382787 A Method for Pre-Use Integrity Assurance with Large Volume Single-Use Bin and Mixer Bags

Wednesday, November 19, 2014: 5:27 PM
206 (Hilton Atlanta)
Adam Sokolnicki, Biomanufacturing Sciences Network, EMD Millipore Corp., Billerica, MA, Takao Ito, Biomanufacturing Science Network, Merck Millipore, Tokyo, Japan and Alexandra Steele, Biomanufacturing Science Network, EMD Millipore, Billerica, MA

Before committing high value products or feed streams into single-use bags, it is a wise business decision to test the bag for integrity following installation into the carrier.  Despite rigorous quality control measures, assembly release integrity testing, and advanced packaging methods for transportation from the vendor’s site, film bags may still incur damage during unpacking, handling and installation if robust handling practices are not in place.  As more biotech firms incorporate single-use bags into their manufacturing work flows, the field continues to lack a recommended method for integrity assurance testing by the end-user.  This work describes such a method for large volume bags, adapted from one vendor’s release testing criteria, and attempts to quantify performance around some common breaches of integrity.  The advantages of this method is ease of implementation, rapid execution, simple interpretation of results, and a defect detection as sensitive as the vendor testing. Furthermore, a correlation is drawn with liquid seepage from the man-made defects to assess the resolution of the integrity assurance method to detect a potential leak prior to use.

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