Class II Implant Steam Sterilizer Validation




We make Class II implants that we will be sterilized by a new steam sterilizer. The new sterilizer was calibrated and validated by an external lab. Upon reviewing the validation, I'm wondering how others have handled such results:

I think it's standard to use 121?C for X minutes and during the validation to run 3 half-cycles and 3 full cycles with some 10^6 BIs. In the end all of the BIs were dead, so it was overall successful.

What happens when some of the readings from the sterilizer (printed out on the tape) show 120?C during exposure? Would this cause any concern (or auditors to question) that at some point the sterilization was operating at less than 121?C? How would one justify that the 120?C readings are acceptable because it was validated that way? Is it enough to state in our procedure or work instruction that 120? is part of the acceptable temperature range?

Similarly, do we need to explain why the external lab's temperature probes at various locations of the sterilizer read less than 121?C at some point during exposure, particularly at the "cold spots"?

Thank you in advance... this is my first time really dealing with a full validation of any sort.


Were the Bi's placed at the hot and cold spots during the chamber? Did you set a uniformity requirement for the mapping study; such as ?1?C?

Do you have a validated load setup, where the load probes will be placed consistently in the load?


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I've held off responding to this as it's not my area, but I can give some general pointers:

Question: are you a manufacturer or a healthcare provider (or their service provider)?

If you are a manufacturer you are in a position to specify your sterilisation parameters, you just have to validate the process is capable of assuring sterility, you can therefore account for temperature deviations and temperature uniformity in this.

If you are a healthcare provider you should follow the instructions provided by the manufaturer otherwise you cannot rely on their assurance of sterility. You should therefore validate your equipment for their reqiurements. I fully appreciate that there is a termperature rise period and non uniformity in the chamber, it may be possible to counter this by running at a higher temperature, but alternatively you could contact the manufacturer and ask for their advise
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