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Integrity Testing (14)
Built-in Integrity Control Strategy All Along the SUS Life CycleWith the growing implementation of single-use bags into commercial production and critical process steps, SUS Integrity (SUSI) has become a critical quality attribute for both end-users, regulatory authorities, and suppliers of SUS, as an integrity failure can significantly impact drug safety, availability, and costs. The ASTM E3244-20 standard practice on SUSI assurance recommends Quality Risk Management (QRM) and life-cycle approach. This is in-line with the EU GMP Annex 1 for manufacturing sterile medicinal products, proposing a risk assessment for QRM and Contamination Control Strategy (CCS). Thus, depending on customer application and criticality of a SUSI breach, specific integrity and leak tests may be needed.
Product Family
Sartocheck® 5 | 5 Plus Accessories
Barcode scanner for flawless data entry and test selection for the Sartocheck® 5/ 5 Plus.
5 m test tube for the Sartocheck® 5 / 5 Plus filter tester.
Pressure Safety Device for Maxicaps® MR