This procedure has been established for validation of steam heat sterilizer i.e. (Autoclave) to verify that the autoclave is continuously capable of sterilizing the items at specified temp/time/ pressure.
Scope:
This procedure is applicable to all the sections equipped with an autoclave.
2.0 Responsibility:
Microbiologist.
production pharmacist.
Production Manager.
Accountability:
Quality Assurance Manager
Quality Control Manager.
Microbiologist.
production pharmacist.
Production Manager.
Accountability:
Quality Assurance Manager
Quality Control Manager.
3.0 Materials:
Biological indicator containing spores of Bacillus stearothermophilus with ATCC 7953
Two SS trays
Items to be autoclaved
4.0 Procedure:
Autoclave Validation
1. Place biological indicators at different locations in two SS trays as per the location map.
2. Place the trays with biological indicators along with the items to be autoclaved in an autoclave.
3. Run the autoclave cycle as per specifications:
o Temperature: 121°C
o Pressure: 15 psi
o Time: 15 minutes
Incubation Period:
4. After the completion of autoclavation, remove the biological indicators and allow them to cool at room temperature.
5. Place the biological indicators in an incubator at 60 ± 2°C for 48 hours.
6. Place one non-sterilized ampoule of the biological indicator in the incubator as a positive control.
Interpretation of Results:
The process of sterilization shall only be considered effective when no change in the color of the solution or the indicator during the incubation period is observed. (The solution must remain clear and the violet color remains the same.)
In case of ineffective sterilization, the violet color of the solution changes to yellow and the solution may appear turbid.
Documentation:
· Note and record the activity in respective logbooks.
Autoclave Validation
1. Place biological indicators at different locations in two SS trays as per the location map.
2. Place the trays with biological indicators along with the items to be autoclaved in an autoclave.
3. Run the autoclave cycle as per specifications:
o Temperature: 121°C
o Pressure: 15 psi
o Time: 15 minutes
Incubation Period:
4. After the completion of autoclavation, remove the biological indicators and allow them to cool at room temperature.
5. Place the biological indicators in an incubator at 60 ± 2°C for 48 hours.
6. Place one non-sterilized ampoule of the biological indicator in the incubator as a positive control.
Interpretation of Results:
The process of sterilization shall only be considered effective when no change in the color of the solution or the indicator during the incubation period is observed. (The solution must remain clear and the violet color remains the same.)
In case of ineffective sterilization, the violet color of the solution changes to yellow and the solution may appear turbid.
Documentation:
· Note and record the activity in respective logbooks.
END OF THE DOCUMENT
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