Autoclave IOQ Protocol.doc

EQUIPMENT CERTIFICATION PROGRAM XG1.DMSD-0.24B Vacuum pulse steam sterilizer Installation Operational Qualification Protocol Documentation Number: PROTOCOL PREPARED BY: _______________________DATE: ________________ PROTOCOL REVIEWED BY: _______________________ DATE: _______________ PROTOCOL APPROVED BY: QUALITY CONTROL: ______________________ DATE: ________________ PLANT ENGINEERING: ______________________DATE: ________________ QUALITY ASSURANCE: ______________________DATE: ________________ PROTOCOL APPROVAL SIGNIFIES CONCURRENCE WITH THE TESTS PROCEDURES AND ACCEPTANCE CRITERIA OUTLINED HEREIN.TABLE OF CONTENTS 1 PURPOSE 3 2 DEVIATION AND CHANGE CONTROL 3 3 INSTRUMENT DESCRIPTION 3 4 INSTALLATION QUALIFICATION 3 4.1 GENERAL 3 4.2 LUBRICANTS 9 4.3 SPARE PARTS LIST AND TOOLS LIST 11 4.4 STANDARD OPERATING, CLEANING, CALIBRATION AND MAINTENANCE PROCEDURES 12 4.5 EQUIPMENT DOCUMENTATION 13 5 OPERATIONAL QUALIFICATION 15 5.1 STANDARD OPERATING PROCEDURE VERIFICATION 15 5.2 CALIBRATION REVIEW 22 TEST PLAN 25 6 TEST INSTRUMENTS AND CALIBRATION 39 7 SIGNATURE / INITIALS LOG 41 8 OTHER RELATED REGULATIONS 43 9 FINAL REPORT STATEMENT 43 PURPOSE This protocol defines the Installation and Operational Qualification requirements and the corresponding acceptance criteria for the XG1.DMSD-0.24B vacuum pulse steam sterilizer located in Quality Control Laboratory of Building A at Anshi Pharmaceutical (Zhongshan) Inc. This qualification will provide documented verification that all key aspects of this equipment and its installation and operation adhere to the manufacturer’s recommendations and the approved pre-determined specifications. Additionally, this document will provide a documentation of baseline installation and operation data to serve as a reference for change control in the future. DEVIATION AND CHANGE CONTROL Deviation and/or change may happen during the qualification process. Should this occur, a corresponding report on the issue w