Robotic Isolators – Challenges and Modern Monitoring Systems
05 May 2022
Objectives
Aseptic production has always been complex and cost-intensive and the risk of contamination high. To minimise the risks, the techniques used have become increasingly sophisticated, from simple cleanrooms, sterile workbenches and RABS to the classic isloators. With the new possibilities of automation, digitalisation and rapid microbiological methods, there are currently even more opportunities to minimise contamination risks and optimise processes. This also, or especially, plays a role in the production of novel therapies with biological starting materials, which often have small batch sizes.
One possible method is the use of modern isolators, without gloves, automated and in combination with modern real time or online monitoring systems. However, when establishing such systems, the user is faced with the challenge that the currently valid regulatory requirements were often oriented towards the previous systems and are difficult to apply across the board for modern systems, either because given limits were derived from the less sensitive systems or because comparability of the results is difficult or impossible to achieve due to the different methodologies.
This workshop will provide an insight into the view of a GMP inspector, an introduction to available techniques and systems, as well as industry experience in implementation and the hurdles that may be encountered in regulatory acceptance.
Target Audience
This workshop is aimed at all those involved in manufacturing, quality assurance and quality control who are concerned with the possibilities of barrier technologies and modern monitoring systems and with the challenges of implementation and the requirements of the authorities for new technologies.
Moderators
Dr Wolfgang Eder
Roche Diagnostics
Axel Schroeder
Concept Heidelberg
Programme
Part 1: Technical Principles and Challenges
Functional principle and background
Christian Siegmund, F. Hoffmann-La Roche
- Zone classifications within the Vanrx SA25
- Horizontal air flow
Challenges in Aseptic Filling
Thomas Thurn, Cilag/JnJ
- Consideration of Robotic Solution in Aseptic Filling
- Aseptic Smart Fill Concept Study
Robotic Fill & Finish
Ute Schleyer, Vetter
- Robotics used for all main activities
- VHP cycle prior to aseptic set-up
Part 2: Challenges and Hurdles – Modern Monitoring in Isolators and Implementation Experiences with Authorities
Monitoring for viables in closed robotic isolators
Winnie Hagen Madsen, Novo Nordisk
- Limitations and possibilities
- Authority expectations
- Use of BioTrak
Process Controls for Gloveless Isolator Systems
Hoang Phan, Roche/Genentech
- Current process controls were designed around cleanroom, RABS, or gloved isolator filling systems
- A new class of gloveless isolator system that have designed out traditional risks should then allow for a different approach to process control
Challenges and requirements during introduction of a continuous monitoring system for viable particles in a new robotic filling line
Ruth Barensteiner, Cilag
- Implementation Strategy
- Example for a continuous monitoring set-up
- Challenges
Health Authority Expectations Regarding Gloveless Isolator Implementation
Kevin Gadient, Emergent
- Process Overview
- Feedback from FDA & Health Canada
Part 3: Personal view and expectations of a GMP Inspector
Dr Daniel Müller, GMP Inspector
- Current regulations for isolators / barrier systems, including EU Annex 1 (revision)
- How far are robotic systems addressed in guidelines?
- Challenges and discussion points
Part 4: CMO Perspective and Experience of Recent Inspections
Youwen Pan, WuXi Biologics
- Experience of recent interactions with inspectors from FDA and China NMPA on Vanrx SA25
Panel Discussions and Q&A with Speakers and Experts
