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Microbiology & Rapid Micro Methods (RMMs)
A selection of articles from European Pharmaceutical Review covering Microbiology & Rapid Micro Methods (RMMs):
3 September 2015 • Michael J. Miller, PhD Microbiology Consultants, LLC
From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation. The final article of the 2012 series introduced the United States Pharmacopeia’s (USP’s) plan to revise informational chapter <1223>, Validation of Alternative Microbiological Methods.1 On June 1, 2015, a substantially modified chapter <1223> was published in the second supplement to USP38/NF33 with an official date of 1st December 2015. Because the original USP chapter was published almost 10 years ago, this article will review the most notable changes and compare them with what is recommended in the Parenteral Drug Association (PDA) Technical Report Number 33 and the proposed revision to European Pharmacopoeia (Ph. Eur.) chapter 5.1.6...
3 July 2015 • European Pharmaceutical Review
In this in-depth focus: Diversity of bacteria in pharmaceutical water: significance and impact on quality, Risk-based environmental control and monitoring and Microbiology Roundtable...
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...
20 April 2015 • Tim Sandle, Bio Products Laboratory
The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in relation to the size of the instruments and in reducing the time taken to collect a fixed volume of air, the essential technology has remained unchanged. However, recently, some new technologies for biological air sampling have been developed (bio-air systems), which will be discussed in this article...
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.
5 November 2014 • Michael J. Miller, Deborah Gessell-Lee, Oliver Gordon, Joe Johnston, Neil Lewis, Jeanne Mateffy, Jeffrey W. Weber
Michael J. Miller discusses rapid microbiological methods and the regulatory environment, the Online Water Bioburden Analyzer Workgroup look at the path to implementing Online Water Bioburden Analyzers, plus RMM roundtable...
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...
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).
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).
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...
22 October 2013 • Michael J. Miller, President, Microbiology Consultants, LLC and Suzan Mohammed Ragheb, Department of Biotechnology, The Nile Company for Pharmaceuticals and Chemical Industries
Rapid microbiological methods (RMM) have gained popularity and acceptance within a number of industry sectors, including food and beverages, diagnostics, environmental, personal care and pharmaceuticals. In recent years, many firms have successfully validated and implemented RMMs for a wide variety of applications. However, many geographic areas around the world still have not benefited from the advantages that RMMs afford, most notably the time to result for critical microbiological analyses. This is particularly true for clinical diagnostics and the detection of foodborne pathogens in developing countries.
21 August 2013 • Emanuele Selvaggio (Pfizer), Chris Delaney (Noonan Services Group)
The rapid microbiological methods revolution.
Controlling contamination in the pharmaceutical industry.
Rapid Micro Methods Roundtable.
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