONS.......................................................................................................7 DATA AND SECURITY.....................................................................................14 ENVIRONMENT...............................................................................................18 CONSTRAINTS...............................................................................................19 MECHANICAL.................................................................................................19 MILESTONES AND TIMELINES.......................................................................20 EQUIPMENT CONSTRAINTS...........................................................................21 COMPATIBILITY AND SUPPORT.....................................................................22 AVAILABILITY................................................................................................23 PROCEDURAL CONSTRAINTS.........................................................................24 MAINTENANCE...............................................................................................25 LIFE-CYCLE....................................................................................................27 DEVELOPMENT...............................................................................................27 TESTING..........................................................................................................27 DELIVERY.......................................................................................................27 SUPPORT.........................................................................................................29

6.0

GLOSSARY......................................................................................................31

7.0

REFERENCES.................................................................................................32

8.0

APPROVAL.......................................................................................................33

9.0

ATTACHMENTS..............................................................................................34

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USER REQUIREMENTS SPECIFICATION

JETT

Wet High-Shear Granulator

Page 4 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 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. GRANULATOR URS Template, JETT Example User Requirements Specification.

1.0 INTRODUCTION Note: Insert your own description and introduction. You may wish to include your own requirements and specifics to allow the inexperienced reader, contractors, and suppliers adequate explanation to understand the scope of the equipment. 1.1

Purpose This document was generated under the authority of the ___________________ Company for the purpose of specifying the user requirement for an automated granulation system. The system shall be used to perform a wet high shear granulation step in which active and/or inactive pharmaceutical ingredients are combined with granulation fluid.

1.2

Scope This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the ____________________ Company.

1.3

General Description The granulation system will be operated independently of other equipment and systems and will be located in a designated operating area.

1.4

Validation Plan An equipment validation plan has been developed to outline the planned tasks and expectations for validation of the granulation system. This plan has been included as Attachment _____. The equipment supplier or vendor has specific responsibilities as outlined by the Validation Plan and this document.

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Wet High-Shear Granulator

Page 5 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

2.0 OVERVIEW This document encompasses the normal range of equipment operations. This section should be expanded to provide a high level description of the system explaining why it is required and what is required of it. Include the background, key objectives and benefits, main functions and interfaces, applicable GxP requirements, and other applicable regulations. Obviously, technology improvements and new applications may require deviation from this template. The User should consider including information on the following: 2.1

Use: Describe what applications the equipment/system will be used to support. Include a brief explanation of the general functions. For example: The granulation system shall mix a _____Kg batch consisting of acetominophen, microcrystalline cellulose, starch, and hydroxypropyl cellulose at a specified RPM and duration. After mixing, purified water will be added slowly over an adjustable period of time at an adjustable flowrate. Mixing will continue until a heavy mass is formed. The mixture will be dried in-situ using a microwave generator until a specific Loss On Drying (LOD) is reached. Final granulation step will be carried out by milling.

2.2

Capacity: Provide a brief description of the equipment/system capacity requirements. For example: The granulator shall be capable of handling batch sizes from ____ Kg to ___ Kg.

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Wet High-Shear Granulator

Page 6 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

3.0 OPERATIONAL REQUIREMENTS 3.1

Capacity Listed below are the capacity requirements for the system. Note: Some granulators will have a minimum percent full load requirement for an effective action, so it is important to clarify both the minimum and maximum batch sizes.

3.2

3.1.1

____Batches per day or ___ Kg per hour (Daily throughput)

3.1.2

Maximum volume/capacity required _____

3.1.3

Minimum volume/capacity required _____

Process Requirements 3.2.1

Range of products (i.e. density, moisture content, viscosity, etc.)

3.2.2

Commodities to be used (i.e. types of containers, or methods, used to charge and discharge materials to and from the granulation system.)

