TOC analytical method in cleaning validations: criteria, limits and robustness of the process
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Designed for the continuous monitoring of water, from ultrapure to drinking water, the M9 Online offers unrivalled precision, accuracy and speed across a dynamic operating range of 0.03 ppb to 50 ppm. It enables compliance with pharmacopoeial standards for water analysis and can be used for real-time cleaning validation and other online applications. In Turbo mode, the M9 performs analyses every four seconds, providing instant results for improved control. Sievers M9 analysers meet or exceed the most common pharmaceutical regulatory requirements for TOC analysis and data integrity.
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Performance specifications*
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The UV lamp contained in this product contains mercury and must be recycled or disposed of in accordance with local, state and federal laws.
* The stated analytical performance can be achieved under controlled laboratory conditions that minimise operator and standard errors.
** Sample temperatures above 60 °C require the optional PVDF iOS.
TOC / TC / IC / Conductivity / T
USP <643> and <645>,
EP 2.2.44 Total Organic Carbon,
IP 2.4.30,
CP Appendix VIII R and JP16 2.59 for purified water and water for injection.
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