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 an international industry association for pharmaceutical and associated companies, which have a direct or indirect involvement with Blow-Fill-Seal (BFS) manufacturing. BFS IOA is a non-profit organization, and is financed by subscription of more than 60 member companies worldwide and by sponsorships from the industry. Blow-Fill-Seal Technologie, das vollautomatische Herstellen, Füllen und Verschließen in einem Arbeitsgang, wird zur aseptischen Abfüllung von Flüssigkeiten und halbfesten Stoffen in der Pharma- und Chemie-Industrie als auch in vielen anderen Bereichen angewandt.Die vorliegende Einführung vermittelt Ihnen die BFS-Grundlagen nach cGMP-Regeln. Für die Gewährleistung eines einheitlichen Ablaufs sind Basisanforderungen und Mindeststandards formuliert.