Sartorius Stedim Biotech FlexAct BT System
As single-use bags are increasingly making inroads in commercial cGMP production, the industry requires higher assurance of single-use container closure integrity (SU-CCI) and more reliable leak test methods at the point of use.
Sartorius Stedim Biotech’s FlexAct BT system enables end-users to implement the ASTM F2095-01 pressure decay test for Flexboy 2D bags at the point of use. The testing solution is designed to detect leaks that could potentially occur during the transportation and handling of these bags.
The system features the Sartocheck 4 Plus Bag tester and a set of two plate holders that perform 100% pressure decay testing. Besides protecting the bag from mechanical stress, the holders enable the test to be performed with a very small inflation volume at high pressure, ensuring a highly reproducible, accurate and sensitive leak test. Furthermore, porous spacers avoid the masking effect of a potential leak when the bag is pressed against the plates.
The leak test system is validated to detect 30 μm leaks across the entire range of Flexboy 2D bag volumes — from 50 mL to 50 L — in less than 10 minutes.