SOP For Steam Heat Sterilizer (Autoclave) Validation

SOP For validation of steam heat sterilizer i.e.(Autoclave) is described in this post which you can follow in the section of  microbiological lab. 

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This procedure has been established for validation of steam heat sterilizer i.e. (Autoclave) to verify that autoclave is continuously capable of sterilizing the items at specified temp/time/ pressure.


This procedure is applicable to all the sections equipped with autoclave.



production pharmacist.

Production Manager.


Quality Assurance Manager

Quality Control Manager. 


Autoclave validation shall be done by using biological indicator containing the spores of  Bacillus Stearothermophilus with ATCC 7953. 

Take two SS trays  and place biological indicator at different location as per location map and place these trays with biological indicator along with the items to be autoclaved in autoclave and run the autoclave cycle as per specifications i.e. (121oC/15psi/15minutes)

Incubation Period:

After the completion of autoclavation remove the biological indicator allow the to cool at room temperature and then move for  incubation at 60 ± 2°C for 48 hrs. 

Place 1 non sterilized ampoule of biological indicator at incubation as positive control. 

Interpretation of Results:

The process of sterilization shall only be considered effective, when no change in the color of solution the indicator during incubation period will be observed i.e. (Solution must remain clear and violet color remains the same).

Incase of ineffective sterilization violet color of the solution changes to yellow and solution may appear turbid.

Note and record the activity in respective logbooks.

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