Annex 1 in practice in 2025
The EU GMP Annex 1 (2022) leaves its mark on the production of sterile molds. In fall 2025, ISPE D/A/CH will provide an outstanding opportunity to explore the latest developments in the field of aseptic processing.
Our CoP “Aseptic Processing” invites you to the 18. and November 19 to Takeda in Linz (Austria) to take part in a seminar and workshops dealing intensively with the challenges of EU GMP Annex 1. This seminar is a must for all professionals working in pharmaceutical manufacturing who want to learn about current standards and best practices.
In addition to a warm welcome and an introduction to the host Takeda, the first day offers three informative presentations covering key topics such as aseptic set-up and aseptic transfers. These presentations will be complemented by three interactive workshops, which will offer participants the opportunity to exchange ideas and gain deeper insights into the topics discussed.
Another highlight of the first day is the evening event, which is dedicated to networking among the participants and personal exchanges with the speakers and moderators. Valuable contacts can be made and experiences shared here.
The second day of the seminar will feature two keynote speeches on innovative topics such as airflow visualization and blended training, followed by a moderated discussion on the future of aseptic manufacturing. New concepts and requirements that are important for the industry will be discussed.
The seminar concludes with an exclusive factory tour in groups, during which participants can experience Takeda’s production facilities at first hand. A wrap-up of the two-day event rounds off the seminar and ensures that all participants leave with valuable insights and new perspectives.
The number of places is limited, so early registration is strongly recommended. Interested parties can register via the ISPE D/A/CH homepage.
Take advantage of this unique opportunity to expand your knowledge and network with industry experts. Join us as we discuss the challenges and opportunities of aseptic processing within the framework of EU GMP Annex 1!
Key Details
Date
18.11.2025 09:00 a.m. – 19.11.2025 4:00 p.m.
Location
Company Takeda
St.-Peter-Strasse 25
A-4020 Linz
Austria
Language
German.
Workshop size
The number of participants is limited to 40 in order to ensure an efficient exchange.
Participation fee
The fees are per participant:
450,- € for ISPE members
750,- € for non-members – This booking option automatically includes a one-year ISPE membership.
Registration
Registration takes place exclusively via the online form.
Agenda
Day 1
09:00 am: Welcome, introduction of ISPE, housekeeping: J. Rauschnabel, ISPE D/A/CH CoP
09:15 am: Presentation Takeda, Linz (Roland Fabris)
09:35 am: “From practice, aseptic setup according to the clean & dirty principle, risk analysis, interventions” – Nils Wieland, BI
10:15 a.m:—Break—
10:45 am: Focus topic 1: “LVP production on a stock line with
Plug sorting according to Annex 1″ – Markus Greiner, Fresenius Kabi
11:30 am: “Aseptic Set-up in Isolators – A practical approach to first air compliance” – Susanne Beissmann, Takeda
12:30 p.m: —Lunch
13:30: “Overview of aseptic transfer according to A and Annex 1 challenges with practical solutions” – Frank Lehmann, SKAN
14:15: Workshop allocation (and short break)
14:30: 3 parallel workshops on the main topics of Annex 1 Joint workshop moderation by members of the steering committee of the CoP Aseptic Processing and Emerging Leaders of ISPE
16:30: —Break and preparation of reports
16:45: Report from the workshops (15 min each)
5:30 pm: Wrap-up of the day and housekeeping
19:00 hrs: Dinner at Restaurant Josef, Linz
Day 2
08:30 am: Welcome and housekeeping
09:00 am: Impulse 1: “Smoke Studies and Airflow Visualization” – Johannes
Rauschnabel, Syntegon
09:45 am: Impulse 2: “Blended training for aseptic working” – Irmhild Bernhard, BI
10:30 a.m:—Break—
11:00 am: “Aseptic Processing in the Future: Requirements for New Filling Line Concepts and Needs” – interactive/moderated collection & discussion -.
12:30 p.m: —Lunch
1:30 pm: Guided tour at Takeda
2 groups in parallel (highlight: RtU syringe filling line in the isolator)
3:30 pm: Wrap-up and farewell
16:00 hrs: End