DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 1 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP APPROVED BY SIGN / DATE DESIGNATION ____________________ ____________________ ____________________ ____________________ QA MANAGER ORIGINATED BY / DATE ____________________ QA/ VALIDATION SPECIALIST (SEERPHARMA) REVIEWED BY / DATE ____________________ JOHN ROGERS SENIOR CONSULTANT (SEERPHARMA) FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 2 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP TABLE OF CONTENTS 1 PURPOSE ....................................................................................................................................3 2 SCOPE .........................................................................................................................................3 3 ASSOCIATED DOCUMENT & REFERENCE .........................................................................3 4 DEFINITION ...............................................................................................................................3 5 RESPONSIBILITY .....................................................................................................................4 6 EQUIPMENT/ PROCESS OVERVIEW ....................................................................................4 7 OVERVIEW OF IQ TESTS AND CHECKS .............................................................................6 8 PREREQUISITE .........................................................................................................................7 9 TESTS AND CHECKS ...............................................................................................................8 10 TEST INSTRUMENTATION...............................................................................................31 11 IDENTIFICATION OF PERSONNEL .................................................................................32 12 LIST OF DEVIATIONS........................................................................................................33 13 REVIEW AND APPROVALS ..............................................................................................34 14 LIST OF APPENDICES........................................................................................................35 15 PROTOCOL REVISION HISTORY ....................................................................................36 FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 3 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 1 PURPOSE This purpose of this Installation Qualification (IQ) is: Establish that the critical components of Tuttnauer Sterilizer are installed correctly and in accordance with design documentation requirements. Ensure that all supporting documentations are in place and of suitable quality. Verify that all critical instrumentations are calibrated. Ensure that Autoclave 69180\1HSD-EP has been entered onto the Xxxx Planned Preventative Maintenance database. This Installation Qualification (IQP/QA/027/2005, revision 01) document supersedes the original IQ document (Installation Qualification Protocol for Tuttnauer Sterilizer 69180\HSDEP, revision 00). This updated protocol has been developed by Xxxx International to ensure that all the latest regulatory requirements are met. The original IQ documentation (Protocol and Report) is still valid and all information contained within auditable. This updated Protocol includes IQ function testing that was omitted from the original documentation, the extra tests include: Computer Validation, Instrument Tagging and Drawing Verification and Control. 2 SCOPE The scope of this IQ is applicable to Tuttnauer Sterilizer, 69180\1HSD-EP located on level 4 of Xxxx International, Singapore. Associated utilities are considered from the point of connection with the equipment. It also includes all ancillary equipments/ components. 