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09:48 Dec 17, 2020 |
French to English translations [PRO] Medical - Medical: Pharmaceuticals / vaccines | |||||||
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| Selected response from: Drmanu49 France Local time: 17:40 | ||||||
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Summary of answers provided | ||||
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4 +3 | claimed (to be sterile / to have a low bioburden) |
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4 | claim |
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3 | sterility requirement/assurance level |
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claimed (to be sterile / to have a low bioburden) Explanation: IMO For the Submission of Documentation for Sterilization ... - FDA www.fda.gov › media › download PDFTraduire cette page This level of sterility assurance should be demonstrated for all parts of the drug product (including the container and closure, if applicable), which are claimed to be ... |
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