Wide Range Filler Urs

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USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

JETT Wide Range Liquid Filler
Rev. 0
August 2005
USER REQUIREMENTS TEMPLATE

for a WIDE RANGE LIQUID FILLER
JOINT EQUIPMENT TRANSITION TEAM

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August 2005
TABLE OF CONTENTS
1 INTRODUCTION................................................................................................................................4
2 OVERVIEW.........................................................................................................................................5
3 OPERATIONAL REQUIREMENTS.................................................................................................5
3.1 FUNCTIONS................................................................................................................................. 5
3.1.1 Operation...................................................................................................................................5
VIAL SIZE....................................................................................................................................................6
NECK FINISH.............................................................................................................................................6
HEIGHT........................................................................................................................................................6
WIDTH..........................................................................................................................................................6
VIAL ID.........................................................................................................................................................6
STOPPER ID................................................................................................................................................6
PLUG/ LYO..................................................................................................................................................6
RATE (V/MIN).............................................................................................................................................6
COMMENTS................................................................................................................................................6
3.1.2 Product Output...........................................................................................................................7
3.1.3 Product Contact Parts...............................................................................................................7
3.1.4 Power Failure and Recovery......................................................................................................8
3.1.5 Emergency Stop.........................................................................................................................8
3.1.6 Alarms and Warnings.................................................................................................................9
3.2 DATA & SECURITY.................................................................................................................... 10
3.2.1 Interfaces.................................................................................................................................10
3.2.2 Interface with Supervisors........................................................................................................11
3.2.3 Interface with Other Systems....................................................................................................11
3.2.4 Interface with Equipment.........................................................................................................12
3.2.5 Data Collection........................................................................................................................12
3.3 ENVIRONMENT.......................................................................................................................... 13
3.3.1 Layout......................................................................................................................................13
3.3.2 Physical Conditions.................................................................................................................13
4 CONSTRAINTS.................................................................................................................................14
4.1 MILESTONES AND TIMELINES.................................................................................................... 14
4.2 COMPATIBILITY......................................................................................................................... 15
4.2.1 PLC Controllers.......................................................................................................................15
4.2.2 Utilities....................................................................................................................................15

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4.3 AVAILABILITY........................................................................................................................... 16
4.4 PROCEDURAL CONSTRAINTS..................................................................................................... 16
4.5 MAINTENANCE.......................................................................................................................... 17
5 LIFE-CYCLE.....................................................................................................................................17
5.1 DEVELOPMENT.......................................................................................................................... 17
5.2 TESTING.................................................................................................................................... 18
5.3 DELIVERY................................................................................................................................. 18
5.3.1 Documentation.........................................................................................................................18
5.4 SUPPORT................................................................................................................................... 19
5.4.1 Start-up Support.......................................................................................................................19
5.4.2 Post Start-up Support..............................................................................................................19
6 GLOSSARY........................................................................................................................................20
7 REFERENCES...................................................................................................................................20
8 APPROVAL........................................................................................................................................20

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August 2005
REVISION HISTORY
Rev. Date Approval Revision Summary
A1 12/21/00 TGP Initial Draft
A2 1/16/01 TGP Incorporated comments from JETT Group and Gary Pardekooper
A2 2/5/01 TGP Incorporated comments from JETT meeting of 1/24/01
A3 3/13/01 TGP Moved notes to second page, modified procedural constraints as
requested from JETT meeting on 2/15/01
B1 7/16/02 TGP Changes from validation review of 1/17/02
C1 04/17/03 MRR Format Review

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Project No.: Wide Range Filler #1234
Document No.: 8111234567
Document Description: Wide Range Filler User Requirements Specification
1 INTRODUCTION
This document was generated under the authority of the ___________________ Company for the
purpose of specifying the user requirement for a wide range filler that will fill, sample checkweigh and
stopper a wide range of vial sizes in a pharmaceutical environment. The User Requirements
Specification (URS) is provided to aid the user through the important components, variables and
options necessary to procure a functional filling stoppering system 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 the wide range filler supply including the design and manufacture of the equipment.
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.
The wide range filler will be interfaced to the output of a depyrogenation tunnel, and will be located in
a designated operating area within a cGMP packaging operation.
An equipment validation plan has been developed to outline the planned tasks and expectations for
validation of the wide range filler. This plan has been included as Attachment _____. The equipment
supplier or vendor has specific responsibilities as outlined by the Validation Plan and this document.

