Whether TOC or VOC, Teledyne Tekmar has the best instruments for your pharmaceutical water-quality testing needs. All Teledyne Tekmar instruments come with a full compliment of 21 CFR Part 11 software tools for your compliance needs.
Introduction of organic mater into water systems occurs not only from living organisms and from decaying matter in source water, but from purification and distribution system materials. A relationship may exist between endotoxins, microbial growth, and the development of biofilms on pipeline walls and biofilm growth within pharmaceutical distribution systems. A correlation is believed to exist between TOC concentrations and the levels of endotoxins and microbes. Sustaining low TOC levels helps to control levels of endotoxins and microbes and thereby the development of biofilm growth. The United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) recognize TOC as a required test for purified water and water for injection (WFI). For this reason, TOC has found acceptance as a process control attribute in the biotechnology industry to monitor the performance of unit operations comprising purification and distribution systems. As many of these biotechnology operations include the preparation of medicines, the Food, Drug Administration (FDA) enacts numerous regulations to protect the health of the public and ensure the product quality is maintained. To make sure there is no cross contamination between product runs of different drugs various cleaning procedures are performed. TOC concentration levels are used to track the success of these cleaning validation procedures especially clean-in-place (CIP).
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