Annual Letter from BFS IOA Chairman

Dear BFS friends,

Like every year, it's now time for me to summarize the BFS IOA year 2012 before our upcoming Annual General Meeting for 2013. This year we have chosen to have the AGM and European meeting a little later than usual, so instead of meeting the spring somewhere in Europe, you will 2013 have the chance to meet the summer in the exiting city of Berlin.

The program for the Berlin meeting will offer you the opportunity to learn more about several aspects of BFS processing, covering topics from resin to final packaging. We in the Board are also happy to once again offer you the possibility to attend a site visit. Thanks to the kind hospitality of Dr. Mann Pharma, we are welcome to visit their production plant located in Berlin. Dr. Mann Pharma is a part of the Bausch +Lomb group, and has been producing eye care products by BFS technique for many years. I hope that our mixture of a wide selection of presentations in combination with this interesting site visit will attract you to come to Berlin !

Last year we saw the wheels turning a bit slower in Europe due to the financial crises in several European countries, and this also affected the development in many other parts of the world. However, this doesn't seem to have had an impact on the BFS industry. Instead, the always present trend to obtain a more efficient production has been even stronger, and has lead to an increased demand for more sophisticated BFS machines and especially for more high-capacity machines. And, as a direct consequence, the higher output the BFS machine gives, the higher the demands for automated packaging equipment becomes. This is one of the reasons why we in the Board have included two presentations on high speed packaging lines in the program this year.

Now, let's take a look at the activities we have had in the BFS IOA during 2012.

We met for our first meeting for the year in the charming capital of Bern, where we had a magnificent view over the snow covered Alps from the conference center. The meeting took place on April 18-20th, and attracted 67 participants, just about average for our European meetings. The presentations focused mainly on topics around the aseptic system, including filtration, CIP, SIP and Aseptic validation. After one and a half day of presentations, we went for a beautiful bus tour over the green hills in the Emmental region to visit the Maropack facility in Zell. The company, that is a member of the Hansen group, has invested in an extended state-of-the-art facility to be able to offer contract manufacturing of high potential biotech products. We learned how they have solved to challenge to secure that no hazardous material can come out from the facility, and anyway offer production that can achieve aseptic conditions. For those of you that were not there, I can assure you that the air handling system really was impressive !

The AGM was as usual held in conjunction to the meeting. Our Officer of Operation, Mr. Jesper Laursen, presented the accounts for 2011 as well as the budget for 2012. They were both approved by the members. There were also voting for three positions of the Board, Technical Officer, Officer of Operation and Board Member. For all positions, the present holders were re-elected.

This gives me the opportunity to present the Board for BFS IOA for 2012/2013 for you;

  • Chairman:  Peter Åkerman, Senior Adviser, AstraZeneca, Sweden,
  • Technical Officer: Kevin Downey, Head of Quality, TEVA Runcorn, UK, (re-election)
  • Officer for Training and Education: Dr. Martin Haerer, Director Pharm. Affairs/Qualified Person Holopack, Germany,
  • Officer of Operation: Jesper Laursen, Business Director, MELITEK, Denmark, (re-election)
  • Board Member: Patrick Poisson, VP Manufacturing Fill/Finish, United Therapeutics, USA (re-election)

For the US meeting in 2012 we went southeast again, this time to Orlando, FL on the 2-3rd of October. Due to the generous hospitality of the Nephron Pharmaceutical company, we were not only invited to see their expanding BFS production, we also got the opportunity to arrange the conference in their big meeting room in the office building. I was very happy to see that the trend of increasing numbers of participants continued also in 2012, and we got a new all-time-high for a US meeting with 90 participants.

The Nephron production in Orlando is located in two separate buildings, one for filling, and one for packaging. For filling, machines from both Weiler Engineering and Rommelag are used. After transport to the packaging site, the ampoules were overwrapped in ultra high speed flow wrappers - this is another example of the efficiency that packaging line nowadays must have to be able to accommodate ampoules coming from several high capacity BFS lines. Last year we saw similar installations during our visit to TRC in Columbia, SC, and I'm convinced that we will see much more of that in the future.

