【文章內(nèi)容簡介】 or VG and 3 steps for FBD) had pleted and 3 steps for drinking water washing/rinse (1 step for VG and 2 steps for FBD) 中英文不一致，確認一下！was not performed. And, steps for drinking water washing/rinse were after CIP100 washing.查看WIP程序的打印報告， 上午10：16，54521報警”Tank loop water flowactual valuemin”發(fā)生在“生在“暫?！辈襟E。在“驟。在暫停”步驟，對Glatt的清洗暫停，飲用水儲罐正在補水。飲用水補水流量太小導致了54521報警的發(fā)生。在“警的發(fā)暫?！辈襟E前，7步飲用水清洗/淋洗（4步VG，3步FBD）已完成，剩余3步飲用水清洗/淋洗（21步VG，12步FBD）還未進行。飲用水清洗步驟是在CIP100清洗步驟后進行的。During stopping period of machine, alarm 1383 “Product container sealleak” occurred and caused the upper seal of FBD deflated. At that time, drinking water might enter the gap between upper seal and FBD bowl rim. The alarm was caused by leakage of pressed air duct. The duct was replaced and alarm was removed after about 16min and the upper seal inflated. Some drinking water might residue in the space between the upper seal and FBD bowl rim.在設(shè)備停止期間，1383報警“Product container sealleak”發(fā)生并導致FBD上上密封圈泄氣，這里是否只寫FBD密封圈泄氣更合適啊？密封圈放氣。此時，飲用水可能進入上密封圈和FBD碗形腔體邊緣的間隙中。該報警是由于壓縮空氣管道漏氣導致的。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。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。Alarm 1383 will occur when the seal pressure of FBD lower seal is min. Confirmed by supplier, this alarm will cause upper seal and lower seal deflate together. Pls. see attachment01 for Explanation for the principle of alarm 1383 provided by the supplier. Moreover, Simulation run and supporting test was performed after the discrepancy occurred: When intentionally stopping the pressed air supply to lower seal, Alarm 1383 occurred, and the upper seal was found deflated at the same time. When intentionally stopping the pressed air supply to upper seal, Alarm 1393 occurred, and the lower seal was also found deflated at the same time.1383報警為FBD碗形腔體的下密封圈的壓力最小值時發(fā)生的報警。經(jīng)供應商確認，該報警會導致上密封圈和下密封圈同時泄氣。供應商對1383報警原理的解釋見附件01。此外，在該偏差發(fā)生后，進行了模擬運行及支持性測試：人為中斷下密封圈的壓縮空氣供應，出現(xiàn)報警1383，同時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，出現(xiàn)報警1393，同時觀察到下密封圈也泄氣了。When the alarms occurred, WIP process was during drinking water washing/rinse after CIP100 washing. There might be some CIP100 residue in drinking water in the space between the upper seal and FBD bowl rim.報警發(fā)生時，WIP程序處于CIP100清洗后的飲用水清洗/淋洗步驟中。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。The last step of WIP process is drying. So, drinking water in space between the upper seal and FBD bowl rim was evaporated, but residue of CIP100 was on upper seal and FBD bowl rim.WIP程序的最后一步為干燥。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。Oute: YES結(jié)果：是可能的原因。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)部員工在取樣前進行了目檢，并確認設(shè)備目視清潔（無殘留和異物）并干燥。Oute: No.結(jié)果：不是可能原因。 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)在再在驗證有效期內(nèi)。維護行動按照維護計劃進行。Oute: No.結(jié)果：不是可能原因。 Environment/環(huán)境方面l Possible cause 1: Temperature, humidity and differential pressure可能原因1：溫濕度及壓差The temperature, humidity and differential pressure of granulation room is within acc