Real-Time Viable Particle Counters, like TSI’s BioTrak™ Products, are a new Rapid Microbial Methods (RMM) technique, which has recently been released to the market.
These new products are based on the measurement technique of Laser-Induced Fluorescence (LIF). With LIF, essentially, when biological particles are excited by a specific wavelength of light, the emit light at a different, known wavelength. While most LIF based products use similar measurements, there are some considerable differences in products offered on the market.
The BioTrak Real-Time Viable Particle Counter is the only product that measures non-viable products, just like Portable Particle Counters, and is capable of classifying a cleanroom. This establishes that room meets the specified airborne particulate cleanliness standard, matching previous measurements.
The BioTrak Particle Counter also comes with excellent discrimination performance. Some of the early products on the market have had issues with determining viable from non-viable particles. This produces too many “false positives”, and provides uncertainty with customers that the measurement works. To address this issue, TSI has conducted extensive testing and developed algorithms that are proven to provide a much better level of discrimination.
Further, through an evaluation program, you should be able to test the BioTrak against typical sample plates and use that information to properly assess future measurements.
Finally, the BioTrak Real-Time Viable Particle Counter comes with a unique built-in sample collection filter that can collect the same particles that were measured. Those samples can then be sent to a lab for more detailed evaluation.
www.tsi.com
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Sanofi has announced that the U.S. Food and Drug Administration has approved Auvi-Q (epinephrine injection, USP) for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis. Auvi-Q is the first-and-only compact epinephrine auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process.
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Pfizer reports results from Phase 3 study of Torisel (temsirolimus)
Pfizer Inc. announced that the Phase 3 INTORACT trial (B1771006), evaluating the combination of bevacizumab plus TORISEL® (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-α-2a) in the first-line treatment of patients with advanced renal cell carcinoma across risk groups, did not meet its primary endpoint of superiority in extending progression free survival in the study population...
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AstraZeneca and Bristol-Myers Squibb complete expansion of diabetes alliance
AstraZeneca and Bristol-Myers Squibb announced that following the successful completion of the acquisition of Amylin Pharmaceuticals by Bristol-Myers Squibb, AstraZeneca has made an initial payment of approximately $3.2 billion to Amylin Pharmaceuticals, now a wholly-owned subsidiary of Bristol-Myers Squibb...
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ACHEMA 2012 - Exclusive video interviews
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 In this one hour instructional webinar we will discuss how handheld Raman reduces costs and improves efficiency, the move to mandatory 100% testing of incoming raw materials, and recent developments in handheld Raman technology.
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Conferences, events & exhibitions:
Genomics Research Europe
4 - 5 September 2012 Frankfurt, Germany
ELRIG Drug Discovery 2012
5 - 6 September 2012 Manchester, UK
HUPO 11th Annual World Congress
9 - 12 September 2012 Boston, USA
Design Control for Medical Device Professionals
10 - 11 September 2012 Berlin, Germany
Design Validation, Verification, and Risk Analysis for Medical Device Professionals
12 - 13 September 2012 Berlin, Germany
Validation of Computer Systems
17 - 18 September 2012 Dublin, Ireland
The EU Clinical Trial Directive
17 - 18 September 2012 Dublin, Ireland
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
17 - 19 September 2012 Dublin, Ireland
The Drug Development Process – From Discovery to Commercialisation
19 - 21 September 2012 Dublin, Ireland
11th Annual Biological Production Forum 2012
24 - 26 September 2012 Dusseldorf, Germany
MipTec 2012
24 - 27 September 2012 Basel, Switzerland
Lab-on-a-Chip World Congress
25 - 26 September 2012 San Diego, USA
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The “Patent Cliff”: How Pfizer has responded to the loss of its best-selling drug
The global pharmaceuticals market was worth $733bn in 2010. With the patents of many of the world’s best-selling drugs expiring, the market is currently in the middle of a “patent cliff”. This Case Study looks at the various routes companies are taking in order to minimize the adverse effects caused by this “patent cliff”.
OTC Pharmaceuticals: Global Industry Almanac 2011
OTC Pharmaceuticals: Global Industry Almanac is an essential resource for top-level data and analysis covering the OTC Pharmaceuticals industry. It includes detailed data on market size and segmentation, textual analysis of the key trends and competitive landscape, and profiles of the leading companies. This incisive report provides expert analysis on a global, regional and country basis.
Johnson & Johnson Case Study: Remicade, a Biotech Blockbuster
Remicade is a drug used in treating a variety of immune system diseases, and its active ingredient is produced through biotechnology. Johnson & Johnson reported Remicade sales of $4.6bn in 2010, and the drug is the best-selling “biologic” in the world. This case study examines its long journey from an academic research laboratory to a leading position in the pharmaceutical market.
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