For the first time ever we have made single-use container integrity robust and compliant.
We can achieve this by correlating the detection limits of our integrity testing with liquid leaks and microbial ingress.
Combined with QbD, process and quality control, product robustness and ease of use, our integrity testing strategy ensures that no liquid leak and no microbial ingress will occur in our customer’s processes.
We are continuously improving our product robustness by applying Quality by Design principles, stringent product validation and extensive process and quality controls.
We have established our extrusion design space and critical process control based on testing 3,000 film samples which ensure consistent lot-to-lot bag robustness.
Bag chambers are visually inspected for the absence of defects and particles and 100% leak tested in the production facility using a pressure decay test.
Our extensive validation of packaging integrity and product shipment, performed according to the most stringent ASTM D4169 standard, provides end-to-end control of single-use system integrity from our production facility to point-of-use.
The self-inflating nature, strength and flexibility of our single-use solutions make them easy to handle, robust and reduces the risk of manual errors.
Flexsafe meets your requirements for outstanding robustness and ease of use at all steps of your manufacturing process. The film's strength and flexibility provide consistent performance and easy handling – even in the most stringent applications like cell culture, long-term storage or shipping of drug products.
Experience enhanced ease of use with fast set up for your large volume liquid storage applications. The robustness of Flexsafe® bags allows self deployment during filling, saving precious operator time.
Our Flexsafe® 3D shipping system is successfully qualified under a selection of ASTM D4169 tests. The test sequences have been chosen after real transportation trips and ASTM D4169 laboratory trials.
The comparison of real shipping values with ASTM D4169 shows a substantial safety margin, thus providing extensive qualification and giving reassurance of security during fluid shipment.
We fully understand that regulatory bodies require specific information such as the correlation between microbial ingress and physical integrity testing methods.
We developed in-house liquid leak and microbial aerosol testing methods to determine and validate the maximum allowable leakage limit (MALL) under which no liquid leak or bacterial ingress can occur.
Our scientific studies, using multiple liquid surface tensions, pressure conditions and leak sizes, established a close relationship between liquid leakage and microbial penetration. Our innovative microbial aerosol test, validated with more than 400 test samples, uses an extremely high microbial concentration of 10^6 CFU/cm², and concludes that 2 μm is the MALL for our bags under any process conditions.
Based on the correlation, we have implemented a helium supplier integrity test with a highly-sensitive detection limit of 2μm. This is the smallest defect size detectable on the market by nondestructive integrity test in a single-use system. Our Supplier Integrity Test (SIT) confirms the integrity of the complete single-use assemblies after our production.
Customers can use our pressure decay integrity test to confirm the absence of defects at the point-of-use. The detection limit of this test can also be correlated to liquid leaks and microbial ingress.
The Strength and Flexibility of Flexsafe®, Flexboy® & Celsius Bags Ensure their Robustness in all Applications: