Hi sorry to bother you guys, however, I am trying to find out the authority for the series of tests required for Validation of an Incubator.
So far I have a 12 / 8 hour thermal map of an empty chamber / (max/min) load, Power failure, Door open and a recovery study on intervention.
I can find many examples of IOQ / PQ of these test but no authority; ( WHO, EN, EU, e.c.t)
Help please
I am affraid that 12/8 hours are not enough… 24h is optimal period because that period cover daily and nightly conditions… For reference you can use DKD R 5-7 - Calibration of Climatic Chambers, DIN 12880 and you can use Binder factory standards…
I’ve always done 24 hour studies for both empty and full. The power loss, open door, and recovery studies do not need to be 24 hours though - just enough time to show how long it takes to go out of range, and then return to range, which is different for each incubator.
Thanks Jared, happy with that, I was looking for where these, tests are stipulated
@joksavs thanks for the pointers, however, after reading those, I am still no further forward, as it is not stated what must be done during validation either PQ or Re-qualification.
Currently I am doing a 24hr empty chamber for OQ to Identify hot and cold spots, the PQ is also a 24hr, this time with a representative load door open with TC in load (Petri dishs with agar gel), when first load TC drops below temp, record and report that duration, Power failure again with TC in load (Petri dishs with agar gel) when first load TC drops out record and report.
Any Re-Qualifications consist of the PQ tests but rather than a 24hr only an 8hr.
Now then, I have seen an in-use protocol for Re-Qualification which has a 24hr thermal mapping test, and then only a door open test.
I understand that incubators in question are in an environmentally controlled area, rather than a laboratory with AC and movement from staff, which all adds up to external variations in temperature.
Or is it just a case of following the Orange guide and doing a risk assessment / Impact assessment to identify the validation required?
This appears to be the best there is:
There is no guide which will exactly tell you what to do in PQ. Mapping of full chamber is pretty ok. We do it for 24h and somebody do 8h…somebody asked from us to have penetrated TC in load to see what is time that load need to reach set temperature (as for media fill 22.5 and 32.5) or to mapping real usage of chamber during the day…but you way is ok for me and we do the same…
The list I gave was for initial qualification. Also, don’t get too hung up on what is in an OQ versus what is in a PQ. Nobody will correct you either way, just as long as those tests are complete. But I guess officially, the OQ might be the empty chamber and the rest of the studies, while the PQ might be with the full chamber. My personal guide/interpretation is that PQ shows interaction between the equipment, and materials you use with it (full), while the OQ just shows how the equipment works (empty).
But additionally, for re-qualification, you can go about it differently I think based on how well you’ve assessed risk and set up continual monitoring. Do you continually monitor the chamber/incubator? Are there 2 probes or 1 probe? How was that probe location selected? If you’ve got the probes in the high and cool location, and you continually monitor the probes via an electronic monitoring/alarming systems, then your revalidation might be to confirm that those hot/cold spots are still hot/cold, or maybe even just review the data and comment on the ongoing operation of the system, and discuss temperature trend changes, and also discuss maintenance and any change events (make sure you defend this with numbers and science and risk assessment. Otherwise you could redo either empty or full studies.
Alternatively, for re-qualificaiton - if you don’t have continual monitoring you should at least do full chamber, and then discuss doing empty chamber as well. But this should be based on review of initial qualificaiton. Often the full chamber is obviously the “worst case” and then should be the re-qualification condition.
One additional piece of information. Regarding temperature controlled chambers, incubators whose temperatures are off a smidgen don’t have as much impact as other chambers (think stability chambers). I know that the requirments might be 22.5 +/- 2.5 C, but in reality if an incubator is off by 0.5 degrees, your bugs will still grow almost just as well. If you had a stability chamber, the 0.5 degrees has a much larger impact, both because of the precision required of stability, and because of the time product is in a stability chamber (months for a stability chamber vs days for in incubator).
One additional piece of information. Regarding temperature controlled chambers, incubators whose temperatures are off a smidgen don’t have as much impact as other chambers (think stability chambers). I know that the requirments might be 22.5 +/- 2.5 C, but in reality if an incubator is off by 0.5 degrees, your bugs will still grow almost just as well. If you had a stability chamber, the 0.5 degrees has a much larger impact, both because of the precision required of stability, and because of the time product is in a stability chamber (months for a stability chamber vs days for in incubator).
This depends on manufacturer of the chamber correct?
I’m not sure I understand mnavarro. I was discussion this from a risked based approach of what you are keeping in the chambers. Bugs are less sensitive to small temperature changes, as they will still grow just fine if the temp is off by a little. While in my experience stability chambers are long term storage, and thus can impact the results more. It’s not a question of the chamber, but of what is stored in the chamber, and for how long - this is a risked based approach to validation of a temperature controlled chamber.
Thank you all for your most helpful input.
I am affraid that 12/8 hours are not enough… 24h is optimal period because that period cover daily and nightly conditions… For reference you can use DKD R 5-7 - Calibration of Climatic Chambers, DIN 12880 and you can use Binder factory standards.
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