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JETT USER REQUIREMENTS SPECIFICATION LABELER Page 1 of 57 Doc ID: Labeler Template Rev. 0 May 2002 USER REQUIREMENTS TEMPLATE For a LABELER JOINT EQUIPMENT TRANSITION TEAM

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USER REQUIREMENTS TEMPLATE

JETTUSER REQUIREMENTS SPECIFICATION

LABELERPage 1 of 11Doc ID: Labeler Template Rev. 0May 2002

User Requirements Template

For a labeler

REVISION HISTORY

Rev.DateAuthorRevision Summary

0July 11, 2002Paul Coury (JETT)Initial revision issued to JETT website.

(Reminder of Page Intentionally Left Blank)

Table of Contents

41.0Introduction

2.0Overview53.0Operational Requirements63.1Capacity63.2Process Requirements73.3Process Control133.4Functions143.5Data and Security173.6Environment224.0Constraints264.1Milestones and Timelines264.2Equipment Constraints274.3Compatibility and Support284.4Availability304.5Procedural Constraints304.6Maintenance325.0Life-Cycle335.1Development335.2Testing335.3Delivery335.4Support356.0Glossary377.0References398.0Approval40

Project No.: Labeler

Document No.: , Rev.

Document Description: Labeler User Requirements Specification

1.0 Introduction

This document was generated under the authority of the ___________________ Company for the purpose of specifying the user requirement for an automatic labeler that will place pressure sensitive labels on pharmaceutical containers. The User Requirements Specification (URS) is provided to aid the user through the important components, variables and options necessary to procure a functional labeler that meets the users needs in the most cost-effective method possible. The URS is then provided to the Supplier to provide a price quote for labeler supply including the design and manufacture of the equipment.

1.1 This URS 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.

1.2 The labeler system will be operated adjacent to conveyor systems on an integrated packaging line and will be located in a designated operating area within a cGMP packaging operation.

1.3 An equipment validation plan has been developed to outline the planned tasks and expectations for validation of the labeler 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.

2.0 Overview

2.1 This URS helps the User to define an automatic labeler to place pressure sensitive labels on pharmaceutical containers. The equipment being defined is intended to receive product containers from an in feed conveyor, apply a label, and discharge the container onto an out feed conveyor. The equipment will provide for container transport through the machine. Pressure sensitive labels are applied to product packaging for the purpose of identifying the product and communicating product information to the consumer. Control over the identity of the pharmaceutical or medical device product is a FDA requirement as described in the cGMP regulations for finished pharmaceuticals.

2.2 The labeler must be capable of continuous operation over a _____ shift, _____ day operation, but will be operated intermittently to satisfy the demands of Packaging Operations.

2.3 The machine shall be used primarily for:

2.3.1 Applying a pressure sensitive label to containers

2.3.2 Printing product information on the label

2.3.3 Inspecting pre-printed and printed characters on the label

2.3.4 Other: _________________________________________

3.0 Operational Requirements

3.1 Capacity

3.1.1 Production Speed

3.1.1.1 The labeler shall be capable of operating at a speed of __________ labels per minute.

3.2 Container Size Table

Table 3.2 Container Sizes

Container Name/ SizeContainer MaterialContainer ShapeContainerHeight(mm)ContainerWidth(mm)Rate

(Parts/ Min)Comments

MaxMinMaxMinMaxMin

3.3 Label Size Table

Table 3.3 Label Sizes

Container Name/ Size1st Label Size2nd Label Size3rd Label SizeLabel Roll WindLabel Roll DiameterPlacement Location

3.4 Outsert Size Table

Table 3.4 Outsert Sizes

Container Name/ SizeOutsert SizeGlue/tapePlacementComments

3.5 Process Requirements

3.5.1 Product Classification

The products/containers being produced on the machine are as follows.

3.5.1.1 Solid Dosage

3.5.1.2 Liquids

3.5.1.3 Ointments

3.5.1.4 Creams

3.5.1.5 Aerosols

3.5.1.6 Pre-filed Syringes

3.5.1.7 Other: ____________________

3.5.2 Intended Use

The equipment will be used for the following application.

