A New Sanitary Conductivity Meter and the Future Management of Pharmaceutical Water

By: Kiichiro Tomioka*

30 November 2006

*Product Planning Project Leader of HORIBA Advanced Techno, Co., Ltd.

We have developed a conductivity meter and sanitary electrodes (two types) for pharmaceutical water that meet the conductivity requirements of the United States Pharmacopeia (USP) General Chapters article 645. In particular, the flow-through type does not have any inner projections inside, which allows a full bore structure and excellent cleanability. Ideal sanitary properties corresponding to strict sanitary conditions for food, etc. are required by customers. We have concurrently developed a validation kit for performance evaluation to support the customer GMP (Good Manufacturing Practice) system. In pharmaceutical processes, analyzers are not used for process control as often as in petrochemical processes. However, the use of analyzers is actively being considered under the leadership of the Food and Drug Administration (FDA). The trend in US Pharmacopeia is toward more reliable and safer water, and the importance of water management is increasing.

(Same content in Japanese is in Readout No.31-Japanese edition-.)

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