Using Validated Technology to Increase Assurance of Integrity and Sterility of Single-use Assemblies Immediately Before Use

Single-use bioprocessing technologies raise persistent concerns about integrity. Sterility of the bag must be maintained in order to avoid contamination resulting in the discarding of the batch, after significant cost and effort.Discover a new highly-sensitive technology for detecting defects in single-use assemblies. Named HIT™, the platform combines the use of helium and electro-detection for testing assemblies immediately before use, at the end user facility.Here we present data demonstrating the 10 micron defect detection capability of HIT™ and showing the correlation between defect size and bacterial ingress probability.