Product Specific Filter Integrity Test
Product wetted integrity test specifications are critical for:
- Post filtration filter integrity testing
- PUPSIT (Pre-Use Post-Sterilization Integrity Testing) where wetting fluid (water) cannot be used due to incompatibility with reference
To achieve this:
- Product wetted integrity test values are compared with reference fluid wetted values for 3 different filter lots.
- An integrity test ratio, so established with the help of appropriate analytical tools, is used to determine the product wetted integrity test specifications.
- Special consideration is given to process conditions like temperature and pressure that may have an impact on the integrity of the filter.