News

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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Rapid Methods - Influence of FDA's Strategic Plan for advancing Regulatory Science

In August, the FDA published a Strategic "Plan to Advancing Regulatory Science at FDA". This plan includes statements to amend microbial safety of products with modern microbiological methods. Read more.

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Sandra Gay and Geert Verdonk become members of the advisory board of ECA's Rapid Methods Group

Effective since 1 September Geert Verdonk from MSD in Oss/Netherlands and Sandra Gay from bioMérieux in Lyon/France become members of the advisory board of ECA's Rapid Microbiological Methods Working Group. Learn more about the new board members.

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WHO in charge of Qualifying QC Laboratories for the UN

Private and governmental quality control laboratories may undergo a standardised quality assessment by the WHO to prove their compliance with the WHO requirements and therefore to be in a position to take over contracts for the UN. Read more here.

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