Monitoring of Autoclave by using Biological Indicators

1.0    OBJECTIVE  :

To lay down a procedure for the Monitoring of Autoclave by using biological indicators.

2.0    SCOPE  :

This SOP is applicable for Autoclave located in Microbiology laboratory.

3.0    RESPONSIBILITY :

QC Microbiologist: To Perform the activity

Head Quality Control: To Ensure the activity 

4.0    PROCEDURE :

4.1    Load the chamber with material to be sterilized as per manufacturer loading pattern.

4.2    Place the Certified Biological Indicator in different locations as per pre-defined location 

4.3    Operate the autoclave for sterilization process as per Cleaning and Operation of Auto Sliding Door Steriliser

4.4    After completion of Sterilization cycle remove the exposed Biological indicator from autoclave.

4.5    Incubate the exposed Biological indicator as per manufacturer guidance. i.e incubation temperature and incubation period.  

4.6   Incubate one unexposed biological indicator as a “Positive control”.

4.7   Incubate media without biological indicator as a “Negative control”.

   Observe the tested Biological Indicator for appearance of microbial growth during incubation period.

4.8  If positive control shows growth & test shows no growth, then autoclave is suitable for sterilization. 

4.9  If it is not complying above criteria, then autoclave is not suitable for sterilization.  

4.10    Record the result 

4.11    Frequency: Once in 3 months ± 3 days

4.12    Maintain the stock details of Biological Indicators 

Autoclave, biological indicators, microbiology