1 BFS IOA_Cairo 2023_opening CS Sterile area

1 BFS IOA_Cairo 2023_opening CS Sterile area

1. by BFS IOA Board Cairo Egypt March 8-9, 2023

2. Welcome in Cairo ! Our first Meeting in Egypt , The Cradle of civilization Expand BFS IOA into new geographical areas. Propose Training seminar around BFS and GMP(s). Enhance the interactions between Operators and the BFS Vendors. Increase the Operators members in the association. Have a better recognition of the Operators/ Vendors / Stakeholders and Authorities. 07 March 2023 2 Why are we here ?

3. BFS IOA is an international industry association for pharmaceutical and associated companies, which have a direct or indirect involvement with Blow-Fill-Seal (BFS) manufacturing. BFS IOA was Established in UK in 1989. BFS IOA is a non-profit organization, financed by subscription of more than 70 member companies worldwide and by sponsorships from the industry. The Pharmaceutical Blow-Fill-Seal International Operators Association (BFS IOA) 07 March 2023 3

4. To educate pharmaceutical industry and regulatory bodies around the world about BFS technology . To promote common understanding worldwide on how BFS technology should be applied. To educate members about current and proposed future guidelines relevant to BFS technolgy to ensure continuous regulatory compliance. To facilitate networking between BFS experts on technical and regulatory matters. Our Mission 07 March 2023 4

5. The BFS IOA Board for 2022/23 Christophe Schwoehrer , Recipharm, France Chairman – elected at AGM in September 2022 Dr Martin Haerer , Rommelag CMO, Germany Regulatory Officer – reelected at AGM in September 2022 Philip Leslie, Apiject, USA/Australia Technical Officer – elected at AGM in September 2022 Jesper Laursen , MELITEK, Denmark Officer of Operation – reelected at AGM in October 2021

6. Meetings (Europe, America and Asia/Pacific) and training seminars Workshops Presentations Plant tour Social event Scope of Activities 07 March 2023 6 Lyon, France September 26-28th Columbia, USA October 10-12th Singapore Nov 30th- Dec 2nd

7. Next meetings : Themes : Annex1. Workshop subjects : USP 771 : Automatic Visual Inspection for Ophtalmics. Annex 1 : Bacteria challenges method on extruder. Scope of Activities 07 March 2023 7 Catania , Italy May 23-24th South Korea Week of Sept. 18th Guadalajara, Mexico Week of Dec4th

8. 2023 : Vials/ Bottle Defect classification Create a list of vial/ bottle defects (continuation from list already presented at BFS IOA meetings in 2022) Evaluate criticality of defect according to use (operator only for this part) Define root cause, corrective action, actions to be taken to reduce occurrence… The conclusion of the work will be incorporated as an annex to BFS IOA’s PTC . Practical news : Deadline for candidacy: March 17, 2023 Kick-off meeting: Week 14, 2023 (April 3, 2023) Workgroup leader: Mr. Loïc BONNE Meeting frequency: Every 2 weeks Format: Primarily by Teams meetings Conclusion and Report: End July 2023 Interested to join - please send email to  [email protected]  or  [email protected]  with short CV with relevant experiences. Scope of Activities 07 March 2023 8 Webinars / Remote workgroup

9. Points to Consider : Provide guidance on how to operate BFS production of pharmaceuticals in a good way. New Version, ed. 2023 : To cover many of the important improvements and trend changes in the equipment technology. To include the EMA GMP Annex 1guidelines for BFS. Workgroup leader : Peter Åkerman. Strong Task Force BFS Experience (Operators and Suppliers). New version, finished by the Annual General Meeting in May 2023. Scope of Activities 07 March 2023 9

10. Communication / Member administration on Website : www.bfsioa.org Interaction with other organisations : 2017 : Cooperation with PDA, resulted in the PDA Technical Report TR 77 for BFS 2023 : First meeting with A3P association to define future collaboration and interaction between the two Associations. Technical work / Sponsor of academic work Scope of Activities 07 March 2023 10

11. Agenda, March 8th 07 March 2023 11 9:30 Welcome and Introduction by the BFS IOA Chairman 9:45 Introduction, Background, and Basics of BFS Technology including resins (Jesper Laursen ) 10:15 Regulatory Aspects of BFS Production including new Annex 1 (Egypt version) Environmental Monitoring (Martin Haerer ) 11:00 Coffee & Tea break 11:30 Layout Installations, Qualification and Validation and Sterile Filtration of BFS Installations including CIP and SIP (Stefan Kiesel)   12 :30   Validation of aseptic fill process/Media fills ( Stéphanie Langle-Vidal)   1:15 Lunch (Pearl 2) 2:15 Down-stream processing including Visual Inspection, Physical In Process Controls and Leak testing of BFS containers (Loic Bonne and Peter Akerman) 3:30   Autoclaving of BFS products including validation (Peter Akerman)   4:15 Coffee & Tea break 4:45 Panel Discussion/Closing of Day 1 6:45  Departure from : River cruise on the Nile including dinner

12. Agenda, March 9th 07 March 2023 12 9:00 BFS Machine Maintenance (Christophe Schwoehrer) 9:45 Filling of heat sensitive Products/Biologicals with BFS equipment (Philip Leslie) 10:30 Coffee & Tea break 11:00 Update/Presentation of BFS IOA PTC (Peter Akerman) 11:30 Panel Discussion/ Closing of Day 2 12:00 Lunch (Pearl 2) 1:00 Departure to ATECO Pharma 2:30 Company Presentation and site Tour at ATECO Pharma 6:00   Return at hotel  

13. 07 March 2023 13 To our Main sponsor To our co-sponsors Thank you

14. 07 March 2023 14 ENJOY OUR CONFERENCE !