3 4 ASSOCIATED DOCUMENT & REFERENCE Validation Master Plan, VMP/GEN/001-2004, Rev. No. 02. Process Validation for Installation Qualification, SG-PRO-004, Rev. No. 01. Installation Qualification Protocol for Tuttnauer Sterilizer 69180\HSD-EP, revision 00. DEFINITION The following table contains the explanations of the abbreviations and terminology used within this IQ. Abbreviation IQ SOP LCD Term Installation Qualification Standard Operation Procedure Liquid Crystal Display FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 4 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 5 RESPONSIBILITY The following table defines the responsibilities of personnel involved in compilation, execution and approval of this IQ. Personnel Responsibilities Preparation of protocol against design documentation. Submittal of completed protocol for approval prior to execution. Execution of tests detailed in the approved protocol with Good Documentation Practices. Compilation of test results or raw data. Initiate and submit Deviation report for review. Preparation of executed Protocol Summary Report. Reviewer Review completed protocol to ensure correctness in execution and completeness in compilation. Approver Ensure that protocol has met its defined purpose. Approval of protocol that met all technical, compliance and quality requirements. Author Executor 6 EQUIPMENT/ PROCESS OVERVIEW The Tuttnauer, Model 69180\1HSD-EP is a Pre and Post Vacuum autoclave with 1015 Litres of chamber volume. It is constructed from stainless steel using a double wall type structure. Saturated steam is used as the sterilizing media; it is supplied by an external steam generator. The autoclave has a max operating temperature of 131oC and maximum pressure of 2.3 bars. It is equipped with one horizontal sliding door operated by a hydraulic system. The autoclave chamber is sealed by a heat resistance silicone rubber gasket mounted on the door frame groove. Sealing occurs when the gasket is pushed against the door by steam pressure and thrust into the groove behind it. The control of the autoclave is based on a microprocessor system, this controls and monitors all of the physical parameters of the process and performs the operation sequence of the machine according to the selected predefined programs. These programs are accessible via an Operator Interface Terminal (OIT); it also allows users to “START” and “STOP” the autoclave cycles. The OIT displays alarms and informative messages on its 4 line LCD screen. After every executed cycle a “once-through” print out is generated via the attached printer. FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 5 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP Cycle control, monitoring and alarm functionality are assessed from the following instruments: Condensate Temperature sensor Drain Temperature sensor Chamber Temperature sensors Chamber Pressure Transducer Jacket Pressure Transducer Gasket Pressure Transducer Three pressure gauges are installed on the autoclave, and are used for visual monitoring of the Chamber, Jacket and Gasket pressure. Typical sequences of the 12 pre programmer cycles are: Air Removal Steam Injection Steam Holding Steam Removal Pressure Equilibration FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 6 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 7 OVERVIEW OF IQ TESTS AND CHECKS The following table defines all the testing within this IQ with its objective. Section Reference Test Description Objective 9.1 Documentation Verification To verify that all relevant lifecycle documentations of the equipment are available and current. 9.2 Drawings Verification To verify that all relevant drawings of the equipment are available and current. 9.3 Utilities Requirements Verification To verify that all supporting utilities of the equipment are available as specified. 9.4 Equipment and Critical Components Verification To verify that installed equipment and its critical components are as specified. 9.5 Control System Verification To verify that installed control system of the equipment is as specified. 9.6 Product Contact Parts Material Review To verify that product contact parts materials are acceptable for use. 9.7 Instrumentation Identification And Calibration Verification To verify that critical instrumentation of the equipment are as specified. Ensure that all calibrations for the instrumentations are current. 9.8 Control System Configuration And Set point Verification To verify that control system configurations and system setpoints are as specified. 9.9 Safety Features Verification To verify that system safety features are available as specified 9.10 Planned Preventative Maintenance System To verify that the autoclave has been entered onto the Planned Preventative Maintenance System FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 7 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 8 PREREQUISITE The following pre-requisite shall be completed prior to the protocol execution commencement. Item Test Description Acceptable (Yes/ No) 1 Site Acceptance Test/ Vendor Commissioning Documentation 2 Completed Equipment Categorization Form 3 Completed Checklist for Installation Qualification Requirements Verified by (Initial & Date) Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 8 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9 TESTS AND CHECKS 9.1 9.1.1 DOCUMENTATION VERIFICATION OBJECTIVE To verify that all relevant lifecycle documentations of the equipment are available and current. 