Technical officer report 2005

2005 has seen the Association active on a number of issues.

Following our input into the consultation and development of Appendix 2 (Blow Fill Seal) to the FDA Guidance on Aseptic Processing, we were asked by the Parenteral Drug Association to prepare and present the section for their training workshops. This we willingly did and sessions have been presented to full audiences in San Francisco, Philadelphia, London and Las Vegas. It is great to know that a premier industry organisation such as the PDA now looks to us for all matters relating to BFS.

Hard on the heels of the FDA's updated aseptic processing guidance, EMEA have published a long awaited draft update to Annex 1 of the EU GMP on their website: This is not the full revision of the annex which many had hoped for but it does have implications for those operating aseptic BFS processes in Europe. The period for comment ends on 30 April and we as an organisation will be submitting our thoughts. Please submit any comments you have to me as soon as possible and I will try to prepare a consolidated position. If you plan to submit comments directly to EMEA please do this as well as it all helps the lobbying. Depending on the dates I hope to be able to discuss our comments at the BFS IOA meeting in Spring.

The technical content of this years three meetings has covered

  • In Europe in Spring we heard from specialist speakers on automated inspection of BFS containers, integrity testing of filters in situ post sterilization and particle levels in operational BFS units. Additionally we had updates on implementation of the FDA Aseptic Guideline and the continuing work on ISO and EN standards for aseptic processing. The latest draft of the Association "Points to Consider" document was also presented.
  • In the US in Autumn we had a day on risk management of aseptic BFS operations with presentations from both the major machine manufacturers and a member of the PDA working party on risk management. The second day of the meeting covered advances in BFS technology with sessions on; co extrusion technology, leak detection, inspection and the use of isolators with BFS machines for insertion technology. Dey Laboratories hosted a plant tour.
  • In Asia this month the programme was devised by our Indian members and focussed on sharing audit experiences during the first day. On the second day a range of topics including a comparison of BFS and traditional processing, water systems, PAT and the use of BFS for Large Volume Parenterals were covered. Fresenius Kabi opened their plant for a tour.

Unfortunately the promised "Points to Consider" document still hasn't progressed vary far and the comments on Annex 1 are likely to take the time early next year but we are still hopeful that this document will be published.

Best Wishes for 2006

Eric Dewhurst
Technical Officer, BFS IOA