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Abstract
Total organic carbon (TOC) presents an essential quality parameter for purified water (AP) and water for injection (WFI). For the monitoring of pharmaceutical water systems, the analysis of TOC occurs online and offline. However, monitoring data collected throughout the industry readily indicates little comparability between available online and offline measurement systems and outlier values are a common occurrence in offline samples while online devices display results with high stability. Using a recently implemented and heavily controlled WFI-system with stable online TOC values of < 4 ppb we analysed the impact of environmental air particle numbers in controlled production and technical areas on offline TOC analyses. The detected correlation strongly links environmental air particle numbers to the accumulation of organic carbon in water samples indicating outlier values do not necessarily represent a loss of quality within the generation or distribution system but rather an environmental impact or hygienic changes in the surrounding area. Our data highlights the importance of comparative and redundant offline and online analyses using various parameters to distinguish systematic and local valve contaminations from the displayed impact via the sampling environment when monitoring and evaluating complex systems.
Published Version
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