{"id":2425,"date":"2024-12-17T10:45:20","date_gmt":"2024-12-17T02:45:20","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2425"},"modified":"2026-02-09T09:58:51","modified_gmt":"2026-02-09T01:58:51","slug":"eo-sterilization-equipment-and-process-characteristic-patterns-and-effect-analysis","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/eo-sterilization-equipment-and-process-characteristic-patterns-and-effect-analysis\/","title":{"rendered":"EO sterilization equipment and process characteristic patterns and effect analysis"},"content":{"rendered":"\n
\"\"<\/figure><\/div>\n\n\n\n
Start cycle phase(Select parameters\/sterilization recipe)<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>选择错误的食谱<\/td>选择配方时不小心<\/td>无效循环。影响产品无菌（重新灭菌）<\/td>1.配方名称不同<\/td>6<\/td>5<\/td>10<\/td>300<\/td>1. 作业指导书 2. 循环开始前的仔细检查 3. 操作员培训<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1. 工作说明 2. 开始循环前仔细检查 3. 操作员培训<\/td>用户<\/td><\/tr>
Loss of product\/packaging functionality and integrity due to unvalidated cycle parameters<\/td>1.配方名称不同<\/td>6<\/td>4<\/td>10<\/td>240<\/td>1. 作业指导书 2. 循环开始前的仔细检查 3. 操作员培训<\/td>2<\/td>4<\/td>4<\/td>32<\/td>1. 工作说明 2. 开始循环前仔细检查 3. 操作员培训<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
预热阶段（柜体加热）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>箱体温度低于下限值<\/td>热水循环泵故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.循环水泵过载报警 3.自动加热时间补偿<\/td>5<\/td>3<\/td>2<\/td>30<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
电加热管故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.自动加热时间补偿<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>
1.冗余温度传感器 2.温差超限报警<\/td>		6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
2<\/td>柜内温度过高<\/td>温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>
1.冗余温度传感器 2.温差超限报警<\/td>		6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
保温阶段（维持柜内温度）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>箱体温度低于下限值<\/td>热水循环泵故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.循环水泵过载报警<\/td>5<\/td>3<\/td>2<\/td>30<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
电加热管故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1.加热超时报警 2.循环水泵过载报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
2<\/td>柜内温度过高<\/td>温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1.加热超时报警 2.循环水泵过载报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
3<\/td>缺乏时间<\/td>编程错误<\/td>重复灭菌<\/td>1.自动循环检查<\/td>2<\/td>4<\/td>2<\/td>16<\/td><\/td><\/td><\/td><\/td><\/td>没有任何<\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
预真空阶段（从腔室中除去空气，使工艺在环氧乙烷可燃性极限以下进行）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>没有去除足够的空气<\/td>真空泵效率低<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.预真空时间超限报警 2.真空泵过载报警 3.自动检测水流量并关闭无水泵<\/td>5<\/td>3<\/td>2<\/td>30<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
错误的阀门<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.预真空时间超限报警 2.真空泵过载报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
压力传感器故障<\/td>易燃区危险<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
2<\/td>真空太多<\/td>压力传感器故障<\/td>Product and\/or packaging damage (classification)<\/td>1、冗余压力传感器 2、压差大于1kpa时发出压差报警。<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
检漏阶段（检查盒子的密封性）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>柜体漏水<\/td>垫片泄漏<\/td>无影响<\/td>1. 泄漏测试失败报警 2. 过程结束<\/td>10<\/td>5<\/td>2<\/td>100<\/td>1.预防性维护<\/td>3<\/td>5<\/td>2<\/td>30<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
阀门泄漏<\/td>无影响<\/td>1.泄漏测试失败报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
循环系统风道漏气<\/td>无影响<\/td>1.泄漏测试失败报警<\/td>4<\/td>3<\/td>2<\/td>24<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮气置换阶段（向腔室填充惰性气体以置换氧气）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>没有足够的氮气进入腔室<\/td>氮气不足<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>流程结束<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
阀门故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>N\/A<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
压力传感器故障<\/td>易燃区危险<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
2<\/td>柜门内氮气过多<\/td>阀门故障<\/td>EO 浓度低于验证值，因为在 EO 注入过程中，如果通过压力控制（再灭菌），则会注入额外的 N2<\/td>1. 室内高压报警 2. 流程结束<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1.预防性维护<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
