Atomic Note

Physical Parameter: TBD

Red Line Consequence: TBD

Physical Signal: TBD

Validation

Data Source: TBD

Context: TBD

Post-Contamination Environmental Monitoring

环境监测范围应与染菌影响范围匹配:种子罐局部监测 vs 发酵车间整体监测。

触发条件说明

IF a contamination incident occurs (seed tank or fermenter), requiring environmental monitoring as part of recovery

执行动作

THEN perform environmental monitoring with scope based on incident severity: seed tank → affected area only (浮游菌/沉降菌/表面微生物, C级区标准); fermenter → entire fermentation workshop + D-level areas full monitoring; multi-batch → entire workshop expanded survey

作用范围

环境监控|染菌后监测

物理锚点(关键参数与监测方法)

  • 种子期染菌: 所在操作区域,符合C级区标准
  • 发酵期染菌: 发酵车间整体+D级区全项目
  • 多批染菌: 整个发酵车间扩大监测范围
  • 监测项目: 浮游菌、沉降菌、表面微生物
  • 合格标准: 符合相应区域级别标准

安全红线

项目内容
级别critical
禁止行为染菌后未进行环境监测即恢复生产
后果环境残留杂菌导致恢复生产后立即二次染菌

关联参考