Ljungqvist B, Reinmüller B
Royal Institute of Technology, Stockholm.
J Parenter Sci Technol. 1993 Mar-Apr;47(2):60-9.
The purpose of this presentation is to describe the theoretical relations for the dispersal of airborne contaminants and to illustrate the validity of these equations occurring during factual situations, where a number of observations on air movements in open unidirectional air flow units supplied with HEPA-filters are described. In factual situations the aerodynamic system which governs the dispersion of contaminants in reality is always very complicated that risk situations must be mapped and assessed empirically. The presence of a person can give risk to wakes that may be stable or unstable. The unstable situations are in most cases caused by the influence of arms and hands. As part of the microbiological assessment of aseptic processes carried out in clean zones, it is important to investigate that such vortices do not occur in the clean working areas. As the level of airborne contaminants in the operational environment may have an effect on the level of product contamination, the microbiological assessment of aseptic processes is important. A system is described for microbiological assessment in unidirectional air flow units by using visual illustrative methods and particle challenge tests (measured by particle counter) for the dispersion and/or induction of particles.
本报告的目的是描述空气中污染物扩散的理论关系，并说明这些方程式在实际情况中的有效性，其中描述了对配备高效空气过滤器的开放式单向气流单元内空气流动的一些观测结果。在实际情况中，控制污染物扩散的空气动力学系统实际上总是非常复杂，因此必须通过经验来绘制和评估风险情况。人员的存在可能会产生稳定或不稳定的尾流风险。不稳定情况在大多数情况下是由手臂和手部的影响造成的。作为在洁净区进行的无菌工艺微生物评估的一部分，重要的是要研究在洁净工作区域中不会出现此类涡流。由于操作环境中空气传播污染物的水平可能会对产品污染水平产生影响，因此无菌工艺的微生物评估很重要。本文描述了一种通过使用视觉说明方法和颗粒挑战测试（通过颗粒计数器测量）来对单向气流单元中的颗粒扩散和/或诱导进行微生物评估的系统。
