Wide Range Filler Urs
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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
USER REQUIREMENTS TEMPLATE for a WIDE RANGE LIQUID FILLER
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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
4.3 4.4 4.5
AVAILABILITY........................................................................................................................... 16 PROCEDURAL CONSTRAINTS..................................................................................................... 16 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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
REVISION HISTORY Rev. A1 A2 A2 A3 B1 C1
Date 12/21/00 1/16/01 2/5/01 3/13/01
Approval TGP TGP TGP TGP
7/16/02 TGP 04/17/03 MRR
Revision Summary Initial Draft Incorporated comments from JETT Group and Gary Pardekooper Incorporated comments from JETT meeting of 1/24/01 Moved notes to second page, modified procedural constraints as requested from JETT meeting on 2/15/01 Changes from validation review of 1/17/02 Format Review
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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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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JETT
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
Vial Size
Neck Finish
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 Vial Width ID
Height
3.1.1.6
Stopper ID
Plug/ Lyo
Rate (V/Min)
Comments
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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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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Page 9 of 23 USER REQUIREMENTS SPECIFICATION
JETT
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
3.1.6 Alarms and Warnings The wide range filler shall be equipped with the following alarms and warnings: Alarm Or Warning
Immediate*
Cycle Stop**
Operate Alert*** X
PLC Battery Low Emergency Stop
X
Machine Overtorque
X
No Vials
X X
Stopper Hopper Low No Stoppers
X
Missing Stoppers
X
Low Air Pressure
X
High Stoppers
X X
Output Full 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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
*** “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 User’s 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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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 User’s 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
Alarms and Warnings.
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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
3.2.6 Data Collection 3.2.6.1 Data required for collection Machine Rate
Vial Count
Checkweigh Data
Alarms and Warnings.
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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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 Supplier’s 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 User’s 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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JETT
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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 decommissioning 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 User’s 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 User’s receiving dock.
5.3.1 Documentation
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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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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Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
5.4
PLC Program Printout and Disk File
OIP Configuration Printout and Disk File
Support
5.4.1 Start-up Support 5.4.1.1 Start-up support shall consist of ______ weeks of full time assistance on the User’s 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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JETT
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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 ISO
Heating, Ventilation, and Air Conditioning 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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JETT
USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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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USER REQUIREMENTS SPECIFICATION
Wide Range Liquid Filler
Doc ID: Wide Range Liquid Filler Rev. 0 August 2005
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.
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
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Date
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