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Microbiology

 

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

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

4 May 2016 | By 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.…

The challenges of riskbased environmental monitoring in sterile product filling
The challenges of riskbased environmental monitoring in sterile product filling
article

The challenges of riskbased environmental monitoring in sterile product filling

29 February 2016 | By

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…

The limitations of the colony-forming unit in microbiology
The limitations of the colony-forming unit in microbiology
article

The limitations of the colony-forming unit in microbiology

6 January 2016 | By Tony Cundell, Microbiological Consulting LLC

The recent revision to USP General Informational Chapter 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…

Rapid methods update: revisions to a United States Pharmacopeia chapter
Rapid methods update: revisions to a United States Pharmacopeia chapter
article

Rapid methods update: revisions to a United States Pharmacopeia chapter

3 September 2015 | By 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.