3.5.2.1 Glass Bottles

3.5.2.2 Plastic Bottles

3.5.2.3 Canisters

3.5.2.4 Syringes

3.5.2.5 Full containers

3.5.2.6 Empty containers

3.5.2.7 Cold containers

3.5.2.8 Wet containers

3.5.2.9 Capped containers

3.5.2.10 Dry containers

3.5.2.11 Hot containers

3.5.2.12 Other: ____________________

3.5.3 Machine Type

The type of machine to be specified shall be as follows.

3.5.3.1 Trunion style

3.5.3.2 Rotary style

3.5.3.3 In-line style

3.5.3.4 Off-line style

3.5.3.5 Table top style

3.5.3.6 Other: ____________________

3.5.3.7 No preference

3.5.4 Direction and Orientation of Container Travel

3.5.4.1 Product Transfer In feed

3.5.4.1.1 Side

3.5.4.1.2 End

3.5.4.1.3 90 Degree

3.5.4.1.4 Other: ______________________

3.5.4.2 Product Transfer Out feed

3.5.4.2.1 Side

3.5.4.2.2 End

3.5.4.2.3 90 Degrees

3.5.4.2.4 Other: ______________________

3.5.4.3 Orientation of Container at In-Feed

3.5.4.3.1 Short Edge Leading

3.5.4.3.2 Long Edge Leading

3.5.4.3.3 Other: ______________________

3.5.4.4 Orientation of Container at Discharge

3.5.4.4.1 Short Edge Leading

3.5.4.4.2 Long Edge Leading

3.5.4.4.3 Other: ______________________

3.5.5 Label Placement

3.5.5.1 Required Accuracy (label placement on product container)

3.5.5.1.1 +/-1/64

3.5.5.1.2 +/-1/16

3.5.5.1.3 +/-1/32

3.5.5.1.4 +/-1/8

3.5.5.1.5 Other: ______________________

3.5.6 Printing System

3.5.6.1 Laser Printing

3.5.6.2 Hot Stamp Printing

3.5.6.3 Pre-Printed

3.5.6.4 List Print Font & Size: __________________

3.5.6.5 Character placement: ___________________

1st Line: ______________________________2nd Line: _____________________________3rd Line: ______________________________4th Line: ______________________________

3.5.6.6 Character Orientation: ___________________

3.5.6.7 Additional information: _________________

3.5.7 Label Inspection System

3.5.7.1 Location

3.5.7.1.1 Inspect on web prior to placement.

3.5.7.1.2 Inspect on web and UV detection of label on container.

3.5.7.1.3 Inspect on container.

3.5.7.1.4 Other (Describe):_______________________

3.5.7.2 Type of Inspection System:

3.5.7.2.1 Character recognition (OCR)

3.5.7.2.2 Character verification (OCV)

3.5.7.2.3 Other (Describe): ______________________

3.5.8 Inspection System Verification

3.5.8.1 Vision System

3.5.8.1.1 Brand/type (describe): _________________

3.5.8.1.2 Specify number of cameras: _____

3.5.8.1.3 Verification of printed information, specify location of printed information: ___________________________________

3.5.8.1.4 Verification of pre-printed information, specify location of pre-printed information: ___________________________________

