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固體車間清潔驗證方案-資料下載頁

2025-05-12 22:57本頁面
  

【正文】 negative pressure of fluid bed dryer. As a result, this point has little contact with water.整粒機下料斗內(nèi)壁取樣點:sampling point on inner wall of feeding hopper of straightening granulator.26 / 41編號:09Serial 取樣位置Sampling locations選擇原因Reasons 物料轉(zhuǎn)移管道通過制粒鍋向流化床的高速排水而沖刷清洗,清洗時間相對短Material transferring pipes are flushed by high speed draining water from granulation pot to fluid bed. Cleaning duration time of this point is short.轉(zhuǎn)移管道內(nèi)壁取樣點:sampling point on inner wall of transferring pipe.編號:10Serial 取樣位置Sampling locations選擇原因Reasons 此處管道直徑遠大于物料轉(zhuǎn)移管道,水從物料轉(zhuǎn)移管道流至此處時流速降低,且此處為上表面,水接觸機會相對小Diameter of this pipe is far larger than that of material transferring pipes. The water flowing from material transferring pipe to this point runs slower. And this point is on upper surface and has little contact with water.流化床進料管道上壁取樣點:sampling point onr surface of feeding pipe of fluid bed 流化床干燥器編號:11Serial 取樣位置Sampling locations選擇原因Reasons 27 / 41物料轉(zhuǎn)移和干燥過程中均與進料口充分接觸,且進料口邊緣不規(guī)則,易殘留化學活性成分。During the process of transferring material and drying, this point has full contact with feeding port. And the edge of feeding port is irregular, so it39。s easy for chemical active ingredients to stay on.上筒內(nèi)壁進料口取樣點: sampling point of feeding port on inner wall of upper cylinder編號:12Serial 取樣位置Sampling locations選擇原因Reasons 物料在干燥過程中與物料鍋壁充分接觸,上筒壁觀察窗邊緣面不規(guī)則,邊角處易殘留化學活性成分。Material has full contact with pot wall during drying. Edge of inspection window on surface of upper cylinder is irregular, which allows chemical active ingredients to stay easily in the edge.上筒內(nèi)壁觀察窗取樣點:sampling point on inspection window on inner surface of upper cylinder編號:13Serial 取樣位置Sampling locations選擇原因Reasons 物料在干燥過程中與物料鍋壁充分接觸,篩網(wǎng)與鍋壁結(jié)合處存在邊角,易殘留化學活性成分。Material has full contact with pot wall during drying. There is an edge on the location where screen connecting to pot wall, which allows chemical active ingredients to stay.篩網(wǎng)與鍋壁銜接處取樣點:sampling point on the location where screen connecting to pot wall28 / 41編號:14Serial 取樣位置Sampling locations選擇原因Reasons 物料在干燥過程中與物料鍋壁充分接觸,料斗觀察窗邊緣面不規(guī)則,邊角處易殘留化學活性成分。Material has full contact with pot wall during drying. The edge of inspection window is irregular, which allows chemical active ingredients to stay.觀察窗邊緣取樣點:sampling point on the edge of inspection window編號:15Serial 取樣位置Sampling locations選擇原因Reasons 處此處有縫隙,易殘留化學活性成分。There is gap here, which allows chemical active ingredients to stay.取樣口取樣點:sampling point on sampling port 干式整粒機 SL600 dry type straightening granulator編號:16Serial 取樣位置Sampling locations選擇原因Reasons 29 / 41干式整粒機出料口,清洗水中的化學活性殘留物容易殘積Discharge port of dry type straightening granulator is a location allows chemical active ingredients to stay easily.干整機出料閥取樣點:sampling point on discharge valve編號:17Serial 取樣位置Sampling locations選擇原因Reasons 篩網(wǎng)遍布小孔,容易殘積化學活性成分There are many meshes on the screen, which allows chemical active ingredients to stay easily.篩網(wǎng)取樣點:sampling point on screen編號:18Serial 取樣位置Sampling locations選擇原因Reasons SL600 干式整粒機通過手工清洗,此處手工清洗難度大,清洗效果相對差SL600 dry type straightening granulator is washed manually,. This part is hard to be cleaned by hand. Cleaning effect is not very good.整粒機上內(nèi)壁取樣點:sampling point on inner surface 自動提升料斗混合機(400L)HZD800 Automatic Lifting Hopper Mixer(400L)編號:19Serial 取樣位置Sampling locations選擇原因Reasons 30 / 41此處為料斗上內(nèi)壁,清潔難度大This point is on inner surface of hopper, which is hard to clean.料斗上內(nèi)壁取樣點:sampling point on inner surface of hopper編號:20Serial 取樣位置Sampling locations選擇原因Reasons 由于此取樣的位置在最下面,各種殘留物容易在此積聚。This sampling location is at the bottom, which is easy for all kinds of residue to accumulate.料斗出料閥取樣點:sampling point on discharge valve編號:21Serial 取樣位置Sampling locations選擇原因Reasons 清洗料斗時,清洗水需通過排水閥排水,容易殘積活性成分While cleaning hopper, cleaning water is drained through draining valve, which allows active ingredients to stay.料斗出料閥取樣點:Sampling point on discharge valve編號:22Serial 取樣位置Sampling locations選擇原因Reasons 31 / 41壓片機供料靴底座不能拆卸清洗,只能通過人工擦拭方法進行清洗,清洗效果不如其他可拆卸部件The mount of supply boot can39。t be disassembled while cleaning. It can only be cleaned by wiping, so the cleaning effect is not as good as that of other parts can be disassembled.供料靴取樣點: sampling point of supply boot編號:23Serial 取樣位置Sampling locations選擇原因Reasons 壓片機沖臺不能拆卸清洗,只能通過人工擦拭方法進行清洗,清洗效果不如其他可拆卸部件Platform of tablet press can39。t be disassembled while cleaning. It can only be cleaned by wiping, so the cleaning effect is not as good as that of other parts can be disassembled. 壓片機沖臺取樣點:sampling point on platform編號:24Serial 取樣位置Sampling locations選擇原因Reasons 軌道形狀不規(guī)則,有清洗難度,不易清潔,殘留物容易在此積聚。The shape of rail is irregular, so it39。s not easy to clean the rail. Residue can accumulate here easily.振蕩篩軌道: rail of oscillating screen 包衣機 coating machine32 / 41編號:25Serial 取樣位置Sampling locations選擇原因Reasons 包衣時出風槳葉插入片床,為包衣出風通道,接觸活性成分機會大,且槳葉表面鏤空,清洗難度大The paddle inserts into the bed while coating. It is an airout channel for coating and has more contact with active ingredients. The paddle is hollow so it39。s hard to clean.編號:26Serial 取樣位置Sampling locations選擇原因Reasons 此處靠近包衣鍋排水口,容易殘積化學活性成分This point is close to draining port of coating pot, which allows chemical ingredients to stay. 鋁塑包裝機 thermoforming machine 編號:27Serial 取樣位置Sampling locations選擇原因Reasons 33 / 41藥品包裝時,此處為藥品通道,接觸化學活性成分,為代表性取樣點While packaging products, this is the product channel which contacts chemical active ingredients. This point is a representative sampling point.鏟形料斗取樣點:sampling point of shovel
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