BFS IOA – Technical Officer’s report for 2006.
In 2006 we held our usual three technical meetings in Europe in Strasbourg in March; in the USA in Washington in September and last but by no means least in the Asia Pacific area in Bangkok last October.
Each meeting had its own themes and highlights.
In Europe we continued the debate on BFS process risks which was started at the US meeting in 2005. We also discussed co extrusion, leak testing and the use of isolators in conjunction with insertion technology in BFS filling.
In the US we held our meeting at the same time as the PDA annual meeting. Whilst I’m not sure how many extra people it drew in, it did make it possible to invite Jim Agallocco to give a plenary presentation on his definitions of advanced aseptic processing. This is a term which can be misused but which is applicable to BFS when operated under appropriate controls. Other subjects covered in Washington were further studies from the Cardinal Health group on microbial challenge to the BFS process, the challenges of visual inspection for particulates in the EU market, and a case study of a high speed overwrapping line.
The Bangkok meeting saw a number of presentations from members from within the Asia Pacific region – a very welcome development. We had presentations on water systems, polymer properties, filters, and steam sterilization of BFS containers. Leak testing by both vacuum and electronic methods were reviewed by their respective manufacturers. We also completed the regional discussions on BFS risks with both the major machine manufacturers presenting their recent developments designed to reduce risk in the process.
Unfortunately work on the Points to Consider document has progressed only slowly. Even though we have tried to remove all non BFS specific content from the document it is still a significant undertaking to ensure appropriate coverage and technical accuracy. A working meeting was held in Paris in June and significant progress was made. The original intent of the document clear in the title “Points to Consider”, was to provide BFS users with information on the many technical issues specific to BFS operation. It was also originally intended to publish the document in the public domain. This was discussed at each of the regional meetings this year and some members felt that if the document were to usefully address some of the more contentious issues then its publication should be restricted to the BFS IOA membership. This issue must be resolved before much more progress can be made.
We took the opportunity to update the data in the BFS IOA media fill survey during 2006. The updated data set reflects that in the original 2003 survey and supports the original conclusion that BFS has a ten times lower failure rate than seen in surveys of conventional technology.
The Association has also worked with PDA on the programme committee for the 1st Annual Global Microbiology Meeting which was successfully held at the end of October.
There is currently some work in Japan on GMPs for BFS and we await the revised EU Annex 1. We will be keeping a close eye on these in 2007.
BFS IOA Technical Officer