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Content and Resources

21 CFR Part 11 Data Integrity for On-line WFI Instruments This application note takes a look at how quality-critical on-line Total Organic Carbon (TOC) and conductivity instrumentation for WFI (water for injection) quality control can be configured to help companies comply with the FDA’s expectations on data integrity, including the use of Microsoft Active Directory and PDF data export.
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>
Aerobic cultivation of high-oxygen-demanding microorganisms in the BioLector XT microbioreactor
Anaerobic cultivation processes of probiotic bacteria in the BioLector XT microbioreactor
Analyzing Mussel/Mollusk Propagation using the Multisizer 4e Coulter Counter

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