Label Er Urs
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Label Er Urs...
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JETT
USER REQUIREMENTS SPECIFICATION LABELER
Doc ID: Labeler Template Rev. 0 May 2002
USER REQUIREMENTS TEMPLATE For a LABELER
JOINT EQUIPMENT TRANSITION TEAM
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
REVISION HISTORY Rev.
Date
0
July 11, 2002
Author
Revision Summary
Paul Coury (JETT) Initial revision issued to JETT website.
(Reminder of Page Intentionally Left Blank)
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JETT
USER REQUIREMENTS SPECIFICATION LABELER
Doc ID: Labeler Template Rev. 0 May 2002
TABLE OF CONTENTS 1.0 INTRODUCTION..................................................................................................4 2.0 OVERVIEW............................................................................................................5 3.0 OPERATIONAL REQUIREMENTS...................................................................6 3.1 CAPACITY.............................................................................................................6 3.2 PROCESS REQUIREMENTS...................................................................................7 3.3 PROCESS CONTROL...........................................................................................13 3.4 FUNCTIONS.........................................................................................................14 3.5 DATA AND SECURITY.........................................................................................17 3.6 ENVIRONMENT...................................................................................................22 4.0 CONSTRAINTS...................................................................................................26 4.1 MILESTONES AND TIMELINES...........................................................................26 4.2 EQUIPMENT CONSTRAINTS...............................................................................27 4.3 COMPATIBILITY AND SUPPORT.........................................................................28 4.4 AVAILABILITY....................................................................................................30 4.5 PROCEDURAL CONSTRAINTS.............................................................................30 4.6 MAINTENANCE...................................................................................................32 5.0 LIFE-CYCLE........................................................................................................33 5.1 DEVELOPMENT...................................................................................................33 5.2 TESTING..............................................................................................................33 5.3 DELIVERY...........................................................................................................33 5.4 SUPPORT.............................................................................................................35 6.0 GLOSSARY..........................................................................................................37 7.0 REFERENCES.....................................................................................................39 8.0 APPROVAL...........................................................................................................40
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
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.
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
2.0
Doc ID: Labeler Template Rev. 0 May 2002
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: _________________________________________
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.0
Doc ID: Labeler Template Rev. 0 May 2002
OPERATIONAL REQUIREMENTS 3.1
Capacity 3.1.1
Production Speed 3.1.1.1
3.2
The labeler shall be capable of operating at a speed of __________ labels per minute.
Container Size Table Table 3.2 Container Sizes Container Name/ Size
Container Material
Container Height (mm)
Container Shape
Max
3.3
Container Width (mm)
Min
Max
Rate (Parts/ Min)
Min
Max
Comments
Min
Label Size Table Table 3.3 Label Sizes Container Name/ Size
3.4
1st Label Size
2nd Label Size
3rd Label Size
Label Roll Wind
Label Roll Diameter
Placement Location
Outsert Size Table Table 3.4 Outsert Sizes Container Name/ Size
3.5
Outsert Size
Glue/tape
Placement
Process Requirements
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Comments
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.5.1
Doc ID: Labeler Template Rev. 0 May 2002
Product Classification The products/containers being produced on the machine are as follows.
3.5.2
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: ____________________
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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.5.2.9
Doc ID: Labeler Template Rev. 0 May 2002
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.
3.5.4
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
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: ______________________
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.5.4.2
3.5.4.3
3.5.4.4
3.5.5
Doc ID: Labeler Template Rev. 0 May 2002
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: ______________________
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: ______________________
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: ______________________
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: ______________________
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.5.6
Doc ID: Labeler Template Rev. 0 May 2002
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: ______________________________
3.5.7
3.5.6.6
Character Orientation: ___________________
3.5.6.7
Additional information: _________________
Label Inspection System 3.5.7.1
3.5.7.2
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):_______________________
Type of Inspection System: 3.5.7.2.1
Character recognition (OCR)
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.5.8
Doc ID: Labeler Template Rev. 0 May 2002
3.5.7.2.2
Character verification (OCV)
3.5.7.2.3
Other (Describe): ______________________
Inspection System Verification 3.5.8.1
3.5.8.2
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.
Outsert Inspection System 3.5.8.2.1
Bar code verifies correct outsert on container.
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.5.8.3
3.5.9
Doc ID: Labeler Template Rev. 0 May 2002
3.5.8.2.2
Photo eye/proximity sensor detection of presence on container.
3.5.8.2.3
Other (Describe): _____________________
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): _____________________
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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
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.
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.6.2
May 2002
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.
