Annual Report from the BFS IOA Chairman for 2008


Dear BFS members,

We are now soon facing our Annual General Meeting for 2009, that this time will take place in Schwäbisch Hall in southern Germany. With these lines, I will first of all welcome you all to this meeting, that kindly will be hosted by Rommelag and Holopack. Thanks to their kind openness, we will have the opportunity to get a presentation of the latest technical achievements in their machine development, as well as a presentation of the state of the art pharmaceutical production at Holopack.

When we now can summarize the past year, we can all be proud of being members of an association that has been in operation for 20 years. As you probably have noticed, we celebrated our 20th anniversary in Camberley UK, in September. Some of the persons that founded the association in 1988 attended the anniversary dinner and gave us a very nice and interesting review of our history. In one way, 20 years might not be a long time, but certainly, we realized that it has happened a lot in our industry during these years. The general demands from the authorities have been raised a lot, but meanwhile the BFS machineries have gone through a huge development, both regarding aseptic safety and efficiency. Today the BFS technique has a stronger position than ever, and is now well recognized around the pharmaceutical world. But, despite these facts, you can really say that life was a bit easier 20 years ago.

Before we start to look at what we have in front of us in 2009, let me give you a short summary of other achievements during 2008. As you probably have seen from our programmes for last year's meetings, we tried to follow a theme around getting a closer understanding of our most important raw material, the plastic resin. We were given interesting presentations from several of the main suppliers of resin, but we also got a view from the QA perspective to learn more about auditing of suppliers, what analytical work you need to do, both from lot to lot, but also when selecting a new material. In another part of our meetings, we have listen to presentations of different techniques for marking the BFS containers, and also how the can be protected by over wrapping in different ways.

Our AGM in 2008 was held in Houston,TX, US in April 7-8, with 42 members present. A result of the voting process was that our Technical Officer Eric Dewhurst as well as our Officer of Operation Jesper Laursen were re-elected for another term of two years. After the European meeting in September, which attracted 66 members, we traditionally returned to Far East for the Asian meeting, that this year was held in Kuala Lumpur, Malaysia on December 3-4. Due to the terrible incident in Mumbai the week before the meeting, and the blockade of the international airport in Bangkok, we were anyway happy to see as many as almost 50 attendees. Otherwise we have noticed a strong growth in the interest for BFS in Asia Pacific, so we are convinced that the trend of increasing numbers of participants at our Asian meetings will continue in the future.

I am very pleased to see that we have managed to attract several new members form several countries during 2008, and we have now reached 70 members in our association. It is maybe not a dramatic increase, but a steady and important growth that reflects the increased interest for BFS technique around the world.

During 2008 we continued our discussions with PDA regarding the publication of our Points To Consider document. In the agreement with PDA we handed over the rights to them to publish the document as a Technical Report. Initially the intention from both sides was the have the Technical Report ready for printing in the autumn 2008. However, during the internal PDA review process there came up some additional items that PDA wanted to include in the document. According to this, we agreed to extend our work on the document together with representatives from PDA to further develop the content before it will be published. The time plan for this work is not yet decided in detail, but as one part of this, there will be a panel discussion in conjunction to a PDA workshop around "Cleanroom Technology and Contamination Control" at the PDA Annual Meeting in Las Vegas in April. I encourage you to take the opportunity to participate in this workshop and to be a part in the important discussions about the advantages with BFS technique for aseptic manufacture. Please see separate invitation letter with more information about this PDA event.

Now to a view of what will happen during 2009. The board has decided that our theme for the meetings this year will be more focused on the BFS machinery itself. This will be very obvious now at our European meeting in Germany, where we will get the opportunity to learn more about the on-going development of the Rommelag BFS machines. Beside interesting presentations, you will also get the chance to visit the assembly hall and see some of the new developed machine that are ready for delivery to customer around the world.

One the second day we will visit the extensive pharmaceutical manufacturing at Holopack. Before that, we will first in the morning go through our formal AGM items, which include presentation of the Accounts for 2008, our proposal for the Budget 2009, voting on Auditor and also voting on the Board. The positions to be open for voting this year is the positions as Chairman, Officer of Training and Board member. The board has nominated the present holders of the actual positions as candidates for one additional term of two years. However, all members are of course welcome to suggest other nominations for these positions. Please contact our Officer of Operation so this can be prepared before the voting at the AGM.

The two other meetings are not definitively settled, but for the moment we plan for an American meeting in Mexico or Chicago in October, and an Asia meeting probably in India in end November. In these two meetings we plan to include some additional topics like autoclave processes for BFS container, maintenance of machinery and others.

But however, it is also up to you as members to suggest any ideas of what subjects you want us to pay special attention to in the Association. And maybe, you might be able to present any work in this area yourself? If so, please feel free to contact the Board to discuss this further. Please remember that any presentation from some of our members can be of great interest not only for your BFS colleagues, but also for the support of the BFS technology in general. As always - one good idea will generate at least two new good ideas.

Finally, on behalf of the whole BFS Association I want to express our sincere gratitude to all our valuable sponsors for their important contribution to our mission

With these words, I want to thank you for your interest in the Association during 2008, and I do hope you have had a good start of the new year 2009. And of course, I am looking forward to see you at one of our meetings during 2009.

Best personal regards

Peter Åkerman
Chairman of the board BFS IOA
March 2009