Total Organic Carbon - Cleaning Validation in the Pharmaceutical Manufacturing Industry - USP <643>

Feb 15

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2/15/2013 12:00 AM  RssIcon

Shimadzu TOC

Cleaning validation for production equipment at pharmaceutical facilities is an evaluation that is conducted to prevent cross-contamination from previously processed products and detergent used for equipment cleaning, as well as foreign material from the environment that could be present in in the production equipment. The amount of Total Organic Carbon (TOC) found is compared with specific permissible limits to make sure they are not exceeded. Of the different techniques used to performed this task, the preferred method is the direct combustion of the swab and analysis by a TOC analyzer equipped with a solids combustion unit capable of accommodating the swabs. The instrument used for this test at Weck Labs is the latest generation Shimadzu TOC-LCPH with the SSM-5000A Swab combustion unit. Read more...

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