Overview of Recent Analytical Development and Commonly Used Analytical Techniques in Pharmaceutical Cleaning Verification: A Review

E. Moore
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Abstract

The pharmaceutical cleaning verification can be a challenging process due to the technicality of the analytical process and the hazardous nature of the contaminant on the surface of the manufacturing equipment. There are a number of parameters to be considered before the analytical method is selected for the cleaning verification. The most commonly used methods fall under two main categories: direct and indirect method. The direct method is where the cleanliness is verified directly by visual inspection or any other means where the contaminant is not removed from the surface of the manufacturing equipment. The principle of indirect methods involves the quantitative removal and analysis of the contaminant chemical from the surface of the equipment. This article provides an overview of the current analytical process used by the pharmaceutical industry and the trend of the future pharmaceutical cleaning verification process.
近年来分析发展概况和常用的分析技术在药品清洗验证:综述
由于分析过程的技术性和制造设备表面污染物的危险性,药品清洗验证可能是一个具有挑战性的过程。在选择分析方法进行清洗验证之前,有许多参数需要考虑。最常用的方法分为两大类:直接法和间接法。直接方法是通过目视检查或任何其他方法直接验证清洁度,其中污染物未从制造设备的表面去除。间接法的原理是对设备表面的化学污染物进行定量去除和分析。本文概述了目前制药行业使用的分析工艺以及未来制药清洗验证工艺的趋势。
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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