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James L. Drinkwater

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The challenges of riskbased environmental monitoring in sterile product filling

Completing risk assessments is an inherent part of good manufacturing…

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…

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Microbiology In-Depth Focus 2015

In this Microbiology In-Depth Focus: Diversity of bacteria in pharmaceutical…

3 July 2015 | By

In this Microbiology In-Depth Focus: Diversity of bacteria in pharmaceutical water: significance and impact on quality, Risk-based environmental control and monitoring and Microbiology Roundtable...

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RMM: In-Depth Focus 2014

Michael J. Miller discusses rapid microbiological methods and the regulatory…

5 November 2014 | By

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...

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Microbiology: In-Depth Focus 2014

In this free-to-view in-depth focus: How to deal with non-sterile…

3 July 2014 | By

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...