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SOP for Validation of Steam Sterilization

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

Scope:
It is applicable to microbiological Lab.

Responsibilities:
  • Production Manager
  • Quality Control Manager
  • Microbiologist.

Procedure:
  • Biological indicators to be used: Strain of bacillus stearothermophilus ATCC 7953Ø
  • Take 3-4 ampoules of above mentioned biological indicator in container in which the other filled ampoules are placed which are to be sterilized in autoclave.
  • These ampoules of biological indicators are placed at different places of autoclave so that 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 with in 2 hours, aseptically add each contents of ampoule in 30 ml of Soybean Casein Digest Medium.
  • Incubate each media at a temperature of 55-60°C. Observe each inoculated medium at 24 hours and 48 hours,and every 1 or 2 days thereafter for a total of 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. 

REVISION HISTORY 
Nil

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