Rapid Microbio Methods Database updated with new systems
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Recommendation
17/18 October 2024
Regulatory Expectations and Practical Experiences
The Database of Rapid Microbiological Methods was updated with new systems.
1. BioTrak® Real-Time Viable Particle Counter
For real-time assessment of environmental microbial conditions. The BioTrak® Real-Time Viable Particle Counter from TSI features:
- The most discriminating data available
- Patented*, field-proven, Laser Induced Fluorescence (LIF) technology
- ISO-21501-4 compliant particle counting
- Integrated particle collection filter for offline analysis of optically analyzed particles
The end results are real-time microbial information, cost savings,and improved process control.
2. EndoZyme® recombinant Factor C (rFC) Assay
EndoZyme® is intended for in vitro quantitative determination of endotoxin (lipopolysaccharide, LPS) in pharmaceuticals and biological substances as well as for medical device testing.
The endotoxin-specificity of EndoZyme® eliminates all false-positive and elevated results seen with LAL due to ß-glucan reactions in the LAL cascade. Adding the ease-of-use and excellent lot-to-lot consistency, EndoZyme® is a representative of modern recombinant methods, moving away from the animal source which for decades has been the horseshoe crab.
Having a homogeneous assay format without a solid phase, EndoZyme® is best suited for non-complex samples and buffer conditions. For complex sample matrices, EndoLISA® is recommended.
3. VITEK® MS Plus (available End of 2013)
Currently, there are 43 different systems listed in the database. That will give you the chance to compare them under the aspects of detection range, analysing method, detectable organisms and several more criteria. This will give you a unique possibility to get an overview about available systems and their possibilities.
The database is available in the website's members' area with your access code. If you want to become a member of the working group, you can register free of charge.
Author
Axel H. Schroeder
Administration Manager
ECA RMM Working Group
www.pharmaceutical-microbiology.org
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