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The manufacture of sterile medicinal and therapeutic products increasingly calls…
The manufacture of sterile medicinal and therapeutic products increasingly calls for aseptic processing using barrier separation technology comprising isolators and restricted access barrier systems (RABS) that have glove-sleeve systems.
Completing risk assessments is an inherent part of good manufacturing…
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…
In this Microbiology In-Depth Focus: Diversity of bacteria in pharmaceutical…
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...
Michael J. Miller discusses rapid microbiological methods and the regulatory…
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...
In this free-to-view in-depth focus: How to deal with non-sterile…
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...
This pharma webinar provides an overview of the new PHSS…
29 May 2014 | By TSI Inc.
This pharma webinar provides an overview of the new PHSS Bio-contamination Monograph and the value of real-time airborne viable particle detection in GMP classified areas.
