184 Lessons learnt from cross contamination/gradient study across pharmaceutical formulation sites

IF 1.8 4区医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Annals Of Work Exposures and Health Pub Date : 2024-06-27 DOI:10.1093/annweh/wxae035.072

Prasanth Kondragunta, Chand Bandaru

引用次数: 0

Abstract

Cross contamination in pharmaceutical industry is a serious issue which can affect the quality and safety of drugs. Methods for conducting the Cross-contamination study, identifying potential routes of contamination and results from the swab and air samples will be presented. The evaluation criteria for the cross contamination study involves calculating the potential contamination in a maximum daily dose of one product and compare it with Permissible Daily Exposure (PDE) values. Key recommendations related to management of ventilation systems and work practices to minimize the cross-contamination will be shared.

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184 从跨制药厂的交叉污染/梯度研究中吸取的经验教训

制药业的交叉污染是一个严重问题，会影响药品的质量和安全。将介绍交叉污染研究的方法、确定潜在的污染途径以及拭子和空气样本的结果。交叉污染研究的评估标准包括计算一种产品每日最大剂量的潜在污染，并将其与每日允许接触量 (PDE) 值进行比较。还将分享与通风系统管理和工作实践有关的主要建议，以最大限度地减少交叉污染。

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

Annals Of Work Exposures and Health Medicine-Public Health, Environmental and Occupational Health

CiteScore

4.60

自引率

19.20%

发文量

期刊介绍： About the Journal Annals of Work Exposures and Health is dedicated to presenting advances in exposure science supporting the recognition, quantification, and control of exposures at work, and epidemiological studies on their effects on human health and well-being. A key question we apply to submission is, "Is this paper going to help readers better understand, quantify, and control conditions at work that adversely or positively affect health and well-being?" We are interested in high quality scientific research addressing: the quantification of work exposures, including chemical, biological, physical, biomechanical, and psychosocial, and the elements of work organization giving rise to such exposures; the relationship between these exposures and the acute and chronic health consequences for those exposed and their families and communities; populations at special risk of work-related exposures including women, under-represented minorities, immigrants, and other vulnerable groups such as temporary, contingent and informal sector workers; the effectiveness of interventions addressing exposure and risk including production technologies, work process engineering, and personal protective systems; policies and management approaches to reduce risk and improve health and well-being among workers, their families or communities; methodologies and mechanisms that underlie the quantification and/or control of exposure and risk. There is heavy pressure on space in the journal, and the above interests mean that we do not usually publish papers that simply report local conditions without generalizable results. We are also unlikely to publish reports on human health and well-being without information on the work exposure characteristics giving rise to the effects. We particularly welcome contributions from scientists based in, or addressing conditions in, developing economies that fall within the above scope.