Validation Requirements for Sterile Filtration
I would appreciate getting folks thoughts on the below table. Trying to ensure alignment to EMA/CHMP/CVMP/QWP/850374/2015 - Guideline on the sterilization of the medicinal product, active substance, excipient and primary container (effective 01 October 2019)
Item Phase I Phase
Phase III Commercial
Bacteria retention in water or saline lactose broth (SLB) with integrity test correlation in water or solvent x x - -
Bacteria retention in product - - x x
Chemical compatibility, effects on the filter integrity x* x* x x
Extractables & Leachables (model solvent – laboratory conditions) x x - -
Extractable & Leachables (product specific fluids) - - x** x**
Sterilization method, effects on filter integrity x*** x*** x x
Integrity test (water or solvent) x x - -
Integrity test method selection (product) - - x x
Toxicity test*** x x x x
Fit for use x*** x*** x x

* Data can be taken from the compatibility tables generated by manufacturers of elastomers or polymers used in o-rings, gaskets, seals, etc.
** Vendor model solvent data can be used, if there is no risk
*** Information and data provided by filter manufacturer