3.2.3

Processed Materials to be used or involved

3.2.4

Production rates

3.2.5

Binder Solution Flowrate

3.2.6

Power Requirements

3.2.7

Time of typical batch process

3.2.8

Quality of products and concentrations

3.2.9

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

3.2.10 Liquid flowrate, viscosity, temperature 3.2.11 Particle size 3.2.12 Moisture content 3.2.13 Granulation time 3.2.14 Mixer / agitator speed

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Wet High-Shear Granulator

Page 7 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

3.2.15 Feed and discharge hoppers 3.2.16 Jacket cooling requirements 3.2.17 Product cannot be exposed to temperatures above ____ C. 3.2.18 Clean In Place capability 3.3

Process Control The critical process parameters are listed below. These parameters have been determined through pilot scale testing.

3.4

3.3.1

Solution Flowrate (____ LPM within ___LPM range, accuracy +/-)

3.3.2

Impeller Speed (___ to ____ RPM, accuracy +/-)

3.3.3

Chopper Speed (____ to _____ RPM, accuracy +/-)

3.3.4

Power Requirements (Endpoint Control (____ to ____KW or Ft/lbs of Torque, accuracy +/-)

3.3.5

Time parameters Process Control Profile: 3.3.5.1

Premix (_____ Min/Sec, accuracy +/-)

3.3.5.2

Solution Delivery (_____ Min/Sec, accuracy +/-)

3.3.5.3

Wet Massing Time (______ Min/Sec, accuracy +/-)

3.3.5.4

Discharge Time (______ Min/Sec, accuracy +/-)

3.3.5.5

Discharge impeller speed adjustment (___ to ____ RPM, accuracy +/-)

Functions 3.4.1

Operation The operational requirements for this granulation system include the following:

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Page 8 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

3.4.1.1

The granulator is to be loaded by gravity feed from a hopper system provided by others with valve and fabric transition to an opening of _____ size.

3.4.1.2

The system shall have a manual mode, which will allow the operator control of all of the major functions of the equipment.

3.4.1.3

The system shall have a maintenance mode, which will allow troubleshooting of the equipment without an excess of constraining interlocks.

3.4.1.4

The system shall have an automated mode utilizing recipes for typical batch process operations having minimal operator interaction.

3.4.1.5

The process control system shall have ____ number of recipes.

3.4.1.6

The parameters listed above in section 3.3 shall be configurable throughout the indicated ranges.

3.4.1.7

The recipe parameters are configurable using the HMI terminal.

3.4.1.8

Operational parameters are defined the following table:

TABLE 3.4.1.8 - OPERATIONAL PARAMETERS Ref. No. 1 2 3 4 5 6 7

Parameter

Indicated on Local HMI

Monitored remotely

Operator adjustable

Determined by recipe

Target Granulation run time: Per operation Actual Granulation run time: Per operation Actual Granulation run time: Total Run Product temperature Vapor Outlet temperature Shell in/out temperature Absolute Pressure

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Data stored/trended

USER REQUIREMENTS SPECIFICATION

JETT

Wet High-Shear Granulator

Page 9 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

TABLE 3.4.1.8 - OPERATIONAL PARAMETERS Ref. No. 8 9 10 11 12 13 14 15

Parameter

Indicated on Local HMI

Monitored remotely

Operator adjustable

Determined by recipe

Data stored/trended

Impeller speed Chopper speed Wet Massing time Granulation system load weight Final product Yield Batch ID Recipe ID Recipe step #

3.4.2

Hand-Wash

3.4.3

Cleaning and/or Sanitization 3.4.3.1

Clean in Place (CIP) Describe how cleaning process is to be initiated and controlled, i.e. locally or remotely. Describe any remote control requirements, such as CIP Start, Stop, Abort, etc. 3.4.3.1.1

The granulator shall be cleaned in place using an automated sequence to be initiated by the operator. An existing centralized CIP system shall be utilized.

3.4.3.1.2

An automated clean-in-place system shall be used to clean the vessel. The unit shall provide connections and spray nozzles in locations as needed to effectively clean the equipment and vessel and route the cleaning solution to a return header. CIP solution supply and return is to be provided by others.

3.4.3.1.3

The unit shall clean all product contact areas automatically. Cleaning efficiency shall be verified in FAT and Site Acceptance testing using Riboflavin solution.