9.1.2 METHOD 9.1.3 Record the Title, Revision No. and Location in the following results table as defined. Ensure that all listed documentations are current. Record and list all deviation/non-conformances observed in Section 12. TEST TOOL Not applicable. 9.1.4 ACCEPTANCE CRITERIA All relevant lifecycle documentations of the equipment are available and current. 9.1.5 RESULTS Document Type Purchase Order Document Reference (Title, Doc. No., Revision No.) Location Acceptable (Yes/ No) Verified by (Initial & Date) Title: Doc. No.: Rev. No.: User Requirement Specification Title: Design Specification Title: Doc. No.: Rev. No.: Doc. No.: Rev. No.: Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 9 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.1.5 RESULTS (CONTINUED) Document Type Document Reference (Title, Doc. No., Revision No.) Operating and Maintenance Manual Title: Control System Operating Manual Title: Thermal Printer Operating Manual Title: Welding Documentation Title: Location Acceptable (Yes/ No) Verified by (Initial & Date) Doc. No.: Rev. No.: Doc. No.: Rev. No.: Doc. No.: Rev. No.: Doc. No.: Rev. No.: Vacuum Testing Documentation Title: Spare Parts List Title: Doc. No.: Rev. No.: Doc. No.: Rev. No.: Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 10 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.1.5 RESULTS (CONTINUED) Document Type Document Reference (Title, Doc. No., Revision No.) Vendor Installation Qualification Protocol Title: Vendor Operational Performance Qualification Protocol Title: SOP Operation Title: Location Acceptable (Yes/ No) Verified by (Initial & Date) Doc. No.: Rev. No.: Doc. No.: Rev. No.: Doc. No.: Rev. No.: SOP Maintenance Title: Doc. No.: Rev. No.: SOP Calibration Title: Doc. No.: Rev. No.: Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 11 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.2 DRAWINGS VERFICATION 9.2.1 OBJECTIVE To verify that all relevant drawings of the equipment are available and current. 9.2.2 METHOD 9.2.3 Record the Drawing No., Revision No. and Location in the following results table as defined. Ensure that drawings are accurate against installation by marking up with YELLOW highlighter if content is correct and RED highlighter if content is incorrect. Correct inaccurate drawings with RED pen with appropriate annotation. Append all markup drawings and record in Section 13. Record and list all deviation/ non-conformance observed in Section 12. TEST TOOL Not applicable. 9.2.4 ACCEPTANCE CRITERIA All relevant drawings of the equipment are available and current. 9.2.5 RESULTS Drawing Title Drawing Reference (Dwg. No., Rev No.) General Arrangement Dwg. No: Rev. No.: Piping Diagram Dwg. No: Rev. No.: Electric Control Diagram Dwg. No: Rev. No.: Location Acceptable (Yes/ No) Verified by (Initial & Date) Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 12 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.2.5 RESULTS (CONTINUED) Drawing Title Drawing Reference (Dwg. No., Rev No.) Location Acceptable (Yes/ No) Verified by (Initial & Date) Dwg. No: Rev. No.: Dwg. No: Rev. No.: Dwg. No: Rev. No.: Dwg. No: Rev. No.: Dwg. No: Rev. No.: Dwg. No: Rev. No.: Dwg. No: Rev. No.: Dwg. No: Rev. No.: Dwg. No: Rev. No.: Dwg. No: Rev. No.: Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 13 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.3 9.3.1 UTILITY REQUIREMENTS VERIFICATION OBJECTIVE To verify that all supporting utilities of the equipment are available as specified. 9.3.2 METHOD 9.3.3 Verify supporting utilities parameters using appropriate test tool. Record details of verification in the following results table. Record and list all deviation/ non-conformance observed in Section 12. TEST TOOL Calibrated Multimeter. 9.3.4 ACCEPTANCE CRITERIA All supporting utilities are available as specified. 9.3.5 RESULTS Utilities As Specified As Found Electricity Voltage: 380V Phase: 3 Phase Frequency: 50 Hz Voltage: Phase: Frequency: Steam Maximum Supply: 540kpa Maximum Supply: Compressed Pressure: 6-8 Bar Air Flow rate: 100 L/m Cold Water Pressure: 4-6 Bar Flow rate Peak: 28 L/m Average: 1020 L/Hr Temperature: 15 oC Acceptable (Yes/ No) Verified By (Initial & Date) Pressure: Flow rate: Pressure: Flow rate Peak: Average: Temperature: Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 14 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.4 9.4.1 EQUIPMENT AND CRITICAL COMPONENTS VERFICATION OBJECTIVE To verify that installed equipment and its critical components are as specified. 