European Microbiology Conference
Im Auftrag der ECA Academy

Programm

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