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Wet High-Shear Granulator

3.4.4

Page 10 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

3.4.3.2

Sterilization Requirements The granulator shall be steam sterilized using an automated sterilize-in-place (SIP) sequence. Steam shall be supplied to the unit from an existing clean steam distribution system. Describe the type of sterilization that will be performed on or within the [equipment/system] and the duration the [equipment/system] will be exposed.

3.4.3.3

Cleaning acceptance criteria Add cleaning acceptance criteria

Power failure/Recovery Power Failure: On power failure, the system shall fail into a “safe state” *. On power restoration, the system shall not restart without operator or communication-link input. * A “safe state” shall be defined as: 1. All motion stopped on the machine 2. Reset required before machine can be restarted 3. Valves and actuating devices go to safe state (define). 3.4.4.1

No damage to machine will occur as a result of going to the safe state.

3.4.4.2

There shall be no product loss when going to a safe state.

3.4.4.3

In the event of a power failure, the system shall protect in the following priority: 1. Personnel 2. Equipment 3. Product

3.4.4.4

Recovery Method: 3.4.4.4.1

Manually re-start based on operator inputs (Operator initiates power recovery sequence).

3.4.4.4.2

Re-start based on last state before loss of power. (System runs through power recovery sequence when operator start signal is given)

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Wet High-Shear Granulator

3.4.5

Page 11 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

3.4.4.4.3

All equipment shall be designed to retain the “controller” program in case of power loss, and be able to recover with minimal operator actions.

3.4.4.4.4

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). Refer to Table 3.4.1.7

“Emergency Stop” 3.4.5.1

Machine shall meet federal, state and local safety requirements

3.4.5.2

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.

3.4.5.3

Emergency-stop buttons shall be supplied within the reach of the operator at normal operator stations. When activated, the emergency stop shall shut the system down immediately in accordance with the following requirements: 3.4.5.3.1

Define applicable personnel access controls that prevent the machine from rotating when hazardous to personnel. For example, access gate, light curtain, door interlocks, and room air pressure sensor.

3.4.5.3.2

No damage to the machine or product will occur as a result of an emergency stop.

3.4.5.3.3

Batch ID, batch status, and sequence information shall not be lost as a result of an E-Stop. Refer to Table 3.4.1.7

3.4.5.3.4

Emergency stop will seal product path or take actions to prevent product contamination if so equipped.

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Wet High-Shear Granulator 3.4.5.3.5

3.4.6

Page 12 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

The machine shall not be allowed to restart without operator intervention. It shall be necessary to restore the emergency stop button to the original state, and reset the system before restarting.

Alarms, Messages, and Alert Operator prompts such as Alarms, Messages, and Alert signals are identified in Table 3.4.4.5. Categories of operator prompts are described in the following: 3.4.6.1

Critical alarms Critical Alarms shall take action via interlock(s) and/or operator procedural response to shut the equipment down and notify the operator of the condition(s) both audibly and visually. Operator action shall be defined by standard operating procedure. 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. “Informational Messages”

3.4.6.2

Non-critical Alarms Non-critical alarms shall notify the operator both audibly and visually to warn the operator of an abnormal condition, and take no further action automatically. Operator action shall be defined by standard operating procedure. Critical alarms are identified in the Table 3.4.6.5

3.4.6.3

Informational Messages Informational messages shall notify the operator both audibly and visually of a routine operational status or event, and take no further action. Operator action shall be defined by standard operating procedure. Critical alarms are identified in the Table 3.4.6.5 Non-critical alarms shall notify the operator both audibly and visually and take no further action. Operator action shall be defined by standard operating procedure. These alarms are identified in Table 3.4.6.5

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Page 13 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

3.4.6.4

Operator Procedural Alert Operator/ Procedural” alarms allow the machine to continue to run, but provide an “alert” message to be displayed on the operator screen. The operator shall be required to acknowledge the alert in order to remove the warning message form the operator screen.

3.4.6.5

The following table by identifies all system critical and non-critical alarms using the alarm definitions that follow the alarm table. Supporting narrative defines how the operator shall be notified and how the alarms shall be presented to the operator. Status messages and alarm logging requirements are described (alarm active, process value and time/date, alarm acknowledged, alarm cleared, process value and time/date).

