环境监测-取样频率

Monitoring requirements may vary widely in the industry depending on several factors including, but not limited to, type of manufacturing process or product, fa-cility/process design, amount of human intervention, use of subsequent terminal sterilization (including sterility test release versus parametric release), and his-torical profiles of the microbiological environmental data. No single sampling scheme is appropriate for all environments. In addition, changes in sampling fre-quency, whether temporary or permanent, may be required based on changes in practices, compendial requirements, development of significant microbiological trends, acquisition of new equipment, or nearby construction of rooms or utilities. The key is to select monitoring frequencies that can identify potential system deficiencies. 
监测要求根据若干因素可能会有很大区别，包括但不限于，制造工艺或产品类型，设施/工艺设计，人员干扰数量，随后最终灭菌的使用（包括无菌测试放行与参数发布的对比），微生物环境数据的历史概况。没有任何单一的取样计划适用于所有环境。此外，根据规范，药典要求，重要微生物的趋势发展，新设备的购置或附近房间或公用事业建设，可能要求取样频率的变化，不论是暂时的或永久的。关键是要选择可以发现潜在系统缺陷的监测频率。

Examples of sampling sites. 

取样点举例

The test frequency per site may be less frequent than the system or area frequency (e.g., one may choose to rotate sample sites). Test frequencies for batch-related, in-process monitoring may differ from those for routine area monitoring. In many cases, monitoring performed in conjunction with batch production may fulfill the requirements for routine area monitoring. 
每个位置的测试频率可能低于系统或区域频率的频繁（例如，可以选择轮换取样点）。批相关的处理中监测的测试频率可能不同于常规区域监测。在许多情况下，与批生产相关的监测可能满足日常区域监测的要求。

Prior to implementing any reduction in frequency, a summary of historical data, along with current and proposed sampling frequencies, should be reviewed and approved by the appropriate Quality Assurance personnel. After reduction, data should be reviewed periodically to determine if the reduced sampling frequency is still appropriate. 
减少任何频率前，历史数据总结以及现有和拟议取样频率，应由相关质量保证人员进行审查并批准。减少后，数据应定期审查，以决定减少后的取样频率是否仍适合。

       文章来源：药品微生物检测

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