Validation of Depyrogenation Cycle

If I already have my scheme (where and how I’m going to put my challenge tests in oven), how many times do I have to repeat a each scheme to say that my process is validated? three times? or review the data that I get and look at their variability? That is, test until the variability remains constant?

Thanks! I have trouble setting a validation time.

By scheme, do you mean load pattern? The common amount is 3 time repeats for a validated process. Of course you should have engineering data taken from cycle development that really should support your validated cycle times prior to even starting the validation. So don’t start validation until you already have times established from engineering studies.

“Validation is a walk down memory lane, not a journey of discovery”

Yes, load pattern :slight_smile:. I got this oven (Binder), I guess the manufacturer previously made qualifications (DQ, IQ, OP - i have a test confirmation, test temperature: 150 °C, and is certified in accordance to DIN EN ISO 9001). Also, my local distributor made a qualification to 100 °C. I know the oven was not qualified specifically for depyrogenation (is for sterilization) but reaches up to 300 ° C. I’m in a small laboratory (not for industry), I intend to use the LAL clot test at points where they are supposed to be colder (close to the door and near to the bottom) to know what temperature to use and for how long (I will try first with 250 °C for 30 min). Can this be done considering my situation? Any advice would be helpful :relaxed:.

You will have to redo your testing including IQ, OQ, and PQ, even if you are only doing R&D and clinical studies…

250 C for 30 minutes is the basis of calculations for depyrogenation. Typically these values are the values used in the depyrocation calculation of reduction (based on temperature only).

OQ will test the depyrogenation oven during empty conditions. The PQ will test the depyrogenation oven for your specific configurations.

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Many thanks :slight_smile: