Filtration Flashcards
You have two 0.2mm filters in sequence for a contract fill. The upstream one fails its post-use FIT. Can you fill or not?
find out if one of the filters was specified in the license as the sterilising filter, ask about the product, is it a real fail was a real fail (i.e. damage to the housing, testing equipment in spec etc. etc.). Could go ahead and fill at risk but want to look at the upstream TVAC in detail and if that was at a level that could challenge the second filter then I may not release. Carry out defined protocol to check valid test e.g. correct wetting agent, valves / fixings connected correctly etc. If a true fail and no issue with the set up the batch is probably in the bin.
How do you do Filter Integrity Testing, what are the potential causes of a filter integrity test failure?
- Visually inspect filter for damage
- We use a Flowstar for testing
- Essentially one end is connected to air pipe the other a beaker of purified water and you measure flow rate of purified water through the filter.
Possible causes of FIT include :- - Debris on filter
- Holes in Filter
- Broken seals / non integral filter housing