压力变送器故障<\/td>注入的 EO 气体过多。环氧乙烷残留量高。延长脱气时间我）<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
3<\/td>柜体温度高于上限t<\/td><\/td>对产品功能的影响（排序）<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
4<\/td>箱体温度低于下限值<\/td>热水循环泵故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.循环水泵过载报警 3.自动加热时间补偿<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
电加热管故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.自动加热时间补偿<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1.冗余温度传感器 2.温差超限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
化油器温度低<\/td>影响产品无菌（重新灭菌）<\/td>1.化油器温度低于限值报警 2.自动加热时间补偿<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.预防性维护<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.预防性维护<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
加湿阶段（通过注入蒸汽增加负载的湿度）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>蒸汽不足<\/td>蒸汽发生器故障<\/td>影响产品无菌（重新灭菌）<\/td>1.蒸汽压力低于限值报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.预防性维护<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
阀门故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.加湿频率极限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.预防性维护<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
Pressure transmitter\/humidity sensor failure<\/td>影响产品无菌（重新灭菌）<\/td>1. Redundant pressure\/humidity sensor 2. Alarm when pressure\/humidity difference exceeds limit<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
过滤器堵塞<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.加湿频率极限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.预防性维护<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
2<\/td>蒸汽注入过多<\/td>阀门故障<\/td>蒸汽喷射过多，纸箱湿（分拣）<\/td>1. 室内高压报警 2. 流程结束<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1.预防性维护<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
Pressure transmitter\/humidity sensor failure<\/td>蒸汽喷射过多，纸箱湿（分拣）<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
3<\/td>温度过高<\/td>温度传感器故障<\/td>对产品功能的影响（排名）<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
4<\/td>箱体温度低于下限值<\/td>热水循环泵故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.加热超时报警 2.循环水泵过载报警 3.自动加热时间补偿<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
电加热管故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.加热超时报警 2.自动加热时间补偿<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1.加热超时报警 2.循环水泵过载报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
加湿停留阶段（平衡湿度）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>缺乏时间<\/td>暂停<\/td>影响产品无菌（重新灭菌）<\/td>1.自动循环检查<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.预防性维护<\/td>1<\/td>5<\/td>2<\/td>10<\/td>1.预防性维护<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮气缓冲阶段（腔内充入惰性气体，稀释氧气）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>进入柜内的氮气不足<\/td>缺乏氮<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1. 开始循环前检查氮气压力 2. 氮气压力低于限值时报警<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td>0<\/td><\/td><\/td><\/tr>
阀门故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>没有任何<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>用户<\/td>1.预防性维护<\/td><\/tr>
压力传感器故障<\/td>易燃区危险<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>用户<\/td>1.预防性维护<\/td><\/tr>
2<\/td>柜内注入氮气过多<\/td>阀门故障<\/td>EO 浓度低于验证值，因为在 EO 注入过程中，如果通过压力控制（再灭菌），则会注入额外的 N2<\/td>1. 室内高压报警 2. 流程结束<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1.预防性维护<\/td>2<\/td>5<\/td>4<\/td>40<\/td>用户<\/td>1.预防性维护<\/td><\/tr>
压力变送器故障<\/td>注入的 EO 气体过多。环氧乙烷残留量高。 （延长脱气时间）<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>用户<\/td>1. 预防性维护 2. 校准<\/td><\/tr>
3<\/td>柜内温度超过上限<\/td>温度传感器故障<\/td>对产品功能的影响（排序）<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>用户<\/td>1. 预防性维护 2. 校准<\/td><\/tr>
4<\/td>箱体温度低于下限值<\/td>热水循环泵故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.循环水泵过载报警 3.自动加热时间补偿<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>用户<\/td>1.预防性维护<\/td><\/tr>
电加热管故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.循环水泵过载报警 3.自动加热时间补偿<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>用户<\/td>1.预防性维护<\/td><\/tr>
温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1.冗余温度传感器 2.温差超限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>用户<\/td>1. 预防性维护 2. 校准<\/td><\/tr>