3.5.8.1.5 Specify total number of characters per label: ___________________________________

3.5.8.1.6 Specify number of characters including spaces: ___________________________________

3.5.8.1.7 Other (Describe):____________________

3.5.8.1.8 Inspection to be conducted label placement on container.

3.5.8.1.9 Inspection to be conducted outsert is applied to container.

3.5.8.2 Outsert Inspection System

3.5.8.2.1 Bar code verifies correct outsert on container.

3.5.8.2.2 Photo eye/proximity sensor detection of presence on container.

3.5.8.2.3 Other (Describe): _____________________

3.5.8.3 Barcode Inspection System

3.5.8.3.1 Verifies correct barcode on label.3.5.8.3.2 Photo eye/proximity sensor detection of presence on bottle.

3.5.8.3.3 Other (Describe): _____________________

3.5.9 Ejection System

3.5.9.1 Reject Tray

3.5.9.2 Reject Bin

3.5.9.3 Reject Conveyor

3.5.9.4 Other (Describe): _____________

3.5.9.5 Verify Reject Occurred? (Yes(No

3.5.10 Conveyor

3.5.10.1 Non-sanitary

3.5.10.2 Sanitary raised wear strip

3.5.10.3 Other (describe): ____________________________

3.5.10.4 Length: ___________________________

3.5.10.5 Height: ___________________________

3.5.11 Label Supply

3.5.11.1 Shut down for label roll change

3.5.11.2 Splice Plate

3.5.11.3 Label Dump Box

3.5.11.4 Redundant heads

3.5.11.5 Other (describe): ________________________

3.5.12 Machine Finish

3.5.12.1 Anodized Aluminum

3.5.12.2 Stainless Steel

3.5.12.3 Painted, Color: _________________________________

3.5.12.4 Enclosure NEMA Rating: ________________________

3.5.12.5 Other (describe): __________________________________

3.6 Process Control

3.6.1 Critical Parameters

3.6.1.1 _____% visual defect detection of defects _____ millimeter or greater in size using black on white media (refer to Attachment _____ for defect examples)

3.6.1.2 _____% missing label detection

3.6.1.3 Production Efficiency: The labeler shall have a machine efficiency rate of _________%, as measured by the actual number of good containers labeled during a one hour test run, divided by the theoretical yield based on machine speed. Machine efficiency rate excludes downtime due to faulty components.

3.6.1.4 Speed set point range: _____ to _____ labels per minute +/-_____ labels per minute

3.6.1.5 Application of lot number and expiration date as required by FDA cGMP regulations.

3.6.1.6 Barcode or part number verification for positive label identification to insure proper label on the product container.

3.6.2 Accuracy of Instrumentation

3.6.2.1 Hot Stamp Temperature Control

3.6.2.1.1 +/- 2(C (Standard)

3.6.2.1.2 +/- 1(C (Special)

3.6.2.1.3 +/- 0.5(C (Custom)

3.7 Functions

3.7.1 Operation

3.7.1.1 Operator interaction is expected to be minimal following the set-up of the labeler. Set-up parameters selected by the Operator include the following:

3.7.1.1.1 Labeler speed

3.7.1.1.2 Vision inspection (on/off)

3.7.1.1.3 Calibration sequence (if vision inspection)

3.7.1.2 The labeler shall operate with a minimum of operator involvement. Automated sequencing shall be provided for the removal of detected label defects. Upon label defect detection, the labeler shall advance to reject the defective product container. If three successive rejects are detected sequentially, the labeler shall stop until reinitialized by an Operator.

3.7.1.3 Labeler operation shall be safe from an Operator and environmental standpoint. The equipment shall have proper safeguards per applicable OSHA and ANSI standards.

3.7.1.4 The labeler shall be operated locally at the equipment itself.

3.7.1.5 Control System Requirements

3.7.1.5.1 Manual only

3.7.1.5.2 Manual/automatic

3.7.1.5.3 Maintenance/Jog

3.7.2 Power Failure/Recovery

3.7.2.1 In the event of a power failure, the labeler shall protect product against damage. The labeler will stop automatically upon loss of electricity, air, or other major utility and will require operator intervention to re-start.

3.7.2.2 Depending upon the options chosen in the overview section, the labeler will:

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

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

3.7.2.2.3 If there is an automatic batch reporting system, the information shall be retained in the event of a power failure (A _____ minute UPS is required for automatic batch reporting systems).

3.7.3 Emergency Stop

3.7.3.1 The labeler shall have an E-Stop string designed to stop all physical movement of the machinery immediately. The E-Stop buttons shall be located in easily accessible areas around the machine as required by local safety standards.

