Integrity Testing of Flexible Container Using the Helium Integrity Testing (HIT) Platform (2-D and 3-D Bags and Manifolds)
Vishwas Pethe, Tony Paganelli, Sergey Terentiev, Alex Terentiev, and Richard Bhella
Introduction
Switching to single-use systems (bags and hardware) can have financial and performance benefits. However, one of the critical challenges for complete acceptance of single-use systems is assurance of bag integrity which in turn means assurance of product sterility and operator safety.
Single-use technologies (SUT) are used frequently in large scale 1,000L+ scale. Main risk with SUT is leaks as transport and handling can induce leaks.
Goal
To demonstrate 10 micron defect detection capability of the Helium Testing Platform – HIT™
Conclusion
- Classical pressure decay tests cannot provide sufficient sensitivity for integrity test of finished complex manifolds or 3D bags.
- Aerosol study shows that 10 micron detection is critical to ensure sterility of a package.
- Prior-to-use, Helium Integrity Testing platform (HIT) is capable of detecting defects of less than 10 micron size on complex manifolds, fully assembled 2D and 3D bags.
This post is sponsored by Pall Corporation.