Atomic Note
Physical Parameter: TBD
Red Line Consequence: TBD
Physical Signal: TBD
Backlinks
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 |