Incubation area for Media Fill

Validation
1

Hello
Where should I incubate the vials resulting from the media fill test?

2

Depending upon the batch size you can use either incubator or stability chamber or rooms-Retention-control rooms

(Provided the area/equipment should be qualified)
-Also keep records of environmental condition for whole incubation period


Thanks

3

After media fill simulation study we have Incubation
On two standard condition.
1st for 20-25°c TYMC & sterlity check
2nd 30-35°c. For TAMC& sterlity check.
Depending upon batch size.
Walk in chamber can be used for Incubation.
Or a well controlled Room dedicated / process validated can be used if batch size is above 1000 vials

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