Incubator

GOOD LABORATORY PRACTICE (cGLP)
1

Dear all, About incubator qualification, anyone have information and recommended article or journal about it?
Because, in my opinion, incubator validation is lokk like oven validation, ex. heat distribution (load and unload), heat pentration. Any other test that I have missed?

Your reply is realy helpfull.

Thanks,
Felisiana

2

[quote=felisia]Dear all, About incubator qualification, anyone have information and recommended article or journal about it?
Because, in my opinion, incubator validation is lokk like oven validation, ex. heat distribution (load and unload), heat pentration. Any other test that I have missed?

Your reply is realy helpfull.

Thanks,
Felisiana[/quote]

Dear Felisiana,

Yes you are right, all the tests are alike to HAS but the duration of challenge must be rationale and also check the alarms generation extensively. And also check the continious data loging paramter.
thanks

Thanks

3

If you are using a humidity incubator you would want to perform a humidity study as well.

4

Is Penetration Study is required for incubator ? as our requirement is to provide desired temp. environment only.

Regards
Himanshu

5

Thanks for you all.
What about heat penetration? Is it still used or not for this qualification?
I’ve found article that required test for time which is needed to reconciliate condition after power outage and after the door is open. Should I do this?
Once more, how long should I do for each test? In my plan, I’ll watch out the condition for 24 hours. Is it enough?

Thanks.

Felisiana;)

6

[quote=felisia]Thanks for you all.
What about heat penetration? Is it still used or not for this qualification?
I’ve found article that required test for time which is needed to reconciliate condition after power outage and after the door is open. Should I do this?
Once more, how long should I do for each test? In my plan, I’ll watch out the condition for 24 hours. Is it enough?

Thanks.

Felisiana;)[/quote]

Yes, you will also have to evaluate the effect of opening door and power failure in PQ. Door opening frequency and time can be rationalized by actual practice. You can select the minimum and maximum door opening time based on your actual prctice like how many minutes you take to load and unload the samples in chamber or to take out individual sample. As far as the power intruption is concerned I suggest to attach UPS for such type of equipments.

7

Yes right,
The door open study and power outage study is required.
You have to simulate these studies to have rational in SOP’s.
In SOP you can allow the incubator to be open for the particular time and justify the rational.
For power outage study, even the UPS get faulty, you can justify the time require for instrument to get out of range limits. This helps to underatnad the conditions in the incubator after power failure.

8

Is Penetration Study is required for incubator ? as our requirement is to provide desired temp. environment only. pls guide me about that and if yes then HOW ?

Regards
Himanshu

9

I think that penetration study is not required for incubators if your any incubation material is not sensitive to temperature fluctuation. Penetration study need for short time processes, when temperature is most critical parameter, just like steam sterilization of porous materials.

10

Max load or min load open door/power failure…thermal mass effects the duration before going out of range.