Improving Water System Performance: A Continuous TOC Measurement Technology To Enhance Real-Time Process Control

Water is the most widely used excipient in pharmaceutical and biotech manufacturing processes. It is used as an ingredient, reagent, solute, delivery device, cleaning material, and in some cases, the water is the end product such as sterile water for injection. In pharmaceutical production, the accurate measurement of water quality is critical to the water purification process. This industry mandates the monitoring of Total Organic Carbon (TOC) as specified in the monographs of the United States Pharmacopoeia (USP) for Purified Water (PW) and Water For Injection (WFI), and in the European Pharmacopoeia (EP) monographs for these same waters, as well as Highly Purified Water (HPW). In these monographs, the specific TOC testing requirements for the waters are referenced in USP <643> and in the EP 2.2.44 general test chapters.

Organics are introduced into natural water systems by leachates in soil, typically from the decomposition of vegetation, animal waste, and soil runoff. Humic acids are a common product of plant decomposition and a main contributor to elevated levels of organics in potable water during the fall season. These compounds are a complex mixture of high molecular weight substances containing carbon, hydrogen, and oxygen predominantly. Organic compounds in water are a concern at all levels of water purity from potable water to pure waters used in the manufacture of pharmaceuticals.