Is it required to qualify my incubator for mammalian cell cultivation at all my required set points( example 33 degrees, 35 degrees and 37 degrees) ? if my temperature mapping data assures that at a particular set point, say 35 degrees, the incubator temperature remains plus or minus 1 degrees range from setpoint, can i use this data to get assurance that at any given setpoint, temperature would remain plus or minus 1 degrees? Or do i need to validate all the required temperature setpoints?
If you don’t map this incubator at the three temperature settings, how would you defend this to an auditor? Common sense isn’t evidence enough. How is your incubator calibrated over this temperature range?
I would map at all three set-points both empty and full-chamber. I’d suggest a minimum of a 12-hour hold period for each. Then we’d re-map this full-chamber annually - maybe just at the lowest and highest temperature settings?
Thanks for your insight. Till now we have only a single process requirement at 37 degrees. So it was not a problem. but moving forward, we would have to have multiple setpoints at different points of time. Currently we do calibration, PM and temperature mapping for revalidation every six months with empty chamber as well as with load (NLT 12 hours). we never had a deviation in this regard. so was wondering which is the regulation (as per CFR?) which talks about temperature validation for process equipment?
Also, have a look at chapter 4 of the following WHO document: “Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products”. There’s a PDF called “TRS961_Annex9.pdf” that will come out at the top of a quick search.
From what you’ve put, it sounds like you are doing everything just fine.