• Facebook
  • Twitter
  • LinkedIn
  • Google +
  • RSS

Microbiology & Rapid Micro Methods (RMMs)

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

 

A novel approach in assessing the antimicrobial efficacy of eye drop products

A novel approach in assessing the antimicrobial efficacy of eye drop products

4 May 2016  •  Mostafa Eissa, Hikma Pharmaceuticals

The microbial contamination of medicinal products constitutes a continuous threat to the health of consumers, which may negatively impact pharmaceutical companies’ reputability. However, multidose sterile pharmaceutical products are prone to contamination either from the normal flora of the human body or from the surrounding environment, following their misuse by patients. With the absence of strict medical supervision from medical professionals, patients can infect themselves with such a contaminated product. The study described in this article provides a new prospective view on the preservative efficacy test (PET) to assess the potency of antimicrobial agent(s) in two formulae of eye drops as well as quantitatively determining the risk of recontamination by the consumer...

The challenges of riskbased environmental monitoring in sterile product filling

The challenges of riskbased environmental monitoring in sterile product filling

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...

The limitations of the colony-forming unit in microbiology

The limitations of the colony-forming unit in microbiology

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...

Arnaud Carlotti, President of Eurofins IDmyk

Under the microscope: Dr. Arnaud Carlotti, PhD, HDR, President of Eurofins IDmyk

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...

RMM In-depth focus

RMM: In-Depth Focus 2015

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...

Rapid methods update: revisions to a United States Pharmacopeia chapter

Rapid methods update: revisions to a United States Pharmacopeia chapter

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...

Microbiology in-depth focus 2015

Microbiology in-depth focus 2015

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...

Reducing microbial contamination via sterile risk assessment

Reducing microbial contamination via sterile risk assessment

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...

Real-time biological particle counting in environmental monitoring

Real-time biological particle counting in environmental monitoring

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...

RMM Webinar Featured Image

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...

 

Webinar: High-throughput MALDI TOF mass spectrometry for drug discoveryFIND OUT MORE
+ +