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2 OVERVIEW
The wide range liquid filler shall process pharmaceutical vials under sanitary conditions with the
following functions:
Vial Filling
Vial Stoppering
Oxygen Reduction
Sample Checkweighing
Vial Eject
Other (specify):
3 OPERATIONAL REQUIREMENTS
3.1 Functions
3.1.1 Operation
The wide range filler is expected to satisfactorily fill and stopper vials at production
speeds up to and including ______________ vials per minute. Satisfactory
performance is defined by the following criteria:
3.1.1.1 Sterilized vials are to be run through the wide range filler without
becoming contaminated, disoriented, marred, scratched, broken or
otherwise damaged in the process. Properly filled vials are defined as
those possessing the desired dose (+/- _____% by weight) with a
properly seated stopper. Specifically, the rejection rate caused by the
wide range filler must not exceed ______ % during any given production
run.
3.1.1.2 The machine shall not experience more than _____ % downtime at
production speeds up to and including the ______ vials per rate
specified, during an eight hour production run.

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3.1.1.3 The vial eject system must be 100% reliable. It must eject all rejected
vials, and not eject acceptable vials.
3.1.1.4 The machine changeover between vial sizes by a single operator is

expected to take no longer than ____ minutes from the last vial out of
the prior run to the first vial out of the next run.
3.1.1.5 Commodity Table

Neck Vial Stopper Plug/ Rate
Vial Size Height Width Comments
Finish ID ID Lyo (V/Min)
3.1.1.6 Vial Handling

The wide range filler shall transfer, fill, checkweigh and stopper
pharmaceutical grade glass or plastic vials at the rates defined in the
commodity table:
The wide range filler shall be operable by one person, with safety related
faults stopping the machine immediately. The machine shall not be
allowed to restart without operator intervention.
3.1.1.7 Vial filling

The wide range filler shall fill vials with
__________________________product that has a specific gravity of
_________________ to an accuracy of +/- __________%. The product
has _______________________________________ foaming
tendencies.

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August 2005
3.1.1.8 Oxygen Reduction

The wide range filler will reduce the levels of oxygen in the headspace of
the vial to __________%, as measured using sparged WFI for a product.
The Oxygen Reduction System must be selectable to allow flow of
nitrogen to the vial only for products that are oxygen sensitive.
3.1.1.9 Stoppering
The wide range filler shall stopper vials with stoppers listed, and at the
rate defined in the commodity table. Silicone treatment of stoppers being
placed is defined as_______________
__________________________________________________________
______________________
3.1.1.10 Checkweighing
The wide range filler shall sample checkweigh vials prior to filling (tare)
and after filling (gross). The weight accuracy shall be +/-__________%
of fill weight. The sampling frequency shall be __________
weighs/minute.
3.1.1.11 Vial Eject

The wide range filler shall eject all vials that are faulty due to
__________________________________________________________
__________________________________________________________
Vials shall be removable from the filler for manual sampling.
3.1.2 Product Output

The wide range filler shall have a machine efficiency rate of ________ %, as
measured by the actual number of good vials filled and stoppered during a one hour
test run, divided by the calculated number at the rate defined in the vial commodity
table. Machine efficiency rate excludes downtime due to faulty commodities or
supply issues.
3.1.3 Product Contact Parts

All product contact parts shall be constructed from materials acceptable to the
product and sterility assurance methods. Certificates for material, weld and finish
shall be provided.

