Autoclave validation

What is the procedure for autoclave validation ?

URS
DQ
FAT
SAT
IQ with calibration of critical components.
OQ
PQ which include:
pressure leak test, vacuum leak test, bowie dick test , vent filter sterilization test , 3 heat distribution test for empty chamber, 3 heat distribution test for each load(detect worst location), 3 heat penetration test with biological indicator challenge for each load.
Revalidation each year (one heat penetration cycle with BI for each load).

you should also validate the minimum load and maximum load in autoclave.

Validation of PSG should be done before autoclave validation.

Follow the Following Steps
Objective
Scope
Responsibilities
Equipment Description and Specification
Abbreviations
Equipment / Instrument Calibration
Validation Frequency
Validation Plan
Vacuum leak test
Bowie-Dick Test
Empty Chamber Heat Distribution HPHV Chemical & Biological Challenge Study
Loaded Heat Distribution with Chemical Indicators & Biological Indicators Challenge Study
Loaded Heat Penetration with Chemical Indicators & Biological Indicators Challenge Study
Estimation of F0 Value
Dryness study after sterilization process
Variance Sheet
List of Annexure
Summary
Conclusion

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