Aseptic Manufacturing & Technology

Objective

Reasons to attend this conference:

  • You will be informed on new regulatory and technological developments in aseptic / sterile manufacturing
  • You will 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

Moderators

Dr Friedrich Haefele
Jörg Zimmermann

Detailed Programme

Presentations - 28 March 2023

Energy Saving in Class C Cleanrooms Through Reduced Air Change Rates – a Case Study from a Biotech Company
Detlef Behrens, University of Applied Sciences / Philips University

  • Regulatory expectations and typically used air change rates in cleanroom manufacturing
  • (Continuous) Control of particles and colony forming units
  • Results of a long-term study in various cleanrooms with different air change rates
  • Actually required air change rates for class C "in operation" and resulting potential for energy saving

Continuous Freeze Drying
Dr Friedrich Haefele, formerly Boehringer Ingelheim Pharma

  • Freeze drying in Food and Pharma
  • Market survey
  • Batch process lyophilization
  • Applications for continuous lyophilization
  • Outlook

Implementing of PAT Tool for Lyophilization
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Dr Frank Deisel, Tempris

  • Implementation of a PAT Tool in aseptic conditions with automatic loading in commercial lyophilization

Single Use V Re-usable the Changing Face of Sterile Filling
Steve Hughes, BPL

  • Current Practice
  • Reason for change
  • Development
  • Testing
  • Completion

What if Final Product Filtration is Not Possible? Challenges and Opportunities of Aseptic Manufacturing for Large Viruses
Margarida Rosa, GenIbet Biopharmaceuticals

  • Process Workflow
  • Validation protocol that comprises operator validation, gowning considerations, and other points as requested in EudraLex Annex I
  • Environmental monitoring strategies
  • Materials and/or the equipment - guarantee their correct flow and proper disinfection to prevent contamination and cross-contamination
Presentations - 29 March 2023

Preparing the Facility for Extended Global Markets-Case Study
Raquel Arenós, INIBSA
Londa Ritchey, Pharmalex

  • Planning, Investments & Timelines
  • Global Compliance Considerations & Challenges
  • Partnering to supplement Compliance Knowledge
  • Change Management - Producing & Improving at the same time
  • Sustaining Compliance with Global Regulations

Fast Track Tech Transfer - Experience & Best Practices: Aseptic Filling & Lyo CSL Behring Project
Steffen Mörler, CSL Behring

  • Key Challenges
  • How to Accelerate
  • Best Practice Example
  • Team Set up

Flexible Solutions for Different Market Requirements
Rainer Glöckler, swissfillon
Ralf Wagner, Optima pharma

  • High potent requirements and technical executions
  • Processing of different primary packaging containers
  • Machine concepts for different outputs including easy scale-up to production

Relocation of a Capping Machine to an Existing Production Line and Insertion of an Automatic Vial Inspection (AVI)
Christoph Möller, Burgwedel Biotech (MSD)
Lizar Duhoki, Chemgineering

  • Relocation of the capping machine
  • Integration of capping and filling line
  • Face opening for the insertion of the AVI
  • Insertion and Installation of AVIEnergy Saving in Class C Cleanrooms Through Reduced Air

Innovative Ozone Decontamination Process Including Areas of Application and Practical Example
Bernd Geis, Managing Partner Process
Matthias Buttazoni, Ortner Reinraumtechnik

  • Microbiological use of ozone as a decontamination agent
  • Technical description of ozone technology in plant construction
    • Ozone generator
    • Required security technology
    • Catalytic decomposition of ozone
  • Comparison of decontamination cycle times
  • Presentation of the technology using the example of a large-scale material lock in the pharmaceutical environment.
  • Effort of process implementation

Critical Thinking and Risk Management in Construction Projects as a Means to maximize Value – a Template for new CR Site in Kaarst
Carsten Jasper, Charles River Laboratories

  • Critical thinking and risk management are defined and a common understanding is created
  • Latest Charles River construction project Kaarst site in Germany is introduced
  • Requirements and inputs for the construction project are described with a focus on reagent manufacturing and the clean room facilities processes
  • Based on the requirements and inputs the challenge of GMP (customer expectation) vs necessary quality level and costs is worked out
  • Critical thinking and risk management are described as levers to design fit-for-purpose solutions and optimize cost-benefitratio (value)
  • Based on a specific challenge method limitations are described (in this case technical limitations of the building)

Airflow Visualization According to New Annex 1
Luigi Scaffidi, Boehringer Ingelheim Pharma

  • Regulatory background
  • Visualization Methods
  • Life Cycle
  • Which tracer particles are suitable for cleanrooms?
  • Case Study: Interface Airflow Visualization to APS
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