Hi,
Is it necessary to integrity test each sterile filter prior to manufacturing as part of your validation batch?
Will this need to be perfromed as part of commercial batches also or can one filter be tested from each batch of filters supplied?
Thank you:confused:
Dear Austin,
It is required to check the filter integrity of all the filters used for sterilisation of media.
It actually helps you while tracing batch failure.
I don’t think its necessary to test each filter PRIOR to use, I guess thats up to the individual company on whether they want to take the risk of using a filter that may be defective. You must always test each filter after use.