Dear BFS friends
Beginning of the year is generally the good time to review the past year and to give you a taste of what will happen in the BFS community in 2023.
This is my first letter to you since I was elected last September. I want to thank again the previous board for my nomination and you, for the trust you placed in me for taking on the role as chairman for BFS IOA.
2022 in a few words:
Board changes and AGM
It was a special year for the association as Mr. Peter Åkerman stepped down as chairman after 15 years of leadership.
I want to express my sincere gratefulness to Peter, for his involvement and the time he devoted to the association. He was a brilliant chairman and served our organization with distinction and kindness.
Welcome and congratulation to Mr. Philip Leslie, for his election at the AGM, as Technical Officer in our board. Philip has a strong experience in BFS, in the manufacture of sterile products and vaccines, but also in support of new product development. To keep the balance of position to be vote each year, Philip´s mandate is for one year.
Congratulation to Mr. Martin Haerer, his re-election as Regulatory Officer.
During this AGM, our Officer of Operation, Mr. Jesper Laursen presented the accounts of 2021 and the budget for 2022. They were approved by the present members.
The board constitution for 2022-2023 is:
Christophe Schwoehrer, Manufacturing Science & Technology Aseptic Filling Expert, Recipharm, France (election)
- Technical Officer:
Philip Leslie, Acting Head of Manufacturing at Apiject System Corp, Australia, (election)
- Regulatory Officer:
Dr. Martin Haerer, Senior Director R&D/Qualified Person Rommelag CMO, Germany, (re-election)
- Officer of Operation
Jesper Laursen, Business Director, MELITEK, Denmark, (re-election)
- Appointed Officer:
Free position, any candidacy has to be sent to BFS@melitek.com
We started two important expert workgroups at the end of the winter.
The first was the implementation of a remote workgroup around Annex 1 and shuttle machines, leaded by Mr. Martin Haerer. Several companies presented their room and machine design and had excellent and interesting exchanges about their Environment Monitoring practices. Conclusion of this workgroup was presented by Mr. Martin Haerer during our conferences last year. The interest of operators and the quality of exchanges encourages us to repeat this type of exercise.
The second, initiated by Mr. Peter Åkerman, is the complete review of our “Point to Consider” document. The current version of the PTC document was last edited in 2017, printed and issued as a booklet by a German publisher “ECV”. The new 2023 edition takes in account the guidelines of new Annex 1 issued by EMA and approved in August 2022. A team of experts, composed of operators, vendors and the board has come together to update the document. To date, over 80% of the new version has been written, and proofreading can begin in the coming month. The board nominated Mr. Peter Åkerman, as Team Leader, a position that he kindly has accepted.
I would like to warmly thank all participants for their commitment to these huge tasks.
After two white years without face-to-face meetings, we held our three meetings in Europe, America and Asia Pacific. They all included operator or vendor presentations, plant tours and workshops around the new Annex 1 and vial/bottle defect classification.
The European meeting, which also was our Annual General Meeting, was held in Lyon at the end of September. We had the opportunity to visit the Excelvision factory in Annonay which is in the process of finalizing the installation of two new BFS lines of pre-filled syringes for vaccines.
A couple of week later, we held our American meeting in Columbia (South Carolina), with the visit of the large, impressive factory of Nephron.
Beginning of December, we arranged our meeting for Asia/ Pacific region in Singapore. As no BFS plant is in operation in this area, Merck Millipore kindly hosted us and presented their development and training center for filtration and Single Use System.
I want to express my gratefulness to:
The sites for inviting the BFS community to visit their factory.
The speakers, for their excellent presentations.
The board, for the preparation, and the animation of the conferences and the workshops.
The attendees, for their interest and participation in Q/A and workshops.
The sponsors, for their support and encouragement.
And to our communication assistant, Mrs. Tine Damgaard, for the excellent organization of these events.
What will happen in 2023:
The new “Point to Consider” document will be released this spring. Additional appendixes on for example methods of evaluation or control will be added in the future. Peter continues to lead this activity and make us regular feedback of new version progress.
A work group concerning “Defects classification” will be launched in the next weeks too. Objective is to have a BFS IOA defects library and associated to it, the determination method for criticality and corrective or preventive actions to avoid or to reduce the occurrence. Our BFS machine suppliers are participating with their expertise, and we want to complete the team with operators. Loic Bonne, Quality Process Manager in Recipharm, is the Team leader of the group.
We will start the year with a training seminar in Egypt on March 8-9th. It will be the first time that the association is organizing a meeting in Africa/Middle East. The seminar will include a plant tour at ATECO Pharma in El-Sokhana. All presentations will be held by experienced BFS operators from leading companies. Online registration is open at the event page and agenda will follow soon.
The European meeting which is also our AGM will be held in Catania on May 23-24th. It will include a workshop around Annex 1, presentations, and a plant tour by SIFI. Two positions in the Board are up for election:
Officer of Operation and Technical Officer, we welcome nominations for candidates and promote all candidacy with a focus to have gender parity in the future.
The third meeting location is fixed now, and for the first time in the association´s history, the American meeting will be held in Mexico, with a plant tour of PiSA Farmacéutica, in Guadalajara.
The location of the Asia/Pacific meeting is not fixed, but we hope to be able to soon provide more information on location and dates.
To have a better recognition of the operators/ vendors/ stakeholders and authorities in the future, the board is working to establish operating standards. The new PTC edition, but also the different workgroups and workshops we will organize, will be oriented in this way.
We are also organizing a meeting with the A3P board in Paris on February 21st to define how the two associations can collaborate in the future, in hope this will provide better access to regulatory bodies in Europe.
We are in progress to define meeting theme(s) for 2024 and the format of the future meetings.
We hope that all these initiatives will continue to make BFS IOA relevant for our members and to allow us to attract new operator companies to join the BFS IOA association, for growth and increased collaboration.
Chairman of the board BFS IOA