Media fill

Is it necessary to incubate the intervented units during media fill. And shall I count this units in acceptance criteria i.e. result.
Our routine procedure is to hold the batch for 24 hrs. after filtration, so is it necessary to hold the media for 24hrs. during media fill

Hi satish
media fill is a process validation here all worst conditions are needs to simulate which can occur during the regular commercial production , hence interventions are very much required, it is part of media fill ,and the unit filled during intervention are required to incubate and considered in batch size ,
media fill should closely simulate the regular the regular manufacturing practice , if you are holding your batch for 24 hrs in regular process same should be simulated in media fill

Regards
tushar

Hi,
What you says about the holding time it is ok but what about the intervented units. In USFDA guideline of Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing it is clearly mentioned that the units filled during intervention shall be removed and if necessary it should not be count in acceptance criteria.
For your reference the link is here on page no. 29 of 63 it is mentioned.

http://www.fda.gov/Cder/guidance/5882fnl.pdf

[quote=tusharpatil]Hi satish
media fill is a process validation here all worst conditions are needs to simulate which can occur during the regular commercial production , hence interventions are very much required, it is part of media fill ,and the unit filled during intervention are required to incubate and considered in batch size ,
media fill should closely simulate the regular the regular manufacturing practice , if you are holding your batch for 24 hrs in regular process same should be simulated in media fill

Regards
tushar[/quote]

Dear Satish
Your interpretations of guide line are wrong, what justification you have for isolation of sample during interventions, all though the interventions are intentionally performed to simulate the process which are mentioned in protocol

,

Okey. but i have one query on that. Suppose for example LAF breakdown for 10 mins. is an intervention, during this time media filled vials qty. is 100, these vials are bound to fail because the LAF is switch off the Class 100 area under LAF is disturbed. So you want to say that these vials are also need to be incubated. Same case is with power failure and AHU breakdown.

[quote=tusharpatil]Dear Satish
Your interpretations of guide line are wrong, what justification you have for isolation of sample during interventions, all though the interventions are intentionally performed to simulate the process which are mentioned in protocol

,[/quote]

I would still incubate the units as a ‘for information only’ part of the study (before anyone says it - I know the FDA hate FIO!). If by some chance of luck the units actually are OK, then this can help with any future interventions that may happen in routine manufacture.