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1.0 OBJECTIVE : To describe procedure for validation of Hot Air Sterilizer.
2.0 SCOPE : This procedure is applicable for the validation of Hot Air Sterilizer installed in Microbiology Laboratory at (Company Name)
3.0 RESPONSIBILITY
3.1 Microbiologist /Quality control officer and Sr. Engineer shall be responsible for operating Hot Air Steriliser as per procedure.
3.2 Sr. officer QA shall be responsible for overall monitoring the operation and planning for the validation activities.
3.3 Manager QC shall be responsible for effective implementation and training of procedure.
3.4 Manager Validation shall be responsible for review and approval of protocol and report.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Sterilization process should be challenged with Heat resistant Bacterial spores of Bacillus atrophaeus ATCC 9372 strip.
5.2 Sterilization process should be verified with chemical sterilization indicators.
6.0 PROCEDURE
6.1 A validation team shall consist of multi-disciplinary team of personnel primarily responsible for conducting and supervising validation studies. The validation team comprises of personnel from Quality Control, Quality Assurance, Engineering & Validation department.
6.2 Operate the Hot Air Sterilizer as per SOP No.: QC118 (Operation and cleaning of hot air sterilizer).
6.3 Test parameters and acceptance criteria for validation of hot Air Sterilizer are defined in Annexure-I.
6.4 Before starting the activity ensure that the data logger/ calibrator is calibrated and verify the calibration report.
6.5 Validate the Hot Air Sterilizer for Heat distribution throughout the chamber by placing four probes at the four corner of the chamber.
6.6 Challenge sterilization process with Heat resistant Bacterial spores of Bacillus atrophaeus ATCC 9372 strip by placing it at the same position beside the temperature probe.
6.7 Verify the sterilization process with chemical sterilization indicators by fixing the indicator label on the four corner of the chamber.
6.8 Verification of datalogger / calibrator temperature printouts and temperature displayed on the temperature controller of Hot Air Sterilizer.
6.9 After completion of the validation activity prepare a compiled report which will contain conclusion of validation study.
6.10 Revalidation Frequency – One year ± 15 days.
