Rapid Micro Biosystems Inc.

Rapid Micro Biosystems Inc.
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Rapid Micro Biosystems Inc.

 •  November 27

Biogen presented a poster, Implementation of the Growth Direct™ System: Driving for Greater Accuracy, Speed, and Efficiency in Microbial Enumeration, during the 12th Annual Parenteral Drug Association (PDA) Conference on Pharmaceutical Microbiology held in Bethesda, Maryland, October 16-18, 2017. To meet the demand for faster and more accurate...

During this year’s European Directorate for the Quality of Healthcare and Medicines (EDQM) meeting, Rapid Micro Biosystems (RMB) presented its latest poster: Simpler RMM Validation for Environmental Monitoring Using Current USP Ch Requirements. The poster was created in response to the question asked by many pharmaceutical microbiologists and...

Are you considering purchasing a rapid microbiological method (RMM) for your QC lab? Quality control labs worldwide are embracing rapid microbial methods (RMM) to help streamline workflows, save resources and provide for sustainable and cost-effective growth. Are you struggling with which method to choose? While there are various methods for rapid...

Rapid microbial methods (RMM) have become a prevalent topic in microbiology quality control (QC)—particularly among QC labs with lean or paperless initiatives. However, RMM is not necessarily a one-size-fits-all proposition for every facility or process. Furthermore, in highly regulated industries such as pharmaceutical manufacturing, it can be...

For pharmaceutical manufacturers, contamination is an obvious cause for concern. Fungal contamination, specifically, poses greater hazards to manufacturing clean areas than some manufacturers may realize. As such, opportunities exist to better address fungal contamination. In fact, Dr. Tim Sandle, head of microbiology at Bio Products Laboratory,...

Contamination is a major issue for pharmaceutical manufacturers that want to mitigate risks that might compromise product quality, efficacy and patient safety. On September 12th, the Pharmaceutical & Healthcare Sciences Society (PHSS) addressed this need by releasing “Technical Document No. 20 – Bio-contamination characterization, control,...

Microbial quality control (QC) testing has made strides over the last several years. And as technologies such as the Growth DirectTM System advance, the easier it becomes to quantify and justify the economic benefits. The automated system, which utilizes rapid microbial methods (RMM), analyzes user-prepared samples—just as the traditional method...

For pharmaceutical manufacturers, validation is one of the most involved aspects of the implementation of rapid microbial methods (RMM). Validation of a new method involves not only external regulatory authorities, but internal quality assurance and other stakeholders. While the validation process will be time consuming, it can be a smooth...

Rapid microbiological methods (RMM) have become more prevalent in the pharmaceutical industry over the last few years, and quite a few companies are now using a rapid method to achieve faster results. Typically, the method is used for a specific application, such as water testing or sterility, with few companies using a single rapid method across...

In the most recent issue (2015 Volume 20, Number 3) of the European Journal of Parenteral & Pharmaceutical Sciences, Kham Nguyen, Anna Mills, Andrew Sage and David Jones published the article, “Validation of the Growth Direct™ System to perform pharmaceutical water bioburden analysis." The peer-reviewed article describes the, “Validation of the...