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Microbiology - Articles and news items

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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…


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…

RMM Webinar Featured Image

Webinar: 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.

Microbiology Supplement 2014

Microbiology: In-depth focus 2014

Issue 3 2014, Microbiology / RMMs, Supplements / 3 July 2014 / Dr. Guenther Gapp, James L. Drinkwater

In this free-to-view in-depth focus: How to deal with non-sterile results in aseptic processing, Risk Profiling and Proactive Response (RPPR) to Bio-contamination in GMP classified and controlled areas, Microbiology Roundtable…


Merck Millipore congratulates winner of the Alice C. Evans Award for Leadership in Clinical Microbiology

Supplier news / 20 May 2014 / Merck

Merck Millipore announced that Bonnie Bassler, Ph.D., Squibb Professor and Chair of the Department of Molecular Biology, Princeton University, has won the 2014 Merck Millipore Alice C. Evans Award for Leadership in Clinical Microbiology…

Syringe and bottle

Microbiology Series: Antimicrobial delivery

Issue 2 2014, Microbiology / RMMs / 15 April 2014 / Joshua Boateng and Harshavardhan Pawar, Department of Pharmaceutical Chemical and Environmental Sciences, Faculty of Engineering and Science, University of Greenwich

Antimicrobial drugs form a significant aspect of disease therapy and are a major means of treating bacterial, fungal and viral infections. The issue of antimicrobial therapy is of current interest and clinical concern. This is mainly due to two key reasons; (i) persistent emergence of microbial resistant strains and (ii) the significant reduction in the rate of successful discovery new generations of more potent antibiotics to combat this resistance epidemic (especially in bacteria).

Microbiology Fungal Contamination

Fungal contamination of pharmaceutical products: a growing menace

Issue 1 2014, Microbiology / RMMs / 19 February 2014 / Tim Sandle, Pharmaceutical Microbiology Interest Group (Pharmig)

Any pharmaceutical product, whether manufactured in the hospital or industrial environment, has the potential to be contaminated with microorganisms. With sterile products, any microbial contamination presents an unacceptable risk; with non-sterile products, the implication of the contamination is dependent upon whether the microorganism can be considered ‘objectionable’, and then to the extent that it can cause patient harm (and here a risk assessment is ordinarily required).

Microbiology pipette test tube

Microbiology: Mould contamination in pharmaceutical drug products and medical devices

Issue 6 2013, Microbiology / RMMs / 15 December 2013 / Tony Cundell, formerly of Merck Research Laboratories

Invasive fungal infections associated with high mortality rates are common in hospital settings, especially in intensive care units where patients may be immune-compromised, subject to invasive procedures and treated aggressively with antibiotics. The most common nosocomial fungal infections in descending order are due to the genera Candida, Aspergillus, Rhizopus, Fusarium and other less frequently isolated moulds. Usually the fungi are passed on from the hands of medical personnel, the indigenous microflora of the patient or the general hospital environment but occasionally pharmaceutical drug products and medical devices are implicated…