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Microbiology & Rapid Micro Methods (RMMs)

A selection of articles from European Pharmaceutical Review covering Microbiology & Rapid Micro Methods (RMMs):

 

RMM Webinar Featured Image

Pharma Webinar: Practical Application of RMM in Pharmaceutical Manufacturing

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.

RMM in-depth focus

RMM: In-depth focus 2014

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...

Microbiology Supplement 2014

Microbiology: In-depth focus 2014

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...

Syringe and bottle

Microbiology Series: Antimicrobial delivery

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

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

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...

Michael J. Miller, President, Microbiology Consultants, LLC

Towards the real application of rapid microbiological methods in developing countries

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.

RMMs & Environmental Monitoring Supplement 2013 - 100

RMMs & Environmental Monitoring: In-depth focus 2013

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.

The Encyclopedia of Rapid Microbiological Methods: The new fourth volume discusses technologies, regulatory acceptance and validation case studies

13 June 2013  •  Michael J. Miller, President, Microbiology Consultants, LLC and rapidmicromethods.com

This is the second paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. As the editor for the Encyclopedia of Rapid Microbiological Methods, I provide a summary of the latest volume, which was published earlier this year. New case studies, regulatory guidance and novel technologies are highlighted, and encourage our industry to adopt new ways of performing microbiology assays across a wide range of applications.

Current activities of the USP Microbiology Expert Committee

18 April 2013  •  Radhakrishna S. Tirumalai

For sterile as well as nonsterile pharmaceutical products, manufacturers must eliminate or minimise potential risks to patients as well as product quality. While many contributing factors may affect the quality of a medicine or its ingredients, microbial contamination control and proper sterilisation methods are critical considerations for the manufacturer throughout the product’s life cycle.

Improving the quantitation of live antigens used to produce rabbit generated serotype specific antiserum

21 February 2013  •  Michael J. Miller, President, Microbiology Consultants, LLC, Silvia Fragoeiro, Ananthi Ramachandran and Paul van Empel MSD Animal Health

This is the first paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. Flow cytometry represents one of a variety of viability-based RMM technologies that are currently available to the pharmaceutical industry. In flow cytometry, individual particles are counted as they pass through a laser beam in a very narrow flow cell.

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

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.