3.7.4 Alarms and Warnings

3.7.4.1 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). The operator shall be required to acknowledge the alarm before the alarm can be reset and the labeler restarted. Once the alarm is reset, the operator may restart the labeler.

3.7.4.2 Informational Messages Informational messages shall notify the operator and take no further action.3.7.4.3 The list of critical alarms in the table below is not intended to be a comprehensive list of all alarms for the labeler. A complete alarm list will be developed and included in the Functional Specification document.

Table 3.7.4.3 Alarms and Warnings

ConditionCritical*Non-Critical**

Emergency StopX

Control Platform Communication Watchdog (Control Platform (Operator-Interface Terminal)X

Control Power FaultX

Main Air FaultX

Safety/Guard FaultX

Mechanical Jam FaultX

Low Material Warning (Labels and print ribbon)X

Depleted Material Fault (Labels and print ribbon)X

Consecutive ____(Insert Number) rejects faultX

Reject Not Detected FaultX

Low Temperature Fault (if hot stamp printer desired)X

Broken Web FaultX

Invalid Product (shift registry)X

Motor FaultsX

Control Platform Battery Low WarningX

* Critical alarms shall take action automatically to shut the labeling machine down and notify the operator. The operator shall be required to acknowledge the alarm before the alarm can be reset and the labeler restarted. Once the alarm is reset, the operator may restart the labeler.

** 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 labeler 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.

3.8 Data and Security

3.8.1 Controls provided with a data collection systems intended for use in the manufacture of pharmaceutical products shall comply with 21 CFR, Part 11 of the FDA cGMP regulations or _______________ Company policy and procedure. The supplier shall stipulate the methods by which this criterion is met.

3.8.2 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:

3.8.2.1 User ID/Password

3.8.2.2 Card Reader

3.8.2.3 Biologic (Fingerprint, eye scan, voice recognition, etc.)

3.8.3 Supplier is to list the application that provides security functions to the labeler, either internal via the local OIP or external via a SCADA system, etc.

3.8.4 User shall describe requirements for resetting the data collection registers.

3.8.5 User Interfaces

3.8.5.1 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.

3.8.6 User Interface with Supervisors and Operators

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

3.8.6.2 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. The Control Platform/Operator-Interface Terminal System shall include interfaces with the Operator, Supervisors, external equipment, and the Users control system to ensure safe, reliable, continuous, and automatic operation and easy, safe, and reliable configuration.

3.8.6.3 The following shall be displayed on the Operator Interface Terminal.

3.8.6.3.1 Alarms and Warnings

3.8.6.3.2 System Status (ready, running, etc.)

3.8.6.3.3 Counters (good product, rejects, etc.)

3.8.6.3.4 Hot Stamp temperature

3.8.6.3.5 Machine Speed (containers per minute)

3.8.6.4 The following items shall be displayed optionally on the Operator Interface Terminal.

3.8.6.4.1 Maintenance Instructions

3.8.6.4.2 Label Head Setup

3.8.6.4.3 Inspection System Challenge

3.8.6.4.4 Other (specify): ____________________

3.8.7 The Control Platform/OIT System shall include interfaces with Supervisors to ensure easy, safe, and reliable configuration of the Equipment. The following shall be accessible only to Supervisors:

3.8.7.1 Security Configurations

3.8.7.2 Control loop variables (i.e., PID tuning parameters).

3.8.7.3 Alarm set points.

3.8.7.4 Other ____________ (specify).

3.8.8 Language Requirements

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

3.8.9 Displayed Requirements

3.8.9.1 The engineering units of measurement shall be Metric (SI) units.

Table 3.8.9.1 Engineering Units

ParameterFormatUnit(s) of measurement

Speed(###) unitsMeters per minute

Temperature(##.#) unitsDegrees Celsius

Label Count(#######)Labels (Ea.)

Label Defects(#####)Defects (Ea.)

3.8.10 Interface with Other Equipment

3.8.10.1 The Control Platform/OIT System shall include interfaces with the Users control system to facilitate automatic operation and configuration.

