Improvements In Single-Use Bioprocess Product Testing
By Gregg A Larson, Product Manager, Single-Use
Testing of single-use bioprocessing products is performed to mitigate risk for customers by validating products will perform as intended and reducing the possibility they will damage or contaminate the biological materials processed through them. The manufacturers’ organization, Bio-Process Systems Alliance (BPSA), has been a leader in providing guidance to manufacturers on recommended testing that is aligned with the needs of the BioPharma customer. The biopharmaceutical organization, BioPhorum Operations Group (BPOG), is also working to standardize the testing protocols performed by manufacturers.
In 2007, the BPSA published consensus quality test matrices(1) to ‘serve as a guide to maintain suitable component quality for operation of single-use systems in pharmaceutical GMP environments.’ These matrices list specific recommended tests manufacturers should perform on several categories of single-use products, including films and containers, connectors, filters, and tubing. Notably absent from this list was single-use sensors. The types of testing suggested in the 2007 BPSA matrices included tests categorized as mechanical, permeability, chemical, biological, functional, and sterilization validation. The compilation of these matrices by competitors working together is commendable but, because the matrices were produced by consensus, these matrices can be thought of as the minimum threshold of testing that should be performed by the manufacturer.