Trends in Barrier Systems & Robotics

8/9 April 2025, 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

Register as a congress delegate for just 690 EUR/day!
This special offer is only valid until 31 December 2024!

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 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.

Detailed Programme

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

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

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

Case Studies and Future Trends for Zero Human Interactions in Aseptic Filling
Dr Arne Schröder, Vetter Pharma-Fertigung
Tobias Resch, Stäubli Tec-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

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

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

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

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

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

Programme last updated: 12 November 2024

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