Annual General Meeting report
Dec 8-9th 2002,New Orleans,USA
Dear BFS colleague,
I have just returned from my trip to US and New Orleans where this years BFS Annual General Meeting (AGM) took place, with good attendance.
The first day, before lunch, was dominated by discussions on the recent revision of the Points to Consider (PTC) document and the recently released FDA concept paper. Although the PTC-document was given out in the AGM binder, it will future wise be more of a living document which can be downloaded from the BFS homepage. Electronic versions will allow for more frequent and hopefully not so time-consuming revisions as the one with have just completed.
A presentation of draft comments to the FDA concept paper on aseptic processing spurred interesting discussions among the audience and suggestions were made for minor changes to make our standpoint more clear until the formal presentation due for next day. We also discussed the need for proving the BFS process robustness towards authorities, by publishing scientific data in recognized journals. It was discussed whether extruder challenge studies were the most prioritized subject or if we should look into the long debated issue of airborne contamination within the parison cutting, shuttling and filling zone.
After lunch, the presentations focused on plastic material changes and its consequences for the pharmaceutical BFS industry.
Day two started off with an update on the Mutual Recognition Agreement (MRA) by the Swedish MCA inspector, Lennart Ernerot. Denise Bohrer of the FederalUniversityin Santa Maria, Brazil then gave an interesting talk on Al-migration in parenteral solutions. Such migration is especially pronounced when using glass containers and formulations of high pH (> 7.3) and can be drastically reduced by selecting plastic packaging such as BFS.
We also listened to Eric Dewhurst giving a talk on pros and cons of 0.1 versus 0.2 micron filtration and Morven McAlister of Pall, US., presented their recent work on qualification of 0.1 micron filters.
Slides from all presentations can be accessed here.
After lunch the second day, it was time to move all attendants to the nearby Ritz Hotel and join the PDA session about the FDA concept paper. Myself and Eric Dewhurst were given the opportunity to step onto the podium and present the Appendix 2 (Blow-Fill-Seal Technology) together with our comments for more than 300 PDA attendants including the main author of the concept paper, Richard L. Friedman of the FDA. Copies of this presentation will be available on the BFS homepage. Mr. Friedman afterwards shook my hand and politely described our comments as “good and interesting” but also admitted that he did not agree with them all. During the coffee break shortly afterwards, many BFS members rushed forward and joined in my discussion with Mr. Friedman. We stressed that BFS processing had many decades of experience and excellent track records on aseptic safety. We also stressed that especially the need for “sterile” surfaces above or nearby the critical zone was something that could be impossible to fulfill. Mr. Friedman welcomed any input from the BFS Association and especially wanted compiled media fill data from across all geographical regions (anonymously submitted). He also persisted in his belief that microorganisms can be swept away from a surface by turbulent airflow (this belief is behind the demand to sterilize surfaces above or nearby the open parison/container). He therefore also welcomed any data to prove him wrong on that point.
The opportunity given to us at the PDA meeting felt like something of recognition of the BFS IOA as the industry experts on BFS processing. This was an important step forward in being the speaking partner for BFS issues against other interest groups and above all against regulatory bodies world-wide. I also think it is now clearer than ever that the only arguments that will help us proving what we all know; that BFS processing is a very safe aseptic technology, is to publish scientific work.
As a first step, I would like to ask all BFS users to submit media fill data (as far back as the last ten years if possible) to me for compilation. If possible, I would also like you to describe (all anonymously if you like) procedures when a container break/leak happens during the fill/seal steps. This information could then be brought up for discussion at the next AGM due in Manchester, U.K.May 7-8th 2003. I also hope we can continue discussions and maybe decide on what studies we need to focus on first. Another activity I would like you all to help out with is to gather as much scientific paper references as possible, connected to BFS processing. We have good start in using the reference list of our PTC-document, and I will put this list (preferably as a searchable directory) onto the homepage. Please help me review this list and e-mail me any additional references you are aware of.
Collecting data from all our users in US, Europeand Asiais for all our good. The future of the BFS technology lies in proving its excellence over other competing techniques both when it comes to safety and cost-efficiency. If we can not prove it safer than other more traditional aseptic technologies, we will not enjoy less regulatory demands which is our ultimate goal.
Please help me to collect the data we need to argue our case; our future depends upon it!
If you have any questions, do not hesitate to contact me.
I am looking forward to seeing you all at future meetings and please register for the next AGM as soon as possible, and do not forget to visit the homepage now and again.
Anders Löfgren, Ph.D.
Technical Officer, European Chamber and Global