Trends in Barrier Systems & Robotics

24/25 March 2026, Wiesbaden/Germany

Objectives

This is why you will benefit from attending this conference:

  • Case studies from various pharmaceutical companies deal with the implementation, qualification and operation of Isolators, RABS systems and Robots.
  • You will discuss the current state of the art and new technological developments in Barrier Systems and Pharmaceutical Robotics Technology.
  • You will learn first-hand about the new EU GMP Annex 1 requirements for barrier systems and how these requirements are interpreted and inspected by inspectors.
  • Experts from pharmaceutical companies will share their knowledge regarding operational experience.

Registration

Background

The protection against microbial contamination is the most important point for drugs produced by aseptic processes. Today the regulators require a stricter separation between operators and product in the form of an access barrier.  

Two systems are on the market – RABS (Restricted Access Barrier System) and Isolators. But only isolators are referred to by the US FDA as advanced aseptic technology. Another consequence of the separation of operator and production process is the increased introduction of Gloveless Isolators and Robot Technology in the aseptic environment.
This conference will focus on current questions of barrier systems and robotics coming from FDA regulations as well as from the revised EU-GMP Annex 1, and it will specifically address the subject from the perspectives of pharmaceutical operators, planners and engineers.

 

Target Audience

This event is directed at decision-makers from pharmaceutical production, automation, development and quality assurance/control. It also addresses engineers and planners who need to be well informed about current developments in the field of barrier systems and robotics.

Moderators

Dr Philip Hörsch, Vetter Pharma-Fertigung
Dr Friedrich Haefele, formerly Boehringer Ingelheim

Detailed Programme

Barrier Systems – Current GMP Requirements and Inspector’s Expectation
Dr Daniel Müller, Local GMP Authority of Baden-Württemberg

  • Regulatory overview: most important guidelines for barriers/isolators
  • Revised Annex 1 section "barrier technologies" - changes and current requirements
  • Annex 1 – fit for future now?

Custom-Designed Aseptic Small Scale Isolated Filling, Freeze-drying & Closing Line
Toni Erhard, Biospring
Patrizia Arcangeli, Tema Sinergie

  • GMP / cGMP-compliant aseptic process for the filling of oligonucleotides in aqueous solutio
  • Fast biodecontamination transfer technology of RTU vials in nest  
  • Automated process performed by 6-axis robot arms, guaranteeing the "first air" during the filling phase, as per the new Annex 1 recommendations
  • Aseptic conditions guaranteed by a fully integrated isolator system
  • Filling line equipped with an integrated freeze-dryer

The Smart Factory Path towards Compliance and Performance in Sterile Filling - Automation of Microbiological Monitoring
Dr Hanno Juhnke, Sanofi
Dr Johannes Rauschnabel, Syntegon

  • Contamination Control Strategy  
  • Strategic use-case selection
  • Smart Factory
  • Environmental monitoring
  • Settle plates
  • Isolator best practice
  • Biofluorescence

Case Study: > 15 Years of Commercial E-Beam  Operations at Pfizer Grange Castle
David Kelly, Pfizer
Manfred Holzer, SKAN

  • Annex 1 requests a validated transfer of RTU pre-filled Syringes into higher grades, preferable with sterilization upon transfer  
  • With regard to the increasing use of RTU Syringes/Vials/Cartridges the different transfer technologies with a focus on E-Beam technology will be presented
  • Pfizer Grange Castle (IRE) using 2 E-Beam lines for PFS syringe filling will give with more than 15 years’ experience deep insight to set up, daily routines & lessons learned
  • Also the E-Beam technology basics & properties, as well as most common FAQ like Residuals / Radiation / Validation-Dosimetry will be clarified

Scaling Analytical Excellence in a growing Company: A Case Study on Hydrogen Peroxide Detection and System Adaptation
Dr Alexandra Heussner, Vetter Pharma-Fertigung

  • RABS VCRT® implementation and isolator VPHP qualification
  • The industry gold standard of H2O2 detection in liquid samples: the Amplex UltraRed assay
  • Trade-offs between scientific and business requirements
  • Case study: upgrading the assay to fulfill the needs of a growing company (new sites, modern clean rooms, international logistics)
  • Challenges and lessons learned

Validation of an E-Beam System with H2O2 Cycles and Dosimetry, with a Case Study of Pfizer
David Kelly, Pfizer
Theresa Ladwig, SKAN

  • H2O2 Cycle development of an ebeam system
  • Validation of an ebeam system with focus on dosimetry
  • When is it required to requalify H2O2 qualification and dosimetry on a running system?
  • Case Study: What has to be done on a daily / yearly routine? What are the authorities looking for?

Eliminating Human Error in Cell and Gene Therapy Filling through Robotic Gloveless Isolator Systems and Automated Isolator Logistics
Patrick Springer, Springer Akademie
Marcel Weizel, Bausch+Ströbel

  • Gloveless system  
  • Small-batch production  
  • Automation by robotics  
  • Aseptic setup  
  • Isolator logistics for transferring sterile equipment into the gloveless system  
  • Surface monitoring

Smart Technology, Skilled Teams: Building Agile Aseptic Operations
Peter Boman, NorthX Biologics
Brent Lieffers, Cytiva

  • Aseptic manufacturing with a gloveless isolator work cell
  • Qualification and validation approach
  • Contamination Control Strategy
  • Regulatory engagement

Enhancing Automated Environmental Monitoring in Gloveless Isolators
Julia Mathy, Roche Diagnostics
Anke Hossfeld, Merck Life Science

  • Introduction to the gloveless isolator implemented at Roche: Overview of the advantages of a gloveless fill and finish process
  • Challenges in automated EM Testing: Discussion on the complexities faced during automated environmental monitoring testing in closed isolators
  • Experience with the iterative development: Advantages on the collaborative development approach of consumable supplier, integrator and user network
  • Introduction of the RTU Isobag Solution for automated EM testing

Future Forward: Implementing and Validating a Gloveless Isolator with Real-Time Biofluorescent Particle Counting
Joachim Vereecke, White Raven
Brent Lieffers, Cytiva

  • A follow-up from our 2025 case study
  • Accelerated GMP approval
  • Biofluorescent particle counting (BFPC)  
  • Validating BFPC for use in Grade A

Innovative Strategies for Environmental Monitoring in Gloveless Isolators
Dr Jennifer Isken, Novartis Pharma
Dr Timo Krebsbach, SKAN

  • Regulatory requirements
  • Strategies for environmental monitoring  
  • Active viable and non-viable counting
  • Continuous monitoring
  • Integration of a RMM device for real time measurement of viable and non-viable particles

Next Level Integrity: Innovative and State-of-the-Art Testing Methods for Rapid Transfer Ports and Pharmaceutical Gloves in High-Class Cleanrooms
Stephan Spurny, MK Versuchsanlagen
NN

  • Containment Relevance: Gloves and RTPs are vital in GMP Grade A environments
  • Verified Testing Models: Fast, validated methods with proven sensitivity and reliability
  • Automation: Seamless workflows with automatic, GMP-compliant reports
  • Reliability: Consistent results through standardized protocols
  • Ease of Use: Intuitive systems for quick integration and minimal training

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