European Aseptic Conference

Objective

Reasons to attend this conference:

  • You will be informed on new regulatory and technological developments in sterile / aseptic manufacture
  • You learn how current GMP and production requirements have to be implemented technologically in sterile manufacture
  • You will get case studies from pharmaceutical companies

Background

GMP regulations only define general requirements for equipment – it has to be suitable for the intended work process, easy to clean and without any negative influence on the product quality. Questions like how these general requirements have to be fulfilled concretely in sterile manufacture, which points call for special attention and which new technologies will be used in the future are in this conference’s focus. Speakers from the pharmaceutical industry and from planning and engineering companies deal with pivotal developments in the field of sterile manufacture.

Target Audience

The event is directed at specialists from the pharmaceutical industry as well as at engineers and planners who have to deal with current aseptic technologies in clean areas in their daily practice. It particularly addresses the departments:

  • Production
  • Quality assurance
  • Engineering / Technology

Moderator

Dr. Friedrich Haefele

Programme Download

Please click on the programme image to download the programme as PDF.

Registration

To register for the conference, please see the registration options.

Detailed Programme

Presentations - 31 May 2022

A new Industry Standard for Automated Fill & Finish of Small Batches
Dr Ute Schleyer, Vetter Pharma-Fertigung
Tobias Goettler, Syntegon Technology

  • Highly flexible production cell
  • Gloveless Isolator
  • Complete automated set-up, filling and monitoring process
  • Processing of aseptic and high-potent micro batches
  • Focus on loss-free filling and fast batch changeover times
  • Compliance with regulatory requirements

SANDBOX Concept Roche Mannheim, Germany – Playground for new Technologies / Robotics in Pharma – Challenges and Chances
Marko Hahn, Roche Diagnostics
Rudolf M. Weiss, Stäubli Tec-Systems

Implemenation of a gloveless Robotic Filling Line at the German CDMO PSM GmbH in Light of the new EU GMP Annex 1 (Draft)
Bianca Bohrer, PSM/Topmedicare
Thorsten Häfner, groninger

  • Planning, decision making process and execution of an industry 4.0 CDMO expansion project
  • Challenges in planning with regards to the new Annex 1 (draft) especially for high potent products
  • Benefits of the installation of a gloveless robotic filling line for a CDMO

Bio-Decontamination of 1,500 m2 Pharma Production using one fully automated Decontamination System
Maria Jasmin Müller, IDT Biologika
Matthias Buttazoni, Ortner Reinraumtechnik

  • Conceptual design, CFD simulations, planning
  • Ventilation, gas injection and application technology
  • Degassing via catalyst system
  • Monitoring and measurement system of H2O2 concentration in a room
  • Fumigation system independent of room loading
  • Cycle development & cycle validation (Geobacillus stearothermophilus, Virus: MVA, MVM)
  • Automation & visualization
  • Safety, flexibility and efficiency of the system

Novel Ways of Rapid Freeze Drying
Benjamin Ledermann, GEA Lyophil

  • Microwave-assisted freeze drying
  • Drying time reduction
  • Process optimization
  • Assessment of critical quality attributes

Use and Design of Disposable Filling Isolator Technology
Frank Pavan, GTP Nano

  • Presentation of a new design of a unique disposable isolator completed by GTP Nano
  • Address all requirements of sterile manufacturing in a worldwide regulated environment
  • Improvement of the SAL
  • Improvement of the capacity of the facility in addition to the business capacity.

STISO® with DECOpulse® – 3 x validated Sterility Test Isolators for Roche Microbiology
Lena Hartling, Roche Diagnostics
Kenan Kanmaz, Metall + Plastic

  • Project challenge from the first step - timeline
  • Room concept of Microbiology Labor an realization
  • Loading of the isolator and handling
  • Key features and advanced technologies of STISO® terility test isolators
  • DECOpulse® H2O2 Bio-decontamination System
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