Microbial Detection - Articles and news items

Application note: Microbial limits testing

Application note: Microbial limits testing

Whitepapers / 18 December 2016 / Wickham Laboratories

In this application note, Wickham Laboratories discuss risk assessments for objectionable organisms…

Wickham Labs logo

Wickham Laboratories announces upcoming webinar on microbial limits testing

Supplier news / 4 October 2016 / Wickham Laboratories

Join us for a free webinar on risks, regulations and determining the best method for your product, 3rd November, 3PM GMT…

A novel approach in assessing the antimicrobial efficacy of eye drop products

A novel approach in assessing the antimicrobial efficacy of eye drop products

Issue 2 2016, Microbiology / RMMs / 4 May 2016 / Mostafa Eissa, Hikma Pharmaceuticals

The microbial contamination of medicinal products constitutes a continuous threat to the health of consumers, which may negatively impact pharmaceutical companies’ reputability. However, multidose sterile pharmaceutical products are prone to contamination either from the normal flora of the human body or from the surrounding environment, following their misuse by patients. With the absence of strict medical supervision from medical professionals, patients can infect themselves with such a contaminated product. The study described in this article provides a new prospective view on the preservative efficacy test (PET) to assess the potency of antimicrobial agent(s) in two formulae of eye drops as well as quantitatively determining the risk of recontamination by the consumer…

New microbial testing technology for cleanrooms announced by MOCON, Particle Measuring Systems

Supplier news / 3 February 2016 / MOCON

Cleanroom operators will now be able to detect the presence of extremely low levels of microbial cells on surfaces much faster than traditional solutions…

Arnaud Carlotti, President of Eurofins IDmyk

Under the microscope: Dr. Arnaud Carlotti, PhD, HDR, President of Eurofins IDmyk

Issue 6 2015, Microbiology / RMMs / 6 January 2016 / Caroline Richards

Caroline Richards, Editor of European Pharmaceutical Review, asks Dr. Arnaud Carlotti, PhD, HDR, President of Eurofins IDmyk, to provide his insights on the microbial testing industry…

RMM Webinar Featured Image

Practical Application of RMM in Pharmaceutical Manufacturing

Microbiology / RMMs, Webinars / 15 December 2014 / Scott Sutton Ph.D. - President of Pharmaceutical Microbiology Forum & Owner of The Microbiology Network & Dr. Yongqiang Zhang - Senior Scientist at BD Diagnostics

Discussion on how a rapid method can provide a solution to a common microbiological testing problem for pharmaceutical manufacturers – process water microbiology testing.

Rapid Method Development and Quality Regulatory Submissions – Combining UPLC, Quality-by-Design (QbD) and Software-Guided Validation

Industry news, Webinars / 8 April 2013 / Waters

During this webinar learn from industry experts some practices to help better manage the investigation process and how to design processes to minimize unnecessary excursions…

managing microbial excursions

Best practices in managing microbial excursions and managing out of specification events

Industry news, Webinars / 8 April 2013 / Rapid Micro Biosystems

This pharma webinar demonstrates best practices to help better manage the investigation process and how to design processes to minimize unnecessary excursions.

Real-time biological particle counting in environmental monitoring

Hot topics in rapid methods: revisions to validation guidance and real-time environmental monitoring

Issue 6 2012, Microbiology / RMMs / 18 December 2012 / Michael J. Miller, President, Microbiology Consultants, LLC

This is the sixth and final paper in our continuing series on Rapid Microbiological Methods (RMM) that have appeared in European Pharmaceutical Review during 2012. As many of you already know, I am keen on staying on top of recent developments in the world of rapid methods, and have used my own blog (http://blog.rapidmicromethods.com) to communicate technology advances and changes to regulatory and validation practices and expectations. In my final article of the year, I am providing an overview of two very interesting topics that have sparked additional discussions within the professional community: the proposed changes to USP’s informational chapter on the validation of alternative microbiological methods and real-time environmental monitoring.

Revision to USP Chapter <1223>: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms such as RMMs.

Because many RMM technologies consist of a combination of instrumentation, software, consumables and reagents, in addition to specific detection, quantitative or identification methodologies, it is important to develop a comprehensive and holistic approach to the validation process to ensure that the entire RMM system is suitable for its intended use.

Foster Jordan, Senior Vice President, Charles River

Under the microscope: Foster Jordan, Senior Vice President, Charles River

Issue 3 2012, Under the Microscope / 10 July 2012 / Helen Difford, Editor, European Pharmaceutical Review

Foster Jordan, Corporate Senior Vice President, Endotoxin and Microbial Detection, Charles River discusses QC testing and why it is so important in the pharmaceutical industry.


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