Alarm or Informational Message

Emergency Stop Control Platform Communication Watchdog Control Power Fault Main Air Fault PLC Battery Low Machine Overtorque Rotation count error Safety gate lifted (or light curtain, door interlock, etc.) Rotation time exceeds normal time limit Encoder fault Acceptable speed limitations exceeded Air pressure low Loading or unloading valves not closed. (Proximity switches or limit switches failed.) Control system fault Motor Faults CONTROL PLATFORM Battery Low Warning

TABLE 3.4.6.5 Response NonCritical Informational Critical Operator Alarm Message Interlock(s)* Alarm Procedural

X X X X

X

X

E-Stop E-Stop E-Stop E-Stop Cycle Stop E Stop Cycle Stop

X

E Stop Cycle Stop Cycle Stop Cycle Stop Cycle Stop Cycle Stop X X

E Stop E Stop

Notes: “E-Stop” alarms shall take action immediately to stop the equipment. The operator shall be required to acknowledge the alarm before the alarm can be reset and the machine restarted.

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Wet High-Shear Granulator

Page 14 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

“Cycle-Stop” alarms shall take action at the end of a rotation cycle to stop the equipment. The operator shall be required to acknowledge the alarm before the alarm can be reset and the machine restarted. The list of critical alarms in the table is not intended to be a comprehensive list of all alarms for the system. A complete alarm list will be developed and included in the Functional Specification document. The equipment vendor is to submit the complete alarm list and differentiate between critical and non-critical alarms. 3.5

Data and Security This section specifies requirements for data collection and security. 3.5.1

cGMP Requirements Data Collection and security features of this system shall comply with cGMP requirements and 21 CFR Part 11 and/or _______________ Company policy and procedure. The supplier shall stipulate the methods by which this criterion is met.

3.5.2

User Interfaces This section addresses the issue of Operator interface access levels, frequency of data point collection, hardcopy/electronic data collection requirements, data retention time on the system, and data storage media. 3.5.2.1

Access to all Input/Output values and system status bits shall be provided through a data-communication link. Security for data and operator access must be provided using User ID/Password, Card Reader, Biometric (Fingerprint, eye scan, voice recognition, etc.), or some other agreed upon method.

3.5.2.2

Data shall be collected at _____ minute intervals and shall be printed in hardcopy and retained and stored electronically.

3.5.2.3

Hardcopy data reporting shall occur during each granulator run and shall be formatted to include a log of critical parameter and time information.

3.5.2.4

Sufficient data storage media shall be provided to accommodate a ____day data retention period.

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USER REQUIREMENTS SPECIFICATION

JETT

Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

Wet High-Shear Granulator 3.5.3

User Interface with Supervisors and Operators The user interface for Supervisors and Operators is described below. 3.5.3.1

The Control Platform system shall include interfaces with the Operator and Supervisor that ensures easy, safe, and reliable operation.

3.5.3.2

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 equipment.

3.5.3.3

Language Requirements The language that information will be displayed in is described below. 3.5.3.3.1

3.5.3.4

The language requirement shall be English for all system functions requiring written or displayed text.

Display Requirements 3.5.3.4.1

The granulator shall have a locally mounted operator interface terminal (OIT) capable of providing a configurable graphical user interface in color.

3.5.3.4.2

Operational parameters to be displayed on the OIT are listed in Table 3.4.1.8.