3.8.10.1.1 A system with an RS-232 communications port shall be provided.

3.8.10.1.2 A system with a Modem (minimum baud rate? Connector?) communications port shall be provided.

3.8.10.1.3 A high-speed (rate? Connector?) configuration/monitoring connection shall be provided.

3.8.10.2 The communications port shall be capable of being configured to communicate the following data to a supervisory control and data acquisition (SCADA) node (Note: The SCADA system shall be supplied and installed by the User):

3.8.10.2.1 The following shall be available.

3.8.10.2.1.1 All process variables

3.8.10.2.1.2 Alarms and Warnings.

3.8.10.2.1.3 Labeler Status (e.g. off, on, standby states, etc.).

3.8.10.2.1.4 Other (specify): _____________

3.8.11 Security Levels

3.8.11.1 Labeler security access shall consist of the following profiles.

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

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

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

3.8.12 Data Collection

3.8.12.1 Archiving and reporting requirements are listed below.

3.8.12.1.1 None

3.8.12.1.2 Recorder

3.8.12.1.3 Process Printout. Refer to Attachment ____ for an example report.

3.8.12.1.4 Electronic process printout, trend and saving

3.8.12.1.5 Electronic process printout, trend and saving

3.8.12.1.6 Upload to company network

3.8.12.2 The following information shall be recorded.

3.8.12.2.1 Number of containers processed

3.8.12.2.2 Number of good containers

3.8.12.2.3 Number of rejected containers (reject types?)3.8.12.2.4 Machine runtime

3.8.12.2.5 Machine downtime

3.8.12.2.6 Machine idle time

3.8.12.2.7 Alarms and warnings

3.8.12.2.8 Label head setup parameters

3.8.12.2.9 Hot stamp setup parameters

3.8.12.2.10 Other (specify): ____________

3.9 Environment 3.9.1 Layout

3.9.1.1 The physical environment in which the labeler will be operated shall consist of the following.

3.9.1.1.1 Allocated floor space for the equipment is a _____ millimeter by _____ millimeter space with at least a _____ millimeter corridor around the periphery for the equipment.

3.9.1.1.2 Vertical clearance is _____ millimeters.

3.9.1.1.3 See attachment _____ for drawing # ____________________(if applicable).

3.9.2 Physical Conditions

3.9.2.1 Room Explosion Classification

3.9.2.1.1 Room will be non-hazardous

3.9.2.1.2 Room will be Class I Div II (Zone 2) (explosive atmosphere present at known times)

3.9.2.1.3 Room will be Class I Div I (Zone 1) (explosive atmosphere present at all times)

3.9.2.2 Environmental Classification

3.9.2.2.1 Class 100, 10,000, or 100,000 (Federal Standard 209E)

3.9.2.2.2 ISO Class 5, 7, or 8 (ISO 14644-1 and ISO 14644-2)

3.9.2.2.3 Class A, B, C, or D (The Rules Governing Medicinal Products in the European Union Annex 1)

3.9.2.2.4 Directional airflow requirement: __________

3.9.2.2.5 Airflow velocity: _____

3.9.2.2.6 Number of air changes: _____

3.9.2.2.7 Particle Ingress: ___________________

3.9.2.3 Biohazard Level

3.9.2.3.1 BL-1

3.9.2.3.2 BL-2

3.9.2.4 Rating of Enclosures

3.9.2.4.1 NEMA 1 (Open)

3.9.2.4.2 NEMA 4 (Wash down)

3.9.2.4.3 NEMA 4X (Wash down and non-Corrosive)

3.9.2.4.4 NEMA 12 (Oil tight)

3.9.2.4.5 NEMA 7 (Explosion-proof)

3.9.3 Cleaning Requirements

3.9.3.1 Hand wash

3.9.3.2 Automated wash

3.9.3.3 Steam Clean

3.9.3.4 Clean in Place (CIP)

3.9.3.5 Rinse in Place (RIP)

3.9.4 Sterilization Requirements

3.9.4.1 The labeler will not be sterilized.

3.9.5 Intended Operating Environment

3.9.5.1 The labeler shall be mounted in a cGMP warehouse environment with a temperature range of _____ to _____ C, non-condensing humidity.

