BFS IOA – Technical Officer’s report for 2004.
Since the publication of the initial FDA “Concept Paper” on aseptic processing the Association has been involved in review and comment on the various drafts. The details of our early comments have been reported previously but I am delighted to report that the final published document has incorporated many of our recommendations.
We focussed our efforts on Annex 2 which addresses BFS specifically and I personally believe that the final version represents a workable set of guidelines. It is difficult to argue technically against any of the points.
I also believe that the Association has built up a good reputation and working relationship with FDA which culminated in senior FDA staff who prepared the guidance sitting on discussion panels at our BFS IOA meetings in Stockholm and Orlando. We are currently working on a presentation on “implementation of the guidelines” to be presented at a series of joint PDA/FDA workshops in the US and Europe through 2005.
Whilst our main efforts have been on the FDA guidance the technical programme has included presentations at the three BFS IOA meetings this year.
In Orlando we heard about the design and build strategy, and inspection experiences for a new BFS facility in the UK. An approach to extruder validation was also presented which covered the theory behind the work.
In Stockholm presentations were given on particle monitoring in a BFS installation and in line vacuum leak testing for BFS ampoules.
At both meetings the results of the survey we carried out to gather data for our discussions with FDA, and the progress of our discussions were presented.
In Goa a series of presentations were made by Board members on media filling, environmental monitoring, the CPMP decision tree for aseptic products, and facility design. The differences between Indian and European guidelines were discussed and a case study of an MHRA inspection of an Indian plant was made. There was also lively debate around environmental requirements and extruder validation.
We also organised a very successful second BFS Training Course at Holopack / Kocher-Plastik in September.
Our Technical Officer made a presentation on the view from a BFS aspect during the “Industrial Views” session of the PDA/R3 Nordic conference on Scientific, Industrial and Regulatory Aspects of Clean Products and Devices.
We had every intention to progress with a revision of our “Points to Consider” document this year. We have agreed with PDA that this will be published as a peer reviewed technical report by PDA. Unfortunately progress has been minimal due to the events descried above. However we hope to be able to present a draft at the Barcelona meeting in March.
Finally we sent the BFS IOA Aseptic survey out at the end of the year and the updated results will help to reinforce our argument that BFS is a robust technology for the filling of sterile products.
So looking forward; 2005 will be as busy as 2004. We have the survey to review and digest, the PTC document to prepare, a series of joint PDA/FDA seminars to present on “Implementation of the FDA guidance” - the BFS case, and the three BFS IOA meetings which will have a technical content.
Work is also likely to start on a joint revision of the ISO and CEN standards on aseptic processing and the BFS IOA are represented on the working group.
The technical side of the organisation provides a forum for discussion of issues around BFS so if you have any topics which you want to raise please let us know.
BFS IOA Technical Officer
14 January 2005