Biopharmaceutical manufacturers and engineers are implementing filter integrity testing procedures that incorporate single-use systems both upstream and downstream in the manufacturing process to improve their processes and reduce risks associated with product contamination. This article addresses how single-use components can be incorporated into manufacturers' filter integrity testing procedures. Specific examples include post filtration integrity testing for a media and buffer, a pre-filtration addition point (application). and filtrations between purification and formulation steps.

The implementation of single-use systems-which can deliver significant value through added flexibility, improved production yields.. and cost savings-is gaining momentum in the biopharmaceutical manufacturing industry. The initial single-use systems that gained market acceptance consisted of tubing, bags, filters, and connectors. Today, additional types of disposable technologies are being used throughout the production cycle. This article discusses how single-use transfer lines can be incorporated into seed train and final rill applications as well as suite-to-suite transfer operations.