Tuesday, December 21, 2010

Standard Operating Procedure : VALIDATION OF STEAM STERILIZATION

Standard Operating Procedure : VALIDATION OF STEAM STERILIZATION
Purpose:
• It is established for the proper validation of the sterilization process.
2. Scope:
• It is applicable to microbiological Lab.
3. Responsibilities:
• GM Production
• Quality Control Manager
• Microbiologist.
4. Procedure:
• Biological indicators to be used:
 Strain of bacillus stearothermophillus ATCC 7953
Ø
• 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 55-60oC. 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.
Quality Record(s)/Form(s)

No comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...
Subscribe to Quality Assurance and GMP by Email