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The Use of TOC Measuring in CIP and Cleaning Validation Applications

METTLER TOLEDO
29 Sept 2015

Pharmaceutical manufacturing is one of the most strongly regulated, particularly in regards to the manufacture, use and testing of Water for Injection (WFI), Pure Water (PW) and Highly Purified Water (HPW). The United States Pharmacopeia (USP) and European Pharmacopeia (EP) and all other pharmacopeias set strict guidelines for water quality (chemical and microbiological impurities) and test equipment as used in pharmaceutical and biotech manufacturing. TOC (Total Organic Carbon) and conductivity are closely monitored as a means of ensuring proper chemical qualities for these waters have been maintained throughout the manufacturing process. This application note demonstrates how measurement of TOC can be used in cleaning validation applications.

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Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Water Content AnalysisWater content analysis is crucial for determining the moisture levels in food, pharmaceuticals, chemicals, and other materials. Accurate measurement ensures product quality and shelf-life. Explore water content analysis tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.Ultrapure WaterUltrapure water is the highest purity water and contains the lowest levels of organic and inorganic contaminants, particulates and microorganisms.Organic CompoundsOrganic compounds are carbon-based molecules that form the building blocks of life. These include hydrocarbons, lipids, proteins, and nucleic acids. Understanding organic compounds is crucial in chemistry, biochemistry, and pharmacology. Explore organic compound analysis tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.

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The Use of TOC Measuring in CIP and Cleaning Validation Applications