Microbiology Articles - Latest

A new official chapter about microbiological sampling will appear in the USP 35 NF 30 (United States Pharmacopeia), which represents a global collaborative effort between industry, regulators and USP expert committees. The intent of the chapter, <610> Alternative Sampling Methods for Non-sterile Inhaled and Nasal Products, is to offer methods for sampling of pharmaceutical products in complex packaging that are difficult to sample in an aseptic manner, which is the necessary microbiological approach. read more

During the past 20 years, the field of alternative and Rapid Microbiological Methods (RMMs) has been gaining momentum as an area of research and application across a number of technology sectors. Recent advances in rapid technologies have also encouraged the pharmaceutical and biopharmaceutical industries to validate and implement RMMs in place of their traditional microbiology methods within QC/QA laboratories and on the manufacturing floor. read more

Microbiological testing is slowly evolving as traditional methods with microorganism detection requiring days or weeks yield to technologies collectively known as Rapid Microbiological Methods (RMM), which may detect the presence of a single organism within hours. read more

This article is a comprehensive 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