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Microbiology - Articles and news items

Whitepaper: Is it essential to sequence the entire 16S rRNA gene for bacterial identification?

Whitepaper: Is it essential to sequence the entire 16S rRNA gene for bacterial identification?

Whitepapers / 1 February 2016 / Charles River

The biopharmaceutical industry, especially manufacturing facilities, needs to implement bacterial identification to avoid the occurrence of a problematic microorganism in the final product that could be harmful for the end user and detrimental to a company’s finances and reputation…

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Emerging trends in microbiological diagnostics: an introduction to rapid microbiological methods

Blog / 29 January 2016 / Adewale Joseph Ogunleye, Adekunle Ajasin University, Akungba Akoko, Ondo State, Nigeria

This article explores how scientists are developing a fast, qualitative and specific technique for the detection and classification of microorganisms…

The limitations of the colony-forming unit in microbiology

The limitations of the colony-forming unit in microbiology

Issue 6 2015, Microbiology / RMMs / 6 January 2016 / Tony Cundell, Microbiological Consulting LLC

The recent revision to USP General Informational Chapter <1223> Validation of Alternative Microbiological Methods that became official on December 1, 2015 contained a section discussing the limitations of the colony-forming unit (CFU) in terms of enumerating only those microorganisms that readily grow on solid microbiological media. The section highlights its inappropriateness as a gold standard for method validation when there are many signals available other than CFUs for the detection, enumeration and identification of microorganisms in water, air, pharmaceutical ingredients and drug products…

Cherwell strengthens team with Microbiology Product Specialist appointment

Cherwell strengthens team with Microbiology Product Specialist appointment

Supplier news / 14 December 2015 / Cherwell Laboratories

Company boosts industrial microbiology expertise to enhance customer support…

Portsmouth PMU selects Cherwell for quality and service in environmental monitoring

Portsmouth PMU selects Cherwell for quality and service in environmental monitoring

Supplier news / 18 November 2015 / Cherwell Laboratories

Cherwell publishes case study discussing key considerations when purchasing an active air sampler…

Wickham Laboratories announces new microbial identification service

Wickham Laboratories announces new microbial identification service

Supplier news / 3 November 2015 / Wickham Laboratories

Introducing the MALDI Biotyper® for rapid microbial identification….

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Merial Sas, GSK, Sanofi Pasteur, Nestle Research Center will meet at the SMi’s 5th Annual Pharmaceutical Microbiology Conference in London

Supplier news / 7 September 2015 / SMi

SMi is delighted to announce that the 5th Annual Conference on Pharmaceutical Microbiology will be taking place on the 20th-21st January 2016 at the Holiday Inn Kensington Forum in London, UK…

Harshad Joshi

Cherwell appoints Harshad Joshi as new Quality Manager

Supplier news / 7 September 2015 / Cherwell Laboratories

Company maintains focus on quality to meet customer expectations…

Cherwell Labs

Cherwell launches refreshed website for Cleanroom Microbiology Solutions

Supplier news / 30 July 2015 / Cherwell Laboratories

Cherwell Laboratories, specialists in cleanroom microbiology solutions for the pharmaceutical and related industries, have announced the launch of a refreshed website….

Outsourcing in the analytical and microbiology area

Outsourcing in the analytical and microbiology area

Contract Research, Issue 2 2015 / 20 April 2015 / Roger A. Stroud, R Stroud Pharmaceutical Quality Solutions Limited

Increasing numbers of pharmaceutical companies are considering outsourcing in the area of analytical and microbiological testing, from the very smallest start-up, virtual, or small company up to the largest multinational. This article will examine the factors that lead to a company deciding to outsource, and provides invaluable guidance on the important considerations that should be made before, during and after the outsourcing process in order to ensure it runs as smoothly as possible…

Reducing microbial contamination via sterile risk assessment

Reducing microbial contamination via sterile risk assessment

Issue 2 2015, Microbiology / RMMs / 20 April 2015 / Guenther Gapp, Lachman Consulting Ltd/Independent Consultant

Several years ago, microbiologist Guenther Gapp created a new sterile risk assessment tool (based on a hazard operability analysis [HAZOP] approach) to identify and reduce the microbial contamination and compliance risk of aseptically-produced sterile products and production plants. The following article describes the operating principle of three risk analysis tools with a special focus on the revised 2015 edition. This latest edition incorporates the improvements that have been implemented in recent years, which make the tool more applicable and thus valuable for the user…

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The role of water activity in the microbial stability of non-sterile pharmaceutical drug products

Issue 1 2015 / 10 March 2015 / Tony Cundell, Consulting Microbiologist, Scarsdale

Aqueous, multiple-use, non-sterile drug products are susceptible to microbial contamination during their shelf life. To protect these products from this potential hazard to patients, they are formulated with antimicrobial preservatives. Other product attributes employed using the hurdle concept to prevent microbial contamination include: low pH, low redox potential, reduced storage temperature, packaging that protects the product and low water activity. Water activity, or Aw, is a measure of available water and when applied to a non-sterile pharmaceutical drug products is a critical physical attribute that determines whether the product will support the growth of microorganisms. Given the knowledge of the minimum water activity for the growth of bacteria, yeast and mold, the microbial stability of a drug product can be determined. This knowledge can be used to set risk-based microbial specification and release and stability testing programs for different dosage forms. This review article will discuss the role of reduced water activity in imparting microbial stability to non-sterile drug products…

 

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