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ECA - Aseptic Processing

Current Aseptic Technologies (9. April 2018)

Objectives

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
  • 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 manufacture.

Moderator

Gert Moelgaard, ECA Validation Interest Group

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
Pharmaceutical industry in digital change

Thomas Reiner, CEO, Berndt+Partner

  • Changes in the value chains
  • Opportunities and risks for production processes
  • What can and will change for packaging?
  • Strategies to benefit from Change

 

Innovative therapeutic options – a challenge to aseptic Technologies
Gert Moelgaard, ECA Validation Interest Group

The landscape of pharmaceutical products and production is changing fast at the moment. The next generation of treatments becomes a reality and raise significant challenges to production, facilities and technologies of the future. New therapies are making significant Progress and the pharmaceutical manufacturing is starting to adapt to the challenges.

The evolution of current aseptic Technologies
Dr. Friedrich Haefele, Boehringer Ingelheim Pharma

Today's aseptic production and regulations holds many interesting possibilities, mainly due to new process improvements such as biotech titer improvements, single use technology and flexible aseptic production technologies and 100% inline controls. The new regulations on EU Annex 1 on Sterile Products and Annex 17 on Real Time Release Testing and Parametric Release gives new challenges and opportunities for practical production.

Case study Vetter Pharma-Fertigung: Next steps in the development of V-CRT®; Analytical monitoring of H2O2 decontamination processes
Dr. Ute Schleyer, Vetter Pharma-Fertigung

  • Within the Vetter Cleanroom Technology (V-CRT®) concept a Batch specific H2O2 decontamination of the entire cleanroom mitigates the risk of microbial contamination
  • To mitigate the risk of the decontamination agent on the drug product, an encompassing H2O2 monitoring system was established
  • Whereas H2O2 is continuously monitored in the cleanroom, Analysis of filled syringes, cartridges and vials is carried out upon customer’s request
  • Therefore, the advanced technology together with the comprehensive analytical approach reaches quality and safety standards well exceeding cGMP requirements

Challenges in the Drug Product Manufacturing of high value, high potent injectable
Daniel Kehl, Swissfillon

  • There is a trend of the pharma market to a wide variety of high potent, complex new drugs
  • Definition of high potent drugs
  • Challenges of the drug product manufacturing
  • Presentation of a validated solution considering the various regulatory and safety influencing parameters related to: Filling machine, Environment, Waste

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.

Bosch PreVAS Single-Use Dosing System PreVAS means: - PreValidated / - PreAssembled / PreSterilized
Robert Bosch

Sterilizer validation / qualification made easy
Ellab

DECOpulse® – The H2O2 bio-decontamination system with atomization-driven Evaporation
Metall + Plastics

Substitution of formaldehyde room decontamination by hydrogen peroxide and acceleration of decontamination process by application of innovative catalyst Technology for effective decomposition of hydrogen peroxide
Stefan Bieler, IDT-Biologika

  • Required performance of the decontamination process (kill of bacterial and viral bio indicators)
  • Comparison of the different decontamination processes regarding room and HVAC requirements
  • Implementation of catalysts in different room and HCAV Scenarios
  • Acceleration of degassing process with catalyst (presenting tests results)
  • Principle of heterogeneous H2O2 catalysis

 

RABS and Isolators (10. April 2019)

Objectives

This is why you will benefit from attending this conference: ƒ.Case studies from various pharmaceutical companies deal with the implementation, qualification and operation of Barrier Systems.

  • You will discuss the current state of the art and new technological developments in Barrier Systems technology.
  • You will get to know first hand the new EU-GMP Annex 1 draft requirements on Isolatores and RABS
  • Experts from pharmaceutical companies will share their knowledge regarding operational experience

Background

The protection against microbial contamination is the most important point for drugs produced by aseptic processes. Today the regulators require a more strict separation between operators and product in the form of an access barrier.

Two systems are on the market – RABS (Restricted Access Barrier System) and Isolators. But only isolators are referred to by the US FDA as advanced aseptic technology.

This conference will focus on current questions of barrier systems coming from FDA regulations as well as from the revised EU-GMP Annex 1, and it will specifically address the subject from the perspectives of pharmaceutical operators, planners and engineers.

Moderator

Didier Meyer, DMCompliance

Target Audience

This event is directed at decision-makers from pharmaceutical production, development and quality assurance/control. It also addresses engineers and planners who need to be well informed about current developments in the field of barrier Systems.

Programme

CONGRESS KEYNOTE
EU GMP Inspection in Sterile/Aseptic Production
Klaus Eichmüller, Wolnzach, c/o Regional Council Darmstadt, GMP Inspectorate, Germany
Head of Inspectorate

  • Main focus areas of inspections
  • Frequently detected findings
  • Data Integrity issues – where are possible weak spots?
  • Possible new areas due to the revision of Annex 1 and further regulatory changes

 

Closure Processing System for rubber stoppers: key aspects to consider to ensure process robustness in routine production
Sandrine Favre, Octapharma

  • Introduction into Octapharma Project
  • CPS design Phase
  • Cycle development and process characterization
  • Learnings

Case study GSK Vaccines: Isolator decontamination by H2O2 nebulization process
Patrick Vanhecke, GSK Vaccines

  • VHP process versus H2O2 nebulization process
  • Cycle development for nebulization process
  • Pros and Cons for both processes
  • Manufacturing applications

Key considerations for gene therapy manufacturing from early stage to fill-finish operations
Thomas Page, Fujifilm Diosynth Biotechnologies

  • The importance of flexibility and high containment requirements;
  • Applications of closed systems in designing the manufacturing process
  • Differences in facility design, qualification and validation for gloveless isolators versus conventional isolators and
  • Treating facilities as pieces of equipment for advanced therapy manufacturing

The specific case of use of isolators and biosafety cabinets type III in Hospital Pharmacy
Prof. Farshid Sadeghipour, Lausanne University Hospital

  • Isolators for Non-Toxic Aseptic preparations
  • Isolators and BSC an for Cytostatic Injectable preparations
  • Sterility testing
  • Perspectives with ATMP
  • Perspectives with automation

Barrier Systems and Annex 1: GMP Inspectors’s point of view
Dr. Daniel Müller, GMP Inspectorate Baden-Württemberg

  • Most important changes of Annex 1 – an update
  • Regulatory comparison of Annex 1 version 2018 and new / intended Annex 1
  • GMP inspector’s comments on new / intended requirements for barriers