首页> 外文会议>Proceedings of the 43rd annual loss prevention symposium >LOPA as Practiced at Pfizer's Global Manufacturing API Facility in Kalamazoo, MI
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LOPA as Practiced at Pfizer's Global Manufacturing API Facility in Kalamazoo, MI

机译:密歇根州卡拉马祖市辉瑞全球制造API设施中的实践LOPA

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摘要

The standard risk assessment practices used in industry since the OSHA 1910.119 regulation was issued, are to conduct Process Hazard Analyses (PHAs) for hazardous and exothermic (or otherwise high risk) processes. During PHAs, the potential consequences of an undesired event are evaluated along with the safeguards that exist to mitigate the consequences or reduce the frequency of the event. If the PHA team determines that the risk is still not tolerable, additional safeguards are recommended to reach a tolerable level of risk. Typically, a Quantitative Risk Assessment (QRA) can be completed to evaluate the effectiveness of these existing or newly proposed safeguards. Unfortunately, this is a complex and time consuming task. The relatively new methodology of Layer of Protection Analysis (LOPA) allows a PHA team to evaluate the effectiveness of safeguards in reducing risk in an efficient yet semi-quantitative fashion using some basic assumptions and standard lookup tables. At Pfizer Kalamazoo, the LOPA methodology has been utilized to evaluate the effectiveness of Safety Instrumented Functions (SIF) (e.g. automated critical interlocks and alarms) in achieving a tolerable risk. Several scenarios will be shared that will provide an overview of how the LOPA methodology has been used in a multi-batch pharmaceutical facility.
机译:自OSHA 1910.119法规发布以来,行业中使用的标准风险评估做法是对危险和放热(或其他高风险)过程进行过程危害分析(PHA)。在PHA期间,将评估意外事件的潜在后果以及为减轻后果或减少事件发生的现有安全措施。如果PHA小组确定该风险仍然不能容忍,则建议采取其他安全措施以达到可容忍的风险水平。通常,可以完成定量风险评估(QRA)以评估这些现有或新提议的保障措施的有效性。不幸的是,这是一项复杂且耗时的任务。相对较新的保护层分析方法(LOPA)使PHA团队可以使用一些基本假设和标准查找表,以有效而半定量的方式评估保障措施降低风险的有效性。在辉瑞(Pfizer Kalamazoo),LOPA方法已被用于评估安全仪表功能(SIF)(例如自动关键联锁和警报)在实现可承受风险方面的有效性。将共享几种方案,以概述如何在多批次制药设施中使用LOPA方法。

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