Down to what level of contamination are you able to test?
This question is part of the following Ask The Expert session:
How to Ensure Integrity and Sterility of Single-Use Assemblies for Manufacturings
Company: PALL Corporation
Job Title: Global Product Manager
The HIT™ System tests for defects in single-use assemblies which could potentially lead to contamination. The HIT™ System uses a control unit that houses highly-sensitive mass spectrometry equipment, and a test chamber with a fully customizable containment rack. The single use assembly to be tested is put into the test chamber and connected to service hoses, and then the test chamber is evacuated. During chamber evacuation, the test unit is pressurized with the helium gas. After a stabilization time, the detector is linked to the vacuum line to detect the helium gas flow through a leak. The full test cycle time averages 10 minutes, depending on the bag compartment size. Defects as small as 10 microns can be detected. Based on third-party validation studies, 12 micron defects were found to be the threshold of microbial ingress in rigorous Log-6 aerosol challenges. This breakthrough technology can also be used for bag and tubing assemblies with multiple single-use components.