European Aseptic Technologies & Annex 1 Conference

24/25 March 2026, Wiesbaden/Germany

Objectives

Reasons to attend this conference:

  • You will be informed about new regulatory and technological developments in aseptic / sterile manufacturing
  • You learn how current GMP and production requirements have to be implemented technologically in sterile manufacture  
  • Pain points will address issues that are difficult to put into practice in the industry
  • You will get case studies from pharmaceutical companies

Registration

Background

The revised EU GMP Guideline Annex 1 was published in August 2022 after extensive discussion  – and came into force in August 2023. Among other things, the consequences of this revised Annex 1 will be presented and discussed with inspectors and industry representatives. The discussion on Annex 1 will be complemented by case studies from pharmaceutical companies on new technological developments in the pharmaceutical production environment.

Target Audience

The event is directed at specialists and managers from the pharmaceutical industry as well as at engineers and planners who have to deal with European Annex 1 and current aseptic technologies in clean areas in their daily practice.

Moderator

Dr Ingrid Walther, Pharma Consulting Walther

Detailed Programme

Challenges in the Technical Implementation of the New Requirements of Annex 1 in Small-Scale Production
Marta Rodríguez Vélez, Letipharma

Considerations and Requirements for Pupsit-Implementation in Existing Clean Rooms and Established Processes
Dr Philip Hörsch, Vetter Pharma-Fertigung

  • Inventory of existing process variants and process characteristics
  • Application of risk management for the design of the Pupsit process
  • Implementation strategy and requirements for the roll-out
  • Process changes and impact on filing

Case Study: Re-Imagining of Controlled Rate Freezing and Thawing Processes
Thorsten Häfner, PSM
Fabian Plaum, HOF Sonderanlagenbau

  • Process overview of plate freezing and thawing processes for single- use bag systems  
  • Sustainable refrigeration technologies with regards to regulatory affairs  
  • Advantages of sustainable solutions  
  • Case Study for the implementation of a HOF Freeze-Thaw Unit Air-Line at the PSM site

Design and Advanced Features of a CDMO High-Potent Freeze-Drying Filling Line
Nils Henrichs, Simtra BioPharma Solutions
Ralf Wagner, Optima pharma

  • Design and special features for filling of high-potent products
  • Isolator technology and filter concept  
  • Isolator zone concept for maximum flexibility during production and bio-decontamination
  • Overall SCADA architecture for filling line, isolator and freeze-dryer  
  • Aseptic set-up of filling path

Integrity Assurance for Closed Single-Use Systems in Aseptic Processing: A Risk-Based Framework Reflecting Practical Realities and Industry Approaches
Dr Simone Biel, Merck Life Science

  • Alignment of integrity assurance of SUS with wider contamination control strategies
  • Insights from an industry-wide benchmarking survey: current practices, operational considerations and practical realities
  • Evolving expectations around integrity assurance approaches

Implementing a Contamination Control Strategy in an Aseptic Biotech Facility: Addressing Annex 1 Challenges in Open RABS Environments
Virginia Valle Lisboa, ICLOS

  • The design and documentation of a CCS tailored to an aseptic biotech facility
  • Risk-based justification for process design
  • Enhancements in environmental and surface monitoring to meet revised Annex 1 standards, including data trending, critical surface assessments, and monitoring strategy adjustments

Navigating Annex 1 Compliance Globally: Strategies and Learnings
Dr Aleksandra Pekosak, Kyowa Kirin

How CFD (Computational Fluid Dynamics) can support C.C.S. in the Design and Operation of a Fill-Finish Aseptic Process
Toni Valente, Pierrel
Lapo Galligani, TECHNICONSULT Firenze

CCS (Contamination Control Strategy) from an Inspector’s Point of View
Dr Frank Sielaff, Regional Authority

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