洁净室和相关控制环境.第17部分：颗粒沉积速率应用

[中文适用范围]： 本文件为洁净室中一个或多个易损表面上的颗粒沉积率测量结果的解释和应用提供了指导，作为污染控制计划的一部分。 它提供了一些有关如何影响颗粒沉积速率并降低易损表面上颗粒污染风险的说明。 本文档提供了有关洁净室用户如何使用颗粒沉积率测量来确定可为易损表面上的大颗粒设置的限制的信息。 它还提供了一种风险评估方法，通过该方法可以确定颗粒沉积到洁净室中易损表面上的可接受的风险，并且当无法实现这一点时，可以使用方法来降低颗粒沉积率。 粒子沉积率的另一种选择是粒子遮蔽率，它决定了粒子在表面区域上的覆盖率随时间的增加率。 粒子遮蔽率可以与粒子沉积率类似的方式使用，并且可以计算指定表面所需的粒子遮蔽率，并降低沉积粒子的风险。 本文件不： ——提供根据粒子沉积率或粒子遮蔽率对洁净室进行分类的方法； ——直接考虑携带微生物的颗粒的沉积，尽管它们可以被视为颗粒； ——考虑接触引起的表面沉积，例如，当人员接触产品并转移污染物时。 [外文原描述]： This document gives direction on the interpretation and application of the results of the measurement of particle deposition rate on one or more vulnerable surfaces in a cleanroom as part of a contamination control programme. It provides some instructions on how to influence the particle deposition rate and reduce the risk of particle contamination on vulnerable surfaces. This document gives information on how a cleanroom user can use the particle deposition rate measurements to determine limits that can be set for macroparticles on vulnerable surfaces. It also gives a risk assessment method by which an acceptable risk of deposition of particles onto vulnerable surfaces in a cleanroom can be established and, when this is not achieved, methods that can be used to reduce the particle deposition rate. An alternative to the particle deposition rate is the particle obscuration rate which determines the rate of increase of coverage of particles onto an area of surface over time. The particle obscuration rate can be used in an analogous way to the particle deposition rate and the required particle obscuration rate for a specified surface can be calculated and the risk from deposited particles reduced. This document does not: — provide a method to classify a cleanroom with respect to particle deposition rate or particle obscuration rate; — directly consider the deposition of microbe-carrying particles, although they can be treated as particles; — give any consideration to surface deposition by contact as, for example, when personnel touch a product and contamination is transferred.