Based on product integrity testing - Focus on high-precision filtration

Wetting media for post-service integrity testing of filters should be specified.
If the wetting medium used is liquid medicine, the verification of product-related integrity standards should be carried out to support the determination of the standards.
A scale-down study at laboratory scale is the first part of the product integrity test. The second part is to periodically monitor the product bubble point or the trend of the product diffusion flow under actual process conditions as part of the validation.

Integrity Test