ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Pure Steam (USP)

Water that has been heated above 100°C (212°F) and vaporized in a manner that prevents source water entrainment. It is prepared from water complying with the U.S. EPA Primary Drinking Water Regulations, or with drinking water regulations of the European Union or Japan, or with WHO drinking water guidelines. It contains no added substance. The level of steam saturation or dryness, and the amount of noncondensable gases are to be determined by the Pure Steam application. Note: Pure Steam is intended for use where steam or its condensate comes in contact with the article of the preparation.

Publication Source: ISPE Baseline® Guide, Vol. 4: Water and Steam Systems (First Edition)
Publication Date: 2001

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