Question

When validating an Autoclave, what are the steps in the qualification study?

Answer 1

Each autoclave should be validated every 40 operating hours.Each time the autoclave is validated, the date of validation, pass/fail and other relevant information should be noted on the Autoclave Validation Log.

When the cumulative time reaches 38-40 hours, a validation test must be performed.  

The steps in the qualification study are

1. Be sure to wear gloves, a lab coat, and any other necessary personal protective equipment (PPE) when working with biological agents and waste.
2. Reference supplier instruction for the Getinge Biosign Steam-24 Biological Indicator.
3. Make sure the Getinge Biosign Steam-24 indicators being used are not expired, and record the lot # and expiration date on the Autoclave Validation Log.
4. Place Getinge Biosign Steam-24 indicator in the center of the load being sterilized/under the bag being autoclaved.

Use another sample of the Getinge Biosign Steam-24 indicator not autoclaved as a control.

1. Process load as per standard operating procedure.
   1. When autoclave cycle is complete, remove and incubate the indicator spores and the positive control as per supplier’s instructions. The Biosign Steam-24 Indicator should be incubated at 55 °C ±3 °C for 24 hours.
   2. After the 24 hour incubation period, look for a color change in the indicator media.
      1. A color change from Red to Yellow indicates positive growth (failure).
      2. No color change indicates no growth (passing).
2. Check the positive control (sample not autoclaved) for color change to ensure the validity of results.
   1. If the test cannot be considered valid, the validation should be performed again with new indicators.
   2. If the test is determined valid, record the results and test parameters on the Autoclave Operation Log and Autoclave Validation Log.
   3. If the test fails, record the results and test parameters on the Autoclave Operation Log and Autoclave Validation Log and notify the area PI immediately.
   4. Label autoclave “Out of Service” until a passing validation test is achieved.
3. Dispose of the used indicators and contaminated PPE as biological waste.