环境监测-取样位置选择

Suitable sample sites vary widely depending on the clean room design and manufacturing process. Each process should be carefully evaluated when selecting sampling sites. The primary purpose of sampling should be to provide meaningful interpretable data that can help identify actual or potential contamination problems associated with specific procedures, equipment, materials, and processes. One should be able to sample those sites most likely to result in product contamination if they become contaminated; however, it may be prudent to identify indicator sites that are near, but not in contact with product. 
合适的取样位置差异很大，取决于洁净室的设计和生产工艺。选择采样点时，应认真评估每个工艺。取样的主要目的应是提供有意义可解释的数据，可以帮助确定与具体程序，设备，材料和工艺相关的实际或潜在污染问题。应能对最能够导致产品污染的位置；但是，它可能会谨慎确定附近的指示器位置，而不与产品接触。

Factors to consider in selecting sites for routine surveillance are: 日常监测选择位置时要考虑的因素：
1. At which sites would microbial contamination most likely have an adverse effect on product quality? 
微生物污染极有可能对产品质量造成不良影响的位置？

2. What sites would most likely demonstrate heaviest microbial proliferation during actual production? 
最有可能表现出实际生产过程中微生物扩散最严重的位置？

3. Should site selection involve a statistical design (e.g., following the calculations in Federal Standard 209E) or should site selection be made on the basis of grid profiling? Should some sites for routine monitoring be rotated? 
选址是否涉及统计设计（例如，继美国联邦标准209E的计算），或选址是否根据网格计算分析？常规监测的位置是否应轮换？

4. What sites would represent the most inaccessible or difficult areas to clean, sanitize, or disinfect? 
哪些位置最难接近或最难清洁，杀菌或消毒？

5. What activities in the area contribute to the spread of contamination? 
该区域的哪些活动有助于污染蔓延？

6. Would the act of sampling at a given site disturb the environment sufficiently to cause erroneous data to be collected or contaminate product? Should sampling only be performed at the end of the shift? 
在指定位置取样是否会干扰环境，导致收集的数据错误或污染产品？取样是否只能在轮班结束时进行？

Note: There are some considerations applicable to specific types of monitoring; they are described in the individual monitoring sections of this document. 
注意：有一些考虑项适用于特定类型的监测，在本文档的监测章节描述。
To establish routine sample sites, action and alert levels, and testing frequency, one should take into consideration the extent of contact or exposure that each element of the manufacturing environment has with the product. Sites having greater opportunity for contributing bioburden to the product should be sampled and monitored. Product contact sources may include compressed gases, room air, manufacturing equipment, tools, critical surfaces, storage containers, conveyors, gloved hands of personnel, and water. Examples of non-product contact sources may include walls, floors, ceilings, doors, benches, chairs, test instruments, and pass-throughs. 
为建立常规取样点，报警和行动等级，测试频率，应该考虑到每个生产环境要素与产品的联系或接触程度。很可能对产品带来生物负荷的位置应进行取样并监测。产品接触源可能包括压缩气体，室内空气，制造设备，工具，关键表面，储存容器，传送带，人员戴手套的手和水。非产品接触源可能包括墙壁，地板，天花板，门，长椅，椅子，测试仪器及传递窗。
It must be recognized, however, that it may not always be practical to select a site at the most critical location. One should consider whether critical site monitoring would actually increase probability of product contamination. Additionally, critical sites may not be monitored if there is a low probability of contamination during processing (e.g., sterilized components which are not manipulated). 
然而，必须承认在最关键的位置选择取样点并不实际。应该考虑到关键位置监测是否实际上增加了产品污染的可能性。此外，如果加工过程中污染的可能性低，则不能监测关键取样点（如未操控已消毒组件）。
As pointed out in other sections of this document, there are many considerations in establishing an appropriate site for sampling (e.g., facility design, line configura-tions, validation data, process, historical data, test methodology, etc.). The sites listed in this section may or may not be applicable to a particular manufacturing process; factors pertaining to site selection are likely to be unique to individual facilities. 
正如在本文件的其他部分提出的，建立相关取样位置需考虑到很多方面（例如，设施设计，线路配置，验证数据，工艺，历史数据，测试方法等）。本节中列出的取样点不一定适用于一个特定的生产工艺，位置选择的相关因素对每个设施可能都是独一无二的。

       文章来源：药品微生物检测

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