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Environmental Monitoring

 

webinar

Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring

19 January 2017 | By Particle Measuring Systems

ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control. This webinar provides a review of the changes and how they affect your environment monitoring...

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Environmental Monitoring In-Depth Focus 2016

24 August 2016 | By European Pharmaceutical Review

In this Environmental Monitoring In-Depth Focus: Bacterial endotoxin contamination and testing limits in ophthalmics; The basics of environmental monitoring in aseptic units; Environmental Monitoring Roundtable...

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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…

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Real-time biological particle counting in environmental monitoring

20 April 2015 | By

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…

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A reduction to practise for siRNA screening utilising high conent analysis (HCA) technologies

10 July 2012 | By Anthony Mitchell Davies & Anne Marie Byrne, Department of Clinical Medicine Trinity College Dublin; Holger Erfle, BIOQUANT-Zentrum Ruprecht-Karls-Universität Heidelberg; Graham Donnelly, Rita Murray & Peadar MacGabhann, Biocroi Ltd

One of the major limitations of performing large-scale High Content Analysis (HCA) screens is reagent cost, indeed this fact has been a key driver in the development of assay size reduction strategies here at The Irish National Centre for High Content Screening and Analysis at Trinity College’s Department of Medicine.…

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Aseptic preparation: The weakest link is getting stronger

12 December 2009 | By Gavin Halbert, Director, Cancer Research UK Formulation Unit, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde

The manufacture of sterile products attracts the greatest regulatory scrutiny of all product types, since manufacturing failures can be fatal and manufacturers are required to utilise the most robust sterilisation method possible to limit the probability of this occurring. However, aseptic preparation, which is the last resort manufacturing method, continues…