3.5.3.4.3

The system of measurement shall be metric (SI) units. Table 3.5.3.4.3

Reference Number 3.5.3.4.3.1 3.5.3.4.3.2 3.5.3.4.3.3 3.5.3.4.3.4 3.5.3.4.3.5

Parameter

Format

Rotation Count Machine Drive Controls (Auto. Manual, Run, Jog) Drive Speed Drive Torque Machine Position selection and indication (Loading, Unloading,

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Unit(s) of measurement

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Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

Wet High-Shear Granulator Table 3.5.3.4.3

Reference Number 3.5.3.4.3.6 3.5.3.4.3.7 3.5.3.4.3.8 3.5.3.4.3.9 3.5.3.4.3.10

3.5.4

Parameter

Format

Unit(s) of measurement

Maintenance, etc.) Loading/Unloading Valve Controls and indications Alarms and Warnings. System Status (e.g. “off,” “ on,” “standby” states, etc.). Phase Logic commands per ISA/ANSI S88.01 (Start, Stop, Hold, Restart, Abort, Reset, Pause, Resume)

Interface with Other Equipment The control system shall include the following interfaces necessary to facilitate operation and configuration. 3.5.4.1

A 10 Mbps Ethernet TCP/IP communication port shall be provided. This port shall accept an RJ style 10 Base T Unshielded twisted pair (UTP) connector. This port shall provide access to all Input/Output values and system status bits by an external computer system(s) to be installed by others. The port shall be configured to accept commands from, and provide status information, to a supervisory control and data acquisition (SCADA) node (Note: the SCADA system shall be supplied and installed by Owner): 3.5.4.1.1

Phase Logic commands per ISA/ANSI S88.01 (Start, Stop, Hold, Restart, Abort, Reset, Pause, Resume)

3.5.4.1.2

Procedural status signals per ISA/ANSI S88.01 (Idle, Running, Complete, Pausing, Paused, Holding)

3.5.4.1.3

System Status (e.g. “off,” “ on,” “standby” states, etc.).

3.5.4.1.4

Process variables as defined in Table 3.4.1.8

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Wet High-Shear Granulator 3.5.4.1.5

3.5.5

Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

The PLC/OIP system shall include interfaces with the User’s control system to facilitate recipe download and configuration.

Security Levels The total numbers of unique security access levels that will be required are presented below along with a general description of the access rights for each level (screen navigation, operational control, control loop variable manipulation, alarm setpoint manipulation, etc.). 3.5.5.1

3.5.6

Page 17 of 33

System security access shall consist of the following profiles. 3.5.5.1.1

Operator – Provides operator access to allow routine operation of all equipment features.

3.5.5.1.2

Engineer – Provides access to Operator level features in addition to critical operating parameters configuration.

3.5.5.1.3

System Administrator – Provides access to the Operator and Engineer level features in addition to system security parameters.

Data Collection Data collection requirements for process variables and operational parameters are specified in Table 3.4.1.8. This section describes the archiving and reporting requirements associated data collection.

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3.6

Wet High-Shear Granulator

Page 18 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

3.5.6.1

Storage of batch ID number.

3.5.6.2

Storage of batch run time.

3.5.6.3

Storage and trending of temperature

3.5.6.4

Process Printout for each granulator run.

3.5.6.5

Electronic process printout (historical trending of critical parameters).

3.5.6.6

Electronic process printout (historical trending and interface to company network).

Environment Details of the physical environment in which the granulator will be operated are presented below. 3.6.1

Layout 3.6.1.1

3.6.2

The physical environment in which the granulator will be operated shall consist of the following. 3.6.1.1.1

Allocated floor space for the equipment is eight feet by eight feet space with at least a three feet corridor around the periphery for the equipment.

3.6.1.1.2

Vertical clearance is twelve feet.

3.6.1.1.3

See attachment _____ for drawing # ____________________.

Physical Conditions The physical conditions in which the equipment will be operated are listed below. 3.6.2.1

Room Electrical Classification The room will be Class I Div II (Zone 2) (explosive atmosphere present at known times).

3.6.2.2

Environmental Classification The system shall be suitable to operate in a Class _______ cleanroom environment.

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Wet High-Shear Granulator 3.6.2.3

Page 19 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

Rating of Enclosures Enclosures shall be rated NEMA 4X (Wash down and non-Corrosive).

4.0 CONSTRAINTS 4.1

Mechanical 4.1.1

Use Sanitary Connectors 3.2.9 – 3.2.12 are mechanical not process

4.1.2

Use Gas purged seals

4.1.3

Use FDA-approved seals and gaskets

4.1.4

Use Dust-tight designs

4.1.5

Vendor is to provide a sanitary “XX inch” connection for dust collector (dust collection system provided by others)

4.1.6

The granulation system will be unloaded via a “XX inch” discharge port. Transfer to downstream fluid bed dryer is by gravity assisted feed.

