Label Er Urs

Page 1 of 42
JETT
USER REQUIREMENTS
SPECIFICATION
LABELER
Doc ID: Labeler Template

Rev. 0
May 2002
USER REQUIREMENTS TEMPLATE

For a LABELER
JOINT EQUIPMENT TRANSITION TEAM
Page 2 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT

Rev. 0
May 2002
REVISION HISTORY
Rev.
Date
July 11, 2002
Author
Revision Summary
Paul Coury (JETT) Initial revision issued to JETT website.
(Reminder of Page Intentionally Left Blank)
Page 3 of 42
JETT
USER REQUIREMENTS
SPECIFICATION
LABELER

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

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.
Page 5 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
2.0

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: _________________________________________
Page 6 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
3.0

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
Comments
Page 7 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
3.5.1

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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

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: ______________________
Page 9 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
3.5.4.2
3.5.4.3
3.5.4.4
3.5.5

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

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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

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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 <prior to, after>

label placement on container.
3.5.8.1.9
Inspection to be conducted <prior to, after>

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

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

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.
Page 14 of 42
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

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
Page 15 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT

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
Page 16 of 42
USER REQUIREMENTS
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LABELER
JETT

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)
Control Power Fault
Main Air Fault
Safety/Guard Fault
Non-Critical**
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USER REQUIREMENTS
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LABELER
JETT

Rev. 0
May 2002
Table 3.7.4.3 Alarms and Warnings

Condition
Critical*
Mechanical Jam Fault
Low Material Warning (Labels and print

ribbon)
Depleted Material Fault (Labels and print
ribbon)
Consecutive ____(Insert Number) rejects fault
Reject Not Detected Fault
Low Temperature Fault (if hot stamp printer

desired)
Broken Web Fault
Invalid Product (shift registry)
Motor Faults
Control Platform Battery Low Warning
Non-Critical**
* 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
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LABELER
JETT

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 Users
control system to ensure safe, reliable, continuous, and
automatic operation and easy, safe, and reliable
Page 19 of 42
USER REQUIREMENTS
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LABELER
JETT

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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).
Page 20 of 42
USER REQUIREMENTS
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LABELER
JETT
3.8.8
May 2002
Language Requirements
3.8.8.1
3.8.9

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 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
Page 21 of 42
JETT
USER REQUIREMENTS
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LABELER

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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JETT

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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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JETT

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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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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

Rev. 0
The labeler will not be sterilized.
Intended Operating Environment
Page 25 of 42
JETT
USER REQUIREMENTS
SPECIFICATION
LABELER

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

____________ <Negligible, Slight, or Severe>
3.9.5.3
The Seismic Zone in the operating environment is

_______________ <Zone 1, Zone 2, Zone 3, Zone 4, or
Zone 4A>.
Page 26 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
4.0

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 Suppliers
local office.
4.1.2
The Supplier shall provide a written proposal within _____ weeks of
Page 27 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT

Rev. 0
May 2002
receipt of this document at the Suppliers 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 Users
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
Page 28 of 42
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

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
Page 29 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT

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 _____
Page 30 of 42
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

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
Page 31 of 42
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

Rev. 0
All equipment and control wiring shall be labeled and

identified in accordance with _______________ Company
standards as outlined in Attachment _____.
Maintenance
Page 32 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
4.6.1

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.
Page 33 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
5.0

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 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.
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
Page 34 of 42
JETT
USER REQUIREMENTS
SPECIFICATION
LABELER

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
Functional Specification/Requirements
Design Specifications
Controls Test
Hardware Installation Test
Operational Test
Factory Acceptance Test
Operator, Maintenance and Service Manuals
Process and Instrumentation Diagram (P&ID) AutoCAD version 12.0 (*.dxf)

Instrument Listing

or Excel 97 (*.xls)
Control Schematics
AutoCAD version 12.0 (*.dxf)
Control Panel Assembly Drawings
Page 35 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT

Rev. 0
May 2002
Equipment Assembly Drawings
Bill of Materials

or Excel 97 (*.xls)
Spare Parts List

or Excel 97 (*.xls)
Component Cut Sheets

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 Users 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.
Page 36 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
5.4.4.2
5.4.5

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.
Page 37 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
6.0

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
Page 38 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT

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
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
Page 39 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT

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
Page 40 of 42
JETT
USER REQUIREMENTS
SPECIFICATION
LABELER

Rev. 0
May 2002
Table 6.0 Glossary

Acronym
7.0
Definition
REFERENCES
Page 41 of 42
JETT
USER REQUIREMENTS
SPECIFICATION
LABELER

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
Page 42 of 42
USER REQUIREMENTS
SPECIFICATION
LABELER
JETT
8.0

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
Date

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Page 1 of 42

Doc ID: Labeler Template

USER REQUIREMENTS TEMPLATE

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

July 11, 2002

Paul Coury (JETT) Initial revision issued to JETT website.

(Reminder of Page Intentionally Left Blank)

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

Project No.: Labeler

Document Description: Labeler User Requirements Specification

This URS will be recognized as an integral part of the procurement agreement

The labeler system will be operated adjacent to conveyor systems on an

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

The machine shall be used primarily for:

Applying a pressure sensitive label to containers

Printing product information on the label

Inspecting pre-printed and printed characters on the label

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

The labeler shall be capable of operating at a speed of

Container Size Table

Label Size Table

Outsert Size Table

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

3.5.2.10 Dry containers

Table top style

Direction and Orientation of Container Travel

Product Transfer In feed

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

Product Transfer Out feed

Orientation of Container at In-Feed

Short Edge Leading

Long Edge Leading

Orientation of Container at Discharge

Short Edge Leading

Long Edge Leading

Required Accuracy (label placement on product container)

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

Hot Stamp Printing

List Print Font & Size: __________________

Character placement: ___________________

Character Orientation: ___________________

Additional information: _________________

Label Inspection System

Inspect on web prior to placement.

Inspect on web and UV detection of label on

Type of Inspection System:

Character recognition (OCR)

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Labeler Template

Character verification (OCV)

Other (Describe): ______________________

Inspection System Verification

_% visual defect detection of defects _ millimeter