3.9.5.2 Vibration levels in operating environment are ____________

3.9.5.3 The Seismic Zone in the operating environment is _______________ .

4.0 Constraints

4.1 Milestones and Timelines

The equipment acquisition model that will be used for the procurement of the labeler is shown below along with project milestones and timing requirements.

4.1.1 The User shall provide sample labels and product components in the following amounts: Labels ______________, Containers _______________, Caps _______________, Other _____________ within _______weeks of receipt of a purchase order at the Suppliers local office.

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

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

4.1.4 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.

4.1.5 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.

4.1.6 The labeler and all support equipment shall be delivered to the Users receiving dock on or before _______________.

4.2 Equipment Constraints

4.2.1 Environmental Conditions

4.2.1.1 The labeler is to be used at the following environmental conditions:

4.2.1.1.1 Altitude: _____ meters above sea level

4.2.1.1.2 HVAC Equipment Constraints

4.2.1.1.2.1 Process air enters the air-handling unit from ___________________.

4.2.1.1.2.2 Indoor Temperature: _____ to _____(C

4.2.1.1.2.3 Minimum Outdoor Temperature: _____( C

4.2.1.1.2.4 Maximum Outdoor Temperature: _____( C

4.2.1.1.2.5 Winter dry bulb: _____(C

4.2.1.1.2.6 Winter wet bulb: _____(C

4.2.1.1.2.7 Summer dry bulb: _____(C

4.2.1.1.2.8 Summer wet bulb: _____(C

4.2.2 Equipment Generated Vibration

4.2.2.1 The maximum allowable equipment vibration generated during operation is ____________.

4.3 Compatibility and Support

4.3.1 Control Platform Controllers

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

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

4.3.1.3 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.

4.3.1.4 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.

4.3.2 Preferred Vendor List

4.3.2.1 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.

4.3.3 Utilities

4.3.3.1 The User shall ensure that the utilities described here 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, Attachment _____.

4.3.3.2 The Supplier shall observe utility data, which is marked with a triangle and specify/design the equipment accordingly.

4.3.3.3 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 labeler design begins.

4.3.3.4 Base Utilities Requirements

4.3.3.4.1 ( Electricity

4.3.3.4.1.1 _____ VAC, ____ Hertz, Phases _____

4.3.3.4.1.2 Current: _____ Amps

4.3.3.4.1.3 Un-interruptible Power Supply _____ minutes (Define use)

4.3.3.4.2 ( Control Air

4.3.3.4.2.1 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.

4.3.3.4.3 ( Other Utility Requirements

4.4 Availability

4.4.1 The labeler is intended to be operated regularly _____ hours per day, _____ hours per week, _____ weeks per year.

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

4.5 Procedural Constraints

4.5.1 Product Contact Materials

4.5.1.1 Product contact is not expected, as the labeler will be contacting labels that are applied to the product package, not the product itself.

4.5.1.2 The supplier shall specify surface finishes. Specific User requirements are included as Attachment _____.

4.5.1.3 Materials in Contact with the Labeler

4.5.1.3.1 The labeler will be used with aqueous cleaning solutions and small quantities of flammable solvents such as isopropyl and ethyl alcohol. Contact with the machine surfaces will be incidental except for areas that are designed for regular cleaning.

4.5.2 Noise Level Constraints

4.5.2.1 The noise level generated during operation of the labeler will not exceed _____ dB as measured from _____ feet away.

4.5.3 EMI/RFI levels

4.5.3.1 The labeler will not be used in an area where two-way radio communication devices are in operation. The labeler shall meet CE requirements for electrical noise immunity and emissions.

