偏差處理案例分析-在線瀏覽
2025-06-03 23:01本頁面
【正文】 ual 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 ），清潔驗(yàn)證目檢時(shí)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(shí)不使用70%Sterile glove is used during visual inspection and CV sampling after clearance. Sterile glove is single used, and no ethanol is used when wearing sterile glove during visual inspection before CV sampling. 在清場后的目檢核清潔驗(yàn)證取樣期間使用無菌手套。在清潔驗(yàn)證前的目檢期間，戴無菌手套時(shí)不使用酒精。生產(chǎn)部目檢時(shí)使用乳膠手套。 Above all, interference of 70% ethanol to the detergent result can be excluded. 綜上，70%乙醇對(duì)酒精對(duì)清潔劑結(jié)果的干擾可以被排除。l Possible cause 4: Glove (for Sampling)可能原因4：手套（用于取樣）The supplier for glove is not changed since last cleaning validation (). According to current sampling procedure (sop0105674 ), the Sterile glove is used during visual inspection and TOC sampling form . Before , the rubber glove is used during visual inspection and TOC sampling. The Sterile glove and rubber glove is single used, and no 70% ethanol is used when wearing glove.自從上次清潔驗(yàn)證（）至今，手套的供應(yīng)商未發(fā)生過變更。目檢和TOC取樣時(shí)使用乳膠手套。Oute: No.結(jié)果：不是可能原因。取樣前的目檢結(jié)果符合可接受標(biāo)準(zhǔn)。l Possible cause 6: Drinking water可能原因6：飲用水The quality monitoring parameters (hardness, chlorine and conductivity) are all within acceptance criteria during clearance according to SRD0101917 “Operational Log Sheet of SHiP PW system”. And, no abnormal trend for these parameters was found.根據(jù)SRD0101917 SHiP飲用水系統(tǒng)運(yùn)行記錄表”，清場期間的水質(zhì)監(jiān)測參數(shù)（硬度、余氯和電導(dǎo)率）均在可接受標(biāo)準(zhǔn)內(nèi)。Oute: No.結(jié)果：不是可能原因。且沒有發(fā)現(xiàn)數(shù)據(jù)有不良趨勢。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(hào)是Texwipe TX761，在分析方法驗(yàn)證和清潔驗(yàn)證過程中所有的清潔劑取樣中均使用該棉簽進(jìn)行取樣，同時(shí)，進(jìn)行使用空白棉簽作為空白對(duì)照樣品，至今未發(fā)現(xiàn)異常結(jié)果。 Man/人員方面l Possible cause 1: Qualification for Operator (Cleaning)可能原因1：操作員工的清潔資質(zhì)All operators participated in the clearance are trained of current SOP0102731”Cleaning procedure for Glatt granulation train in HP plant”. They are all qualified for manual cleaning with qualification certificate.所有參與清場的員工都被培訓(xùn)過現(xiàn)行版SOP0102731“高致敏車間Glatt 制粒干燥系統(tǒng)的清潔程序”。Oute: No.結(jié)果：不是可能原因。Oute: No.結(jié)果：不是可能原因。在“驟。飲用水補(bǔ)水流量太小導(dǎo)致了54521報(bào)警的發(fā)生。飲用水清洗步驟是在CIP100清洗步驟后進(jìn)行的。此時(shí)，飲用水可能進(jìn)入上密封圈和FBD碗形腔體邊緣的間隙中。報(bào)警發(fā)生16分鐘后，管道被更換，報(bào)警消除，上密封圈FBD密封圈重新充氣。一些飲用水可能殘留在上密封圈和FBD碗壁間的空隙中。經(jīng)供應(yīng)商確認(rèn)，該報(bào)警會(huì)導(dǎo)致上密封圈和下密封圈同時(shí)泄氣。此外，在該偏差發(fā)生后，進(jìn)行了模擬運(yùn)行及支持性測試：人為中斷下密封圈的壓縮空氣供應(yīng)，出現(xiàn)報(bào)警1383，同時(shí)觀察到上密封圈也泄氣了；人為中斷上密封圈的壓縮空氣供應(yīng)，出現(xiàn)報(bào)警1393，同時(shí)觀察到下密封圈也泄氣了。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。所以，在上密封圈和FBD碗形腔體邊緣之間的空隙中的飲用水蒸發(fā)了，但是CIP100 可能殘留在上密封圈和FBD碗形腔體邊緣上。l Possible cause 2: Visual inspection before sampling 可能原因2：取樣前的目檢MSAT, QV and Prod person have performed visual inspection before sampling, and confirmed the equipment was visual clean (no residue and foreign objects) and dry.MSAT, QV和生產(chǎn)部員工在取樣前進(jìn)行了目檢，并確認(rèn)設(shè)備目視清潔（無殘留和異物）并干燥。 Machine/設(shè)備方面l Possible cause 1: Glatt granulation and FBD system可能原因1：Glatt制粒干燥系統(tǒng)The Glatt granulation and FBD system is within revalidation due date. Maintenance is performed according to maintenance plan.Glatt制粒干燥系統(tǒng)在再在驗(yàn)證有效期內(nèi)。Oute: No.結(jié)果：不是可能原因。Oute: No.結(jié)果：不是可能原因。查看本次清場的WIP打印記錄，WIP程序完整。Oute: No.結(jié)果：不是可能原因
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