Interventions Risk Evaluation and Management in Aseptic Manufacturing.

Q3 Medicine
Hal Baseman, Subrata Chakraborty, Michael A Long
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引用次数: 0

Abstract

Interventions performed by personnel during an aseptic process can be a key source of microbiological contamination of sterile biopharmaceutical products, irrespective of the type of manufacturing system used. Understanding the relative risk of this source of contamination provides valuable information to help make decisions for the design, qualification, validation, operation, monitoring, and evaluation of the aseptic process. These decisions can be used to improve the aseptic process and provide assurance of the sterility of the products. To achieve these goals, an assessment of the contamination risk is needed. This risk assessment should be objective, accurate, and useful. This article presents an Intervention Risk Evaluation Model (IREM) philosophy and an objective, accurate, and useful method for intervention risk determination. The IREM uses a key word approach to identify, obtain, measure, and evaluate intervention risk factors. This article presents a general discussion of the method with the help of a case study to illustrate the development of the model, whereas subsequent parts would focus on application of this model with practical examples. This not only attempts to create objectivity of the entire process, but it develops awareness of the associated risks among shop floor operators, which can lead to a reduction of the overall risk level of the process and an improvement in the sterility assurance level.

无菌生产干预风险评价与管理。
人员在无菌过程中进行的干预可能是无菌生物制药产品微生物污染的主要来源,与使用的制造系统类型无关。了解该污染源的相对风险可提供有价值的信息,有助于对无菌工艺的设计、确认、验证、操作、监控和评价做出决策。这些决定可用于改进无菌工艺并保证产品的无菌性。为了实现这些目标,需要对污染风险进行评估。这种风险评估应该是客观、准确和有用的。本文提出了干预风险评估模型(IREM)的理念,并提出了一种客观、准确、实用的干预风险确定方法。IREM使用关键字方法来识别、获取、测量和评估干预风险因素。本文通过案例研究对该方法进行了一般性讨论,以说明模型的发展,而后续部分将通过实际示例重点介绍该模型的应用。这不仅试图建立整个过程的客观性,而且还培养了车间操作员对相关风险的认识,这可以降低过程的整体风险水平,并提高无菌保证水平。
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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来源期刊
CiteScore
1.90
自引率
0.00%
发文量
34
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