The standard 20 was developed by pharmaceutical industry experts. It provides structure and path to design, test, verify, and independently certify a specific ISC. It sets the minimum requirements for qualifying ISC to meet regulatory expectations. (ISTA) The Standard 20 testing sequence involves: Design Testing (initial lab testing to affirm the design is performing according to 7E temperature profiles), Thermal Testing (lab testing to affirm accuracy and repeatability of the design testing using 7E temperature profiles), Physical Qualification of the ISC (lab testing to affirm packaging integrity is sufficient to assure thermal performance), and Thermal Qualification Verification (field testing to assure lab thermal testing results are repeatable in field conditions and is performed using sensor placement determination by prior lab testing). (ISTA)
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