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ECA - Current Aseptic Technologies

 

Current Aseptic Technologies (24 March 2020)

Objectives

Reasons to attend this conference:

  • You will be informed on new  technological developments in sterile / aseptic manufacturing
  • You will learn how current GMP and production requirements have to be implemented technologically in sterile manufacturing
  • You will get case studies from pharmaceutical companies
  • Live Demos will show you how technologies perform

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 manufacturing.

Moderator

Gert Moelgaard, ECA Validation Interest Group
Jörg Zimmermann, Vetter Pharma-Fertigung

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

 

Programme

CONGRESS KEYNOTE

Annex 1 Revision – the long and winding road
Dr. Bernd Renger, Immediate Past Chair, European Qualified Person AssociationThe drivers of change

  • New paradigms and concepts
  • Contamination Control und Quality Risk Management
  • Stakeholder consultation
  • New expectations to Media Fills and Lyophilisation
  • The big challenges – CCIT and PUPSIT

 

Challenges in manufacturing high value lyophilized oncologics - a case study
Fabio Gentilini, BSP Pharmaceuticals

  • BSP’s requirements for a flexible CMO sterile suite with space constrains for high value oncological products containing solvents under isolation technology
  • Suppliers provided solutions including:
    • Reduced foot-print equipment
    • Innovative loading/unloading system (including cold shelf loading)
    • PAT tools (including nucleation)

From design to construction of a new integrated fill & finish facility – combination of proven and new
technologies
Dr. Gabriele Sabine Roidl, Lonza

  • Installation of a new drug production line
  • Using modern and innovative technologies
  • Vial filling line with isolator technology and 2 lyophilizers

LIVE DEMOS
In the practical part of the conference, suppliers will show you different components and solutions. You will come in contact with the equipment and you have the chance to discuss your questions immediately with technology experts.

B+S Multi Dosing System - 3 in 1
Bausch + Ströbel
Collaborative robots
Steriline
Isolator Technology & RTP Transfer Systems
Metall + Plastics / Castus

Case Study: Cycle Development & Validation of automated AHP decontamination processes for cleanrooms
Markus Lesch, Vetter Pharma-Feritung

  • Design of decontamination system & cleanroom
  • Optimization of aerosolized amount of H2O2
  • Selection of positions to be challenged with indicators
  • Optimization of relative humidity
  • Optimization of decontamination time
  • Value of chemical indicators for validation of AHP processes

EirGen Pharma – How state-of-the-art fill & finish equipment flexibility supports CMO business
Dermot O'Riordan, EirGen

  • Possibilities and challenges when processing various RTU packaging components
  • Challenges of filling non- to high-potent products
  • Flexibility in aseptic filling processes
  • Challenges of manufacturing different products with different batch sizes