JETT-CapsuleFillerURS.doc

JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 1 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 USER REQUIREMENTS SPECIFICATION for Capsule Filler JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 2 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM TABLE OF CONTENTS 1INTRODUCTION 4 2OVERVIEW 5 3OPERATIONAL REQUIREMENTS 5 3 1FUNCTIONS 5 3 2DATA SECURITY 8 3 3ENVIRONMENT 11 4CONSTRAINTS 12 4 1MILESTONES AND TIMELINES 12 4 2COMPATIBILITY 14 4 3AVAILABILITY 15 4 4PROCEDURAL CONSTRAINTS 15 4 5MAINTENANCE 16 5LIFE CYCLE 16 5 1DEVELOPMENT 16 5 2TESTING 16 5 3DELIVERY 17 5 4SUPPORT 18 6GLOSSARY 20 7REFERENCES 21 8APPROVAL 22 JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 3 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM REVISION HISTORY Rev DateApprovalRevision Summary 010 18 2005TGPInitial Release to JETT Website for use JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 4 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM Project No Document No Document Description Capsule Filler User Requirements Description 1INTRODUCTION This document was generated under the authority of the Company for the purpose of specifying the user requirement for a capsule filler The User Requirements Specification URS is provided to aid the user through the important components variables and options necessary to procure a functional capsule filler that meets the user s needs in the most cost effective method possible The URS is then provided to the Supplier to provide a price quote for purchase of the capsule filler 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 An equipment validation plan has been developed to outline the planned tasks and expectations for validation of the capsule 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 JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 5 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 2OVERVIEW The capsule filler is used to encapsulate product dry liquid in gelatin capsules Empty capsules are loaded into the capsule hopper where they are fed into the magazine Capsules initially enter the magazine un oriented From the magazine the capsules enter the sorting block where they are properly oriented smaller end on the bottom The capsules are then separated by vacuum The lower portion of the capsule is filled The upper portion of the capsule is inspected to ensure the capsule is separated If the capsule is not separated or is faulty a pin will dislodge the capsule and the vacuum will remove it from the system The two halves are then joined together The finished capsule is discharged to a chute and the station is cleaned with an air blast The capsule filler can use all makes of capsules Non separated or improperly inserted capsules will be automatically rejected Capsule target fill weight can be adjusted quickly At the end of a run only a small quantity of product will be remaining in the hopper 3OPERATIONAL REQUIREMENTS 3 1 Functions 3 1 1Operation The capsule filler is expected to satisfactorily fill capsules at production speeds up to and including capsules per minute Satisfactory performance is defined by the following criteria JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 6 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 3 1 1 1Capsules are to be transferred through the capsule filler without becoming broken split crushed dented or otherwise damaged in the encapsulating process Filled capsules should be defect free upon visual inspection 3 1 1 2Capsules will be filled to the target weight 3 1 1 3The machine shall not experience more than downtime at production speeds up to and including the capsules per minute specified during an eight hour production run 3 1 1 4The machine changeover between capsule sizes by a single operator is expected to take no longer than hours from the last capsule out of the prior run to the first capsule out of the next run 3 1 1 5Commodity Table Capsule SizeFill MediumFill Weight Rate Capsules Min Comments The capsule filler shall encapsulate at the sizes fill mediums fill weights and output rates defined in the commodity table above The capsule 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 JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 7 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 3 1 2Product Output The capsule filler shall have a machine efficiency rate of as measured by the weight of good capsules encapsulated during a one hour test run divided by the calculated weight of capsules at the rate defined in the commodity table 3 1 1 5 Machine efficiency rate excludes downtime due to faulty commodities or supply issues 3 1 3Product 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 Product contact parts are defined as those parts which the fill material or capsules come into contact with during the encapsulation process 3 1 4Power 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 harm shall come to the operator machinery or product as a result of going to the safe state during a power failure 3 1 5Emergency 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 All motion stopped on the machine No damage to the machine will occur as a result of an emergency stop 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 JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 8 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 3 1 6Alarms and Warnings The capsule filler shall be equipped with the following alarms and warnings Alarm Or WarningImmediate Operator Alert Emergency stopX Protective guards not in placeX No capsulesX Low product levelX Control power faultX Main air faultX PLC communication watchdog faultX PLC battery lowX Immediate alarms shall take action immediately to stop the capsule filler The operator shall be required to acknowledge the alarm before the alarm can be reset and the machine restarted 