4.5.4 Containment

4.5.4.1 Explosion Protection

4.5.4.1.1 The design of areas in which small quantities (squeeze bottle applicators) of flammable solvents will be used for cleaning purposes shall consider the flammable nature of the solvent. The equipment design must allow for the cleaning operation.

4.5.5 Labeling

4.5.5.1 All equipment and control wiring shall be labeled and identified in accordance with _______________ Company standards as outlined in Attachment _____.

4.6 Maintenance

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

4.6.1.1 Maintenance activities for all sub-systems (maintenance and operation manuals of vendor equipment)

4.6.1.2 A comprehensive lubrication list and recommended lubrication schedule

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

4.6.1.4 Supplier shall supply ______ copies of operation, installation, maintenance and de-commissioning manuals.

5.0 Life-Cycle

5.1 Development

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 Users 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 labeler and documentation.

5.2 Testing

5.2.1 In order to verify labeler 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, Attachment _____, for applicable procedures.

5.3 Delivery

5.3.1 The labeler, with all options, equipment, and the documentation listed below, shall be delivered to the Users receiving dock.

5.3.2 Documentation

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

5.3.2.2 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.

5.3.2.3 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.

5.3.2.4 All documents shall be in the language of the destination country and supplied with hard copies and electronic versions supplied in the format identified for each document:

5.3.2.5 Document format shall comply with the following requirements.

Project PlanMicrosoft Word 97 (*.doc)

User Requirements SpecificationMicrosoft Word 97 (*.doc)

Functional Specification/RequirementsMicrosoft Word 97 (*.doc)

Design SpecificationsMicrosoft Word 97 (*.doc)

Controls Test Microsoft Word 97 (*.doc)

Hardware Installation TestMicrosoft Word 97 (*.doc)

Operational TestMicrosoft Word 97 (*.doc)

Factory Acceptance TestMicrosoft Word 97 (*.doc)

Operator, Maintenance and Service ManualsMicrosoft Word 97 (*.doc)

Process and Instrumentation Diagram (P&ID)AutoCAD version 12.0 (*.dxf)

Instrument ListingMicrosoft Word 97 (*.doc)

or Excel 97 (*.xls)

Control SchematicsAutoCAD version 12.0 (*.dxf)

Control Panel Assembly DrawingsAutoCAD version 12.0 (*.dxf)

Equipment Assembly DrawingsAutoCAD version 12.0 (*.dxf)

Bill of MaterialsMicrosoft Word 97 (*.doc)

or Excel 97 (*.xls)

Spare Parts ListMicrosoft Word 97 (*.doc)

or Excel 97 (*.xls)

Component Cut SheetsMicrosoft Word 97 (*.doc)

or Excel 97 (*.xls)

Control Platform Program XXX Program Development Printout and Disk File format

OIT Configuration Printout and XXX Program Development Disk File format

5.4 Support

5.4.1 Start-up Support

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

5.4.2 Training

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

5.4.3 Post Start-up Support

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

5.4.4 Technical Support

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.

5.4.5 User Site Support

5.4.5.1 The Supplier shall notify the User of preventative maintenance system improvement availability.

6.0 Glossary

A glossary of terms and acronyms is provided below and includes definitions of terms that may be unfamiliar or terminology that may have meanings specific to entries in the URS.

Table 6.0 Glossary

AcronymDefinition

(CDegrees Celsius

ANSIAmerican National Standards Institute

ASMEAmerican Society of Mechanical Engineers

BLBiohazard Level

CEThe CE mark is the official marking required by the European Community for all Electric- and Electronic equipment that will be sold, or put into service for the first time, anywhere in the European community. It proves to the buyer -or user- that this product fulfills all essential safety and environmental requirements as they are defined in the so-called European Directives.

CFRCode of Federal Regulations

CFR 21, Part 11Part of the FDA Code of Federal Regulation. Part 11 deals with Electronic Records and Electronic Signatures. Specific requirements are laid out for the production, storage, and editing of electronic records.

