【正文】 l Causal Analysis/因果分析: Alarm 1383 occurred and upper seal of FBD bowl deflated → Drinking water with CIP100 entered the gap between seal and FBD bowl rim → Alarm 1383 removed and upper seal reinflated → Drinking water with CIP100 remained in the space between upper seal and FBD bowl rim→ Drinking water was evaporated after drying step but CIP100 residue remained on FBD bowl rim→ Detergent test result out of acceptance criteria出現(xiàn)報警1383，F(xiàn)BD碗形腔體的上密封圈泄氣 → 含CIP100的飲用水進入上密封圈和腔體邊緣的縫隙 → 報警1383 解除，上密封圈重新充氣 → 飲用水及CIP100留在上密封圈和腔體邊緣的空隙中→ 干燥過程中飲用水蒸發(fā)，但CIP100殘留在腔體邊緣上→ 清潔劑樣品結(jié)果超出接受標準Follow up action / 后續(xù)行動CAPA TW1097877 has been initiated to reduce the risk to manufacturing process/cleaning process resulted from improper/inadequate alarm handling by establishing process on handling critical GMP alarms and updating risk assessment documents.開啟CAPA TW1097877：通過建立關(guān)鍵GMP報警的處理流程及更新風險評估文件，來降低由于報警處理不當/不足而對生產(chǎn)流程/清潔流程造成影響的風險。 and remained and couldn’t be cleaned after upper seal reinflated.上密封圈泄氣時，帶有CIP100殘留的飲用水進入上密封圈和FBD碗形腔體邊緣的間隙中；上密封圈重新充氣后留在間隙中，且無法被清洗干凈。根據(jù)現(xiàn)行版SOP0102731有高致敏車間Glatt 制粒干燥系統(tǒng)的清潔程序”，F(xiàn)BD碗的邊緣和上密封圈在檸檬酸清洗后和整個WIP程序后進行。Oute: No.結(jié)果：不是可能原因。殘留在上密封圈和FBD碗形腔體邊緣之間的空隙中的飲用水中可能有CIP100殘留。報警發(fā)生16分鐘后，管道被更換，報警消除，上密封圈FBD密封圈重新充氣。在“驟。l Possible cause 8: TX761 sampling swab 可能原因8：TX761取樣棉簽Type of sampling swab is Texwipe TX761, and it is used in the analytical method validation and cleaning validation of detergent sampling activities, and it is used blank swab as blank sample. Abnormal result is never found till now.取樣棉簽的型號是Texwipe TX761，在分析方法驗證和清潔驗證過程中所有的清潔劑取樣中均使用該棉簽進行取樣，同時，進行使用空白棉簽作為空白對照樣品，至今未發(fā)現(xiàn)異常結(jié)果。取樣前的目檢結(jié)果符合可接受標準。 Above all, interference of 70% ethanol to the detergent result can be excluded. 綜上，70%乙醇對酒精對清潔劑結(jié)果的干擾可以被排除。無菌手套和乳膠手套均為一次性使用，戴手套時不使用70%查看相關(guān)日志，沒有發(fā)現(xiàn)異常情況。在WIP期間，員工始終在清潔劑儲罐旁邊并確保所有檸檬酸溶液用盡。The quantity of citric acid was weighed by two operators and formulation of citric acid solution was performed by two operators. Citric acid solution was pumped into detergent storage container for use. Operator checked the set point of dosing pump was correct. During WIP process, operator was always beside the detergent storage container and confirmed all citric acid solution was used up. No remark of abnormity was found on logbook.檸檬酸由雙人稱量，檸檬酸溶液由雙人配制。CIP100被吸入清潔劑儲罐中待用。在手工清潔期間沒有使用過70% 乙醇。According to current sampling procedure (sop0105674 ), the Sterile glove is used during production visual inspection form . Before , the rubber glove is used during production visual inspection. The Sterile glove and rubber glove is single used, and no 70% ethanol is used when wearing glove.依據(jù)現(xiàn)行版取樣程序（sop0105674 ），生產(chǎn)部在目檢樣時使用無菌手套。無菌手套和乳膠手套均為一次性使用，戴手套時不使用70% 乙醇。l Possible cause 7: Purified water可能原因7：純水The quality monitoring parameters (ozone and conductivity) are all within acceptance criteria during clearance according to printout of SHiP PUW system. And, no abnormal trend for these parameters根據(jù)SHiP純水系統(tǒng)的打印記錄，清場期間的水質(zhì)監(jiān)測參數(shù)（臭氧和電導率）均在可接受范圍內(nèi)。l Possible cause 2: Qualification for sampling staff 可能原因2：取樣員工的資質(zhì)Sampling person is trained and qualified, and have taken CV samples for almost 3 years.取樣員工受過培訓過，是有資質(zhì)的，且已進行近3年的清潔驗證取樣。During stopping period of machine, alarm 1383 “Product container sealleak” occurred and caus