{"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>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>選擇錯誤的食譜<\/td>選擇配方時不小心<\/td>無效循環。影響產品無菌（重新滅菌）<\/td>1.配方名稱不同<\/td>6<\/td>5<\/td>10<\/td>300<\/td>1. 作業指導書 2. 循環開始前的仔細檢查 3. 操作員培訓<\/td>2<\/td>5<\/td>4<\/td>40<\/td>1. 工作說明 2. 開始循環前仔細檢查 3. 操作員培訓<\/td>使用者<\/td><\/tr>
Loss of product\/packaging functionality and integrity due to unvalidated cycle parameters<\/td>1.配方名稱不同<\/td>6<\/td>4<\/td>10<\/td>240<\/td>1. 作業指導書 2. 循環開始前的仔細檢查 3. 操作員培訓<\/td>2<\/td>4<\/td>4<\/td>32<\/td>1. 工作說明 2. 開始循環前仔細檢查 3. 操作員培訓<\/td>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
預熱階段（櫃體加熱）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>箱體溫度低於下限值<\/td>熱水循環幫浦故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 2.循環水泵過載警報 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>使用者<\/td><\/tr>
電熱管故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 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>使用者<\/td><\/tr>
溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>
1.冗餘溫度感測器 2.溫差超限警報<\/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>使用者<\/td><\/tr>
2<\/td>櫃內溫度過高<\/td>溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>
1.冗餘溫度感測器 2.溫差超限警報<\/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>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
保溫階段（維持櫃內溫度）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>箱體溫度低於下限值<\/td>熱水循環幫浦故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 2.循環水泵過載警報<\/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>使用者<\/td><\/tr>
電熱管故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/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>使用者<\/td><\/tr>
溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.加熱超時報警 2.循環水泵過載警報<\/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>使用者<\/td><\/tr>
2<\/td>櫃內溫度過高<\/td>溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.加熱超時報警 2.循環水泵過載警報<\/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>使用者<\/td><\/tr>
3<\/td>缺乏時間<\/td>程式設計錯誤<\/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>沒有任何<\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
預真空階段（從腔室中除去空氣，使製程在環氧乙烷可燃性極限以下進行）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>沒有去除足夠的空氣<\/td>真空幫浦效率低<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.預真空時間超限警報 2.真空幫浦過載警報 3.自動偵測水流量並關閉無水泵<\/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>使用者<\/td><\/tr>
錯誤的閥門<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.預真空時間超限警報 2.真空幫浦過載警報<\/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>使用者<\/td><\/tr>
壓力感知器故障<\/td>易燃區危險<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
2<\/td>真空太多<\/td>壓力感知器故障<\/td>Product and\/or packaging damage (classification)<\/td>1.冗餘壓力感測器 2、壓力差大於1kpa時發出壓力差警報。<\/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>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
檢漏階段（檢查盒子的密封性）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>櫃體漏水<\/td>墊片洩漏<\/td>無影響<\/td>1. 洩漏測試失敗警報 2. 過程結束<\/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>使用者<\/td><\/tr>
閥門洩漏<\/td>無影響<\/td>1.洩漏測試失敗警報<\/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>使用者<\/td><\/tr>
循環系統風道漏氣<\/td>無影響<\/td>1.洩漏測試失敗警報<\/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>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮氣置換階段（向腔室填充惰性氣體以置換氧氣）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>沒有足夠的氮氣進入腔室<\/td>氮氣不足<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/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>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/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>使用者<\/td><\/tr>
壓力感知器故障<\/td>易燃區危險<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/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 注入過程中，如果透過壓力控制（再滅菌），則會注入額外的 N2<\/td>1. 室內高壓警報 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>使用者<\/td><\/tr>
