FDA Guidelines require integrity testing of sterilizing filters used in the processing of sterile solutions such as large volume parenterals (LVPs) and small volume parenterals (SVPs).
There are two classifications of integrity testing: destructive and non-destructive. We not only perform destructive testing as a lot release criteria on samples from each manufacturing lot of fabricated sterilizing-grade filters, but also conduct non-destructive testing on sterilizing-grade filters prior to sale to ensure integrity.
Integritest® 4 System - Easy-to-use, portable, networkable, and fully-automated integrity test systems that offer reliable, repeatable measurements fast.