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.