Biopharma Filters

Integrity Test Devices

Integrity Test Devices

Description:

Integrity test devices validate the performance of membrane filters through bubble point, diffusion, or pressure hold testing. These devices ensure sterility assurance before and after filtration in GMP environments. They come in portable or automated formats, supporting 21 CFR Part 11 compliance and electronic documentation. Compatible with sterilizing-grade filters, they are used in vaccine production, sterile API filling, and critical bioburden control steps. Integrity testers are key to meeting EU GMP Annex 1 and PDA TR guidelines, offering both manual and automated test modes for validation protocols.