Autoclave Revalidation and tests

Validation
1

Dear All,
What are the revalidation test conducted for sterilizers (laboratory Autoclave)?
And how many times different loads (garments, SS, Fluid, disinfectant) should be repeated during revalidation?

Thanks

2

the re-validation tests conducted to the re-validation of autoclave are:pressure leak test,vacuum leak test,Bowei Dick test,vent filter sterilization test and finally one heat penetration study for each concerned load with Biological indicator challenge

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3

Thank you Mr. Ahmed,
Just for reference, could you please provide the guideline reference of these test to be conducted,

as what i got to know from HTM 2010 for laboratory test Bowie dick test, vent filter is not covered in revalidation test schedule.

Also if you can put some light on Steam quality test to be done or no!!??

Thanks

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4

Steam quality test
Non condensable Gases test
Dryness fraction test
Vent filter integrity & sip
Bioburden enumeration test

Vaccum leak test
Bowie dick test

One heat distribution study ( each recipe) with Chemical challenge test
Heat penetration study. (Each recipe) chemical challenge test and Bio burden challenge test

Reference: HTM 2016
EN 285
ISO 11138
ISO 11140
USP 1229

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5

Thank you Mr. Rakesh.

6

PDA TR-01
PDA TR-48
EN285 2016

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