Review of the “Annex 1 in practice 2025” seminar at Takeda in Linz
Concentrated listening, committed discussions, an honest exchange of experiences and unfiltered “lessons learned” characterized the two-day Annex 1 practical seminar at Takeda in Linz on 18. and November 19.
Our conference began with keynote speeches on the “classics” of Annex 1 interpretation:
Setting up stopper sorting on SVP lines (Nils Wieland, Boehringer-Ingelheim) according to the “clean/cleaner principle.”
LVP lines with linear sorting (Markus Greiner, Fresenius)
Filling needles (Sabine Beissmann, Takeda)
Overview of aseptic transfers (Frank Lehmann, Skan, and Volker Storn, Roche).
This was followed by three workshops on the topics of Transfers, Aseptic Setup, and Intervention/First Air, which were moderated by our emerging leaders Rebecca Roscher, Diego Church Wise, and Florian Burkart.
The highlight of networking was a cozy evening at the restaurant “Josef” in Linz, where the satisfaction with the first day and the team spirit among the participants and speakers was palpable.
The second day began with two presentations on the Implementation of Smoking Studies (Johannes Rauschnabel, Syntegon) and Blended Training (Irmhild Bernhard, Boehringer Ingelheim) – again followed by another workshop session under the motto “I wish…“, which once again highlighted the needs in a very pointed way.
The practical implementation according to the current state of knowledge could then be viewed and discussed in a factory tour at Takeda at 2 stations: automatic, visual inspection and filling on an isolator high-performance line for ready-to-use syringes.
We would like to thank the host Takeda for the inspiring atmosphere of this seminar with its unique conference venue (a renovated active ingredient production hall) and its dedicated employees – especially the plant manager Roland Fabris, who personally supported this ISPE event.
Dr. Johannes Rauschnabel
