非无菌环境监测取样点如何选择？

LOGFILE Feature 36/2020 – Environmental Monitoring for Non-SterileManufacturing: Establishing Where to Sample

非无菌药品生产环境监测：在何处取样？

Excerpt from the PDA/DHI bookContamination Control in Healthcare Product Manufacturing, Volume 5

摘自 PDA/DHI 《医药保健产品制造中的污染控制》第 5 卷

by Crystal Booth

When selecting the number of sites to be sampled, the author recommendsutilizing established guidelines. For example, ISO 14644-1:2015 contains atable used to establish the number of nonviable (total) particulate samplesrequired based on the size of the room to be monitored. As part of theenvironmental monitoring performance qualification (EMPQ), surface and activeviable air samples are typically taken near the same locations as the nonviableparticulate samples.

在选择采样点数量时，建议使用既定的指南。例如，ISO 14644-1：2015 包含一个表，用于根据待监测的房间大小确定所需的非活性（总）粒子取样点数量。作为环境监测性能确认（EMPQ） 的一部分，表面微生物和空气微生物取样通常与非活性粒子取样位于同一位置附近。

A common approach in establishing the monitoring sites includes obtaininga map of the room, gridding the room into equal sections, and using the riskassessment analysis results to choose the most appropriate locations to sample.The information obtained from the risk assessment is then used to plot outwhere in the grid the sample(s) should be taken. Samples should be collected atthe sites identified to contain the highest risk of contamination.

确定取样点的常用方法是获取房间图纸，将房间网格化为相等部分，并使用风险评估分析结果选择最合适的采样位置。然后，从风险评估中获得的信息用于确定应在网格中的何处取样。应在具有最高污染风险的位置进行取样。

Equipment surface monitoring sites should also be based on risk assessmentand will change from company to company depending on the equipment and theproducts being manufactured (Sutton, 2009). Note that all risk assessmentdecisions should be documented.

设备表面取样点也应基于风险评估，并在不同公司因设备和所生产的产品不同而有所不同（Sutton，2009 年）。请注意，应记录所有风险评估决策。

Samples can be taken randomly within the grid section, at the same placeeach time within the grid section, evenly distributed within the grid sections,or the sample sites can be determined by risk assessment (Sandle, 2016). Adocumented risk assessment for the selection of the sample sites should beperformed (PDA TR 13).

样品可以在网格内自由选择，每次在网格内的同一位置取样，在网格内均匀分布，或者通过风险评估确定（Sandle，2016 年）。取样点的选择应执行书面的风险评估（PDA TR 13）。

By using the risk assessment approach, one can base the samplesites on thefollowing information:

通过使用风险评估方法，可以基于以下信息对取样点进行基础分析：

  • Room layout (Sandle, 2016).

  • 房间布局

  • Equipment type (Sandle,     2016).

  • 设备类型

  • Airflow patterns (Sandle,     2016).

  • 气流组织

  • Position of air supply and     return vents (Sandle, 2016).

  • 送风和回风的位置

  • Air-change rates (Sandle,     2016).

  • 换气次数

  • Room activities (Sandle,     2016).

  • 房间活动

  • The proximity to the exposed     product (USP <1116>).

  • 与暴露产品的距离

  • The proximity to the exposed     containers (USP <1116>).

  • 与暴露容器的距离

  • The proximity to the exposed     closures (USP <1116>).

  • 与暴露密封部件的距离

  • Sites that demonstrate     heaviest microbial proliferation (USP <1116>).

  • 微生物增殖最严重的位置

  • Sites that are difficult to     clean (USP <1116>).

  • 最难清洁的位置

  • Sites that are difficult to     set up (USP <1116>).

  • 最难组装的位置

  • High traffic areas (USP     <1116>).

  • 活动频繁的区域

  • Material and waste flow (USP     <1116>).

  • 物料和废弃物流向

  • Impact of interventions (USP     <1116>).

  • 干预活动的影响

  • Length of the process (USP     <1116>).

  • 工艺的时长

  • Sites that might contribute     to microbe dispersal (USP <1116>).

  • 可能有助于微生物传播的位置

  • Product contact surfaces     (USP <1116>).

  • 产品接触表面

  • Proximity to utilities or     drains.

  • 靠近共用设施或排水口的位置

  • Storage areas.

  • 储存取样

  • Spatial coverage.

  • 空间覆盖率

  • Construction materials.

  • 建筑材料

  • Potable water usage.

  • 饮用水的使用

Sample sizes should be sufficient to optimize detection of environmentalmonitoring contaminants (FDA, 2004). Figure 1 demonstrates a room layout grid,which defines the sample locations to bemonitored during an EMPQ.

取样量应足以确保环境监测污染的检测（FDA，2004年）。图 1 展示了房间布局网格，该网格定义了EMPQ（环境监测性能确认） 期间需要监测的示例位置。

Figure 1 Sample Site Planning for EMPQ

图1 EMPQ（环境监测性能确认）计划取样点

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