The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology

This key document, produced by the BFS IOA, outlines important aspects on operation of BFS technology to ensure both compliance with cGMP regulations and the production of drug products of the appropriate quality, safety and efficacy. The Points to Consider document provides recommendations specific to the operation of Blow-Fill-Seal technology for the manufacture of sterile pharmaceuticals and liquid medical devices. One of the aims of this document is to define the minimum standards expected and to develop consistency across all users of BFS technology for the manufacture of drug products.The Pharmaceutical Blow-Fill-Seal International Operators Association (BFS IOA) is…