8th European Microbiology Conference

Programme

Agency’s current thinking on microbiology related topics
Regulatory Developments/Microbiological Inspection Experiences/
Control Sterile Products
Dr Jessica Cole, FDA/CDER Office of Pharmaceutical Quality, Division
of Microbiology Assessment

Module 1: Methods and Method Validation

BioTrak - Three Portable Instruments in One
BioTrak Real-Time Data – Benefits
RMM Challenges
Real Case Studies: BioTrak Applications

Validation of an Automated Rapid Bioburden Enumeration System for
Pharmaceutical Water Testing
Validating the Growth Direct System against common microorganism isolates found in pharmaceutical water systems
Stressed organism validation method and results
Time-to-Result determination
LIMS integration with Growth Direct system for direct data entry

A newly developed approach for the rapid detection and identification of
adventitious viruses in biopharmaceuticals
The background
The idea/principle
The assay performance

These two events offer you a unique possibility to become acquainted with ongoing regulatory requirements, the development of microbiological methods for quality and process control as well as with the recent experiences in microbial contamination control. Speakers from different scopes of pharmaceutical microbiology will give you the chance to get to know the different views on versatile microbiological topics. Also, as a participant you will have ample opportunity to discuss your specific issues with speakers and other participants

The role of pharmaceutical microbiology is getting more and more important. It is also increasingly in the focus of regulators during product submission and inspections. With the harmonisation of the different pharmacopoeias the harmonised methods must be implemented. The challenge is therefore to satisfy regulatory requirements alongside management’s financial expectations.
Furthermore, the field of Rapid Microbiological Methods has been developing very fast in the last years. It promises possibilities to optimise the factors time and money in microbiological in-process-control and release

This conference is of interest to professionals in microbiology from
Pharmaceuticals and Biopharmaceutical Companies
Academic Research Institutions
Government Agencies
Contract Service Laboratories
who are involved in
Quality Affairs
Research and Development
Validation
Regulatory Affairs
Contamination Control
Monitoring

Sven M. Deutschmann, Barbara Gerten, Axel Schroeder


Agency’s current thinking on microbiology related topics
Regulatory Developments/Microbiological Inspection Experiences/
Control Sterile Products
Dr Jessica Cole, FDA/CDER Office of Pharmaceutical Quality, Division
of Microbiology Assessment

Module 1: Methods and Method Validation

BioTrak - Three Portable Instruments in One
BioTrak Real-Time Data – Benefits
RMM Challenges
Real Case Studies: BioTrak Applications

Validation of an Automated Rapid Bioburden Enumeration System for
Pharmaceutical Water Testing
Validating the Growth Direct System against common microorganism isolates found in pharmaceutical water systems
Stressed organism validation method and results
Time-to-Result determination
LIMS integration with Growth Direct system for direct data entry

A newly developed approach for the rapid detection and identification of
adventitious viruses in biopharmaceuticals
The background
The ideaprinciple
The assay performance

Evaluation of classical and modern methods for bacterial identification: Comparison of VITEK®-2 compact (biochemical analysis ) to VITEK®-MS (MALDI-TOF mass spectrometry) and MicroSeq® Microbial Identification System (16S-rDNA sequencing)
Brief introduction of the various identification methods and their pros and cons
Comparative identification of microorganisms from hygiene monitoring using biochemical as well as molecular methods
Which method is most suitable for which purpose?

New Bioindicators for H2O2 Sterilisation
Highest quality indicators
Reproducible D-values
Lot size (up to 50000 indicators)

Qualification/Validation of moist heat and dry heat sterilization processes:
Microbiological Studies
Design of microbiological studies within the Qualification/Validation of moist heat and dry heat sterilization processes
Usage of bioindicators and endotoxin indicators
Methods
Case-studies and problems

Module 2: Contamination Control and Disinfection

Validation of Disinfectants for use in Cleanrooms
The process for evaluation of disinfectants to be used in cleanrooms
Review of disinfectant testing methods and their suitability for evaluation of cleanroom disinfectants
Points for consideration when defining the validation protocol

New Studies – Light induced disinfection of garment and surfaces
New innovative cleanroom textile with a light induced self-disinfection
Mechanism and efficacy
Conception of gowning areas for such new garment system

Solutions for overcoming testing challenges with disinfectant coupon studies
Fungal and Bacterial spore case studies in cleanrooms will be covered.
Advancs in cleaning and disinfection methods will be covered.
Industry regulations and warning letters will be covered related to disinfectant qualification and spore outbreaks.
Common causes for coupon testing failures will be covered and solutions will be covered to overcome obstacles.

Holding Studies and Microbial Challenge Tests
Review of some challenges in Antimicrobial Effectiveness Testing of preserved and non-preserved products
Microbial growth promotion test and determination of growth rates for different test strains
Microbial Challenge Test and Bioburden simulation
Case studies and failure investigations

Module 3: Learning from cognate industries

Implementation Modern Microbiological Methods at Cosmetic Manufacturing
The thought processes and criteria for the selection of rapid methods
Difficulties and issues during implementation
Combination of rapid and traditional methods
Need for an industry wide approach

Further Developments of ISO Methods Revision
Validation of alternative methods in food and drinking water testing
New and revised ISO methods in food and water testing