SOP for Validation of Steam Sterilization

Purpose

It is established for the proper validation of the sterilization process.

Scope

It is applicable to microbiological Labs.

Responsibilities

• Production Manager
• Quality Control Manager
• Microbiologist.

Procedure

• Biological indicators to be used: Strain of bacillus stearothermophilus ATCC 7953Ø
• Take 3-4 ampoules of the above-mentioned biological indicator in a container where the other filled ampoules are to be sterilized in an autoclave.

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• These ampoules of biological indicators are placed at different places in the autoclave to check the proper sterilization process. Close the access door and continue to operate the apparatus.

• After completion of the sterilization procedure, and at a noted time within 2 hours, aseptically add each ampoule content in 30 ml of Soybean Casein Digest Medium.
• Incubate each media at a temperature of 55-60°C. Observe each inoculated medium at 24 and 48 hours, and every 1 or 2 days after that for 7 days. If after 7 days of incubation, there is no growth in the medium the test for sterilization is met.

Abbreviations

SOP: Standard Operating Procedure. 

Annexure

Nil

Revision History

Nil

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