4.1.7

State the ASME Vacuum/pressure rating of vessels or tanks

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JETT 4.2

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USER REQUIREMENTS SPECIFICATION

Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

Wet High-Shear Granulator Milestones and Timelines

Based on the model outlined below, establish the project milestones with a timeline:

4.3

4.2.1

The Supplier shall provide a written proposal within _____ weeks of receipt of this document at the Supplier’s local office.

4.2.2

The Supplier shall provide a Functional and Design Specifications within _____ weeks of receipt of the purchase order.

4.2.3

The User shall review, comment and/or approve, and return the Functional and Design Specification to the Supplier within _____ weeks of receipt from the Supplier.

4.2.4

The Supplier shall provide the Factory Acceptance Test Specification within _____ weeks of receipt of approved the Functional and Design Specification. The User shall review, comment and/or approve, and return the test specifications to the Supplier within _____ weeks of receipt from the Supplier.

4.2.5

The granulator and all support equipment shall be delivered to the User’s receiving dock on or before _______________.

Equipment Constraints The granulator will be required to meet the following conditions For example: 4.3.1

Environmental Conditions The granulator is to be used at the following environmental conditions: Altitude ________ ft above sea level.

4.3.2

HVAC Equipment Constraints 4.3.2.1

Indoor Temperature: _____ to _____C.

4.3.2.2

Outdoor Temperature 4.3.2.2.1

Minimum:

 C.

4.3.2.2.2

Maximum:

C.

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Wet High-Shear Granulator 4.3.2.3

4.4

Page 21 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

Climatic Conditions 4.3.2.3.1

Winter dry bulb _____C.

4.3.2.3.2

Winter wet bulb _____C.

4.3.2.3.3

Summer dry bulb _____C.

4.3.2.3.4

Summer wet bulb _____C.

4.3.3

Equipment Generated Vibration The maximum allowable equipment vibration generated during operation is ____________.

4.3.4

The top of the granulator shall be accessible from a platform height of six feet or less.

Compatibility and Support The requirements for compatibility with other User systems are as follows. 4.4.1

Control System Compatibility

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JETT

Wet High-Shear Granulator

4.4.2

Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

4.4.1.1

The Supplier shall utilize _____ Control Platform Controllers that shall include _____ communications port for each unit.

4.4.1.2

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

4.4.1.3

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.

4.4.1.4

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.

Preferred Vendor List This section describes preferred components, instrumentation, and procedures. 4.4.2.1

4.4.3

Page 22 of 33

If the supplier or vendor wishes to deviate from the preferred component, instrumentation, or procedures list (Attachment _____), a listing of the proposed components, instrumentation, or procedure along with sub-vendors indicating type and model numbers shall be submitted with the quotation, along with an explanation of why the deviation is recommended.

Utilities 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. 4.4.3.1

The Supplier shall specify utility data as follows; 4.4.3.1.1

Electricity 4.4.3.1.1.1

_____ VAC, ____ Hertz, Phases _____.

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USER REQUIREMENTS SPECIFICATION

JETT

Wet High-Shear Granulator

4.4.3.1.2

Current: _____ Amps.

4.4.3.1.1.3

_____ Minute Uninterruptible Power Supply (Define use).

Control Air Pressure _____ Bar (must be clean, dry ISA instrument quality air, capacity to be determined by size of equipment). Recommend at least 6 Bar constant air pressure for all equipments, unless specified.

Other Utility Requirements 4.4.3.1.3.1

4.5

Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

4.4.3.1.1.2

4.4.3.1.2.1

4.4.3.1.3

Page 23 of 33

Provide details regarding any other utility systems that are required to support operation of the equipment/system.

Availability Equipment availability based on anticipated usage is listed below.

4.6

4.5.1

The granulator is intended to operate regularly _____ hours per day, _____ hours per week, _____ weeks per year.

