i need a guide line for the moisture sterilizer heat distribution study to know how many temperature sensor should i use inside the autoclave
minimum 16 probes is placed inside the chamber for heat distribution study of autoclave, but it can very according to the size of chamber, for further detail let see PDA Technical Monograph #1.
Look for Technical Report No. 1 2007 Validation of Mosit Heat Sterilization Processes. at the PDA Journal.
Ask it in private if you need some idea about the content.
I couldn´t find where says that 16 are needed, we are using 12 probes to make the qualification, but in case that some failed with 10 the test could be approved anyway.
Regards
Having said that… It will depend on the size of your Autoclave. For laboratory sterilizers, this is a good rule of thumb, but for industrial size autoclaves, you should base the number of loggers on a Risks Assessment. Also a note to remember that if it’s liquids in the Sterilizer (Product), penetration studies (Inside the product container) are required as opposed to distribution studies (outside the product container).
On larger Autoclaves, an Empty mapping study will give the base information needed for the risk assessment to establish the cooler/ hotter spots in the Autoclave (Obviously if a cold spot is found, it fails the validation) and an indication of where loggers must be placed… the mapping will once again be conducted with a full load and based on that information, a reduced logger plan is achievable with backing evidence. The full study should however be re-conducted annually as a minimum.
Hope this helps…
Good luck!
Hello ,
Moisture Heat Sterilizer Revalidation Cycle Parameter
Each Load Pattern 3 Trail Is OK or each Load Pattern 1 Trail Is OK
Nice post guys