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.
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- 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.
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