Vishwas Pethe, Tony Paganelli, Sergey Terentiev, Alex Terentiev, and Richard Bhella
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.
To demonstrate 10 micron defect detection capability of the Helium Testing Platform – HIT™
- 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.