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3.1.4 Power Failure and Recovery

On power failure, the system shall fail into a safe state. On power restoration, the
system shall not restart without operator or communication-link input.
All equipment shall be designed to retain the PLC program in case of power loss,
and be able to recover with minimal operator actions.
A safe state shall be defined as:

All motion stopped on the machine
Reset required before machine can be restarted
No damage to machine will occur as a result of going to the safe state.
3.1.5 Emergency Stop

Emergency-stop buttons shall be supplied within the reach of the operator at normal
operator stations. When activated, the emergency stop shall shut the system down
immediately in accordance with the following requirements:
No damage to the machine will occur as a result of an emergency stop.
Emergency stop will seal product path or take actions to prevent product
contamination if so equipped.
The machine shall not be allowed to restart without operator intervention. It shall
be necessary to restore the emergency stop button to the original state, and reset the
system before restarting.

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3.1.6 Alarms and Warnings

The wide range filler shall be equipped with the following alarms and warnings:
Cycle Operate
Alarm Or Warning Immediate*
Stop** Alert***
PLC Battery Low X
Emergency Stop X
Machine Overtorque X
No Vials X
Stopper Hopper Low X
No Stoppers X
Missing Stoppers X
Low Air Pressure X
High Stoppers X
Output Full X
Checkweigh Low Alarm X
Checkweigh Low Alert X
Checkweigh High Alert X
Checkweigh High Alarm X
* Immediate alarms shall take action immediately to stop the wide range filler. The operator shall
be required to acknowledge the alarm before the alarm can be reset and the machine restarted.
** Cycle-Stop alarms shall take action at the end of a fill cycle to stop the wide range filler. The
operator shall be required to acknowledge the alarm before the alarm can be reset and the machine
restarted.

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*** Operator Alert allows the machine to continue to run, but provides an alert message to be
displayed on the operator screen. The operator shall be required to acknowledge the alert in order
to remove the warning message form the operator screen.
3.2 Data & Security
3.2.1 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.
3.2.2 Interfaces
The Programmable Logic Controller / Operator-Interface Panel system (hereafter
referred to as the PLC/OIP 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.
3.2.2.1 Interface with Operators
The PLC/OIP system shall include interfaces with the Operator that ensures
easy, safe, and reliable operation.
An operator-interface panel shall be provided and mounted on the machine.
This panel shall provide the necessary switches, indicators, and devices to
operate the wide range filler. The following shall be displayed:
Machine Drive Controls
Vial Transfer Controls
Filling Controls
Checkweigh Controls
Stoppering Controls
Eject Controls
Utility Controls
Alarms and Warnings.
System Status (e.g., ready, running, etc.).
Other (specify).

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3.2.3 Interface with Supervisors

The PLC/OIP system shall provide supervisory access to specific functions to ensure
easy, safe, and reliable configuration of the wide range filler. The following shall be
accessible only to Supervisors:
Fill Volume Adjustment
Checkweigh Alarm and Alert Settings
Vial Counter Reset
Alarm Settings.
Other (specify).
3.2.4 Interface with Other Systems

Access to all Input/Output values and system status bits by an external computer
system(s) shall be provided through a data-communication link to the PLC and/or
PLC/OIP. Security for data and operator access is provided by ______________.
List the application that provides security functions to the system, either internal
via the local OIP or external via a SCADA system, etc.
The PLC/OIP system shall include interfaces with the Users control system to
facilitate recipe download and configuration.
The port shall be 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):
Machine Rate
Vial Count
Checkweigh Data
System Status (e.g. off, on, standby states, etc.).
Other (specify).
3.2.5 Interface with Equipment

The PLC/OIP system may include interfaces with external equipment to ensure safe,
continuous transfer of vials without operator intervention.

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3.2.6 Data Collection
3.2.6.1 Data required for collection

Machine Rate
Vial Count
Checkweigh Data
System Status (e.g. off, on, standby states, etc.).
Other (specify).
3.2.6.2 Data Collection and Storage Requirements

None
3.3 Environment
3.3.1 Layout
Allocated floor space for the wide range filler is _______ inches wide by ________
inches deep with a 24 inch corridor around the periphery of the machine.
Vertical clearance is _________ inches.
See attached drawing #________________________ (if applicable).
3.3.2 Physical Conditions

The wide range filler shall be mounted in an environment with a temperature range
of ______ to ______ Fahrenheit and non-condensing humidity.