壓力變送器故障<\/td>注入的 EO 氣體過多。環氧乙烷殘留量高。延長脫氣時間我）<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
3<\/td>櫃體溫度高於上限t<\/td><\/td>對產品功能的影響（排序）<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
4<\/td>箱體溫度低於下限值<\/td>熱水循環幫浦故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 2.循環水泵過載警報 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>使用者<\/td><\/tr>
電熱管故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 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>使用者<\/td><\/tr>
溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度感測器 2.溫差超限警報<\/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>使用者<\/td><\/tr>
化油器溫度低<\/td>影響產品無菌（重新滅菌）<\/td>1.化油器溫度低於限值警報 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>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
加濕階段（透過注入蒸氣增加負載的濕度）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>蒸氣不足<\/td>蒸汽發生器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.蒸汽壓力低於限值警報<\/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>使用者<\/td><\/tr>
閥門故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.加濕頻率極限警報<\/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>使用者<\/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>使用者<\/td><\/tr>
過濾器堵塞<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.加濕頻率極限警報<\/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>使用者<\/td><\/tr>
2<\/td>蒸氣注入過多<\/td>閥門故障<\/td>蒸氣噴射過多，紙箱濕（分類）<\/td>1. 室內高壓警報 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>使用者<\/td><\/tr>
Pressure transmitter\/humidity sensor failure<\/td>蒸氣噴射過多，紙箱濕（分類）<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
3<\/td>溫度過高<\/td>溫度感測器故障<\/td>對產品功能的影響（排名）<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
4<\/td>箱體溫度低於下限值<\/td>熱水循環幫浦故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.加熱超時報警 2.循環水泵過載警報 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>使用者<\/td><\/tr>
電熱管故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.加熱超時報警 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>使用者<\/td><\/tr>
溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.加熱超時報警 2.循環水泵過載警報<\/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>使用者<\/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>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>缺乏時間<\/td>暫停<\/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>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮氣緩衝階段（腔內充入惰性氣體，稀釋氧氣）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>進入櫃內的氮氣不足<\/td>缺乏氮<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1. 開始循環前檢查氮氣壓力 2. 氮氣壓力低於限值時報警<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td>0<\/td><\/td><\/td><\/tr>
閥門故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>沒有任何<\/td>6<\/td>3<\/td>3<\/td>54<\/td>1.預防性維護<\/td>2<\/td>3<\/td>3<\/td>18<\/td>使用者<\/td>1.預防性維護<\/td><\/tr>
壓力感知器故障<\/td>易燃區危險<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/td>6<\/td>3<\/td>2<\/td>36<\/td>1.預防性維護<\/td>2<\/td>3<\/td>2<\/td>12<\/td>使用者<\/td>1.預防性維護<\/td><\/tr>
2<\/td>櫃內注入氮氣過多<\/td>閥門故障<\/td>EO 濃度低於驗證值，因為在 EO 注入過程中，如果透過壓力控制（再滅菌），則會注入額外的 N2<\/td>1. 室內高壓警報 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>使用者<\/td>1.預防性維護<\/td><\/tr>
壓力變送器故障<\/td>注入的 EO 氣體過多。環氧乙烷殘留量高。 （延長脫氣時間）<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td>1. 預防性維護 2. 校準<\/td><\/tr>
3<\/td>櫃內溫度超過上限<\/td>溫度感測器故障<\/td>對產品功能的影響（排序）<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td>1. 預防性維護 2. 校準<\/td><\/tr>
4<\/td>箱體溫度低於下限值<\/td>熱水循環幫浦故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 2.循環水泵過載警報 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>使用者<\/td>1.預防性維護<\/td><\/tr>
電熱管故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 2.循環水泵過載警報 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>使用者<\/td>1.預防性維護<\/td><\/tr>
溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度感測器 2.溫差超限警報<\/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>使用者<\/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.化油器溫度低於限值警報 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>使用者<\/td>1. 預防性維護 2. 校準<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
EO注入階段（將EO氣體充滿櫃體）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>進入櫃內的環氧乙烷不足<\/td>缺少環氧乙烷<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.EO缸孔警報 2.EO噴射超時報警<\/td>10<\/td>5<\/td>2<\/td>100<\/td>1. 操作員訓練 2. 循環開始前的 EO 重量檢查<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 操作員訓練 2. 循環開始前的 EO 重量檢查<\/td>使用者<\/td><\/tr>
閥門故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.EO注入超時報警<\/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>使用者<\/td><\/tr>
環氧乙烷管線洩漏<\/td>超過合格期限的批次可再次滅菌<\/td>沒有任何<\/td>6<\/td>5<\/td>3<\/td>90<\/td>1. 預防性維護 2. LEL EO 偵測器警報<\/td>2<\/td>5<\/td>2<\/td>20<\/td>1. 預防性維護 2. LEL EO 偵測器警報<\/td>使用者<\/td><\/tr>
壓力感知器故障<\/td>EO濃度低於驗證值（重新滅菌）<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
2<\/td>液態EO進入櫃內<\/td>化油器溫度低<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.化油器溫度低於極限警報<\/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>使用者<\/td><\/tr>
由於閥門故障，化油器中的水不足<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.化油器水位低於極限警報<\/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>使用者<\/td><\/tr>
3<\/td>櫃內環氧乙烷輸入過多<\/td>閥門故障<\/td>隔離時間更長，需要額外檢測<\/td>1.室內高壓警報<\/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>使用者<\/td><\/tr>
壓力感知器故障<\/td>隔離時間更長，需要額外檢測<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
4<\/td>櫃內溫度超過上限<\/td>溫度感測器故障<\/td>對產品功能的影響（排序）<\/td>1. 冗餘溫度感測器 2. 箱體高溫警報 3. 溫差超限警報<\/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>使用者<\/td><\/tr>
5<\/td>箱體溫度低於下限值<\/td>熱水循環幫浦故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 2.循環水泵過載警報 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>使用者<\/td><\/tr>
電熱管故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 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>使用者<\/td><\/tr>
溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度感測器 2.溫差超限警報<\/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>使用者<\/td><\/tr>
化油器溫度低<\/td>影響產品無菌（重新滅菌）<\/td>1.化油器溫度低於限值警報 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>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮帽階段（添加N2覆蓋EO）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>進入櫃內的氮氣不足<\/td>缺乏氮<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1. 開始循環前檢查氮氣壓力 2. 氮氣壓力低於限值時報警<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
閥門故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>沒有任何<\/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>使用者<\/td><\/tr>
壓力感知器故障<\/td>易燃區危險<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
2<\/td>櫃內注入氮氣過多<\/td>閥門故障<\/td>機艙處於正壓狀態。這個循環將會結束。<\/td>1. 室內高壓警報 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>使用者<\/td><\/tr>
3<\/td>櫃內溫度超過上限<\/td>溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1. 冗餘溫度感測器 2. 箱體高溫警報 3. 溫差超限警報<\/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>使用者<\/td><\/tr>
4<\/td>箱體溫度低於下限值<\/td>熱水循環幫浦故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 2.循環水泵過載警報 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>使用者<\/td><\/tr>
電熱管故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 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>使用者<\/td><\/tr>
溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度感測器 2.溫差超限警報<\/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>使用者<\/td><\/tr>
化油器溫度低<\/td>影響產品無菌（重新滅菌）<\/td>1.化油器溫度低於限值警報 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>使用者<\/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>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>缺乏時間<\/td>程式設計錯誤<\/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>使用者<\/td><\/tr>
