Pharmaceutical water measurement and control requirements have been drastically revised in the last decade. To maximize manufacturing efficiencies, the United States Pharmacopoeia (USP) developed new requirements for Water for Injection and for Purified Water in support of on-line conductivity, <645> and TOC <643> measurements. These requirements have enabled pharmaceutical manufacturers to provide real-time process controls, increase productivity and throughput, and support FDA's Process Analytical Technology (PAT) initiative.
USP initiated global HARMONIZATION efforts with the European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) and Chinese Pharmacopoeia (ChP) to help bring consistency to worldwide pharmaceutical water requirements. Mettler-Toledo Thornton is positioned as the global leader for HARMONIZATION activities for conductivity and TOC measurements.
Visit: In-line measurements for batch-to-batch consistency and quality
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