Atomic Note

Physical Parameter: TBD

Red Line Consequence: TBD

Physical Signal: TBD

Validation

Data Source: TBD

Context: TBD

Fermentation Tank Contamination Disposal

发酵期染菌处置时限较种子期更长,因物料量更大,需充分的时间进行灭菌和消毒。

触发条件说明

IF contamination is confirmed in 3000L fermentation tanks during fermentation stage

执行动作

THEN immediately (1) stop culture, (2) close inlet/outlet valves, (3) assess contamination extent, (4) sterilize at 121°C and discharge, (5) perform CIP cleaning and disinfect, (6) conduct area fumigation, (7) initiate 5M1E investigation — all within 11 hours total

作用范围

设备操作|灭菌控制|发酵罐

物理锚点(关键参数与监测方法)

  • 阶段: 发酵期(3000L发酵罐)
  • 灭菌温度: 121°C高压蒸汽
  • 总时限: ≤11小时(发现→确认1h,确认→隔离15min,隔离→处置2h,处置→消毒8h)
  • 紧急处置: 停止培养,关闭进气/出气阀
  • 环境消杀: 臭氧熏蒸或过氧化氢雾化

安全红线

项目内容
级别critical
禁止行为发酵期染菌未彻底灭菌消毒即进入下一批次
后果设备残留杂菌导致连续批次染菌,生产全线停顿

关联参考