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- Title
Single‐Use Systems in Aseptic Processing: Sterility Risk Mitigation Using a Point of Use Integrity Test.
- Authors
Batt, Nicholas; Biel, Simone; Raye, Charles; Rutigliani, Nicola
- Abstract
In this case study, a biotech drug product manufacturing site located in Bari/Italy was looking to develop a single‐use system integrity test at the point of use. The aim was to support the implementation of single‐use technology for filling of an innovative immune‐oncologic drug using a state‐of the‐art manufacturing isolator line. This publication describes the method development and validation of a process‐specific single‐use system integrity test considering both the technical challenges of testing the integrity of a single‐use system as well as the integrity assurance requirements in a good manufacturing practice environment.
- Subjects
BARI (Italy); ITALY; ASEPTIC packaging; CURRENT good manufacturing practices; DRUG factories; TECHNOLOGICAL innovations; TEST systems; REMANUFACTURING
- Publication
Chemie Ingenieur Technik (CIT), 2022, Vol 94, Issue 12, p1985
- ISSN
0009-286X
- Publication type
Article
- DOI
10.1002/cite.202200194