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- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
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- Microbiology & RMMs
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- Raman Spectroscopy
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Microbiology & Rapid Micro Methods (RMMs)
A selection of articles from European Pharmaceutical Review covering Microbiology & Rapid Micro Methods (RMMs):
29 February 2016 • James L. Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society
Completing risk assessments is an inherent part of good manufacturing practice (GMP) and risk-based environmental control and monitoring (EM) in sterile product filling within isolators and restricted access barrier systems (RABS). This article considers the challenges the pharmaceutical industry faces in characterising conventional risk assessments like failure modes and effects analysis (FMEA) for determination of risk-based EM programs, considering aspects of the filling machine, barrier separation technology, surrounding cleanroom environment, monitoring methods/systems and process operations. The requirement for process monitoring for the manufacture of sterile medicinal products is starting to be discussed in the revision of EU GMP Annex 1, so as to bring together all EM data and hence consider the process holistically...
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...
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...
22 October 2015 • David Roesti, Erik Wilkens, Mostafa Eissa, Hideharu Shintani
Implementation of a rapid methods portfolio at a pharmaceutical manufacturing site; Use of RMMs in quality control: challenges and benefits; Rapid assay for bioburden and other contaminations; RMM Roundtable...
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).
ABB Analytical Measurement ABL&E Group ABS Laboratories ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Andor Technology Astell Scientific Ltd Axis-Shield Diagnostics Ltd Bachem AG Bibby Scientific Limited Bio-Rad Laboratories Biopharma Group Black Swan Analysis Limited CAMO Software AS Celsis International Charles Ischi AG | Kraemer Elektronik ChemAxon Cherwell Laboratories CI Precision Cobalt Light Systems Comark Instruments Coulter Partners CPC Biotech srl DiscoverX Dotmatics Limited Edinburgh Instruments Enterprise System Partners EUROGENTEC F.P.S. Food and Pharma Systems Srl HunterLab IDBS IONICON Analytik GmbH kbiosystems ltd L.B. Bohle Maschinen + Verfahren GmbH LabWare Linkam Scientific Instruments Limited MKS Umetrics Molins Technologies Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc Portalis Ltd Powder Systems Limited (PSL) RADWAG Reach Separations ReAgent Russell Finex Limited Source BioScience Spectrum®Labs.com Stratech Scientific Limited Takara Clontech Thermal Detection Ltd. Tuttnauer Vaisala Ltd VIAVI OSP Waters Corporation Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Ytron-Quadro (UK) Limited Yusen Logistics