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1.0 OBJECTIVE : To describe procedure for Validation of Autoclave used in microbiology laboratory.
2.0 SCOPE : This procedure is applicable for validation of Double Door Autoclave(QC/031) and Vertical Autoclave(QC/032) installed in Microbiology Laboratory at (Company Name).
3.0 RESPONSIBILITY
3.1 Microbiologist /Quality control officer and Engineering officer shall be responsible for operating autoclave 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 or his nominee 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 Validation activity should be carried out according to the protocol.
5.2 Sterilization process should be Challenged with Heat resistant Bacterial spores of Bacillus stearothermophilus ATCC 7953.
5.3 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 Autoclave as per procedure. (SOP No.: QC119 & QC120)
6.3 Follow the details of autoclave loading, No. of cycles, Acceptance criteria are defined in Annexure-I.
6.4 Before starting the activity ensure that all the gauges, temperature controller, Data logger/ calibrator etc. are calibrated and verify the calibration report.
6.5 Carryout the validation activity in accordance with the approved protocol.
6.6 Validate the autoclave for following parameters:
6.6.1 Heat distribution with empty chamber.
• Verification of data logger / calibrator temperature printouts and temperature, pressure gauge readings on autoclave.
6.6.2 Heat distribution with loaded chamber.
• Heat distribution shall be done with minimum and maximum load.
• Verification of data logger / calibrator temperature printouts and temperature, pressure gauge readings on autoclave
• Challenge of sterilization process with Heat resistant bacterial spores of Bacillus stearothermophilus ATCC 7953.
• Confirmation of sterilization process with chemical sterilization indicators.
6.6.3 Heat penetration with loaded chamber.
• Heat distribution shall be done with minimum and maximum load.
• Verification of data logger / calibrator temperature printouts and temperature, pressure gauge readings on autoclave
• Challenge of sterilization process with Heat resistant bacterial spores of Bacillus stearothermophilus ATCC 7953.
• Confirmation of sterilization process with chemical sterilization indicators.
6.7 The maximum and minimum load is defined and is given bellow:
6.7.1 For Double Door Autoclave :
6.7.2 For Vertical Autoclave :
6.8 Calculated F0 value for each cycle.
6.8.1 F0 value should not be less than 12 minutes.
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.
