Firstly, it should be recognised that hazard varies on a continuum scale and that there are no firm cut off points, risk should be controlled on a proportionate basis. However, as a broad hypothetical model the following figure could be considered to show the increasing level of hazard (red being highest hazard) presented by products and there should be a commensurate increase in the level of control to prevent potential cross contamination in a shared facility. Actual HBEL values should be used in QRM studies to determine the actual controls required.
首先，要认识到危害性程度是一个连续的概念，并无明确的切分点，风险应在相应水平进行控制。但是，可以考虑使用下图作为广义假设模型来展示产品所呈现的危害水平增长，相对应在共用设施中防止潜在交叉污染的控制水平也应增加。PDE值<10µg/代表了高风险，PDE值>10000µg/天为最低。在QRM研究中应使用实际PDE值来确定实际所需控制。
风险渐增基于健康的暴露限（HBEL）---- PDE

Diagram developed from an original concept published by ISPE. Source: ISPE Baseline® Pharmaceutical Engineering Guide, Volume 7 – Risk-Based Manufacture of Pharmaceutical Products, International Society for Pharmaceutical Engineering (ISPE), Second Edition, July 2017.
上图从ISPE发布的原始概念发展出来的。来源：ISPE基准：药物工程指南，卷7—基于风险的药品生产，国际制药工程协会（ISPE），第2版，2017年7月。