Biopharma companies are embracing pre-use post-sterilization integrity testing in line with stricter GMP requirements.
Correction: This article was edited on 15 September 2022 to correct Jorg Zimmermann's title. Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to ...
The Integritest 4 Was Assessed Using Oversize Volumes to Determine Accuracy of Results Sterilizing-grade filters are designed to reproducibly remove microorganisms from the process stream producing a ...