CIPClean In Place

dBDecibels

EMIElectro-Magnetic Interference

E-StopEmergency Stop

FATFactory Acceptance Test

FDAU.S. Food and Drug Administration

FtFeet

GAMPGood Automated Manufacturing Practices. A system for producing quality equipment using the concept of prospective validation following a life-cycle model. Specifically designed to aid suppliers and user in the pharmaceutical industry.

GMP/cGMPGood Manufacturing Practices. Regulations of the FDA and comparable non-US agencies that describe the minimum standards for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packaging, or holding of a drug to assure that such drugs meet the requirements of the Act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.

GUIGraphic User Interface

GUIGraphic User Interface

HEPAHigh Efficiency Particle Arrestance

HEPA filtered air is 99.97% free of all particulate down to 0.3 microns (including bacteria, fungal and other opportunistic micro biological).User Requirement Specification

HMIHuman Machine Interface

HVACHeating, Ventilation, and Air Conditioning

IDIdentification

IQInstallation Qualification

ISAInternational Society for Measurement and Control

ISOInternational Organization for Standardization

JETTJoint Equipment Transition Team

LELLower Explosion Limit

MMeter

maxMaximum

minMinimum

mmMillimeter

NEMANational Electric Manufacturers Association

OCROptical Character Recognition

OCVOptical Character Verification

OIPOperator Interface Panel

OQOperational Qualification

OSHAOccupational Safety & Health Administration

POPurchase Order

PSIGPounds per square inch gauge

RFIRadio Frequency Interference

RFQRequest for Quote

RIPRinse In Place

RS-232Recommended Standard number 232, revision C from the Electronic Industry Association. It provides an interface between data terminal equipment and data communications equipment employing serial binary data interchange.

S.I.International System of Units (Metric)

SCADASupervisory Control and Data Acquisition

UPSUninterruptible Power Supply

URSUser Requirement Specification

UVUltraviolet

VACVoltage Alternating Current

7.0 REFERENCES

Table 7.0 References

DocumentAttached to URS (Yes / No)

Equipment Validation Plan

Current revision of GAMP Guidelines

Vendor Piping Certification (if applicable)

Customer Connection Diagram

Approved Instrumentation List

Process Flow Diagram

21 CFR Part 11

National Electric Code

S88 Batch Standard

8.0 Approval

This document has been reviewed by the User Project Manager and approved for use by the Supplier.

Printed/Typed Name SignatureDate

This document has been reviewed by the User Quality Assurance Group and approved for use by the Supplier.

Printed/Typed Name SignatureDate

This document has been reviewed by the Supplier Project Manager and approved for use by the Supplier Project Team.

Printed/Typed Name SignatureDate

PAGE \# "'Page: '#''" Font sizes, colors, background colors?

PAGE \# "'Page: '#''" Barcode types expected?

PAGE \# "'Page: '#''" Elsewhere in the document no SI units are used e.g.3.5.5.1.

PAGE \# "'Page: '#''" Do you want to state non-shedding however?

PAGE \# "'Page: '#''" Insert a note to author to cover the situation where two way radios will be used in proximity. Shields or labels.

PAGE \# "'Page: '#''" Rewrite to allows for language(s) to be specified by author

JOINT EQUIPMENT TRANSITION TEAM

_1082873035.ppt


Integrate with ValidationDocumentation (as appropriate)

BASELINE EQUIPMENT ACQUISITION MODEL

SUPPLIER

USER/(CONSULTANT if applicable)


Master Validation Plan

RFQ

User Audit of Supplier User Initiates

Proposal

Quality Plan Project Plan

Equipment Validation Plan

Explanation to Supplier (Living Document)

User Requirements Specification (URS)(Living Document)

Proposal Analysis

Proposal

P.O.

Detailed DesignDocumentation(traceable to Functional Specification)

Review Functional Specification

Review Detailed Design

System Acceptance TestSpecifications (IQ/OQ)

Hardware Software

Review SystemAcceptance Test Specifications

System AcceptanceTesting and Results(User Witness Optional)

Maintenance & SupportDocumentation

Approval

Approval

Approval

RFQ