From Challenges to Solutions: Enhancing Automated Environmental Monitoring in Gloveless Isolators
WEBINAR
Follow an engaging webinar that explores the latest advancements in automation within fill & finish processes, with a special emphasis on the Ready-to-Use (RTU) Isobag® Auto solution and its role in enabling the automation of Environmental Monitoring (EM). This session highlighted the significant benefits of a gloveless fill-and-finish process, ensuring compliance with Annex 1 requirements for sterility and safety.
We addressed the challenges associated with conducting Environmental Monitoring within closed isolators and underscored the critical importance of collaboration among stakeholders in developing robotic-friendly consumables and solutions. By showcasing successful partnerships, we demonstrated how innovation can enhance operational efficiency.
Insights from industry leaders, including Groninger and Roche, provided valuable perspectives on the complexities and solutions for implementing effective automated EM testing, ensuring ongoing compliance and safety in fill-and-finish operations. Don’t miss this opportunity to learn how these advancements can transform your processes and drive success in your organization.
In this webinar, we cover:
- Advantages of a gloveless fill & finish process and introduction to the robocell equipment developed by Groninger
- Challenges associated with automated EM testing in a closed isolator
- Benefits of a user network in developing a RTU solution
- Importance of robotic-friendly consumables and introduction to the RTU Isobag® solution
Speakers
Anke Hossfeld
Merck
Marketing Director, Automation & Digitalization
Anke is Marketing Director for Automation and Digitalization at the Life Science business of Merck KGaA, Darmstadt, Germany. She is responsible for the innovation strategy of new products for microbial QC testing in the pharmaceutical industry using automation, robotics and digitization. Anke started her career in 2008 at Biotest AG as International Product Manager for alternative pyrogen and mycoplasma tests. In 2011, Anke joined as Global Product Manager and has since been responsible for the product portfolio, life cycle management and new product developments in various QC applications such as bioburden, sterility, pyrogen and rapid technologies.
Julia Mathy
Roche
Primary Packaging and Product Process Lead
Julia joined Roche in 2020 and went through roles such as Process Engineer, Subproject Lead for visual inspection, and took over the Process Lead role for our new gloveless Robotic Filling Line in 2023.
Julian Petersen
Groninger
Head of Business Development Pharma
Julian actively contributes to the industry as a member of the PDA SAB and co-leader of the PDA Sterile Processing Interest Group. Additionally, he is involved in several task forces, such as drafting Points to Consider (PtC) documents on Aseptic Filling and Restricted Access Barrier Systems (RABS). Julian’s industry contributions extend to being the President of the newly founded PDA D/A/CH Chapter.
Furthermore, Julian is part of the planning committee for the PDA Annual Meeting and the latest PDA workshop on Manufacturing Meets Legislation. He also contributes actively to ISPE as part of the Sterile Products Processing COP Steering Committee and is involved in other industry initiatives, such as BioPhorum.
Analytical chemistry
- Microbiological testing
期间:1h
语言:English
场次 1:往期 November 6, 2025
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