Annex 1 in Practice – 2026 – Seminar and Workshops at Boehringer-Ingelheim in Ingelheim
The seminar on the practical implementation of Annex 1 took place on the 10th and 11th at Boehringer-Ingelheim in Ingelheim, with over 50 participants.
The first day of the event featured technical presentations and follow-up workshops focused on the practical implementation of Annex 1 and the associated technical and regulatory issues.
Presentations on:
- Aseptic Setup in the Isolator: Stephan Schönenborn (Bayer)
- Integrity of single-use systems: Cornelia Stöhr (Roche) with Simone Biel (Merck)
- Filling Systems in Light of Annex 1: Barbara Moser (CSL) with Johannes Rauschnabel (Syntegon)
- Current Technologies for Environmental Monitoring: Christine Müller and Sophia Pfeiffer (both BI) with Miriam Schönenberger (mbv) and Kai Dirscherl (Novo Nordisk)
were presented by supplier/user pairs and set the key topics for the subsequent workshops, which were moderated by three emerging leaders: Rafael Jurek (castus), Andrii Rabets (Eli Lilly), and Christoph Grünenberg (Boehringer Ingelheim).
There were many discussions regarding regulatory acceptance of real-time biofluorescence particle counters (BFPCs), which were further fueled by the PIC/S Q&A document published shortly before the seminar. Kai Dirscherl clearly described the long journey toward regulatory acceptance of the first BFPC-only (plus swabs) filling line and pointed out that a simple copy is not possible; rather, it must be adapted to the specific situation.
After a wonderful end to the first day at the Winzerkeller in Ingelheim, the second day began with four practical presentations:
- Retrofitting for First Air compliance in existing buildings (Julian Petersen, groninger, with Markus Zimmermann, Optima)
- CCS as a new approach that goes far beyond a single document (Dieter Bachmann, JnJ)
- The path from a CRL on an existing line to regulatory acceptance (Gregor Holenstein, JNJ)
- and a smart approach to retrofitting a PUPSIT within a tight timeframe (Daniel Frache with Julius Nolzen, both from BI).
The practical assessment then took place during a guided tour of the manufacturing facilities at the Ingelheim site—including a visit to a filling line in the qualification phase and a filling operation in the isolator at full production capacity. The CoP would like to express its heartfelt thanks to the host, Boehringer-Ingelheim: especially to Nils Wieland, the main point of contact and our “on-site” coordinator, to the BI colleagues who assisted with the tour, and also to Julia Dumont and Thomas Allard for their kind support and welcoming remarks at the start.
The seminar will continue on November 16 and 17, 2027, at Vetter in Ravensburg.
