Best Assurance of Container Closure Integrity

With the increasing advances of single-use bags into commercial production and critical process steps, the industry requires a higher assurance of single-use container closure integrity and more reliable integrity test methods. As part of the continuous improvement of our process capabilities and to mitigate the risks Sartorius Stedim Biotech is implementing the most sensitive test methods at both the supplier and the end-user for a better assurance of integrity.

The assurance of container closure integrity of Flexboy® 2D bag is the result of QbD, process validation, process controls and integrity testing along its entire life cycle. For critical process steps, a 100% point-of-use leak test avoids the risk of losing high value product and enhances patient and operator safety by ensuring that no damage occurred during shipping, storage and handling of Flexboy® bags at the user site.

Leak Test Your Flexboy® Bag in a Safe, Fast, Easy and Reliable Way

Benefit From our 20-year Leak Test Experience at Your Point of Use

We have been testing all our 2D bags in our production for the last 2 decades using the pressure decay test derived from ASTM F2095-01 Standard Leak Test for Non Porous Flexible Packages. With FlexAct® BT you can benefit from our know how and implement the ASTM pressure decay test for 2D bags at your point of use. The pressure decay leak test method meets all the requirements for a 100% leak test at point of use: it is safe, fast and easy to implement, easy to validate, reliable, non destructive and it maintains the sterility of the system during testing.

FlexAct® BT


Technical Note for FlexAct® BT – Point-of-Use Leak

PDF | 2.6 MB

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