EFHSS Questions and Answers - Question Q00477

Dear Sir,

I appreciate if you could explain me the following points with regards to qualifying the sterilizer good to use.
1) What is the criteria for approving the sterilizer good to use? Is it the Chemical Indicator/Bowie & Dick test/Biological test or the circular recorder mounted on the sterilizer. What happens if the circular chart recorder shows some slight deviations to the time/temperature/pressure due to human error while inserting the chart paper or recorder pens. Have we to depend on the cycle graph produced by the recorder( Circular recorder) or the chemical indicator/ bowie & dick test for accepting/qualifying the sterilizer to be working in good order.

Thanks and best regards,
Norberto

Hi Norberto,

To verify a sterilizer is fit for use, you need to perform testing on many more of the sterilizers functions. As a general rule, these tests need to be performed daily, weekly, quarterly and annually (although your guidlines may differ slightly). Your chart recorder should be calibrated and maintained at least 6 monthly.

A satisfactory Bowie and Dick test only confirms the air removal function and should not be used to approve a complete cycle. Only satisfactory time / temperature and a confirmation from the sterilizer can deem a satisfactory cycle.

For example, some of the other tests you may need to perform (or contract in) are leak rate test, thermometric testing (small load, max load) test for air detector, automatic control test and verification of the calibration of sterilizer instruments.

Human error can be eliminated to a degree by good training and good equipment. You could eliminate this completly by using a digital recorder.

If you need any more info, let me know.

Hope this helps.
Gary