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Achieving on-aim product quality control by design

机译:通过设计实现准时产品质量控制

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One important reason for delivering excellent dynamic performance in a new or existing process centers on the need to control product quality on-aim (defined as keeping product quality variables at a given target with low variability around that target). This consistency requirement is a particularly key issue for pharmaceuticals, food ingredients, specialty chemicals, monomers, polymers, fibers, etc., where it is often impossible to measure all properties and where small differences in impurities can cause a significant change in end-use characteristics. Achieving the ability to control product quality on-aim does not happen by accident, it happens by deliberate design. This paper summarizes an industrial view on incorporating controllability and developing plantwide control strategies at the stage where a new process is being designed. It presents several industrial examples to highlight key concepts.
机译:在新的或现有的过程中提供出色的动态性能的重要原因集中于对目标产品质量进行目标控制的要求(定义为将产品质量变量保持在给定目标上,并且该目标周围的变化较小)。对于药品,食品成分,特种化学品,单体,聚合物,纤维等而言,这种一致性要求是一个特别关键的问题,在这种情况下,通常无法测量所有性能,并且杂质中的细微差异会导致最终用途的重大变化特征。实现目标产品质量控制的能力并非偶然,而是通过精心设计而实现的。本文总结了在设计新工艺阶段纳入可控性和制定全厂控制策略的行业观点。它提供了几个工业示例来突出关键概念。

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