化油器温度低<\/td>影响产品无菌（重新灭菌）<\/td>1.化油器温度低于限值报警 2.自动加热时间补偿<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>用户<\/td>1. 预防性维护 2. 校准<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
EO注入阶段（将EO气体充满柜体）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>进入柜内的环氧乙烷不足<\/td>缺少环氧乙烷<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.EO缸孔报警 2.EO喷射超时报警<\/td>10<\/td>5<\/td>2<\/td>100<\/td>1. 操作员培训 2. 循环开始前的 EO 重量检查<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 操作员培训 2. 循环开始前的 EO 重量检查<\/td>用户<\/td><\/tr>
阀门故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.EO注入超时报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.预防性维护<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
环氧乙烷管道泄漏<\/td>超过合格期限的批次可再次灭菌<\/td>没有任何<\/td>6<\/td>5<\/td>3<\/td>90<\/td>1. 预防性维护 2. LEL EO 探测器报警<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. LEL EO 探测器报警<\/td>用户<\/td><\/tr>
压力传感器故障<\/td>EO浓度低于验证值（重新灭菌）<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
2<\/td>液态EO进入柜内<\/td>化油器温度低<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1、化油器温度低于极限报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.预防性维护<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
由于阀门故障，化油器中的水不足<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1、化油器水位低于极限报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.预防性维护<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
3<\/td>柜内环氧乙烷输入过多<\/td>阀门故障<\/td>隔离时间更长，需要额外检测<\/td>1.室内高压报警<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护 2.EO残留检查<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.预防性维护 2.EO残留检查<\/td>用户<\/td><\/tr>
压力传感器故障<\/td>隔离时间更长，需要额外检测<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
4<\/td>柜内温度超过上限<\/td>温度传感器故障<\/td>对产品功能的影响（排序）<\/td>1. 冗余温度传感器 2. 箱体高温报警 3. 温差超限报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
5<\/td>箱体温度低于下限值<\/td>热水循环泵故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.循环水泵过载报警 3.自动加热时间补偿<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
电加热管故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.自动加热时间补偿<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1.冗余温度传感器 2.温差超限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
化油器温度低<\/td>影响产品无菌（重新灭菌）<\/td>1.化油器温度低于限值报警 2.自动加热时间补偿<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.预防性维护<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.预防性维护<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮帽阶段（添加N2覆盖EO）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>进入柜内的氮气不足<\/td>缺乏氮<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1. 开始循环前检查氮气压力 2. 氮气压力低于限值时报警<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
阀门故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>没有任何<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
压力传感器故障<\/td>易燃区危险<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
2<\/td>柜内注入氮气过多<\/td>阀门故障<\/td>机舱处于正压状态。这个循环将会结束。<\/td>1. 室内高压报警 2. 流程结束<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1.预防性维护<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
3<\/td>柜内温度超过上限<\/td>温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1. 冗余温度传感器 2. 箱体高温报警 3. 温差超限报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
4<\/td>箱体温度低于下限值<\/td>热水循环泵故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.循环水泵过载报警 3.自动加热时间补偿<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
电加热管故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.自动加热时间补偿<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1.冗余温度传感器 2.温差超限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
化油器温度低<\/td>影响产品无菌（重新灭菌）<\/td>1.化油器温度低于限值报警 2.自动加热时间补偿<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.预防性维护<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.预防性维护<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
EO暴露阶段（对产品进行消毒）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>缺乏时间<\/td>编程错误<\/td>重复灭菌<\/td>1.自动循环检查<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.预防性维护<\/td>1<\/td>5<\/td>2<\/td>10<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
2<\/td>箱体温度低于下限t<\/td>热水循环泵故障<\/td>该周期被锁定在一个阶段，直到经过一段待机时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>加热超时 2.循环水泵过载报警 3.自动加热时间补偿<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
