SOP for Validation of Autoclave with Biological Indicator for Sterilization Efficiency

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Standard operating procedure to validate the Autoclave using Biological Indicators for sterilization efficiency.

OBJECTIVE

To describe the procedure to validate autoclave with the biological indicator for sterilization efficiency at pharmaceutical manufacturing site.

SCOPE

This is applicable to validate autoclave with the biological indicator for sterilization efficiency at pharmaceutical manufacturing site.

RESPONSIBILITY

Microbiologist – Quality Control.

Manager – QC/QA

PROCEDURE

Autoclave validation

Load the autoclave chamber with routine accessories and glassware.
Take three strips and mark with location and put inside the autoclave as described below.
Put one strip in the inner side, one side in middle and one strip outer side, near the door of the autoclave chamber.
Keep one strip unexposed for + ve control.
Run the autoclave cycle at 121ºC and 15 lb pressure for 20 minutes/validated time.
Mark the pre-incubated sterile SCDM (Soybean Casein Digest Medium) tubes (20ml) with location no., date etc. and transfer the strips aseptically to respective labeled SCDM tubes.
Transfer one unexposed for + ve control.
Keep one SCDM tube un-inoculated for – ve control.
Incubate all the tubes at 55ºC- 60ºC for 7 days.
Observe the tubes daily up to 7 days for turbidity/ growth in the SCDM tubes having strips.
Positive control should show growth within 72 hours.

Frequency –Monthly
Organism – Bacillus stearothermophilus.

Perform the initial count of one strip of Bacillus stearothermophilus spores from the strips of given lot/ batch which are to be used for validation purpose.

If no growth observed in any one of the SCDM tube having autoclaved strips, test complies.
If growth observed in any one of the SCDM tube, identity the growth of B. stearothermophilusperforming gram staining, simultaneously comparing it with + ve control. In case of failure, investigate for non-compliance of validation and repeat the cycle.
Inform the QC manager /QA manager/engineering dept. for corrective action.

ABBREVIATIONS

SOP – Standard Operating Procedure
SCDM – Soybean Casein Digest Medium

QC – Quality Control

QA – Quality Assurance

ANNEXURE –I

AUTOCLAVE VALIDATION WITH BIOLOGICAL INDICATOR

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