Integrity Redefined: Consistent Robustness and Integrity Testing Lead to Enhanced Process Integrity and Patient Safety

With the increasing adoption of single-use systems (SUS) in critical stages of biopharmaceutical manufacturing, any lack of system integrity can significantly affect drug product quality and patient safety, as well as incur additional costs due to product loss and disrupted production cycle. This article from Sartorius Stedim Biotech, describes how determining the correlation between liquid leakage and microbial ingress can be used to define MALLs (Maximum Allowable Leakage Limits) of SUS for different process steps. The article also details the development of methods and specifications for implementing reliable physical tests to control the integrity of SUS both at a supplier’s site and point of use.

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Corresponding author Marc Hogreve is senior scientist of Integrity Testing (marc. [email protected]); 49-551- 308-3752, at Sartorius Stedim Biotech GmbH in Göttingen, Germany. Carole Langlois is marketing manager, Traditional Vaccines; Katell Mignot is a subject matter expert, Single Use Technologies; and Jean-Marc Cappia is head of Segment Marketing Vaccines, at Sartorius Stedim Biotech in Aubagne, France.

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