The BFS year 2012 then ended with the Asia meeting, for which we this time returned to India on November 26-27. Since we had got an invitation to visit the modern BFS plant of Aishwarya Pharmaceuticals in Baddi, we had chosen to arrange to conference in the nearby town Chandigarh, about one hours flight north of Delhi. In total we were 65 persons from all over Asia that attended the meeting.

Before seeing the BFS lines, we were served a delicious lunch in the nice garden in front of the factory. From there, you had an impressing sight of the spurs of the Himalaya. The modern BFS machines and their installations looked just like any BFS site around the world, but for us coming from the fully automated packaging lines in US, it was a contrast to see all the people doing the manual work for packaging.

I now want to take the opportunity to express my sincere gratefulness to all the three sites for inviting the BFS community to come to visit their facilities. And of course, I also want to say thank you for the all the nice treatment we have received regarding food and refreshments before and after the visits.

During all these three site visits, we have appreciated all the openness we have met, but we also felt the great pride of the companies who have got the possibility to show their philosophy around BFS production. I hope this will inspire other companies to show their production facilities in the future. We have a lot of common interests in the rather small BFS world that we can share and support each other with. It's important that we don't hide behind the "competition ghost" !

However, the BFS year also includes other businesses beside the meetings. I want to start with some words about the latest news on the earlier announced cooperation between BFS IOA and the Parenteral Drug Association, (PDA). During a meeting in Orlando between the BFS IOA, the leader of the PDA Interest Group for Blow-Fill-Seal, Mr. Chuck Reed, and Mr. Ken Muhvich, the Memorandum of Understanding regarding the future work on the PDA Technical Report about BFS technology, were signed. Mr. Ken Muhvich will be leading a task force to develop this TR, and a list of candidates for the work was compiled. There have been some meetings in the task force, and we will inform you more on the progress at the Berlin meeting.

Then to another subject where I'm sad to inform you about a further delay; as you have heard before, we also have the intention to perform a survey around Particle and Environmental monitoring in BFS operation. Unfortunately, this work has been even more delayed due to constraints in time and resources. This time I don't want to give any new estimates of a date when we can send the survey out, but I can assure you that we still feel confident that this will be of great value for the BFS community, and I hope it can be realized within a not too long time from now.

Now a quick look at BFS IOA plans for 2013. As I already have mentioned in the introduction of this letter, we will have our European meeting in Berlin in a few days. The meeting is also the Annual General Meeting for 2013, which as usual will offer you as members a chance to review and vote for approval of the Accounts for the past year, and our Budget for the coming year. There will also be a vote for two positions in the Board; Chairman and Officer for Training and Education.

According to the current plans, also 2013 will be a year when we can offer you the opportunity to have site visits in connection to all our three meetings. The AGM will as mentioned above be accomplished by a visit to the Dr. Mann Pharma facility. For the US meeting, that is planned to take place in Chicago, we are right now in the final discussions and hope to offer you site visits to either Catalent or Ampac, (more information to come). The preliminary dates for the US meeting are September 16-17th, and the meeting will then be followed by a meeting in the PDA task force for the new TR on September 18-19th.

Then finally, the Asia meeting 2013 will be our first visit to Australia. Our BFS friends from "down under" have for many years been force to travel long distance to come to the BFS meetings, so we think it's not more than fair the we now go there instead. The meeting will be arranged in Sydney, and will include a site visit to the AstraZeneca plant in North Ryde, just some miles from down town Sydney. The final dates are not yet confirmed, but as usual it will be around November/December. Please be prepared for this unique opportunity to go to Australia for a BFS meeting !

As every year, I once again want to encourage you all as members to come up with suggestions of topics that you want us to put more attention to in our programs. And, even better, if you have something you want to present from your own experience that will be even more appreciated! You are always welcome to us in the Board to discuss any ideas that can contribute to return a better value for the BFS community.

Finally, I want to thank you all for your interest in the Association during 2012, and I hope you will continue to support the Association with your membership also in 2013.

On behalf of the whole BFS Association I want to take the opportunity to express our sincere gratitude to all our valuable Sponsors for their important contribution to our mission.

Most welcome to the meeting in Berlin, and looking forward to see you there!

Best personal regards

Peter Åkerman
Chairman of BFS IOA
June 2013