参考PI 032-2 Technical Interpretation of Revised Annex 1 to PIC/S GMP Guide（官网已撤销，不过可参考）
     In general, clean room / clean air device classification is required to be performed according to EN ISO 14644-1 with the applicable limits for particle counts defined in the table in section 4 of GMP Annex 1. Probe-locations should be chosen in order to demonstrate the homogeneity across the room. A classification report should be prepared according to section 4.4 of ISO 14644-1 and section B.1.4 of ISO 14644-3.

    Monitoring, on the other hand, does not need to be performed according to EN ISO 14644-1. It can be performed for a reduced number of sampling points and sampling volumes. A formal risk analysis study based on experiments and analysis of the monitoring data (over at least 6 month operation) should provide a basis for the determination of frequencies and limits. Frequencies and limits should be process based and the results of the initial qualification and on going monitoring should be taken into account when setting operational alert and action limits. These limits and sample locations should be periodically reviewed for on-going validity of the risks initially considered.

       通常洁净级别确认测试取样点位置及最低数量应当符合ISO 14644要求，同时空调系统的PQ微生物取样参考悬浮粒子取样位置和数量；
       另一方面，对于日常监测，则无需依照 EN ISO 14644-1 要求取样数量进行，可以减少采样点和采样量。基于测试和监测数据（至少 6 个月运行）的正式风险分析研究为确定频率和限值提供依据。频率和限值应基于工艺，并在设定操作警戒和行动限值时考虑初始确认和持续监测的结果。这些限值和采样位置应定期审查，以持续验证最初考虑的风险的有效性。

1、第七十九条，说的是洁净级别确认，取样点指的是悬浮粒子，不包括微生物取样。

2、14644的适用范围包括制药行业和其他行业，如电子行业；他提供了最基本的14644-1的取样点位置及数量。GMP无菌附录要求无菌生产区的A\B级应在14644-1的基础上再增加额外取样点。说的都是悬浮粒子，

3、日常环境监测，除粒子外，还包括微生物取样，可以通过风险评估减少风险低的取样点或减少取样频次（比洁净级别确认时少点）。

洁净级别确认时，应是全部取样点，日常监控，根据评估可能比确认时减少。

所有的（包括微生物）的取样位置，一是参考ISO 14644，二是要基于自身产品特点、工艺，通过风险评估确定取样点和额外的取样点，形成风险评估报告作为支持性布点的依据。