European Microbiology Conference

Programme

Inspection of Microbiological Laboratories
Dr Franz Schönfeld, GMP Inspectorate Upper Franconia

• Room requirements
• Equipment - qualification, calibration
• Typical findings and weak points

Case Studies on Contamination Control Strategies for Non-Sterile Manufacturing Facilities
Dr Michael Miller, Microbiology Consultants LLC

• Understand the regulatory expectations for contamination control in non-sterile manufacturing
• Review recent contamination and recall events for aqueous-based products due to contamination issues
• Discuss practical examples of strategies to remediate and prevent contamination by relevant microorganisms, including Gram-negatives

Observations related to the use of environmental isolates in microbiological quality control testing – How to handle
Brice Lantheaume, Microbiologics

• Why to include environmental isolates in pharmaceutical testing?
• Factors which make an organism objectionable
• Determining which organism to use in routine Microbiology testing

Taking a Macro view of your Microbiota: how COVID bugged your Contamination Control Strategy
Duncan Barlow, CRL

• Effect of the pandemic in terms of implementation of new procedures and disinfection processes
• Is there an impact on industrial microflora and if so, how?
• Case Study: Identification of isolates in pharmaceutical companies before, during and after the pandemic
• Trends and Analysis

FDA’s Current Regulatory Expectations for Rapid Microbiological Method Validations
Dr Michael Miller, Microbiology Consultants LLC

• Review FDA’s expectations for regulatory submissions of quantitative and qualitive method validations, based on discussions held at the October 2022 Rapid Microbiology Methods workshop
• Understand how to conduct relevant validation criteria and gain FDA approval, for limit of detection, specificity, ruggedness and robustness
• Discuss when it is required to perform method suitability and equivalence studies, and when actual product is required to be tested
• Learn how to validate short shelf life products, including ATMPs, when available product is in limited supply

Evaluation for implementation of an analytical technique for microbial identification in the quality control exemplified by MALDI-TOF MS
Laura Bagschik, Roche

• Data research by a state-of-the-art market analysis
• Comparison of possible techniques and suppliers
• Cost/Benefit and business case calculations
• Conclusions and discussion of the results

EU GMP Annex 1 – Extended active viable air sampling
Dr. Gunter Neuer, Becton Dickinson

• Impact of the EU GMP Annex 1 regards active air sampling
• Influencing factors
• Results of active, continuous air sampling - duration and limitations
  

EPAA-EDQM Conference “Ending in Vivo Testing for Pyrogenicity”
Dr Sven M. Deutschmann, Roche

• EU-Council’s and EDQM’s Perspective
• Industry Perspective
• Regulatory Session

Development of a cell culture model for the detection of bacterial pyrogenic contamination in parenteral drugs using digital PCR
Nicole Paland, Minerva Biolabs

• Available test methods - what is measured?
• Nucleic acid amplification techniques (NAT) using digital PCR (dPCR)
• What is measured with the technique?

The Application of Next Generation Sequencing (NGS) in Pharmaceutical and Biopharmaceutical Manufacturing
Dr Christine E. Farrance, CRL

• Technology and bioinformatic (data analysis) overview
• Regulatory requirements that can be met with NGS
• Current commercial applications in Charles River
• Additional applications under development
• The need for GMP compliant reference libraries

Halal Culture Media for Media-Fill and other applications
Adele Gisselmann and Dr Andreas Bubert, Merck Life Science

• Principles of Media-Fill tests and culture media for environmental control
• General background of halal certified culture media
• Potential risk for contamination in halal manufacturing facilities

Properly Qualified Media – A must have for EM and a successful Contamination Control Strategy
Juliane Hornung, Labor LS

• Growth media in the context of CCS
• Which aspects of media need to be qualified?
• Growth Promotion Testing and Growth Controls
• Validation of Shelf-life
• Neutralizing Properties

Microbiological Growth Studies versus Preservative Efficacy Testing
Christian Lomb, Labor LS

• Presentation of different types of growth studies
• Differences between growth studies and the preservative efficacy test
• Case studies

Optimising Gaseous Decontamination Cycles for Sterility Test Isolators
Miriam Guest, Astra Zeneca

• The use of Vapour Phase Hydrogen Peroxide in Sterility Test Isolators
• Introduction to Enzyme Indicator Technology
• How the use of Enzyme Indicators has optimised cycle design and increased efficiency
• Considerations for Implementation

ASEPTING PROCESSING – Biological Indicators for Vaporized Hydrogen Peroxide (VH2O2) Process
Maria Luisa Bernuzzi, MesaLabs

• Understanding critical characteristics of a biological indicator designed for VH2O2 decontamination processes
• Challenges and best practices for accurate outcomes and interpretation of your results

Update on USP Microbiology General Chapters
Marsha Steed, Resilience, USP Mircobiology Expert Committee

• Sharing the latest revisions and proposed revisions
• Overview of proposed activities
• Current activities and priorities