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Vibration levels are:

Negligible.
Other (specify).
Electromagnetic interference levels are:

Negligible.
Other (specify).
This area is intended for the following use:

Class 100 Cleanroom.
Other (specify).
4 CONSTRAINTS
4.1 Milestones and Timelines
The Supplier shall provide a written proposal within _______ weeks of receipt of this
document at the Suppliers local office.
The Supplier shall provide a Functional and Design Specifications within ________ weeks
of receipt of the purchase order.
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.
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.
The wide range filler shall be delivered to the Users receiving dock on or before
_________________.
The Preferred Format Is:
Date written proposal/quote required:

Date purchase order will be placed by:
Functional and Design Specification delivery date:
Factory Acceptance Test Plan due for review:
Factory Acceptance Test Plan due for approval:
Date equipment is required on-site:

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4.2 Compatibility
4.2.1 PLC Controllers

The Supplier shall utilize manufactured programmable logic
controllers that shall include a ___________________ communications port. The
Supplier shall provide documentation that the program (embedded software) was
developed and coded utilizing _______ program development and
documentation software.
The Supplier shall identify the impact of adhering to the attached Preferred
Manufacturers List.
4.2.2 Product Contact Parts

All product contact parts shall be constructed from materials acceptable to the
product and sterility assurance methods. Certificates for material, weld and finish
shall be provided.
4.2.3 Utilities
The User shall ensure that the following utilities are available and that the utility
supply lines and piping are terminated with fittings or connections, which are
compatible with those described on the Customer Connection Drawing.
The Supplier shall specify utility data, which is marked with an asterisk (*).
Utility requirements, which are not specified or marked with an asterisk, shall be
brought to the attention of the User. These requirements shall be approved by both
the User and the Supplier before system design begins.
4.2.3.1 Primary Conditions

Primary Electrical Service: _______ VAC, _______ amps, _______ ph, ______ Hz
Secondary Electrical Service: _______ VAC, _______ amps, _______ ph, ______ Hz
Instrument Air: _______ cfm @ _______ _____ psig (minimum: 2 cfm @ 80 psig).
Clean, Filtered Air: _______ cfm @ _______ _____ psig (minimum: .5 cfm @ 80 psig).
Nitrogen: _______ cfm @ _______ _____ psig (Minimum: 3 cfm @ 25 psig).
SIP Steam: _______ C @ ________ _____ psig (Minimum: 135C @ 30 psig).

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4.3 Availability
The Wide Range Filler is intended to be operated:
Continuously
Regularly
_________ hours per day.
_________ hours per week.
Other (specify).
_________________________________________________________________________
_________________________________________________________________________
Operation of the wide range filler shall be shut down, and the machine shall be available for
maintenance or service:
_______ hours per week.
_______ continuous hours per week.
_______ days per month.
_______ weeks per year.
4.4 Procedural Constraints

The wide range shall be designed to meet the appropriate GMP regulations. e.g.: cGMP 21 CFR part
210 and 211 as published at the time of order.
Controls for the wide range filler shall meet the appropriate electrical requirements. e.g.: NFPA/NEC
70 and 79 for industrial machinery.
Control panels for the wide range filler shall meet the appropriate certifications. e.g.: Underwriters
Laboratories UL-508A certification for industrial equipment.
The wide range filler shall meet the appropriate safety regulations. e.g.: OSHA regulations for the
safety of operators of equipment with regards to safety, guarding and noise.
The wide range filler shall meet CE requirements if delivered to the European Community.
All piping welds shall meet the appropriate piping regulations. e.g.: ASME and 3A specification
requirements.

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Other standards are attached. The Supplier shall adhere to the indicated sections only.
Installation, operation, and maintenance instruction documentation for the system shall be developed
to a level that is comprehensible by a high school graduate.

