JETT
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USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
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Page of 27
Doc ID: Wide Range Filler_URS_Example
Rev. A2
May 20, 2003
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User Requirements Specification Example
for a JETT Consortium
Wide Range Liquid Filler
Table of Contents
1.0Introduction 3
2.0Overview 4
3.0Operational Requirements 5
3.1Commodities 5
3.2Performance 6
3.3Functions 6
3.4Power Failure and Recovery 8
3.5Emergency Stop 8
3.6Alarms and Warnings 10
3.7Data & Security 11
3.8Interfaces 11
3.9Supervisory Interface 13
3.10Data Collection 13
4.0Environment 14
4.1Layout 14
4.2Physical Conditions 14
5.0Constraints 15
5.1Milestones and Timelines 15
16
6.0Compatibility 16
6.1Controls 16
6.2Product Contact Parts 17
6.3Utilities 17
7.0Availability 18
7.1Duty Cycle 18
8.0Procedural Constraints 18
8.1Regulatory Compliance: 18
9.0Maintenance 19
9.1Instructions 19
9.2Tools 19
9.3Spare Parts 20
10.0Life-Cycle 20
10.1Development 20
10.2Testing 21
10.3Delivery 21
10.4Documentation 21
10.5Support 22
11.0Glossary 24
12.0References 25
13.0Approval 26
REVISION HISTORY
Rev.
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Date
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Approval
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Revision Summary
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A0
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02/25/03
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TGP
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Initial Draft
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A1
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5/20/03
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LM
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Comments from Terry Petro
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A2
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8/22/03
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TGP
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Remove PLC/HMI details
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Project No.: JETT Consortium Wide Range Filler #1234
Document No.: 8111234567
Document Description: Wide Range Filler User Requirements Specification
Introduction
This document was generated under the authority of the JETT Consortium for the purpose of specifying the user requirement for a wide range filler that will fill, sample checkweigh and stopper a specified range of vial sizes in a pharmaceutical environment. The User Requirements Specification (URS) is provided to define the important components, variables and options necessary for the Supplier to provide a functional filling stoppering system that meets the JETT Consortium needs in the most cost-effective method possible. The URS is also provided to the Supplier to provide a price quote for the wide range filler supply including the design and manufacture of the equipment.
This URS is an integral part of the procurement agreement with the Supplier. The Supplier will abide by the information and conditions set forth by this document as well as the standard purchasing terms and conditions of the JETT Consortium.
The wide range filler will be interfaced to the output of an existing depyrogenation tunnel, and will be located in a designated operating area within a cGMP packaging operation.
An equipment validation plan has been developed to outline the planned tasks and expectations for validation of the wide range filler. This plan has been included as Attachment A. The Supplier has specific responsibilities as outlined by the equipment validation plan and this document.
Overview
The liquid vial filler shall process pharmaceutical vials under sanitary conditions with the following functions:
Vial unscrambling
Vial filling
Vial stoppering
Oxygen reduction
Sample checkweighing
Vial eject
Operational Requirements
Commodities
Commodity Table
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