{"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>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>選擇錯誤嘅配方<\/td>選擇配方時缺乏謹慎<\/td>無效嘅周期。 影響產品無菌（重新滅菌）<\/td>1.不同嘅配方名稱<\/td>6<\/td>5<\/td>10<\/td>300<\/td>1.工作指示2。 循環開始前仔細檢查3。 作員培訓<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1.工作指示2。 開始循環前仔細檢查3。 作員培訓<\/td>用戶<\/td><\/tr>
Loss of product\/packaging functionality and integrity due to unvalidated cycle parameters<\/td>1.不同嘅配方名稱<\/td>6<\/td>4<\/td>10<\/td>240<\/td>1.工作指示2。 循環開始前仔細檢查3。 作員培訓<\/td>2<\/td>4<\/td>4<\/td>32<\/td>1.工作指示2。 開始循環前仔細檢查3。 作員培訓<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
預熱階段（機櫃加熱）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>箱體溫度低於下限值<\/td>熱水循環泵故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 循環水泵過載報警3。 自動加熱時間補償<\/td>5<\/td>3<\/td>2<\/td>30<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
電熱管故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 自動加熱時間補償<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>
1.冗餘溫度傳感器2。 溫差超限報警<\/td>		6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
2<\/td>機櫃內部溫度過高<\/td>溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>
1.冗餘溫度傳感器2。 溫差超限報警<\/td>		6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
絕緣台（保持櫃體溫度）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>箱體溫度低於下限值<\/td>熱水循環泵故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 循環水泵過載報警<\/td>5<\/td>3<\/td>2<\/td>30<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
電熱管故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.加熱超時警報2。 循環水泵過載報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
2<\/td>機櫃內部溫度過高<\/td>溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.加熱超時警報2。 循環水泵過載報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
3<\/td>缺乏時間<\/td>編程錯誤<\/td>重複滅菌<\/td>1.自動循環檢查<\/td>2<\/td>4<\/td>2<\/td>16<\/td><\/td><\/td><\/td><\/td><\/td>冇<\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
預真空階段（從腔室中去除空氣，使工藝喺低於EO可燃性限值嘅情況下進行）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>去除嘅空氣不足<\/td>真空泵效率低<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.預抽真空超時超限報警2。 真空泵過載報警3。 自動檢測水流並關閉無水泵<\/td>5<\/td>3<\/td>2<\/td>30<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
錯誤嘅閥門<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.預抽真空超時超限報警2。 真空泵過載報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
壓力傳感器故障<\/td>易燃區危險<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護2。 校準<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
2<\/td>真空度過高<\/td>壓力傳感器故障<\/td>Product and\/or packaging damage (classification)<\/td>1.冗餘壓力傳感器2。 当壓差大於1kpa時發出壓差報警。<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
執漏階段（檢查箱嘅密封性）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>機櫃洩漏<\/td>墊圈洩漏<\/td>無影響<\/td>1.洩漏測試失敗警報2。 進程結束<\/td>10<\/td>5<\/td>2<\/td>100<\/td>1.預防性維護<\/td>3<\/td>5<\/td>2<\/td>30<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
閥門洩漏<\/td>無影響<\/td>1.執漏失敗報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
循環係統風道洩漏<\/td>無影響<\/td>1.執漏失敗報警<\/td>4<\/td>3<\/td>2<\/td>24<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮氣置換階段（用惰性氣體填充腔室以置換氧氣）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>冇足夠嘅氮氣進入腔室<\/td>氮氣不足<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>流程結束<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
閥門故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>N\/A<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
壓力傳感器故障<\/td>易燃區危險<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
2<\/td>櫃門內氮氣過多<\/td>閥門故障<\/td>EO濃度低於驗證值，因為在EO注射期間，如果由壓力控制（再滅菌），則會注入額外的N2<\/td>1.室內高壓報警2。 流程結束<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1.預防性維護<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
壓力變送器故障<\/td>注入過多嘅EO氣體。 高EO殘留。 延長脫氣時間me ）<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