4.5.2

Operation of the granulator shall be suspended, and the system shall be available for preventative maintenance or routine service _____ hours per week.

Procedural Constraints 4.6.1

Product Contact Materials Describe any local procedural requirements such as local standards, which must be adhered to if applicable.

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Wet High-Shear Granulator

Page 24 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

4.6.1.1

All piping welds and product contact welds shall meet ASME and 3A specification requirements.

4.6.1.2

Product contact metal to be (316L Stainless Steel, 316 Stainless Steel, 304 Stainless Steel, etc.)

4.6.1.3

List critical requirements for surface finish, roughness, etc. Other standards are attached. The Supplier shall adhere to the indicated sections only. 4.6.2

Product in Contact with Materials 4.6.2.1

All product contact parts shall be constructed from materials acceptable to the product and sterility assurance methods.

4.6.2.2

Certificates for material, weld, and finish shall be provided.

4.6.2.3

All product contact parts should be considered.

The [equipment/system] will be used for (aqueous solutions, low LEL (lower explosion limit) solvents, high LEL solvents, etc.). 4.6.3

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.

4.6.4

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.

4.6.5

Containment

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Wet High-Shear Granulator 4.6.5.1

4.6.6 4.7

Page 25 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

Explosion Protection This section is only valid if the product being used is highly reactive. Insert containment guidelines here (i.e. Bar Construction with isolation and suppression, 10 Bar construction with isolation only, Closed-Loop Nitrogen System, etc.).

Labeling All equipment and control wiring shall be labeled and identified.

Maintenance The expected hardware and software maintenance support including ease of maintenance, expansion capability (software only), likely enhancements (software only) expected lifetime and long-term support are described below. 4.7.1

System shall be maintained on a schedule as indicated by the supplier. Supplier is to provide (at minimum) the following maintenance instructions. 4.7.1.1

Maintenance activities for all sub-systems provided (Maintenance and operation manuals of vendor equipment).

4.7.1.2

A comprehensive lubrication list and recommended lubrication schedule.

4.7.1.3

A comprehensive recommended maintenance (regular recommended inspection intervals, wear points, recommended spare parts list).

4.7.1.4

Supplier shall supply ______copies of Operation, Installation, Maintenance and de-commissioning manuals.

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JETT

Wet High-Shear Granulator

Page 26 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

5.0 LIFE-CYCLE 5.1

Development This section lists the requirement for vendor involvement in the equipment supply and includes testing, delivery, and support.

5.2

5.1.1

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.

5.1.2

The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.

5.1.3

The project shall utilize the GAMP methodology when developing the system and documentation.

Testing This section describes the Supplier testing requirements and should reference the Validation Test Plan, Factory Acceptance Test, special tests, etc.

5.3

5.2.1

In order to verify system performance, the User shall witness the execution of the Factory Acceptance Test (FAT) procedures. The Supplier shall notify the User _____ weeks in advance of the start of this test.

5.2.2

The FAT 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 FAT Specification.

5.2.3

Refer to the Equipment Validation Plan for applicable procedures.

Delivery This section lists the delivery requirements of the equipment. 5.3.1

The granulator, with all options, equipment, and the documentation listed below, shall be delivered to the User’s receiving dock.

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Wet High-Shear Granulator 5.3.1.1

Page 27 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

Documentation 5.3.1.1.1

Installation, operation, and maintenance instruction documentation for the system shall be developed to a level that is comprehensible to a high school graduate.

5.3.1.1.2

The Supplier shall use the formats described in the current 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.

5.3.1.1.3

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.

5.3.1.1.4

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.

5.3.1.1.5

The documentation and format requirements for this project are listed below.



