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FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing

In June, the FDA has published a new Question and Answer Guidance for Endotoxin and Pyrogen Testing. It should reflect the current thinking of the agency on that topic. Read more here.

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New Homepage of ECA's Rapid Microbiological Methods Working Group

The new Rapid Microbiological Working Group website is now online - providing additional information about RMM. More details can be found here.

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ECA's Rapid Microbiological Methods Conference

The annual Rapid Microbiological Methods Conference of the ECA will take place on 11. and 12 December in Munich, Germany. Many speakers from authorities, industry and method development already confirmed their participation. Get the details.

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Case Study of New Growth-based Rapid Microbiological Method (RMM) detects the Presence of Specific Organisms

In the March Edition of the American Pharmaceutical Review, Dr Michael Miller published a case study of a New Growth-based Rapid Microbiological Method (RMM) that Detects the Presence of Specific Organisms and provides an Estimation of Viable Cell Count. Read more.

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FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus

Scientists at the U.S. Food and Drug Administration (FDA) have confirmed that plasma specimens are well-suited for detecting the genetic material of hepatitis C virus (HCV) in potential blood donors who are infected with the virus. Read more.

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Rapid Microbiological Methods Database updated with new Systems

The RMM Working Group's database with Rapid Microbiological Methods Systems is continuously growing. Please see the information on just added and updated systems.

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Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005-2010 Revision Cycle

Scott Suttion and Radhakrishna Tirumalai issued a review of the published activities of the Microbiology and Sterility Assurance Expert Committee (MSA EC) of the United States Pharmacopeial Convention (USP) Council of Experts for the 2005–2010 revision cycle. Read more here.

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New Endotoxin Testing System based on ELISA

A new rapid microbiology method is being marketed for endotoxin testing. The EndoLISA has been developed by a company called Hyglos and was launched on 1st September 2011. Read on.

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Rapid Micro Methods Database updated with new Systems

With the addition of new systems from BioVigilant and  from Pall Life Sciences the database now comprises 29 different systems. Read more.

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Faster Sterility Tests for Biological Products

The FDA published a scientific poster on "Identifying faster Sterility tests for Biological Products - Regulatory Research Seeks to Reduce the Time Needed to Ensure the Safety of Critical Products". Read more.

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