Hi, I am currently validating two brand new units (one set at 22.5°C for a range of 20-25°C and one set at 32.5°C for a range of 30-35°C). For the performance qualification , we are monitoring temperature with Distribution Thermocouples only. There are no studies with the penetration of the load. The incubator will be filled up with environmental plate samples or media broth from sterility samples during normal use. The maximum load was a mixture of the two (2) types of samples that will be used in the incubator. Would this be sufficient data for a validated use of the incubator for one sample or the other? For clarification, can I only do one maximum load with a mixture or should I perform two (2) separate load configurations even though the same mass will be filled for both?
FYI- I have performed Empty Chamber Temperature Uniformity, Open Door and Power Failure tests all with the incubators empty.
I have limited experience, if my questions appear to be quite basic. I appreciate the advice. Thank you.
If the two types of samples will result in equivalent mass / density of the incubator load, one could use the combination of the two samples to validate. Provide scientific rationale for your approach - e.g. mass, density, load configuration - demonstrating that the challenge load represents routine loads and use of the incubator.
One can always take the conservative route and validate both sample types (with no rationale for why that is necessary). However, that does not demonstrate that one understands ones process - which in my opinion is a compliance deficiency.
You should perform temperature mapping at both set temperatures but one worst case load is good solution. I should perform min and max load tempearture mapping. As law5rules said you should provide scinentific rationale for your worst case load. Maybe samples with bigger mass is your worst case load, not mixed? Put photos of the load (every audit likes to see photos to have picture of incubator load). Be aware to leave enough space for air circulation between load and not to touch chamber walls. You should understand your process and equipment and it is always better way than perform million tests.
And there is no basic questions in validation
in this case i guess thr is no need for performace qualification…oq is enough with chamber calibration. bcoz unlike autoclave thr is no need to check the heat penetration inside load. for incubation the required ambient temp need to be reached…we have to make sure that the ambient temp is evenly distributed within d chamber and precisely displayed on the transmeter
You will be fine with the tests you have chosen. What do your Site documents say, Master Plans etc? You would only need penetration study if the load is for process e.g. shake flask to grow cells. Since it is a lab incubator with multiple “configurations” I would just load up the chamber with the largest possible mass. I would use the lasrgest sample bottle loading the chamebr to challenge air flow as much as possible to create a worst case scenario. Cheers. V
In addition to temperature distribution test, I advice to perform the “open door” and “power failure” tests.
These indicative tests will help you to understand what will happend in case of these unexpected circumstances.
