- Datum:
-
- Kongress
Trends in Barrier Systems & Robotics - Part of PharmaCongress 2025
- Veranstaltungsort:
- Wiesbaden
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
Tuesday, 8 April 2025
09.00 - 18.00 h
Air Velocity at Working Position and other Cleanroom (Airflow) Challenges in new Annex 1
Jörg Zimmermann, Vetter Pharma-Fertigung
Dr Johannes Rauschnabel, Syntegon Technology
- Working position / working level
- UDAF
- Crossflow
- Ready-to-Use transfer
- RABS / Isolator
- Open door
- Smoke study
GMP Risk Assessment for performing the Test for Sterility in an Isolator
Dr Bettina Rietz-Wolf, Local GMP Authority of Baden-Württemberg
Dr Timo Krebsbach, SKAN
Presentation of a practical approach:
- All essential steps in performing the sterility test
- Cleaning and decontamination
- Annex 1 requirements
are examined and evaluated and then summarized in a risk matrix
Upgrade of integrated H2O2 Bio-Decontamination System for Production of Vial Filling Line with oRABS – Part II
Pasquale Cataldo, Roche Diagnostics
Kenan Kanmaz, Optima pharma containment
- Current process, the upgrade is a must – Annex 1
- Timeline & installation/shutdown vs. current production
- Risk and other key tasks of upgrading
- Case Study: Results of project and benefits
- Key features and advanced technologies of DECOpulse® - effective H2O2 Bio-decontamination system
A novel Way for Measuring H2O2 in an Isolator
Paul Devuyst, GlaxoSmithKline
Theresa Ladwig, SKAN
- Current measuring options
- SKAN optaria: measurement principle & features
- Annex 1 considerations
- Case Study: GSK
“Case study: E-Beam used as Transfer Technology for RTU Pre-filled Syringes at Pfizer Puurs on Multiple Filling Lines“
Marcus Hoppe, Pfizer
Manfred Holzer, SKAN
Implementation of RABS Systems in Small Volume Manufacturing
Marta Rodríguez Vélez, Letipharma
- Challenges for the implementation of RABS systems in manual fill&finish processes
- Main questions and considerations when facing the implementation of barrier systems in small volume manufacturing processes
- Project phases and milestones
- Lessons learnt
Wednesday, 9 April 2025
09.00 - 17.00 h
Aseptic Process Simulation with a gloveless robotic Filling Line
Thorsten Häfner, PSM
Sebastian Hillbrand, SKAN
- Lessons Learned of the first European based gloveless robotic filling line APS
- APS strategy
- Exchange with local authorities
- Feedback and comments
A Case Study highlighting the Validation of a closed gloveless Aseptic Filling Workcell
Joachim Vereecke, White Raven
Brent Lieffers, Cytiva
- Developing a robust validation plan
- Identifying what parameters to validate and how to test
- Contamination control strategy
- Ensuring all relevant hazard pathways are addressed
- Airflow visualization
- Using CFD and smoke studies to ensure product protection
- Environmental monitoring strategy
- Meeting Annex 1 intent for demonstrating Grade A conditions
- Execution summary at White Raven
- Bringing it all together to demonstrate compliance
Challenges and benefits for modern and state-of-the art fill & finish equipment to reduce glove interventions
Dr Christian Matz
Patrick Wieland
- What's required by Annex 1
- Identifying critical glove Interventions
- Ways to reduce glove interventions
- Challenges and benefits of gloveless fill & finish systems
Case Studies and future Trends for Zero Human Interactions in Aseptic Filling
Dr Arne Schröder, Vetter Pharma-Fertigung
Tobias Resch, Stäubli Tech-Systems
- Design of new cleanrooms with robots for automatic transportation steps – case study
- Retrofitting of existing cleanrooms to meet Annex 1 compliance by implementing robots – case study
- Mobile Robots are the answer for various manual operations within the cleanroom – case study and new technologies and opportunities
- Possibilities for replacing manual interventions by robotic telemanipulation
Compliance of Annex 1 Requirements for Glove Integrity Testing
Jason Creek, Roche Diagnostics
Kenan Kanmaz, Optima pharma containment
- Usual glove testing process in the field & basics
- The requirements of Annex 1
- Case Study: Results of the different glove integrity tests
- Game Changer: Results and benefits of the new solution
- Upgrade of the current production process
- Key features and advanced points of integrated glove testing system
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
