Point-of-use leak test system FlexAct® BT enhances integrity of single-use bags

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 new 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 in a safe, fast, easy and reliable way. Besides protecting the bag from mechanical stress, the holders also 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. A MultiUnit test option can be used to test two single-use bags in parallel as well as to integrity-test filters.

Provided with a robust validation package and on-site validation support, FlexAct® BT is the safest, fastest, easiest and most reliable solution for point-of-use leak testing of single-use bags. As part of Sartorius Stedim Biotech’s innovative FlexAct family of flexible, ready-to-connect and configurable solutions, it improves the quality assurance of bag integrity, which is of paramount importance in critical process steps of cGMP commercial production of active pharmaceutical ingredients and medical drug products.