3<\/td>櫃體溫度高於上限t<\/td><\/td>對產品功能嘅影響（排序）<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
4<\/td>箱體溫度低於下限值<\/td>熱水循環泵故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 循環水泵過載報警3。 自動加熱時間補償<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
電熱管故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 自動加熱時間補償<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度傳感器2。 溫差超限報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
化油器溫度低<\/td>影響產品無菌（重新滅菌）<\/td>1.化油器溫度低於極限時報警2。 自動加熱時間補償<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
加濕階段（通過注入蒸汽增加負載嘅濕度）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>蒸汽不足<\/td>蒸汽發生器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.蒸汽壓力低於極限時報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
閥門故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.加濕頻率限制報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
Pressure transmitter\/humidity sensor failure<\/td>影響產品無菌（重新滅菌）<\/td>1. Redundant pressure\/humidity sensor 2. Alarm when pressure\/humidity difference exceeds limit<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
過濾器堵塞<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.加濕頻率限制報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
2<\/td>蒸汽注入過多<\/td>閥門故障<\/td>蒸汽噴射過多、紙箱潮濕（分揀）<\/td>1.室內高壓報警2。 流程結束<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1.預防性維護<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
Pressure transmitter\/humidity sensor failure<\/td>蒸汽噴射過多、紙箱潮濕（分揀）<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
3<\/td>溫度過高<\/td>溫度傳感器故障<\/td>對產品功能嘅影響（排名）<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
4<\/td>箱體溫度低於下限值<\/td>熱水循環泵故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.加熱超時警報2。 循環水泵過載報警3。 自動加熱時間補償<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
電熱管故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.加熱超時警報2。 自動加熱時間補償<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.加熱超時警報2。 循環水泵過載報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
加濕停留階段（平衡濕度）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>缺乏時間<\/td>超時<\/td>影響產品無菌（重新滅菌）<\/td>1.自動循環檢查<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護<\/td>1<\/td>5<\/td>2<\/td>10<\/td>1.預防性維護<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮氣墊階段（用惰性氣體填充腔室以稀釋氧氣）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>氮氣進入機櫃不足<\/td>缺氮<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.開始循環前檢查N2壓力2。 当N2壓力低於限值時發出警報<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td>0<\/td><\/td><\/td><\/tr>
閥門故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>冇<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>用戶<\/td>1.預防性維護<\/td><\/tr>
壓力傳感器故障<\/td>易燃區危險<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>用戶<\/td>1.預防性維護<\/td><\/tr>
2<\/td>向機櫃中注入的氮氣過多<\/td>閥門故障<\/td>EO濃度低於驗證值，因為在EO注射期間，如果由壓力控制（再滅菌），則會注入額外的N2<\/td>1.室內高壓報警2。 流程結束<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1.預防性維護<\/td>2<\/td>5<\/td>4<\/td>40<\/td>用戶<\/td>1.預防性維護<\/td><\/tr>
壓力變送器故障<\/td>注入過多嘅EO氣體。 高EO殘留。 （延長脫氣時間）<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>用戶<\/td>1.預防性維護2。 校準<\/td><\/tr>
3<\/td>櫃內溫度超過上限<\/td>溫度傳感器故障<\/td>對產品功能嘅影響（排序）<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>用戶<\/td>1.預防性維護2。 校準<\/td><\/tr>
4<\/td>箱體溫度低於下限值<\/td>熱水循環泵故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 循環水泵過載報警3。 自動加熱時間補償<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>用戶<\/td>1.預防性維護<\/td><\/tr>
電熱管故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 循環水泵過載報警3。 自動加熱時間補償<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>用戶<\/td>1.預防性維護<\/td><\/tr>
溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度傳感器2。 溫差超限報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>用戶<\/td>1.預防性維護2。 校準<\/td><\/tr>
