Hi Folks,
Just putting the feelers out there to see whats done in other places around filter integrity testing of filters during a temperature mapped SIP cycle.
Is there a need to check the filters integrity pre and post studies ?
Would you be able to stand over over thermal data /BI results even with a non- integeral filter ?
thanks
[quote=griffinneil]Hi Folks,
Just putting the feelers out there to see whats done in other places around filter integrity testing of filters during a temperature mapped SIP cycle.
Is there a need to check the filters integrity pre and post studies ?
Would you be able to stand over over thermal data /BI results even with a non- integeral filter ?
thanks[/quote]
It will depend on the location and use of the filter in question. If you can explain why the filter broke and if there is minimum risk involved, you may be able to get away with it. Most of the times, you don’t want to explain filter integrity failure to the regulatory agency, as it may end up opening another can of worms. You caqn get away with pre-integrity testing with CofA of the filter, but not doing a post integrity is not recommended.