In 1988, the BFSIOA was established as an interest group of pharmaceutical and associated companies actively involved with BFS processing. The Association was formed to provide its members with an opportunity to exchange ideas and opinions, and to formulate agreement on operating standards. It also provided a forum to speak with a unified voice to machine manufacturers, commercial suppliers, and regulatory bodies. Over the years the Association has expanded worldwide and now has over 60 member companies. To date the Association has members from Europe, the Americas and Asia.

Scope of Activities

Annual meetings in Europe, Americas and Asia/Pacific regions.

This is a core aspect of the BFS IOA — each meeting is well attended by BFS machine operators, machine manufacturers, and other key suppliers to the BFS process from all around the world e.g. polymeric resin, leak detection machines and foil suppliers. The meetings are held in a relaxed environment and are structured to facilitate the maximum opportunity to network with peers and suppliers and discuss the latest trends and issues related to BFS technology. Each meeting consists of presentations on a wide range of BFS related topics by leading industry experts (both operators and suppliers). Members get to hear presentations on the latest developments in BFS related technology and best practices. The meetings also frequently involve a tour of one of our member’s sites which always proves very popular and informative.

The meetings are usually held in beautiful or interesting locations which contributes to the unique ambience and camaraderie at these meetings. For example over the last few years meetings have been held in Berlin (Germany), Bern (Switzerland), Como (Italy), Hong Kong, Singapore, Goa (India) and Charleston and Washington in the USA.

Points To Consider Document

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.

Other activities undertaken by the BFSIOA:

  • Communication of relevant news and regulatory updates relevant to BFS operation via our website and periodic newsletters.
  • Interaction with regulatory authorities on new guidelines.
  • Interaction with industry organizations (e.g. PDA, ISPE) on matters related to BFS technology.
  • Training seminars for BFS operators.
  • Technical scientific work and surveys conducted in cooperation with universities and member Companies.