2<\/td>箱體溫度低於下限t<\/td>熱水循環幫浦故障<\/td>該週期被鎖定在一個階段，直到經過一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>加熱超時 2.循環水泵過載警報 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>使用者<\/td><\/tr>
電熱管故障<\/td>該週期被鎖定在一個階段，直到在等待一段時間後恢復並重新啟動。超過合格週期的批次可再次滅菌。<\/td>1.加熱超時報警 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>使用者<\/td><\/tr>
溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1.冗餘溫度感測器 2.溫差超限警報<\/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>使用者<\/td><\/tr>
3<\/td>櫃內溫度超過上限<\/td>溫度感測器故障<\/td>影響產品無菌（重新滅菌）<\/td>1. 冗餘溫度感測器 2. 箱體高溫警報 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>使用者<\/td><\/tr>
4<\/td>沒有獲得足夠均勻的 EO 混合物<\/td>循環風扇故障<\/td>影響產品無菌（重新滅菌）<\/td>1.低速警報<\/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>使用者<\/td><\/tr>
產品定位非常靠近空腔壁<\/td>影響產品無菌（重新滅菌）<\/td>1.護欄用於防止產品接觸空洞壁<\/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>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>沒有排出足夠的氣體<\/td>真空幫浦效率低下<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.EO去除超時報警 2.真空幫浦過載警報 3.自動偵測水流量並關閉無水泵<\/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>使用者<\/td><\/tr>
閥門故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.EO去除超時報警 2.真空幫浦過載警報<\/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>使用者<\/td><\/tr>
壓力感知器故障<\/td>由於去除的 EO 氣體較少，因此需要更長的隔離時間和額外的測試<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
2<\/td>排出過多氣體<\/td>壓力感知器故障<\/td>Product and\/or packaging damage (classification)<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
氮氣吹掃階段（確保室內環境不燃）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>沒有足夠的氮氣進入腔室<\/td>缺乏氮<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1. 開始循環前檢查氮氣壓力 2. 氮氣壓力低於限值時報警<\/td>3<\/td>3<\/td>2<\/td>18<\/td><\/td><\/td><\/td><\/td><\/td>N\/A<\/td><\/td><\/tr>
閥門故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>沒有任何<\/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>使用者<\/td><\/tr>
壓力感知器故障<\/td>易燃區危險<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
更長的隔離需要額外的測試<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/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>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>沒有排出足夠的氣體<\/td>真空幫浦效率低下<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.EO去除超時報警 2.真空幫浦過載警報 3.自動偵測水流量並關閉無水泵<\/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>使用者<\/td><\/tr>
閥門故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.EO去除超時報警 2.真空幫浦過載警報<\/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>使用者<\/td><\/tr>
壓力感知器故障<\/td>由於去除的 EO 氣體較少，因此需要更長的隔離時間和額外的測試<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
2<\/td>排出過多氣體<\/td>壓力感知器故障<\/td>Product and\/or packaging damage (classification)<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr>
3<\/td>機艙內空氣不足<\/td>閥門故障<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.注氣時間超限警報<\/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>使用者<\/td><\/tr>
過濾器堵塞<\/td>週期鎖定在一相，直到經過一段時間後恢復並重新啟動<\/td>1.注氣時間超限警報<\/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>使用者<\/td><\/tr>
壓力感知器故障<\/td>更長的隔離需要額外的測試<\/td>1. 冗餘壓力感測器 2. 壓力差超限警報<\/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>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
去除階段（去除產品中的殘留物）<\/td><\/tr>
序號<\/td>潛在風險內容<\/td>現有製程條件下的風險評估<\/td>採取措施後的結果風險評估<\/td>建議採取的行動<\/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>嚴重性<\/td>檢查<\/td>風險優先級<\/td>採取行動<\/td>事件<\/td>嚴重性<\/td>檢查<\/td>風險優先級<\/td><\/tr>
1<\/td>曝氣時間小於規定時間<\/td>程式設計錯誤<\/td>重複滅菌<\/td>1.自動循環檢查<\/td>2<\/td>3<\/td>2<\/td>12<\/td>1.定期重新啟動計算機<\/td>1<\/td>3<\/td>2<\/td>6<\/td>1.定期重新啟動計算機<\/td>使用者<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

如果您想了解更多有關氧化乙烷滅菌的信息<\/h2>\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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