European Aseptic Technologies & Annex 1 Conference

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

Tuesday, 24 March 2026

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

• Global Adoption of EU GMP Annex 1
• Ongoing Challenges in Sterile Manufacturing related to Annex 1
• Monitoring Annex 1 Compliance Across CMOs and Manufacturing Facilities
• QP Role in Batch Certification

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

• Highlight new GMP Annex 1 requirements, mainly tailored to large-scale industrial manufacturing
• Discuss the unique challenges faced by small and medium-scale operations (products, processes, interventions, materials, technologies)
• Examine key focus areas: RABS and barrier technologies, PUPSIT, single-use systems (SUS), aseptic process simulation (APS)
• Address the role of process automation in maintaining compliance and efficiency

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
  
  

Unlocking PUPSIT: Key to Successful Automation
Laura Prijot, Cilyx

• Presentation of automated PUPSIT skid
• Explanation of strategy to reduce product loss optimization
• Experience from users
  
  

Paramtric Release
Dr Ingrid Walther, Walther Pharma Consulting

Contamination Control Strategy – Recent Insights
Dr Frank Sielaff, Regional Authority

• Understanding of the requirements
• Inspector's expectations
• Experiences from GMP-inspections

Wednesday, 25 March 2026

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

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

• How CFD can support the design and optimizaton of a cleanroom ventilation system in a CCS-oriented way
• Case-study: Filling Room of the new Pierrel cartridge department for the aseptic production of dental anesthetics
  • Protected by a RABS
  • Integrated within a B-grade cleanroom
  • Full-coverage HEPA filter air diffusion

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
  
  

Development of Sterilization Validation Strategy For a Special Application
Cecilia Pierobon, Steris Life Sciences
Jasmin Knobe, Atec Pharmatechnik

• Perspective of Annex 1 and ISO regulations on sterilization validation and routine monitoring
• Bowie-Dick test and bioindicators principles and functioning
• Special design characteristics and challenges for implementation
• Development of bioindicators mapping strategy
• Realization of air removal test for routine monitoring

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