根据《 PDA TR69 Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations》中建议，

“It is up to the product manufacturer to establish and justify in-process bioburden and endotoxin limits. However, the best approach is to establish alert and action limits based on process-design criteria and capabilities, product safety and quality attributes, intended use, and the ability of the product to support microbial growth. ”

应由产品制造商确定并证明过程中的生物负载和内毒素限值。然而，最好的方法是根据工艺设计标准和能力、产品安全和质量属性、预期用途以及产品支持微生物生长的能力来建立警报和行动限制。  

但是如果是新产品，

“For processes with insufficient trend data, such levels may be established based on in-process and final product microbial attributes with the goal of showing bioburden reduction from the beginning to the end of downstream production. It is also common to set the alert limit at 50% of the action limit when trend data are not available." 

对于趋势数据不足的过程，可以根据过程中和最终产品的微生物属性建立这样的水平，目的是显示从下游生产开始到结束的生物负载减少。当趋势数据不可用时，通常将警报限制设置为行动限制的 50%。

"A product intended for aseptic filling should meet an acceptance criterion of <10 CFU/100 mL prior to the final sterilizing filtration step. Smaller test volumes and different test limits maybe used with justification.”

用于无菌灌装的产品在最终除菌过滤步骤 之前应满足 <10 CFU/100 mL 的验收标准。可以使用较小的测试量和不同的测试限制，并有正当理由。

在证实和满足工艺能力的条件下可以暂时不设，根据三批工艺验证IPC设定初始，然后持续监测