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 from the operator screen 3 2 Data Security 3 2 1Controls provided with a data collection system 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 2Interfaces 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 using commonly accepted standards JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 9 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 3 2 2 1Interface with Operators The PLC OIP system shall include interfaces with the Operator that use commonly accepted standards for 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 capsule filler The following shall be displayed Machine drive controls Utility controls Alarms and warnings System status e g ready running etc Other specify JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 10 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 3 2 3Interface with Supervisors The PLC OIP system shall provide supervisory access to specific functions to ensure easy safe and reliable configuration of the capsule filler The following shall be accessible only to Supervisors Machine configurations Alarm settings Other specify 3 2 4Interface 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 The PLC OIP system shall include interfaces with the User s control system to facilitate recipe download and configuration 3 2 5Interface with Equipment The PLC OIP system may include interfaces with external equipment to ensure safe continuous transfer of capsules without operator intervention JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 11 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 3 2 6Data Collection 3 2 6 1Data required for collection Machine rate Alarms and warnings System status e g off on standby states etc Other specify 3 2 6 2Data Collection and Storage Requirements None 3 3 Environment 3 3 1Layout Allocated floor space for the capsule filler is inches wide by inches deep with a inch corridor around the periphery of the machine Vertical clearance is inches See attached drawing if applicable Attached drawing shows location of utility connections electricity compressed air vacuum 3 3 2Physical Conditions The capsule filler shall be installed in an environment with a temperature range of to Fahrenheit and relative humidity range of to Vibration levels are Negligible Other specify Electromagnetic interference levels are Negligible Other specify JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 12 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM This area is classified as Non hazardous Class I Div II Class I Div I Other specify The rating requirements of the enclosures in this environment are NEMA 1 NEMA 4X Other specify 3 3 3Cleaning The equipment will be cleaned using the following compounds cleaning agents detergents It is anticipated the equipment will be cleaned on a basis 4CONSTRAINTS 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 capsule filler shall be delivered to the User s receiving dock on or before JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 13 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 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 JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 14 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 4 2 Compatibility 4 2 1PLC 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 4 2 2Utilities 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 2 1 Primary Conditions Primary Electrical Service VAC amps ph Hz Instrument Air cfm psig Vacuum cfm psig Suction Air cfm psig JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 15 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 4 3 Availability The capsule filler is intended to be operated Continuously Regularly hours per day hours per week Other specify Operation of the capsule 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 capsule filler shall be designed to meet the appropriate GMP regulations e g 21 CFR part 210 and 211 as published at the time of order Controls for the capsule filler shall meet the appropriate electrical requirements e g NFPA NEC 70 and 79 for industrial machinery Control panels for the capsule filler shall meet the appropriate certifications e g Underwriters Laboratories UL 508A certification for industrial equipment The capsule 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 capsule 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 JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 16 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 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 4 5 Maintenance 4 5 1The capsule filler shall be maintained on a schedule as indicated by the supplier Supplier is to provide at minimum the following maintenance instructions 4 5 1 1Maintenance activities for all sub systems maintenance and operation manuals of vendor equipment 4 5 1 2A comprehensive lubrication list and recommended lubrication schedule 4 5 1 3A comprehensive recommended maintenance regular recommended inspection intervals wear points recommended spare parts list 4 5 1 4Supplier shall supply copies of operation installation maintenance and de commissioning manuals 5LIFE 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 FAT procedures The Supplier shall notify the User weeks in advance of the start of this test JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 17 of 22 Doc ID Capsule Filler Rev 0 October 18 2005 JOINT EQUIPMENT TRANSITION TEAM 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 Refer to the Equipment Validation Plan attachment for applicable procedures 5 3 Delivery The capsule filler with all options equipment and the documentation listed below shall be delivered to the User s receiving dock 5 3 1Documentation 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 JETT USER REQUIREMENTS SPECIFICATION Capsule Filler Page 18 of 22 Doc ID Capsule Filler Rev 0 Oct