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Category: Calibration

Are You Calibrated?

September 20, 2013 by Victoria Marquard-Schultz

If your equipment is used in the manufacture, processing, packing, and holding of a drug product it must be routinely calibrated, inspected, or checked according to a written program designed to ensure proper performance. Heres what we recommend for common oxygen equipment. Servomex Or Paramagnetic Analyzer Paramagnetic oxygen analyzers are required by the FDAs current good manufacturing practices. Paramagnetic oxygen analyzers are different from handheld analyzers because they are more precise, and the final testing for USP oxygen must be done with a paramagnetic analyzer. Your analyzer should be calibrated every fill day and sent in annually for preventative maintenance. Gauges and Thermometers High pressure gauges, vacuum gauges, and thermometers should be calibrated to NIST standards annually. NIST stands for National Institute of Standards and Technology. The FDA specifically references this standard in their Guidance for Industry. Pigtails Pigtails used on your

Posted in Calibration, Servomex, High Pressure Gauges, Thermometer, Pigtails, NIST Standards

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