Project Plan

Microsoft Word XX (*.doc)



User Requirements Specification

Microsoft Word XX (*.doc)



Functional Specification/Requirement

Microsoft Word XX (*.doc)



Design Specifications

Microsoft Word XX (*.doc)



Controls Test

Microsoft Word XX (*.doc)



Hardware Installation Test

Microsoft Word XX (*.doc)



Operational Test

Microsoft Word XX (*.doc)



Factory Acceptance Test

Microsoft Word XX (*.doc)



Operator, Maintenance and Service Manuals

Microsoft Word XX (*.doc)

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Wet High-Shear Granulator

Page 28 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003



Process and Instrumentation Diagram (P&ID)



Instrument Listing



Control Schematics

AutoCAD version XX.X (*.dxf)



Control Panel Assembly Drawings

AutoCAD version XX.X (*.dxf)



Equipment Assembly Drawings

AutoCAD version XX.X (*.dxf)



Bill of Materials

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



Spare Parts List

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



Component Cut Sheets

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



CONTROL PLATFORM Program Printout and Disk File

XXX Program Development format



OIP Configuration Printout and Disk File

XXX Program Development format

5.4

AutoCAD version XX.X (*.dxf) Microsoft Word XX (*.doc) or Excel XX (*.xls)

Support The following support activities are required after acceptance. The paragraphs outlined below provide the areas of consideration. 5.4.1

Start-up Support 5.4.1.1

5.4.2

Training 5.4.2.1

5.4.3

User training shall consist of _____ hours of Operator training and _____ hours of Maintenance training.

Post Start-up Support 5.4.3.1

5.4.4

Start-up support shall consist of _____ weeks of full time assistance on the User’s site for punch listing activities and _____ weeks of commissioning support.

Post start-up shall consist of monthly User site visits for a period of _____ months after the completion of commissioning activities.

Technical Support

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USER REQUIREMENTS SPECIFICATION

JETT

Wet High-Shear Granulator

5.4.5

Page 29 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

5.4.4.1

Technical support shall be provided via telephone for a period of _____ years following the completion of validation activities.

5.4.4.2

A recommended replacement parts list including normal lead times shall be provided for the machine and all sub-assemblies.

User Site Support 5.4.5.1

The Supplier shall notify the User of preventative maintenance system improvement availability on a regular basis).

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Wet High-Shear Granulator

Page 30 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

6.0 GLOSSARY If necessary, attach a glossary, which includes definitions of terms that may be unfamiliar to the Supplier or terminology that may have meanings specific to entries on this User Requirements Check sheet. For example (example list is not intended to be complete): Acronym

Definition

C

Degrees Celsius

BL

Biohazard Level

CFR

Code of Federal Regulations

DB

Decibels

EMI

Electro-Magnetic Interference

Ft

Feet

GUI

Graphic User Interface

HMI

Human – Machine Interface

HVAC ISO

Heating, Ventilation, and Air Conditioning International Organization for Standardization

JETT

Joint Equipment Transition Team

LEL

Lower Explosion Limit

OIP

Operator Interface Panel

RFI

Radio Frequency Interference

URS

User Requirement Specification

IBC

Intermediate Bulk Container The process of creating granules. The powder morphology is modified through the use of either a liquid that causes particles to bind through capillary forces or dry compaction forces. The process will result in one or more of the following powder properties: enhanced flow; increased compressibility; densification; alteration of physical appearance to more spherical, uniform, or larger particles; and/or enhanced hydrophilic surface properties. (SUPAC IR/MR: US FDA, Jan. 1999.) Wet high-shear granulator subclasses are primarily distinguished by the geometric positioning of the primary impellers; impellers can be top, bottom, or side driven.

Granulation

Wet High-Shear Granulator

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JETT

USER REQUIREMENTS SPECIFICATION

Wet High-Shear Granulator

Page 31 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

7.0 REFERENCES A list of references that were used in preparing this document or that provided additional details is shown below. 7.1 Equipment Validation Plan 7.2 Current revision of GAMP Guidelines 7.3 Vendor Piping Certification (if applicable) 7.4 Customer Connection Diagram 7.5 Approved Instrumentation List 7.6 Process Flow Diagram 7.7 21 CFR Part 11 7.8 National Electric Code 7.9 S88

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Wet High-Shear Granulator

Page 32 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 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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Wet High-Shear Granulator

Page 33 of 33 Doc ID: Granulator URS TEMPLATE Rev.C1 September 2003

9.0ATTACHMENTS

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