Billerica, MA August 26, 2003 Millipore today announced that its Milli-Q and Elix water purification systems meet US Pharmacopeia (USP) requirements for total organic carbon (TOC) analysis and conductivity tests of purified water.
The USP is a non-government organization that establishes state-of-the-art standards to ensure the quality of medicines and other health care technologies. Its water quality standards are primarily used by pharmaceutical manufacturers in drug production, research and development, and quality control laboratories.
Millipore says it has developed a series of protocols to comply with USP 26 – NF 20 monographs 643 and 645 for periodic checks of TOC analysis and water conductivity. According to the standard in monograph 643, purified water must be controlled by a calibrated TOC monitor (either in-line or off-line) with a detection limit < 0.05 mg/L of carbon. Suitability of the apparatus must be periodically demonstrated. Similar to the TOC measurement, monograph 645 requires that the conductivity measurement must be obtained using calibrated instrumentation. Millipore’s customer care engineers provide the tools and service for suitability testing to streamline the validation process.