化油器溫度低<\/td>影響產品無菌（重新滅菌）<\/td>1.化油器溫度低於極限時報警2。 自動加熱時間補償<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>用戶<\/td>1.預防性維護2。 校準<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
EO注射階段（用EO氣體填充機櫃）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>冇足夠嘅環氧乙烷進入機櫃<\/td>缺少EO<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.EO氣缸孔報警2.EO注射超時報警<\/td>10<\/td>5<\/td>2<\/td>100<\/td>1.作員培訓2。 循環開始前檢查EO重量<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.作員培訓2。 循環開始前檢查EO重量<\/td>用戶<\/td><\/tr>
閥門故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.EO注射超時報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
EO管道洩漏<\/td>超過鑑定期嘅批次可以再次滅菌<\/td>冇<\/td>6<\/td>5<\/td>3<\/td>90<\/td>1.預防性維護2。 LEL EO探測器警報<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 LEL EO探測器警報<\/td>用戶<\/td><\/tr>
壓力傳感器故障<\/td>EO濃度低於驗證值（再滅菌）<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
2<\/td>液體EO進入機櫃<\/td>化油器溫度低<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1、化油器溫度低於極限報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
由於閥門故障，化油器中嘅水不足<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1、化油器水位低於限位報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
3<\/td>機櫃中嘅環氧乙烷輸入過多<\/td>閥門故障<\/td>隔離時間更長，需要額外的檢測<\/td>1、室內高壓報警<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護2。 EO殘留檢查<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.預防性維護2。 EO殘留檢查<\/td>用戶<\/td><\/tr>
壓力傳感器故障<\/td>隔離時間更長，需要額外的檢測<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護2。 校準<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
4<\/td>櫃內溫度超過上限<\/td>溫度傳感器故障<\/td>對產品功能嘅影響（排序）<\/td>1.冗餘溫度傳感器2。 腔室高溫報警器3。 溫差超限報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
5<\/td>箱體溫度低於下限值<\/td>熱水循環泵故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 循環水泵過載報警3。 自動加熱時間補償<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
電熱管故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 自動加熱時間補償<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度傳感器2。 溫差超限報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
化油器溫度低<\/td>影響產品無菌（重新滅菌）<\/td>1.化油器溫度低於極限時報警2。 自動加熱時間補償<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮帽階段（添加N 2以覆蓋EO ）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>氮氣進入機櫃不足<\/td>缺氮<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.開始循環前檢查N2壓力2。 当N2壓力低於限值時發出警報<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
閥門故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>冇<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
壓力傳感器故障<\/td>易燃區危險<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
2<\/td>向機櫃中注入的氮氣過多<\/td>閥門故障<\/td>機艙處於正壓狀態。 呢個循環會結束。<\/td>1.室內高壓報警2。 流程結束<\/td>6<\/td>5<\/td>4<\/td>120<\/td>1.預防性維護<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
3<\/td>櫃內溫度超過上限<\/td>溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度傳感器2。 腔室高溫報警器3。 溫差超限報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
4<\/td>箱體溫度低於下限值<\/td>熱水循環泵故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 循環水泵過載報警3。 自動加熱時間補償<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
電熱管故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 自動加熱時間補償<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度傳感器2。 溫差超限報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
化油器溫度低<\/td>影響產品無菌（重新滅菌）<\/td>1.化油器溫度低於極限時報警2。 自動加熱時間補償<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
EO暴露階段（對產品進行消毒）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>缺乏時間<\/td>編程錯誤<\/td>重複滅菌<\/td>1.自動循環檢查<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護<\/td>1<\/td>5<\/td>2<\/td>10<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
2<\/td>箱體溫度低於下限t<\/td>熱水循環泵故障<\/td>該周期喺一個階段被鎖定，直到它在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>加熱超時2。 循環水泵過載報警3。 自動加熱時間補償<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
