Bioequivalence and Bioavailability Forum

Dear Suchit,

❝ Segregation we are doing on dry ice. So is it necessary to maintain temperature during segregation ?

As you are doing segregation in dry ice so it is always advisable to monitor temperature (not required to be maintain ) and please confirm that the temperaure at which you are doing segration should be well covered for specific period during method validation e.g. long term/short term stability at specific temperature).

Apart from that you also have to check if any thawing of samples was happenening. In such case again you have to confirm the all freeze thaw cycles till completion of bioanalysis as per method validation e.g number of freeze thaw cycle validated.

❝ is it necessary to maintain temepreture data for that ?

If you are monitoring the temperature it is better to maintain temepreture data for that provided this data should be reviewed throughly and justified properly as per validated method if required.
Care should be taken if any deviation happened then same shold be justified by repeating respective validation parameter agin.

Hope it will satisfy your concern.

Regards,
Swapnil Kuche

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Edit: Standard quotes restored. [Helmut]