Accuracy of Instrumentation 3.6.2.1
3.7
Doc ID: Labeler Template Rev. 0
Hot Stamp Temperature Control 3.6.2.1.1
+/- 2C (Standard)
3.6.2.1.2
+/- 1C (Special)
3.6.2.1.3
+/- 0.5C (Custom)
Functions 3.7.1
Operation 3.7.1.1
3.7.1.2
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)
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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
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.
3.7.2
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
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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
UPS is required for automatic batch reporting systems). 3.7.3
“Emergency Stop” 3.7.3.1
3.7.4
The labeler shall have an E-Stop string designed to stop all physical movement of the machinery immediately. The EStop buttons shall be located in easily accessible areas around the machine as required by local safety standards.
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 Condition
Critical*
Emergency Stop Control Platform Communication Watchdog (“Control Platform Operator-Interface Terminal”)
X
X
Control Power Fault
X
Main Air Fault
X
Safety/Guard Fault
X
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Non-Critical**
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
Table 3.7.4.3 Alarms and Warnings Condition
Critical*
Mechanical Jam Fault
X
Low Material Warning (Labels and print ribbon) Depleted Material Fault (Labels and print ribbon) Consecutive ____(Insert Number) rejects fault
X
Reject Not Detected Fault
X
Low Temperature Fault (if hot stamp printer desired) Broken Web Fault
X
Invalid Product (shift registry)
X
Motor Faults
X
Control Platform Battery Low Warning
Non-Critical**
X
X
X
X
* “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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
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
3.8.6
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.
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/OperatorInterface Terminal System shall include interfaces with the Operator, Supervisors, external equipment, and the User’s control system to ensure safe, reliable, continuous, and automatic operation and easy, safe, and reliable
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
configuration. 3.8.6.3
3.8.6.4
3.8.7
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)
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): ____________________
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).
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.8.8
May 2002
Language Requirements 3.8.8.1
3.8.9
Doc ID: Labeler Template Rev. 0
The language requirement shall be English for all labeler functions requiring written or displayed text.
Displayed Requirements 3.8.9.1
The engineering units of measurement shall be Metric (SI) units. Table 3.8.9.1 Engineering Units Parameter
Format
Speed Temperature Label Count Label Defects
(###) units (##.#) units (#######) (#####)
Unit(s) of measurement Meters per minute Degrees Celsius Labels (Ea.) Defects (Ea.)
3.8.10 Interface with Other Equipment 3.8.10.1 The Control Platform/OIT System shall include interfaces with the User’s 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
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JETT
USER REQUIREMENTS SPECIFICATION LABELER
Doc ID: Labeler Template Rev. 0 May 2002
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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
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 3.9
Other (specify): ____________
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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
_____ millimeter by _____ millimeter space with at least a _____ millimeter corridor around the periphery for the equipment.
3.9.2
3.9.1.1.2
Vertical clearance is _____ millimeters.
3.9.1.1.3
See attachment _____ for drawing # ____________________(if applicable).
Physical Conditions 3.9.2.1
3.9.2.2
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)
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: _____
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
3.9.2.2.7 3.9.2.3
3.9.2.4
3.9.3
3.9.4
May 2002
Particle Ingress: ___________________
Biohazard Level 3.9.2.3.1
BL-1
3.9.2.3.2
BL-2
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)
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)
Sterilization Requirements 3.9.4.1
3.9.5
Doc ID: Labeler Template Rev. 0
The labeler will not be sterilized.
Intended Operating Environment
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JETT
USER REQUIREMENTS SPECIFICATION LABELER
Doc ID: Labeler Template Rev. 0 May 2002
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 _______________ .
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
4.0
Doc ID: Labeler Template Rev. 0 May 2002
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. “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
Proposal
RFQ
po Pro
s al
P.O .
Approval Review Functional Specification
• Quality Plan • Project Plan
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
Approval
System Acceptance Testing and Results (User Witness Optional) Maintenance & Support Documentation
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 Supplier’s local office.
4.1.2
The Supplier shall provide a written proposal within _____ weeks of
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
receipt of this document at the Supplier’s local office.
4.2
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 User’s receiving dock on or before _______________.
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 airhandling unit from ___________________.
4.2.1.1.2.2
Indoor Temperature: _____ to _____C
4.2.1.1.2.3
Minimum Outdoor Temperature: _____ C
JOINT EQUIPMENT TRANSITION TEAM
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
4.2.2
May 2002
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
Equipment Generated Vibration 4.2.2.1
4.3
Doc ID: Labeler Template Rev. 0
The maximum allowable equipment vibration generated during operation is ____________.
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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
user in a timely fashion to prevent downtime of the equipment. 4.3.2
Preferred Vendor List 4.3.2.1
4.3.3
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 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 _____
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
4.3.3.4.2
4.4
4.5
May 2002
4.3.3.4.1.2
Current: _____ Amps
4.3.3.4.1.3
Un-interruptible Power Supply _____ minutes (Define use)
Control Air 4.3.3.4.2.1
4.3.3.4.3
Doc ID: Labeler Template Rev. 0
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
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.
