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ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems <span style="color: #4d4d4d;">Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters</span><span style="color: #4d4d4d;">. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document</span><span style="color: #4d4d4d;">2</span><span style="color: #4d4d4d;">&nbsp;from the International Conference on Harmonisation.</span>
Anaerobic cultivation processes of probiotic bacteria in the BioLector XT microbioreactor
Analyzing Mussel/Mollusk Propagation using the Multisizer 4e Coulter Counter
Classifying a Small Cleanroom using the MET ONE HHPC 6+ This applications note will demonstrate the classification of a small ISO Class 5 Clean room and associated ISO Class 7 gowning room using a MET ONE model HHPC 6+ handheld particle counter. Reference will be made to the ISO 14644-1 clean room classification standard with regards to sample size, locations selected, limits and calculations necessary to determine the compliance status of the clean zone to ISO 14644-1 Class 5.
Air Particle Monitoring ISO 21501-4 Impact

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