Autoclave validation

Microbiology
1

What is the procedure for autoclave validation ?

2

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).

3

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

4

Validation of PSG should be done before autoclave validation.

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5

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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6

Dear sir,
Would you please mention some standard guidance for Autoclave Validation ?

Thanks

7

You can use guidance from these references:

  • USP <1229>
  • ISO 17665
  • EN 285
  • PDA TR#01
8

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