9.4.2 METHOD 9.4.3 Visually verify and record the details of the installed equipment against the specification detailed in the results table. Record and list all deviation/ non-conformance observed in Section 12. TEST TOOL Not applicable. 9.4.4 ACCEPTANCE CRITERIA Installed equipment and its critical components are as specified. 9.4.5 RESULTS A. AUTOCLAVE Item As Specified Manufacturer Tuttnauer Model No. 69180 EP-1H As Found Acceptable (Yes/ No) Verified By (Initial & Date) Equipment ID Serial No. Sterilizing Agent/Media Chamber Volume Saturated Steam Location Level 4 1015 L Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 15 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.4.5 RESULTS (CONTINUED) B. ELECTRIC STEAM GENERATOR Item As Specified Manufacturer Tuttnauer Model No. 350GEN As Found Acceptable (Yes/ No) Verified By (Initial & Date) As Found Acceptable (Yes/ No) Verified By (Initial & Date) Equipment ID Serial No. Power 60kW C. VACUUM PUMP Item As Specified Manufacturer Speck Model No. V95 Equipment ID Serial No. Motor Power Max Suction Capacity 2.2kW/ 3 HP 70 m3/h Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 16 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.4.5 RESULTS (CONTINUED) D. WATER PUMP Item As Specified Manufacturer Speck Model No. CY 4081 As Found Acceptable (Yes/ No) Verified By (Initial & Date) As Found Acceptable (Yes/ No) Verified By (Initial & Date) Equipment ID Serial No. Motor Power 2.2kW/ 3 HP E. HEAT EXCHANGER Item As Specified Manufacturer Heatran Model No. 31 ORZ2 Equipment ID Serial No. Type Plate Type Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 17 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.4.5 RESULTS (CONTINUED) F. AIR FILTER Item Manufacturer As Specified As Found Acceptable (Yes/ No) Verified By (Initial & Date) Domnick Hunter Equipment ID Filter Model No. Lot No. Filter Type Filter Rating Housing Model No. Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 18 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.5 9.5.1 CONTROL SYSTEM VERIFICATION OBJECTIVE To verify that installed control system of the equipment is as specified. 9.5.2 METHOD 9.5.3 Visually verify and record the details of the control system against the specification detailed in the results table. Record and list all deviation/ non-conformance observed in Section 12. TEST TOOL Not applicable. 9.5.4 ACCEPTANCE CRITERIA Installed control system of the equipment is as specified. 9.5.5 RESULTS A. CONTROL PANEL Item As Specified Manufacturer CAT Technology Model No CAT 2007 As Found Acceptable (Yes/ No) Verified By (Initial & Date) Firmware Version Serial No. Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 19 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.5.5 RESULTS (CONTINUED) B. CONTROL BOARD Item As Specified Manufacturer CAT Technology Model No. CAT 2004 Version No. No of PT100 Inputs No of 4-20mA Input No of 4-20mA Output No of Digital Inputs No of Digital Outputs No of Serial Ports As Found Acceptable (Yes/ No) Verified By (Initial & Date) As Found Acceptable (Yes/ No) Verified By (Initial & Date) 6 7 2 16 24 4 C. PRINTER Item As Specified Manufacturer Seiko Instruments Model No. DPU-414 Serial No. Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 20 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.5.5 RESULTS (CONTINUED) D. SOFTWARE/ APPLICATION Item Manufacturer As Specified As Found Acceptable (Yes/ No) Verified By (Initial & Date) CAT Technology Programmer File Name Version Backup Copy Available Backup File Name Backup File Version Backup File Storage Location Yes Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 21 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.6 9.6.1 PRODUCT CONTACT PARTS MATERIALS REVIEW OBJECTIVE To verify that product contact parts materials are acceptable for use. 9.6.2 METHOD 9.6.3 Use one or both of the following methods: a. Visual verification. b. Material Certificate/ Declaration review. Record details of observation in the following results table. Record and list all deviation/ non-conformance observed in Section 12. TEST TOOL Not applicable. 9.6.4 ACCEPTANCE CRITERIA All product contact parts materials are acceptable for use. 9.6.5 RESULTS Item Internal of Chamber Door As Specified Verification Method As Found Acceptable (Yes/ No) Verified By (Initial & Date) 316 SS 304 SS Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 22 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.7 9.7.1 INSTRUMENTATION IDENTIFICATION AND CALIBRATION VERIFICATION OBJECTIVE To verify that critical instrumentation of the equipment are as specified. Ensure that all calibrations for the instrumentations are current. 