Trends in Barrier Systems & Robotics

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 get to know first-hand the new EU-GMP Annex 1 requirements on Barrier Systems
  • Experts from pharmaceutical companies will share their knowledge regarding operational experience.

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.


click on the image to download the programme as PDF.

Registration

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

Didier Meyer, DMCompliance
Dr Florian Witte, Boehringer Ingelheim Pharma

Detailed Programme

Tuesday, 19 March 2024

Isolator / RABS: What is really new in Annex 1
Dr Florian Witte, Boehringer Ingelheim Pharma

  • Classification by the authorities and in the current Annex 1
  • What is suitable for whom?
  • Advantages and disadvantages of isolators and RABS
  • What is new about the classic cleanroom?

Tackling Annex 1 Requirements by Robotics: On the Way to zero human Interaction in Lyo Vial Filling
Dr Arne Schröder, Vetter Pharma-Fertigung

  • Cleanroom layout and processes for zero human interaction in lyo vial filling
  • Replacement of manual processes by robots
  • Challenges of implementing robots
  • Lessons learned during the first years of commercial use

Robotics and Automation – Th e Enabler for a higher Quality and Annex 1 CCS Compliance
Robert Kibele, groninger & co

  • Current Annex 1 requirements and the reduction or elimination of human intervention within the ISO 5 environment
  • How the usage of automation and robotics can support CCS
  • Applying robotics in the pharmaceutical environment based on executed applications within aseptic environments
  • Details about how to completely remove an operator from the aseptic environment

Aseptic Process Simulation in a Robotic Filling Line
Dennis Dürr, Roche Diagnostics

  • Short introduction/Oversight into APS and Robotic filling line
  • Aseptic process simulations in robotic vs. conventional lines
  • Thoughts and Rationales for APS in robotic filling line
  • Insights into APS-concept for a robotic filling line

Pre-Validation Steps of a fully gloveless Aseptic Isolator – A Case Study at the German CDMO PSM
Bianca Bohrer, PSM

  • How to execute an APS for gloveless filling lines
  • Challenges to overcome regarding the new Annex 1
  • Is monitoring necessary in closed systems
  • Lessons learned in discussions with authorities

Barrier Systems – Current GMP Requirements
Dr Daniel Müller, Local GMP Authority of Baden-Württemberg, Germany

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

Wednesday, 20 March 2024

Case Study on Management of Indirect Products Contact Parts in an Isolator
Antoine Toussaint, GlaxoSmithKline Vaccines

  • Definition of indirect product contact part
  • Regulation’s requirement
  • Example of implementation along the all lifecycle of indirect product contact parts

Meeting EU GMP Annex 1 Requirements: Sterilization of indirect Product Contact Parts in Filling Lines using Sterilization Container
Dr Annika Bernsdorf, GlaxoSmithKline Biologicals

  • Overview of the design of the current filling isolators at a GSK Vaccines manufacturing site and the challenges linked to traditional sterilization methods for parts indirectly in contact with the product
  • Explanation of the features and benefits of sterilization containers as a compliant solution
  • Customization of the containers to accommodate larger parts, such as the stopper bowl and stopper hopper
  • Development of an improved line setup with enhanced contamination control

Upgrade of H2O2 Decontamination System for Production of RABS Vial Filling Line
Pasquale Cataldo, Roche Diagnostics
Kenan Kanmaz, Optima pharma containment

  • Current process, why this upgrade – Annex 1
  • Project challenge – timeline & installation vs. production
  • Production shutdown and realization
  • Risk and other key tasks of upgrading
  • Results of project, cycles development and benefits
  • Key features and advanced technologies of DECOpulse® – effective H2O2 Bio-decontamination system

Case Study Janssen: Flexible fill & finish Equipment for Multi-Product Manufacturing Processes
Dr Göran Crucius, Cilag / Janssen
Patrick Wieland, Bausch+Ströbel

  • Flexible multi-product fill and finish lines in pharmaceutical manufacturing offer several benefits that can help pharmaceutical companies improve their efficiency, flexibility and overall productivity
  • Case Study of Janssens flexible pharma production to meet varying market demands and maintain product quality

Modern Sterile Test Isolators – Safe, Compliant, Efficient, Versatile
Katharina Schlereth, Labor L+S
Harald Kiesel, Skan

  • Components of a modern Sterile Test Isolator
  • Safe for operator and process
  • Compliant during all aspects of use
  • Efficient by adaptable to required processes
  • Versatile in handling options

Case Study: E-Beam – A validated Transfer Method for RTU into Grade A in Compliance with Annex 1
Anette Mörbel-Witte, Sanofi-Aventis Deutschland
Manfred Holzer, Skan

  • E-beam used as transfer technology related to Annex 1
  • Options for transfer of RTU
    • Emitter Technology
    • Properties of E-beam
  • Validation
  • History & Outlook
  • Case study Sanofi Multi-Fill line
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