What are the forums thoughts on validation required for a CO2 Incubator?
I would obviously include thermal map, door opening, power off, humidity mapping and I would test the CO2 set point.
Does anybody know if there any requirements testing CO2 % in different locations within the chamber?
USFDA
#2
Here in US, CO2 % recording during the thermal mapping period is carried out at the geometric center of the incubator using a CO2 probe.
For another client, I have done recording of the CO2 % at each shelf’s center at 15 minutes intervals for one hour.
US FDA