电加热管故障<\/td>该周期被锁定在一个阶段，直到在等待一段时间后恢复并重新启动。超过合格周期的批次可再次灭菌。<\/td>1.加热超时报警 2.自动加热时间补偿<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1.冗余温度传感器 2.温差超限报警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
3<\/td>柜内温度超过上限<\/td>温度传感器故障<\/td>影响产品无菌（重新灭菌）<\/td>1. 冗余温度传感器 2. 箱体高温报警 3. 温度报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
4<\/td>没有获得足够均匀的 EO 混合物<\/td>循环风扇故障<\/td>影响产品无菌（重新灭菌）<\/td>1.低速报警<\/td>6<\/td>5<\/td>3<\/td>90<\/td>1.预防性维护<\/td>2<\/td>5<\/td>3<\/td>30<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
产品定位非常靠近空腔壁<\/td>影响产品无菌（重新灭菌）<\/td>1.护栏用于防止产品接触空腔壁<\/td>2<\/td>5<\/td>3<\/td>30<\/td><\/td><\/td><\/td><\/td>0<\/td>N\/A<\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
EO Removal Phase(Create vacuum\/remove sterilization gas)<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>没有排出足够的气体<\/td>真空泵效率低下<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.EO去除超时报警 2.真空泵过载报警 3.自动检测水流量并关闭无水泵<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
阀门故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.EO去除超时报警 2.真空泵过载报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
压力传感器故障<\/td>由于去除的 EO 气体较少，因此需要更长的隔离时间和额外的测试<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
2<\/td>排出过多气体<\/td>压力传感器故障<\/td>Product and\/or packaging damage (classification)<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮气吹扫阶段（确保室内环境不可燃）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>没有足够的氮气进入腔室<\/td>缺乏氮<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1. 开始循环前检查氮气压力 2. 氮气压力低于限值时报警<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
阀门故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>没有任何<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.预防性维护<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
压力传感器故障<\/td>易燃区危险<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
更长的隔离需要额外的测试<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Air cleaning stage(Create vacuum\/remove residual sterilization gas, eliminate residual EO)<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>没有排出足够的气体<\/td>真空泵效率低下<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.EO去除超时报警 2.真空泵过载报警 3.自动检测水流量并关闭无水泵<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
阀门故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1.EO去除超时报警 2.真空泵过载报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.预防性维护<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
压力传感器故障<\/td>由于去除的 EO 气体较少，因此需要更长的隔离时间和额外的测试<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
2<\/td>排出过多气体<\/td>压力传感器故障<\/td>Product and\/or packaging damage (classification)<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr>
3<\/td>机舱内空气不足<\/td>阀门故障<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1、注气时间超限报警<\/td>6<\/td>4<\/td>3<\/td>72<\/td>1.预防性维护<\/td>2<\/td>4<\/td>3<\/td>24<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
过滤器堵塞<\/td>循环被锁定在一相，直到经过一段待机时间后恢复并重新启动<\/td>1、注气时间超限报警<\/td>6<\/td>4<\/td>3<\/td>72<\/td>1.预防性维护<\/td>2<\/td>4<\/td>3<\/td>24<\/td>1.预防性维护<\/td>用户<\/td><\/tr>
压力传感器故障<\/td>更长的隔离需要额外的测试<\/td>1. 冗余压力传感器 2. 压差超限报警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1. 预防性维护 2. 校准<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1. 预防性维护 2. 校准<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
去除阶段（去除产品中的残留物）<\/td><\/tr>
序列号<\/td>潜在风险内容<\/td>现有工艺条件下的风险评估<\/td>采取措施后的结果风险评估<\/td>建议采取的行动<\/td>职责和现状<\/td><\/tr>
故障名称<\/td>原因<\/td>故障影响<\/td>立即控制<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td>采取行动<\/td>事件<\/td>严重性<\/td>检查<\/td>风险优先级<\/td><\/tr>
1<\/td>曝气时间小于规定时间<\/td>编程错误<\/td>重复灭菌<\/td>1.自动循环检查<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.定期重新启动计算机<\/td>1<\/td>3<\/td>2<\/td>6<\/td>1.定期重新启动计算机<\/td>用户<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

如果您想了解更多有关环氧乙烷灭菌的信息<\/h2>\n\n\n\n

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网站：hzbocon.com<\/a> zjbocon.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Start cycle phase(Select parameters\/sterilization recipe) Serial number Potentially risky content Risk assessment under existing process conditions Risk assessment of the 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