实验室批次、放大批次、展示批次、商业批次工艺参数的比较

Gnana Prakash
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引用次数: 0

摘要

本工作的目的是评估关键工艺参数和技术,提高质量,减少铸造和放大时间。制药行业的研发是指从药物发现到产品开发的成功过程。确定目标市场的需求,产生和评估替代产品概念,并为未来的发展选择单一概念。概念是对产品的功能和特性的描述,是有用的。放大是定义为增加批量大小或增加不同物理参数的过程。旧的工艺放大技术不涉及关键工艺参数的研究(原始工艺)。扩大批量工业,以提高产品质量,从扩大批量/展示批次和验证批次转移。从实验室小批量到商业规模的转化依赖于经验和概率,涉及到更多的技术。由于这种成功的可能性是对关键工艺参数和工艺的理解较少,因此在制造过程中能够控制关键步骤工艺参数,并成功地从实验室规模转变为展示批次和商业批次。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of Process Parameter of Lab Batches, Scale-Up Batches Exhibit Batches Commercial Batches
The aim of the present work is to evaluate the critical process parameters and techniques and improve the quality and reduce cast and scaling up time. The pharmaceutical industry R & D refers to the process of successful progress from drug discovery to product development. The need to the target market are identified alternative product concept are generated and evaluate and single concept of selected for future development. The concept is a description of the from function and features a product and a usefully. The Scale up is the process as define to increasing the batch size or increasing different physical parameter the output of volume. The old process scale up techniques doesn’t involve studying the critical process parameters (Raw Process). The scale up batches industry to improve quality of the product in moving from Scale up batches/Exhibit Batches and validation batches. To improve the batches quality scale up of a process Transformation of small scale lab batches into commercial scale depended on experience and probability and involving the more technique. Due to this probability of success is less understanding of critical process parameters and process enables control of critical step process parameter during manufacturing and successful transformation from lab scale to Exhibit batches and commercial batches.
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