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4.5 Maintenance
4.5.1 The vial washer shall be maintained on a schedule as indicated by the supplier. Supplier is to
provide (at minimum) the following maintenance instructions.
4.5.1.1 Maintenance activities for all sub-systems (maintenance and operation manuals of vendor
equipment).
4.5.1.2 A comprehensive lubrication list and recommended lubrication schedule.
4.5.1.3 A comprehensive recommended maintenance (regular recommended inspection intervals, wear

points, recommended spare parts list)
4.5.1.4 Supplier shall supply ________ copies of operation, installation, maintenance and de-
commissioning manuals.
5 LIFE-CYCLE
5.1 Development
The Supplier shall provide a Quality and Project Plan as part of its proposal. The Supplier shall have
a quality system in place. Internal quality procedures shall be available for the Users review.
The Supplier shall provide a Project Manager for the project to provide a single communication point
with the User.
The project shall utilize the GAMP methodology when developing the system and documentation.
5.2 Testing
In order to verify machine performance, the User shall witness the execution of the approved Factory
Acceptance Test procedures. The Supplier shall notify the User _______ weeks in advance of the
start of this test.
5.3 Delivery
The wide range filler, with all options, equipment, and the documentation listed below, shall be
delivered to the Users receiving dock.
5.3.1 Documentation

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The Supplier shall use the formats described in the current version of the GAMP Supplier Guide 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.
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.
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:
Project Plan
User Requirements Specification
Functional Specification
Design Specification
Software Module Test
Software Integration Test
Controls Test
Hardware Installation Test
Operational Test
Factory Acceptance Test
Operator, Maintenance and Service Manuals
Process and Instrumentation Diagram (P&ID)
Instrument Listing
Control Schematics
Control Panel Assembly Drawings
Machine Assembly Drawings
Bill of Materials
Spare Parts List
Component Cut Sheets

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PLC Program Printout and Disk File

OIP Configuration Printout and Disk File
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 rigging,
installation, start-up and commissioning.
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 support 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 commissioning.
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 GLOSSARY
Table 6.0 Glossary
Acronym Definition

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C Degrees Celsius
BL Biohazard Level
CFR Code of Federal Regulations
DB Decibels
EMI Electro-Magnetic Interference
M Meter
GUI Graphic User Interface
HMI Human Machine Interface
HVAC Heating, Ventilation, and Air Conditioning
ISO International Organization for Standardization
JETT Joint Equipment Transition Team
LEL Lower Explosion Limit
OIP Operator Interface Panel
RFI Radio Frequency Interference
URS User Requirement Specification

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7 REFERENCES
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

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8 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.
This document has been reviewed by the Supplier Project Manager and approved
for use by the Supplier Project Team.

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Page 0 of 23

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

USER REQUIREMENTS TEMPLATE

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

Project No.: Wide Range Filler #1234

Document No.: 8111234567

Document Description: Wide Range Filler User Requirements Specification

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

3.1.1.4 The machine changeover between vial sizes by a single operator is

3.1.1.5 Commodity Table

3.1.1.6 Vial Handling

3.1.1.7 Vial filling

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

3.1.1.8 Oxygen Reduction

3.1.1.11 Vial Eject

3.1.2 Product Output

3.1.3 Product Contact Parts

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

3.1.4 Power Failure and Recovery

A safe state shall be defined as:

3.1.5 Emergency Stop

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

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

3.1.6 Alarms and Warnings

Stopper Hopper Low X

Low Air Pressure X

Checkweigh Low Alarm X

Checkweigh Low Alert X

Checkweigh High Alert X

Checkweigh High Alarm X

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

3.2 Data & Security

3.2.2.1 Interface with Operators

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

3.2.3 Interface with Supervisors

3.2.4 Interface with Other Systems

The port shall be configured to communicate the following data to a supervisory

3.2.5 Interface with Equipment

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

3.2.6 Data Collection

3.2.6.1 Data required for collection

3.2.6.2 Data Collection and Storage Requirements

Vertical clearance is _________ inches.

See attached drawing #________________________ (if applicable).

3.3.2 Physical Conditions

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Wide Range Liquid Filler

Vibration levels are:

Nitrogen: ___ cfm @ _ ___ psig (Minimum: 3 cfm @ 25 psig).

SIP Steam: ___ C @ _ psig (Minimum: 135C @ 30 psig).