February 22, 2018
A loss of integrity of a single-use system (SUS) during commercial manufacturing can lead to drug contamination or operator safety concerns. Therefore, assurance of integrity of SUS has become a hot topic in our industry and the need for very sensitive integrity tests at SUS suppliers has arisen.
The Pall Helium Integrity Test (HIT™) system for Allegro™ 2D SUS is a cutting-edge supplier integrity test for SUS implemented in critical processing steps of drug substance or drug product, to enhance patient safety. This test can detect down to 2 µm defects in SUS.
Pall Helium Integrity Test (HIT™) system used with Allegro™ 2D single-use systems (SUS) is a cutting-edge supplier integrity test for SUS implemented in critical processing steps of drug substance or drug product, to enhance patient safety. This test can detect down to 2 µm defects.