The Use of TOC Measuring in CIP and Cleaning Validation Applications

Pharmaceutical manufacturing is one of the most strongly regulated, particularly in regards to the manufacture, use and testing of Water for Injection (WFI), Pure Water (PW) and Highly Purified Water (HPW). The United States Pharmacopeia (USP) and European Pharmacopeia (EP) and all other pharmacopeias set strict guidelines for water quality (chemical and microbiological impurities) and test equipment as used in pharmaceutical and biotech manufacturing. TOC (Total Organic Carbon) and conductivity are closely monitored as a means of ensuring proper chemical qualities for these waters have been maintained throughout the manufacturing process. This application note demonstrates how measurement of TOC can be used in cleaning validation applications.