A comprehensive review on pilot plant scale up and platform technology

Kishore Bandarapalle, R. K. Kumarachari, Kamasani Teja Sri, Boyalapalli Neeraja, Chejarla Likhitha, Krishna Chaitanya, C. Y. Bhargavi
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Abstract

The pharmaceutical business uses pilot plant scale-up strategies to create reliable manufacturing procedures and turn lab-scale formulas into commercial products. The place called Pilot is where the five elements Material, Man, Method, and Machine are combined to manufacture things. A tiny, basic lab scale formula will be tested on a replica of the intended plant in the pilot plant before spending a significant amount of money on a production unit. Scaling up a pilot plant provides information on formula examination, reviewing the range of pertinent processing equipment, understanding raw material specifications, production rate, and physical space requirements. It can hold accurate documentation and reports for analysis in support of the GMP procedure. This review research discusses the factors for solids, liquids, and semisolids for scaling up pilot plants. The primary goal of a pilot plant is to "identify errors on a small scale and generate revenue on a large scale."
全面回顾试验工厂规模化和平台技术
制药企业利用中试车间放大战略来创建可靠的生产程序,并将实验室规模的配方转化为商业产品。所谓中试,就是将材料、人、方法和机器这五大要素结合起来进行生产的地方。在花费巨额资金购买生产设备之前,将在中试车间的预定工厂复制品上对实验室规模的微小基本配方进行测试。扩大试验工厂规模可提供配方检查信息,审查相关加工设备的范围,了解原材料规格、生产率和物理空间要求。它还能提供准确的文件和报告,用于分析以支持 GMP 程序。本综述研究讨论了扩大试验工厂规模的固体、液体和半固体因素。试验工厂的主要目标是 "在小规模上发现错误,在大规模上创造收益"。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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