Annual Report from the BFS IOA Chairman for 2011

Dear BFS members,

In a few days it is time for the first meeting in 2012 for the Blow-Fill-Seal Association, and I hope you will take the opportunity to come to meet BFS colleagues, peers and suppliers to the BFS world. This time we will meet in the beautiful capital of Switzerland, Bern. We will start day 1 with a really full program of interesting presentations in several areas related to BFS manufacturing. Day 2 we will get the opportunity to visit the new factory for production of biological products at Maropack, located in Zell just one hour drive from Bern.

Since this BFS IOA meeting also is our Annual General Meeting, it is time for me to summarise the year 2011 from a BFS IOA perspective.

Also in 2011, the demand for even more BFS machines continued. According to the information I have available, it is the traditional mixture of both brand new customers that want to examine the advantages of BFS manufacturing as well as the existing producers that want to upgrade to machinery with higher capacity and the latest modern features. In the end of the day, this means that the BFS community continues to grow strongly, and by this, an increasing number of people can get medical treatment with products manufactured by a technique that offers highest possible safety and functionality.

In April 7-8th 2011 the BFS IOA had the first meeting in the Italian city of Como, situated just where the Alps raises up from the flat land around the river Po valley. This magnificent area is perfect for stimulating meetings with the nice mixture of beautiful landscape, culture, fantastic food and when adding informative BFS presentations, the combination is great. Once again we reached a rather high number of participants, this time up to about 70 persons. Among the presentations I can mention that we got the opportunity to understand the pros and cons for different techniques for integrity testing since we had three different suppliers informing about what they could offer to us. There were also a most interesting presentation about leachables and extractables, how this may impact our products, and how the risks can be mitigated. Another topic was interventions in the BFS environment, and here the audience got the chance to compare how this can be handled by different BFS manufactures, since four companies gave short presentations in this field.

At the AGM the Accounts for 2010 and the Budget for 2011 were approved. The proposals for Board members were also accepted by the members present. This gives me the opportunity to present the Board for BFS IOA for 2011/2012 for you;

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

In September we traditionally had our meeting with the American chapter. The meeting was this time held in the picturesque town of Charleston, SC, the 28-29th of September. The trend from the year before with very high number of interested members showing up continued, actually we set a new record for an US meeting - 83 persons. Almost all the major BFS manufacturers were represented at the meeting, which gave excellent opportunities to mingle with colleagues in a warm and friendly atmosphere. Several of the presentations from the European meeting were given also in Charleston, but there were also some new ones, for example an interesting case study of how to perform a extruder validation.

Of course, one of the reasons for this high number was the fact that we on the 30th of September all were invited to visit the Ritedose BFS manufacturing facility in Columbia, SC. It was impressive to see this modern and very efficient plant, and I want to take the opportunity to once again express the sincere thanks from myself and the BFS community for the openness and kind hospitality from Ritedose. I can guarantee that site tours like this is some of the most appreciated parts of the BFS IOA activities.

Like the last years, we ended the BFS year with the Asia meeting. After visits to India and China/Hong Kong, we returned to the lovely city of Singapore, were we had our meeting on the 5-6th of December. Singapore has the second greatest harbour in the world, not surprising taking in consideration the fantastic grows in this region. But instead of the traditional boat trip, we were invited to take a tour in the Singapore Flyer wheel, 165 m high! That was absolutely one of the highlights during our stay.

The BFS meeting went over almost two full days, including some of the presentations from the earlier meetings in 2011, but also two brand new presentations, one about the BFS development in China, and one about the use of colorants in BFS containers - both much interesting. We were also happy to see that we attracted about 70 members to come to the meeting, the highest number ever for an Asian meeting.

Although arranging the meetings is the most important task for the BFS IOA Board, we also try to proceed some other activities between the meetings. One of them is to update the BFS IOA Points to Consider document. Those of you who have attended any of our meetings in 2010/2011 have got a presentation of the latest draft version. Thanks to valuable comments from our members, we have now finalised the document as the "Points to Consider, edition March 2012". I'm very pleased to now be able to inform you that this edition will be published on our homepage just before the AGM meeting in Bern.

We hope that you will find this new version useful in your daily work, but of course we understand that there are still a lot of topics that could be described even more in detail. Our intention is that the PTC should be a living document reflecting the current best practise in the BFS community. Therefore, please send in comments, suggestions or questions related to the PTC document to us in the Board. In this way, we can hopefully issue an even better version of the PTC in a few years.

Then some words about the progress of the earlier announced cooperation between BFS IOA and the Parenteral Drug Association, (PDA). In conjunction to the US meeting last year, we had a meeting between the board of BFS IOA and the newly appointed leader of the PDA Interest Group for Blow-Fill-Seal, Mr. Chuck Reed, and Mr Ken Muhvich. Ken will be leading the task force to develop a PDA Technical Report about BFS technology. We discussed how the two organisations could cooperate in the best way, and we agreed the set up a Memorandum of Understanding regarding the rights for the PDA IG to use our Points to Consider document as the base for the new PDA TR. The wording in the MoU is for the moment up for final sanction by the PDA management team. The future cooperation between BFS IOA and the PDA IG for BFS will be further discussed during the year to find out the best way forward.

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 delayed, but we will make a new start this spring, and I hope to send out the survey to all our members before the summer 2012. I want to take the opportunity to encourage you all to spend some time to answer the questions in the survey, and by this supporting our organization to further develop best standards for BFS operation.

Now a quick look at BFS IOA plans for 2012. As you already have read in the introduction of this letter, we will have our European meeting in Bern in a few days. The meeting is also the Annual General Meeting for 2012, which as usual will offer you as members a chance to review and vote for approval of the Accounts for 2011, and our Budget for 2012. There will also be a vote for three positions in the Board; Technical Officer, Officer for Operation and Board member.

According to how the plans look for the moment, 2012 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 be accomplished by a visit to the Maropack facility for biological products, and when we later in the year go across the ocean to Orlando, FL, for our US meeting, there will be a site visit to the Nephron manufacturing facility. The US meeting dates are October 2-3.

The Asia meeting 2012 will take place in India November 26-27, this time in the northern part of the country, in Chandigarh. We are there invited to make a site visit to Aishwarya Pharmaceuticals facility in Baddi. Due to the kind hospitality from these three companies, I think this is the first time we managed to arrange site visits to all the meetings in a year. Of course something that is highly valued!

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 2011, and I hope you will continue to support the Association with your membership also in 2012.

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 Bern, and looking forward to see you there!

Best personal regards

 

Peter Åkerman
Chairman of the board BFS IOA
April 2012