9.7.2 METHOD 9.7.3 Verify and record details of installed instruments in the following results table. Verify that calibrations of instruments are valid. Ensure that calibration certificates are available. Record location of where certificates are kept. Record and list all deviation/ non-conformance observed in Section 12. TEST TOOL Not applicable. 9.7.4 ACCEPTANCE CRITERIA All critical instrumentations are as specified and its calibrations are valid. Records of calibration are correct and available. FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 23 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.7.5 RESULTS DRAIN TEMPERATURE SENSOR Item As Specified As Found Acceptable (Yes/ No) Verified By (Initial & Date) As Found Acceptable (Yes/ No) Verified By (Initial & Date) Tag Number Manufacturer MMB Model No. Serial No. Type Calibration Due Date Calibration Cert No. Calibration Cert. Location PT100 MEDIA TEMPERATURE SENSOR Item As Specified Tag Number Manufacturer MMB Model No. Serial No. Type Calibration Due Date Calibration Cert No. Calibration Cert. Location PT100 Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 24 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.7.5 RESULTS (CONTINUED) LOAD TEMPERATURE SENSOR Item As Specified As Found Acceptable (Yes/ No) Verified By (Initial & Date) Tag Number Manufacturer MMB Model No. Serial No. Type Calibration Due Date Calibration Cert No. Calibration Cert. Location PT100 Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 25 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.7.5 RESULTS (CONTINUED) CHAMBER PRESSURE TRANSDUCER Item As Specified As Found Acceptable (Yes/ No) Verified By (Initial & Date) As Found Acceptable (Yes/ No) Verified By (Initial & Date) Tag Number Manufacturer Tecsis Model No. 3296 Serial No. Range Calibration Due Date Calibration Cert No. Calibration Cert. Location 0 – 10 bar JACKET PRESSURE TRANSDUCER Item As Specified Tag Number Manufacturer Tecsis Model No. 3296 Serial No. Tag No: Calibration Due Date Calibration Cert No. Calibration Cert. Location 0 – 10 bar Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 26 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.7.5 RESULTS (CONTINUED) GASKET PRESSURE TRANSDUCER Item As Specified As Found Acceptable (Yes/ No) Verified By (Initial & Date) As Found Acceptable (Yes/ No) Verified By (Initial & Date) Tag Number Manufacturer Tecsis Model No. 3296 Serial No. Range Calibration Due Date Calibration Cert No. Calibration Cert. Location 0 – 10 bar CHAMBER PRESSURE GAUGE Item As Specified Tag Number Manufacturer Wika Serial No. Range Calibration Due Date Calibration Cert. No. Calibration Cert. Location 0 – 500 kPa Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 27 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.7.5 RESULTS (CONTINUED) JACKET PRESSURE GAUGE Item As Specified As Found Acceptable (Yes/ No) Verified By (Initial & Date) As Found Acceptable (Yes/ No) Verified By (Initial & Date) Tag Number Manufacturer Wika Serial No. Range Calibration Due Date Calibration Cert. No. Calibration Cert. Location 0 – 500 kPa GASKET PRESSURE GAUGE Item As Specified Tag Number Manufacturer Wika Serial No. Range Calibration Due Date Calibration Cert. No. Calibration Cert. Location 0 – 500 kPa Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 28 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.8 9.8.1 CONTROL SYSTEM CONFIGURATION AND SETPOINT VERIFICATION OBJECTIVE To verify that control system configurations and system setpoints are as specified. 9.8.2 METHOD 9.8.3 Verify and record control system configuration and system setpoints in the following results table. Ensure that recorded details are as specified. Append system configuration and/or system setpoints printout if available. Record and list all deviation/ non-conformance observed in Section 12. TEST TOOL Not applicable. 9.8.4 ACCEPTANCE CRITERIA Control system configuration and system setpoints are as specified. 9.8.5 RESULTS Item As Specified Chamber & Jacket Safety Valve Set point 40 psi Gasket Safety Valve Set point 40 psi As Found Acceptable (Yes/ No) Verified By (Initial & Date) Pressure Switch set point Thermal Printer SW1 Dip Switch Thermal Printer SW2 Dip Switch Thermal Printer SW3 Dip Switch Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 29 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.9 9.9.1 SAFETY FEATURES VERIFICATION OBJECTIVE To verify that system safety features are available as specified. 