European Aseptic Conference

Implementing of PAT Tool for Lyophilization
Dr Patricia Desmaris, Merck Serono
Anton Mangold, Tempris

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

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
  
  

Energy Saving in Class C Cleanrooms Through Reduced Air Change Rates – a Case Study from a Biotech Company
Dr 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
  
  

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)
  
  

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

Inspection Readiness in View of Annex 1
Dr Stephan Heck, Bipso
Dr Ralf Aubeck, gempex

• Regulatory background
• Contamination Control Strategy – The new document
• Key aspects of new Annex 1 – Qualification & shop floor excellence
• Authority inspections - local & virtual

Getting the Basics right
Owen Prichard, Consultant

• Viral vaccine manufacture: upscaling, process validation, and sterility testing
• Supply chain issues and inter-departmental change control procedures
• Repeated problems for lack of communication

Cross-Contamination: Other Aspects than Cleaning Validation
Dr Jean-Denis Mallet, ECA

• Secondary aspects affecting that risk
• Personnel gowning and personnel behavior
• Materials handling from the synthesis to the compounding
• Equipment not fully designed for the tasks of handling highly potent materials e.g. not preventing all spillages
• Environment, that should be normally free of (any) active substance while a proper aseptic "cascade" can also bring particules away from the point of fill
  
  

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
  
  

Sustainable way of flexible filling – prepared for future demands
Martin Frei, Lonza
Patrick Wieland, Bausch + Ströbel

• Optimizing utility consumption
• Minimizing product waste by reducing reject rates
• Saving resources and boosting efficiency
• Maximizing the use of available space
• Could fill-finish systems really be ready for future demands?
  
  

Annex 1 and the Related Improvements Out of Machine Vendor Perspective
Dr Fritz Haefele, formerly Boehringer Ingelheim Pharma
Jill Dietrich, Bausch + Ströbel

• Expectation of the pharmaceutical industry
• Impacts on existing equipment
• Challenges for new equipment installations
• Recommendation by a machine vendor how to be prepared for the future

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
  
  

Innovative Ozone Decontamination Process Including Areas of Application and Practical Example
Bernd Geis, Process [.-ING] Gesellschaft für Projekt- und Qualitätsmanagement
Julian Ott, Process [.-ING] Gesellschaft für Projekt- und Qualitätsmanagement
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
  
  

Flexible Solutions for Different Market Requirements
Rainer Glöckler, ten23 health
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
• Facade opening for the insertion of the AVI
• Insertion and Installation of AVIEnergy Saving in Class C Cleanrooms Through Reduced Air
  
  

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