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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
4.5.1.3.1
4.5.2
The noise level generated during operation of the labeler will not exceed _____ dB as measured from _____ feet away.
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.
Containment 4.5.4.1
Explosion Protection 4.5.4.1.1
4.5.5
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.
Labeling 4.5.5.1
4.6
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.
EMI/RFI levels 4.5.3.1
4.5.4
May 2002
Noise Level Constraints 4.5.2.1
4.5.3
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All equipment and control wiring shall be labeled and identified in accordance with _______________ Company standards as outlined in Attachment _____.
Maintenance
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
4.6.1
Doc ID: Labeler Template Rev. 0 May 2002
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.
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
5.0
Doc ID: Labeler Template Rev. 0 May 2002
LIFE-CYCLE 5.1
5.2
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 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 labeler and documentation.
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 User’s 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
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JETT
USER REQUIREMENTS SPECIFICATION LABELER
Doc ID: Labeler Template Rev. 0 May 2002
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 Plan
Microsoft Word 97 (*.doc)
User Requirements Specification
Microsoft Word 97 (*.doc)
Functional Specification/Requirements
Microsoft Word 97 (*.doc)
Design Specifications
Microsoft Word 97 (*.doc)
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)
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USER REQUIREMENTS SPECIFICATION LABELER
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Doc ID: Labeler Template Rev. 0 May 2002
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
OIT Configuration Printout and Disk File
XXX Program Development format
5.4 Support 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 _____ years after the completion of commissioning activities.
Technical Support 5.4.4.1
Technical support shall be provided via telephone for a period of _____ years following the completion of validation activities.
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
5.4.4.2
5.4.5
Doc ID: Labeler Template Rev. 0 May 2002
A recommended replacement parts list including normal lead times shall be provided for the machine and all subassemblies.
User Site Support 5.4.5.1
The Supplier shall notify the User of preventative maintenance system improvement availability.
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
6.0
Doc ID: Labeler Template Rev. 0 May 2002
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 Acronym C
Definition Degrees Celsius
ANSI
American National Standards Institute
ASME
American Society of Mechanical Engineers
BL
Biohazard Level
CE
The 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.
CFR
Code of Federal Regulations
CFR 21, Part 11
Part 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.
CIP
Clean In Place
dB
Decibels
EMI E-Stop
Electro-Magnetic Interference Emergency Stop
FAT
Factory Acceptance Test
FDA
U.S. Food and Drug Administration
Ft GAMP
GMP/cGMP
Feet Good 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. Good Manufacturing Practices. Regulations of the FDA and
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
Table 6.0 Glossary Acronym
Definition 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.
GUI
Graphic User Interface
GUI
Graphic User Interface
HEPA
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 micro biological).User Requirement Specification
HMI HVAC
Human – Machine Interface Heating, Ventilation, and Air Conditioning
ID
Identification
IQ
Installation Qualification
ISA
International Society for Measurement and Control
ISO
International Organization for Standardization
JETT
Joint Equipment Transition Team
LEL
Lower Explosion Limit
M
Meter
max
Maximum
min
Minimum
mm
Millimeter
NEMA
National Electric Manufacturers Association
OCR
Optical Character Recognition
OCV
Optical Character Verification
OIP
Operator Interface Panel
OQ
Operational Qualification
OSHA
Occupational Safety & Health Administration
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
Doc ID: Labeler Template Rev. 0 May 2002
Table 6.0 Glossary Acronym PO
Definition Purchase Order
PSIG
Pounds per square inch gauge
RFI
Radio Frequency Interference
RFQ
Request for Quote
RIP
Rinse In Place
RS-232
S.I. SCADA
Recommended 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. International System of Units (Metric) Supervisory Control and Data Acquisition
UPS
Uninterruptible Power Supply
URS
User Requirement Specification
UV
Ultraviolet
VAC
Voltage Alternating Current
JOINT EQUIPMENT TRANSITION TEAM
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USER REQUIREMENTS SPECIFICATION LABELER
Doc ID: Labeler Template Rev. 0 May 2002
Table 6.0 Glossary Acronym
7.0
Definition
REFERENCES
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USER REQUIREMENTS SPECIFICATION LABELER
Doc ID: Labeler Template Rev. 0 May 2002
Table 7.0 References Document Attached 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
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USER REQUIREMENTS SPECIFICATION LABELER
JETT
8.0
Doc ID: Labeler Template Rev. 0 May 2002
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
JOINT EQUIPMENT TRANSITION TEAM
Date
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