9.9.2 METHOD 9.9.3 Verify that listed safety features listed are available. Record and list all deviation/ non-conformance observed in Section 12. TEST TOOL Not applicable. 9.9.4 ACCEPTANCE CRITERIA System safety features are available as specified. 9.9.5 RESULTS Item Emergency Stop (In Front) As Specified As Found Acceptable (Yes/ No) Verified By (Initial & Date) Available Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 30 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 9.10 PLANNED PREVENTATIVE MAINTENANCE VERIFICATION 9.10.1 OBJECTIVE To verify that the autoclave has been entered onto the planned preventative maintenance system. 9.10.2 METHOD Verify that autoclave Tuttnauer Sterilizer 69180\1HSD-EP has been entered onto the planned preventative maintenance system. Record and list all deviation/ non-conformance observed in Section 12. 9.10.3 TEST TOOL Not applicable. 9.10.4 ACCEPTANCE CRITERIA The autoclave has been entered onto the planned preventative maintenance system. 9.10.5 RESULTS Item Tuttnauer Sterilizer 69180\1HSD-EP As Specified As Found Acceptable (Yes/ No) Verified By (Initial & Date) Autoclave Tuttnauer Sterilizer 69180\1HSD-EP has been entered onto the planned preventative maintenance system Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 31 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 10 TEST INSTRUMENTATION All test instrumentation used in this protocol shall be recorded in the table below. Calibration of Test Instrumentation must be valid and copies of calibration certification shall be appended to this document. Instrument Type Manufacturer Serial Number Calibration Cert. No. Cal Due Date Initial & Date Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 32 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 11 IDENTIFICATION OF PERSONNEL The following is a record of each individual who is involved in the execution of this protocol. Personnel profiles for all non-Xxxx personnel must be attached in this IQ protocol. Company/ Title Name Department Signatures Full Date Initials Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 33 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 12 LIST OF DEVIATIONS The following table details of all deviation/ non-conformance identified during the performance of the IQ. All deviations/ non-conformances identified require the initiation of a Deviation Report Form. Deviation Report No. Ref. Protocol Section Deviation Details Corrective Action Implemented By: Date Resolved Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 34 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 13 REVIEW AND APPROVALS 13.1 Approval To Proceed To OQ The tests and checks specified in this protocol have been carried out in a satisfactory manner and the results documented correctly. All remaining Deviation Reports listed in Section 12 have been considered and will not affect the correct operation of the equipment. The Tuttnauer Sterilizer is ready for Operational Qualification. Note: If there are no outstanding Deviation Reports proceed directly to Final Approval. APPROVAL TO PROCEED TO OQ Department Title Name Signature Date Technical Services Engineering & Maintenance Production Quality Assurance 13.2 Final Approval The tests and checks specified in this protocol have been carried out in a satisfactory manner and the results documented correctly. All Deviation Reports listed in Section 12 have been resolved. The Tuttnauer Sterilizer Installation Qualification is complete. FINAL APPROVAL Department Title Name Signature Date Technical Services Engineering & Maintenance Production Quality Assurance FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 35 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 14 LIST OF APPENDICES The table below documents and numbers each Appendix of IQ. If extra Appendices are required during execution, they may be entered by hand. Appendix Number Appendix Title Protocol Test Section(s) Comments: Reviewed By: Date: FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL No of Pages DOCUMENT NUMBER IQP/QA/027/2005 TITLE REVISION 01 PAGE 36 of 36 INSTALLATION QUALIFICATION FOR TUTTNAUER STERILIZER 69180\1HSD-EP 15 PROTOCOL REVISION HISTORY Rev. No Date Issued By Remarks FOR USE BY AFFILIATES OF XXXX PTE LTD THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION – IT MUST NOT BE REPRODUCED OR DISCLOSED TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL
