European Microbiology Conference + Workshop Bioindicators

Programme

Current and recent activities of the
USP Microbiology Expert Committee
Radhakrishna Tirumalai, USP
Recent approvals of new chapters and revisions
(<1211>, <1222>)
Recent major proposals in PF ( <1085, <1071>, <60>)
Future plans

What the Neighbours have learned – Validation of Methods – The Guidance for Food Microbiology
Barbara Gerten, Merck
Introduction to ISO 16140 Method Validation
Validation of reference and alternative methods
Verification during implementation in the laboratory

Monitoring Sytems – Requirements and Experiences Monitoring Sytems – Experiences with Valimon and Labwatch
Peter Huonker, Früh Verpackungstechnik
Why and when do you need a monitoring system?
Experiences with two different systems
Pro’s and Con’s

Development of a highly sensitive PCR/DNA chip method to detect mycoplasmas in a modified live vaccine
Blandine de Saint-Vis, Boehringer Animal Health
Annett Kilic,Greiner Bio-One
CytoInspect as a test sytem for the rapid detection and identification of mycoplasmas
Methodology and preparation of spiked samples
Use of 5 Eur. pharmacopoeial reference strains of mycoplasmas
Validation criteria of limit of detection
Sensitivity and specificity of the method in a modified live vaccine

Validation of Hold Times for aseptic processing
Alexandra Stärk, Novartis
Overview of relevant hold times: product hold times & equipment hold times
Validation approaches
Experiences from Inspections and Product-Submissions

Status Updates: Current Topics in Quality Microbiology at the FDAAn overview of the quality microbiology review process
Erika Pfeiler, FDA
A description of quality microbiology related policy initiatives
A discussion of current information requests frequently sent to
applicants

IMD-W “In-line system for purified water systems” and other decvices for rapid water bioburden analyses
Ulrich Zuber, Roche
Feasibility studies as offline device in the lab
Feasibility study as online device at a purified water loop
Challenges and possiible solutions for online WFI bioburden analysis

Qualification of Laboratory Heaters and Refrigerators
Patrick Koch, CSL Behring
Differences of Temperature Mapping - the Past and Today
Implemention of : DQ/IQ/OQ/PQ

Microbiology, Personnel and Qualification – who’s
affected and what’s included
Robert Schwarz, FH Campus Vienna
QC Lab Microbiology - the equipment, the method and the operator and how qualification and validation is handled
Aseptic processing - qualification of operators and validation of processes from a microbiological perspective
From Guidelines to daily business - examples from the industry

Microbiological Control of Primary Packaging
Marcel Goverde, MGP
Guiding documents for the microbiological testing of primary packaging
Potential methods and suitability test approaches
Acceptance criteria

Microbiological Aspects of Filter Validation
Matthias Schaar, Novartis
Requirements
How to set up a microbiological filter validation
How does the Integrity test correlates to bacterial retention

Individualized Strategies for the Test of Sterility based on Hygenie Monitoring Evaluation
Speaker Labor LS

Recurring Microbial Contamination in grade A
(ISO 5) filling Restricted Access Barrier System (RABS)
Walid El Azab, Steris
Initial Investigation and Root Cause Analysis
Corrective and Preventive Actions
Ongoing Deviation
Cross Functional Investigation
Short- and Long Term CAPA’s

Risk-based aseptic process step simulation for
automated cell processing
Nadja Gilles, Miltenyi Biotec
Automated processing of human cells with regulatory requirement for media fill
Risk analysis based on clustered process steps
Aseptic process step simulation shortened by bracketing

Workshop

USP Thinking on Bioindicators
Radhakrishna Tirumalai, USP
Biological Indicators ( BI) are only tools to measure efficacy of the sterilization process
BI is not the target of the Sterilization process. It is the bioburden in the article that is being sterilized that should be the focus for the process.
Complete destruction of a BI is not necessary to develop a validated sterilization process

Biological Indicators for H2O2 Biodecontamination - Requirements, BI Production, Quality Control
Verena Ehrlicher, Microcoat Biotechnologie GmbH
Dr. Berthold Düthorn, Robert Bosch Packaging Technology
User requirements for H2O2 process validation
Challenges of BI development and results
Case study: Application of new BIs

Bioindicators – Expectations and Reality from
Manufacturers’ and Users’ Point of View
Christian Doriath, Skan
Expectations from regulatory requirements, customers and manufacturers
H2O2 Biological Indicators (BI): Model behavior of BI and design of BI components

Bioindicators in sterilization and decontamination validation - pitfalls and some maths
Robert Schwarz, FH Campus Vienna
Differences in bioindicators for sterilization and decontamination
Comparative D-Value Study
Time is money - considerations for optimization
Calculation models vs biological system
Routine control of bioindicators for steam
sterilization
Matthias Schaar, Novartis
Requirements
Spore count determination
D-value determination

Industrial Experiences
Peter Annel, NovoNordisc

Biological Indicators – Common challenges
observed
Walid El Azab, Steris and Customer (TBC)
Supplier qualification and validation (production to shipping)
Common challenges/failure observed at end-users’ site
Common challenges during QC testing
Failure decision tree

Enzyme BioIndicators
Phillip Godden, Protak
Frank Pavan, Eurocom
What is an Enzyme Indicator
Key improvements compare to Biological Indicators
Case studies