235 Posts
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)
* 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
Item | Phase I | Phase II |
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
Replies