電熱管故障<\/td>該周期被鎖定喺一個階段，直到在待機期後恢復並重新啟動。 超過合格周期嘅批次可以再次滅菌。<\/td>1.加熱超時警報2。 自動加熱時間補償<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度傳感器2。 溫差超限報警<\/td>6<\/td>5<\/td>2<\/td>60<\/td>1.預防性維護2。 校準<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
3<\/td>櫃內溫度超過上限<\/td>溫度傳感器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度傳感器2。 腔室高溫報警器3。 溫度警報<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
4<\/td>冇得到足夠均勻嘅EO混合物<\/td>循環風扇故障<\/td>影響產品無菌（重新滅菌）<\/td>1.低速報警<\/td>6<\/td>5<\/td>3<\/td>90<\/td>1.預防性維護<\/td>2<\/td>5<\/td>3<\/td>30<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
產品定位非常靠近型腔壁<\/td>影響產品無菌（重新滅菌）<\/td>1.採用護欄防止產品接觸型腔壁<\/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>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>吹掃嘅氣體唔夠<\/td>真空泵效率低下<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.EO移除超時報警2.真空泵過載報警3.自動檢測水流並關閉無水泵<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
閥門故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.EO移除超時報警2.真空泵過載報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
壓力傳感器故障<\/td>由於去除嘅EO氣體較少，因此需要更長嘅隔離時間同額外嘅測試<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護2。 校準<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
2<\/td>廢氣過多<\/td>壓力傳感器故障<\/td>Product and\/or packaging damage (classification)<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮氣吹掃階段（確保室內環境不易燃）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>冇足夠嘅氮氣進入腔室<\/td>缺氮<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.開始循環前檢查N2壓力2。 当N2壓力低於限值時發出警報<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
閥門故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>冇<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
壓力傳感器故障<\/td>易燃區危險<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
隔離時間較長需要額外檢測<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
Air cleaning stage(Create vacuum\/remove residual sterilization gas, eliminate residual EO)<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>吹掃嘅氣體唔夠<\/td>真空泵效率低下<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.EO移除超時報警2.真空泵過載報警3.自動檢測水流並關閉無水泵<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
閥門故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.EO移除超時報警2.真空泵過載報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
壓力傳感器故障<\/td>由於去除嘅EO氣體較少，因此需要更長嘅隔離時間同額外嘅測試<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護2。 校準<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
2<\/td>廢氣過多<\/td>壓力傳感器故障<\/td>Product and\/or packaging damage (classification)<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>4<\/td>2<\/td>48<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr>
3<\/td>機艙內空氣不足<\/td>閥門故障<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.注氣時間超限報警<\/td>6<\/td>4<\/td>3<\/td>72<\/td>1.預防性維護<\/td>2<\/td>4<\/td>3<\/td>24<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
過濾器堵塞<\/td>循環鎖定喺一個階段，直到喺待機期後恢復並重新啟動<\/td>1.注氣時間超限報警<\/td>6<\/td>4<\/td>3<\/td>72<\/td>1.預防性維護<\/td>2<\/td>4<\/td>3<\/td>24<\/td>1.預防性維護<\/td>用戶<\/td><\/tr>
壓力傳感器故障<\/td>隔離時間較長需要額外檢測<\/td>1.冗餘壓力傳感器2。 壓差超過限值時報警<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護2。 校準<\/td>2<\/td>4<\/td>2<\/td>16<\/td>1.預防性維護2。 校準<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
去除階段（去除產品中嘅殘留物）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有工藝條件下的風險評估<\/td>採取措施後對結果進行風險評估<\/td>建議嘅作<\/td>職責和現狀<\/td><\/tr>
故障名稱<\/td>原因<\/td>故障影響<\/td>立即控制<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td>下手<\/td>事件<\/td>嚴厲<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>曝氣時間小於規定時間<\/td>編程錯誤<\/td>重複滅菌<\/td>1.自動循環檢查<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.定期重啟電腦<\/td>1<\/td>3<\/td>2<\/td>6<\/td>1.定期重啟電腦<\/td>用戶<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

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<\/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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