We comprehend and value the critical importance of establishing drug product wetted integrity test specifications to ensure filter efficiency. The drug product / process fluid, due to different components, may have different surface tension than the filter manufacturer specified wetting fluid, impacting the drug – filter interface and consequently the integrity test values exhibited by the filter.

Our validation services for establishing product specific filter integrity test specifications help correlate product wetted integrity test values with those exhibited with the reference fluid (filter manufacturer specified) which in turn are already correlated to bacterial retention as per ASTM -838-05.

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.