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代理說(shuō)明: | 本系列配液罐嚴(yán)格遵循《藥品生產(chǎn)質(zhì)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(jìn)行設(shè)計(jì),制造驗(yàn)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(biāo)準(zhǔn)ISO快裝卡盤式,內(nèi)膽選用進(jìn)口不銹鋼SUS316L或SUS304制造,內(nèi)表面鏡面拋光至Ra≤0.28um,外表面拋光、鏡面、噴砂或冷軋?jiān)珌喒,符合GMP醫(yī)藥標(biāo)準(zhǔn)。 3、 攪拌器的密封采用進(jìn)口衛(wèi)生級(jí)機(jī)械攪拌密封或磁力全密封攪拌裝置,攪拌轉(zhuǎn)速可任選。 4、 管口設(shè)有液位計(jì)口(靜壓式、電容式、無(wú)觸點(diǎn)式、超聲波式、玻璃管式)、空氣呼吸器、溫度計(jì)(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(jìn)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(shí)際需要進(jìn)行設(shè)計(jì)、制造。 6、 隨機(jī)附著有關(guān)GMP驗(yàn)證資料(含材質(zhì)報(bào)告、外購(gòu)件合格證、驗(yàn)證表格等)。 The liqukd arrangement tank strictly tallies with the 31st and 32nd 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(shù)參數(shù)Technology Parameter:
本公司生產(chǎn)的N(X)PG系列濃、稀配罐設(shè)計(jì)合理,工藝*,*符合國(guó)家GMP認(rèn)證要求。罐體均采用立式雙層結(jié)構(gòu),內(nèi)膽拋光精度RaO.45。內(nèi)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(zhì),其余均采用304材質(zhì)。內(nèi)罐底部封頭為凹凸型,采用偏壁式軸向流攪拌,罐體頂部設(shè)進(jìn)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(shè)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(bào)警功能。根據(jù)用戶要求,稀配罐可增加充氮?dú)庋b置和PH計(jì)。 |
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