04:02 Apr 19, 2020 |
French to English translations [PRO] Medical - Medical: Pharmaceuticals / manufacturing | |||||
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Summary of answers provided | ||||
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3 | weighing of start-up waste |
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Discussion entries: 5 | |
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pesees des dechets de reglages weighing of start-up waste Explanation: In a systematic approach to determine the minimum tablet compression batch size, the following factors can be considered: tablet weight, API percentage, manufacturing process, and SET-UP WASTE from similar products and/or processes. [... ] START-UP WASTE is generated due to INITIAL ADJUSTMENTS TO ACHIEVE THE IN-PROCESS QUALITY ATTRIBUTES (I.E., TABLET WEIGHT, HARDNESS, THICKNESS, FRIABILITY, AND DISINTEGRATION) prior to starting the compression process. Process performance qualification samples are collected after start up, where all the in-process specifications are achieved at an established consistent tablet-press speed. In- process quality attributes are maintained by the force-control mechanism throughout the compression process. Because the tablets manufactured as start-up waste are disposed of, the start-up waste generated should be considered for the minimum batch quantity requirement. http://www.pharmtech.com/determining-minimum-batch-size?page... • START UP WASTE inadequately segregated from main batch https://www.pharmamanufacturing.com/assets/Media/MediaManage... |
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