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本系列配液罐嚴格遵循《藥品生產(chǎn)質量管理規(guī)范》GMP總則（1998年修訂版）第三十一、三十二條要求，根據(jù)GB150－98《鋼制壓力容器》，JB/T4735－97《鋼制焊接常壓容器》要求進行設計，制造驗收。

1、            容器保溫材料采用耐高溫、抗老化聚胺脂發(fā)泡或珍珠棉。

2、            接口采用通用標準ISO快裝卡盤式，內膽選用進口不銹鋼SUS316L或SUS304制造，內表面鏡面拋光至Ra≤0.28um，外表面拋光、鏡面、噴砂或冷軋原色亞光，符合GMP醫(yī)藥標準。

3、            攪拌器的密封采用進口衛(wèi)生級機械攪拌密封或磁力全密封攪拌裝置，攪拌轉速可任選。

4、            管口設有液位計口（靜壓式、電容式、無觸點式、超聲波式、玻璃管式）、空氣呼吸器、溫度計（數(shù)顯式或表盤式）、CIP清洗口、視鏡、防爆視燈（視鏡視燈一體化）、SIP滅菌口、進出液口及衛(wèi)生人孔等。

5、            容積有100L－10000L等規(guī)格，也可根據(jù)客戶實際需要進行設計、制造。

6、            隨機附著有關GMP驗證資料（含材質報告、外購件合格證、驗證表格等）。

The liqukd arrangement tank strictly tallies with the 31^st and 32^nd clauses of 《Medicine Production Quality Management Norm》---GMP General Principles(1998Revised Edition),and is designed ,manuracturde and accepted according to the require-ments of GB150-98《Steel Welding Norma Vessel》.

1、                   Heat preservation material of the vessel adopts high-temperature resistant and anti-aging polyurethane blister or pearl cotton.

2、                   Joints adopt international general ISO package chuck,inner container adopts inported stainless steel SUS316l or SUS304,internal surface is polished to Ra≤0.28m,and external surface polishing mirror polish,sand blasting or cold-rolled nature-color surface polishing.All is in accordance with GMP medical standards.

3、                   Sealing of mixer adopts imported sanitation-grade mechanical stirring enchosing or magnetic totally-enclosed stirring device.The mixing rotary speed is optional.

4、                   Orifice is set with level gauge(static-pressure type,capacitance type,non-contact type,ultrasonic type and glass tube type),air respirator,thermometer(digital display type or dial plate type),CIP cleaning mouth ,viewing mirror,exlosion-proof viewing lamp(viewingmirror and viewing lamp integration),SIP sterilizing mouth,liquid entrance-exit gate and sanitary inlet.

5、                   Volume Specification:100L-10000L orto be designed and manufactured at customers ,actual request.

6、                   Relevant GMP testing data are attached in the machine.(including material report,external components cer-tificate of quality and verification form).

技術參數(shù)Technology Parameter：

本公司生產(chǎn)的N（X）PG系列濃、稀配罐設計合理，工藝*，*符合國家GMP認證要求。罐體均采用立式雙層結構，內膽拋光精度RaO.45。內筒體纏繞螺旋帶加熱，并充填聚氨酯材料保溫。外部采用鏡面板或磨砂板保溫，罐體光澤一致。凡接觸藥液部件均采用316L材質，其余均采用304材質。內罐底部封頭為凹凸型，采用偏壁式軸向流攪拌，罐體頂部設進水口、回流口、消毒口、清洗球、入孔填料口、呼吸口安裝0.22um空氣呼吸器、攪拌系統(tǒng)。罐體底部設凝水口、出料口、排污口、取樣口、溫度探頭、液位傳感器。配有控制柜操作，儀表顯示藥液溫度、液位，提供上、下限報警功能。根據(jù)用戶要求，稀配罐可增加充氮氣裝置和PH計。