Destin A. LeBlanc,Cleaning Validation Technologies,Technical Consulting Services Cleaning Memo for APRIL 2004 This Cleaning Memo will address the proper selection of sampling materials used if Total Organic Carbon (TOC) is the sampling method of choice. Particularly since TOC is subject to a multitude of interferences, it is necessary to make sure that the sampling materials provide a consistent TOC value due to those “interfering” materials. Those materials contribute to the TOC “blank”, and are preferably materials which provide a blank with a low, consistent TOC value.
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As defined by regulatory standards, validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.
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