Hazard analysis and risk assessment in the development of biomedical drug formulation equipment.
Hazard analysis and risk assessment in the development of biomedical drug formulation equipment.
复制标题
生物医药制剂设备开发中的危害分析与风险评估。
DOI：
10.1007/s10439-011-0451-x
复制
发表时间：
2012
影响因子：
3.8
通讯作者：
Delucas,LawrenceJ
中科院分区：
文献类型：
--
作者：
Johnson,DavidH;Bidez,MarthaW;Delucas,LawrenceJ
危害分析和风险评估技术在许多私营部门行业和政府机构（包括医疗器械和制药行业）的结构化流程中得到应用，以控制人身伤害以及环境和财产损失。在美国，联邦药品管理局（FDA）要求对所有医疗器械进行危害分析。虽然有生物医学工程的应用报告，其中处理人类的危害，在临床，病人护理环境，没有以前的研究扩展这些传统技术，以大学为基础的，研究环境。本研究采用分层方法对生物医学，大学为基础的研究环境进行危害分析和风险评估，设计高通量平台，筛选化学辅料（添加剂）增加蛋白质溶解度的能力。每个设计阶段（概念、初步、系统和详细）都需要基于可用信息的独特危险分析技术。这里应用的分析技术进行评估，其使用在生物医学研究环境中，实验精度是一个主要问题。
Hazard analysis and risk assessment techniques are utilized within many private sector industries and government agencies, including the medical device and pharmaceutical industry, within a structured process to control human injuries and environmental and property damage. In the U.S. the Federal Drug Administration (FDA) requires a hazard analysis be performed on all medical devices. While there are biomedical engineering applications reported which deal with human hazards in clinical, patient care environment, no previous studies extend these traditional techniques to a university-based, research environment. This study applies a tiered approach to hazard analysis and risk assessment to a biomedical, university-based, research environment in the design of a high throughput platform that screens chemical excipients (additives) for their ability to increase protein solubility. Each design stage (conceptual, preliminary, system, and detailed) requires a unique hazard analysis technique based on available information. The analysis techniques applied here are evaluated for their use in a biomedical research environment where experiment accuracy is a primary concern.