European Aseptic Technologies & Annex 1 Conference

Objectives

Reasons to attend this conference:

• You will be informed on 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

Register as a congress delegate for just 690 EUR/day!
This special offer is only valid until 31 December 2024!

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.

Moderators

Dr Ingrid Walther, Pharma Consulting Walther
Robert Schwarz, FH Campus Wien und GXP-TrainCon

Tuesday, 8 April 2025

09.00 - 18.00 h

Pain Points with Annex 1

Quality Risk Management in Aseptic Manufacturing: Reasonable Use
Dr Ingrid Walther, Pharma Consulting Walther

Sterile Filtration – PUPSIT and Requirements beyond
Dr Frank Sielaff, Regional Authority Darmstadt

• Requirements of Annex 1
• Expectations on PUPSIT
• Expericences from inspections
  
  

Practical Application of setting up an annual Contamination Control Strategy (CCS) Assessment
Ruben van der Galiën, GE HealthCare
Dr Prachi Sawant Raschdorf, GE HealthCare

• Practical application of setting up an annual CCS assessment within a pharmaceutical sterile and/or aseptic manufacturing company
• Annually assessment of the effectiveness of a CCS
• Keeping the CCS up to date by reflecting the current state of all sources of contamination
• Room for continual improvement
  
  

"RTU + RTS Materials – GMP Requirements for the Pharmaceutical Manufacturer and Supplier Qualification”
Dr Rainer Kahlich, Local GMP Authority of Baden-Württemberg Tübingen

• Effects of the Annex 1 revision
• Expectations for supplier qualification
• Incoming goods inspection and handling at the pharmaceutical manufacturer
• Benefits of certification according to ISO 15378
  
  

Contamination Control Strategy of RTU-Packaging Systems in relation to Annex I
Horst Koller, HK Packaging Consulting
Katharina Golly, Novartis Pharma

• Product Containers & Closures
• Sterilization Validation
• Transport Simulation
• Aseptic Processing
  
  

Steam Sterilized Isolators solve indirect Product
Contact Surface Dilemma (bowls/lanes)
Dr Geert Vandenbossche, C&E Solutions BV

• The new Annex-1 revision requires sterilization of all surfaces that touch critical components
• Possible solutions:
  • Snap-on caps
  • Offline autoclaving
  • In-situ SIP of critical component contact items
    
    

Wednesday, 9 April 2025

09.00 - 17.00 h

Fill & Finish of various Ready-to-Use Containers from clinical late Stage until commercial Launch of Biologicals through to high-potent Products
Stylianos Sampanis, Sanofi-Aventis Deutschland GmbH
Ralf Wagner, Optima pharma

• Filling line for a maximum of flexibility and various product requirements
• Technologies for minimizing product loss and solutions for reduced change over times
• Robotic applications for various requirements in isolator environment
• Clinical late stage applications until commercial launch

Accelerating Pharmaceutical Manufacturing: A Case Study of entering Syringe and Cartridge Fill-Finish Production
Henning Austermann, Siegfried Hameln
Klaus Ullherr, Syntegon Technology

• The seamless integration of a state-of-the-art fill finish solution within an existing production environment
• Key technical features of the machine
• Packstyle flexibility, enabling rapid adaptation to changing market requirements
• No-touch-transfer system ensuring sterility and contamination control
• 100% in-process control (IPC) enhancing product quality and compliance
• Integration of in-air isolator
• Operational efficiency with peristaltic pump with single-use filling systems
• Implementation of Annex 1 requirements in practice
  
  

H₂O₂ Ingress Study Approach for Isolator Decontamination of the AT-Vials
Dr Maria Loos, Johnson and Johnson
Adrian Keller, SKAN

• Study objective: To investigate H2O2 entry into AT vials and its effects on the filled product
• Study design: Details of the experimental setup and control groups
• Results: Interesting findings and conclusions
• Implications: Possible effects on product quality and safety
  
  

Container Closure Integrity Test
Luigi Scaffidi, Boehringer Ingelheim Pharma

• Regulations / Guidelines / Recommendations
• Overview Test procedures (in development and production)
• Norm leakage
• Case Study Boehringer Ingelheim
  
  

Flexible Production for Parenterals, from Vision to Execution
Dr Friedrich Haefele, Formerly Boehringer Ingelheim

• Evolutionary and revolutionary aspects in innovative facility design for parenteral products
• Aseptic filling & closing in gloveless isolators or better closed systems
• Unit operations for aseptic filling & closing
• Unit operations of aseptic lyophilization and/or coating of biomolecules
• Unit based 100% IPC and parametric release