New Developments in Barrier Systems & Robotics

Retrofitting RABS - Upgrade to V-CRT
Dr Ute Schleyer, Vetter Pharma-Fertigung

• After Vetter had already built 4 new clean rooms with V-CRT technology, 2 clean rooms have been added.
• These two clean rooms previously operated as RABS for several years before being upgraded to the V-CRT system.
• Challenges and differences to the newly built cleanrooms to the retrofitted are presented.
  
  

Process Automation in a Small Scale Aseptic Manufacturing Site for Clinical Trial Products.
Dr Tim Stöveken, Merz Therapeutics
Martin Glättli, ProSys Group

• Presentation of flexible manufacturing concept for sterile liquid products for clinical trials
• Filling of small batches with automation of the most critical processes
• Implementation of Isolator technology into an existing building
• Training and operation concept in a non-routine environment
  
  

Replacement of H₂O₂ Generator from Existing Vial Filling Line
Dr Simone Bläsi, F. Hoffmann-La Roche
Kenan Kanmaz, Metall+Plastic

• Project challenge from the first step – timeline
• Production shutdown and realization
• Risk and other key tasks of upgrading
• Results of cycles development with the new H₂O₂ Generator RG4
• DECOpulse® - effective H₂O₂ Bio-decontamination System
  
  

Barrier Systems and Automation - the Needs and the Potential considering Contamination Control Strategy (CCS)
Robert G. Schwarz, FH Campus, Wien

• Annex 1 - game-changer for RABS or documented state of the art?
• RABS vs Isolator - the decision prior robotics
• Struggling in updating existing Barrier Systems - are all of us ready for robotics in aseptic processing?
  
  

Benefits of Robotics in a CDMO Environment – A Case Study at the German CDMO PSM GmbH about using gloveless robotic Filling System in the Light of Contamination Control Strategy (CCS)
Julian Petersen, groninger & co
Thorsten Häfner, PSM

• Layouts and processes for using a gloveless robotic filler for high value drugs
• Replacement of manual processes by robots
• Minimizing humans in the aseptic area
• Comparison of traditional technologies with robotic applications
  
  

Barriers & Robotic Isolators in New Annex 1 (2022 version)
Dr. Daniel Müller, Local Government, Germany

• Requirements for barriers/ isolators
• Major changes for barriers (version 2008 vs. 2022)
• How far are robotic isolators addressed?
• Challenges, discussion points & GMP inspector's view
  
  

The Use of Robotic Systems in Aseptic Processing and the Pharma-Industry Overall
Jörg Zimmermann, Vetter Pharma-Fertigung

• Automation and Robotics in the pharmaceutical industry
• Robots for cleanrooms: things to consider
• Robotic automation in aseptic processing: implementation examples and outlook
• Use of robotics in compounding, testing and secondary packaging
  
  

Validated Technology for a Flexible Aseptic Robotic Parts Handling in Isolator Environment
Sascha Wittig, WEISS ROBOTICS

• STERIGRIP – smart solution with plug-in technology reduces complexity in the handling process
• Challenges, possible applications and technical requirements
• How process device data can support the GMP monitoring process vs. the manual intervention with gloves
  
  

Automated Thawing Process: Combining Robotic and Manual Process Steps
Maren Jahn, Vetter Pharma-Fertigung

• Concept: the path from process needs to first ideas
• echnical Challenges: operator safety versus processing time; integration of specific robotic solution in mulit-use facility
• Implementation Challenges: Comparison of manual versus automated homogenization process of API bottles; integration in batch documentation;
• interaction between robot and operator
  
  

Disposable Isolator and Robotic Input, Why Not?
Frank Pavan, GTP Nano

• Introduction of fill and finish activities in grade A
• Use of Disposable filling Grade A isolator for parenteral manufacturing
• Containment of Highly potent products using Disposable isolator
  
  

New Methods to develop Pharma Automation and Robotic Solutions in Warp Speed
Milad Jami, Novo Nordisk
Julien Lora, Stäubli Tec-Systems GmbH Robotics

Fill&Finish Machine for Cell&Gene Therapy: From Requirements to Concept and Realization
Alexandre Daune, UCB
Matteo Tagliabue, Steriline

• Presentation of UCB’s requirements and drivers
  • for small batches (1000pcs. - 2R vial)
  • RTU vials in nests, SiO2 vials
  • 100% IPC
  • no product loss (also during the production start)
  • conventional stoppering and aluminum capping
  • compact footprint
  • under Isolator
  • Environmental conditions:
    • Outside surface of the outer bag exposed to the decontamination agent under Grade C
    • Tub debagging under Grade A air supply
    • Tub opening under Grade A
    • Filling & Closing Under Grade A
    • Crimping at least Grade A air Supply.
• Presentation of machine concept
  • 3D drawings and movie clips of our robotic design
  • No-Loss-Philosophy: Re-filling, Re-stoppering, Re-capping functionalities