本系列配液罐嚴格遵循《藥品生產質量管理規范》GMP總則(1998年修訂版)第三十一、三十二條要求,根據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醫藥標準。
3、 攪拌器的密封采用進口衛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、進出液口及衛生人孔等。
5、 容積有100L-10000L等規格,也可根據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 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).
技術參數Technology Parameter:
公稱容積 | 工作壓力(Mpa) 工作溫度(℃) 攪拌轉速(轉/分) H(mm) H1(mm) D(mm) D1(mm) h(mm) |
100 | 0.25 100 0-720 1750 450 Φ750 Φ550 300 |
200 | 0.25 100 0-720 1950 600 Φ850 Φ650 300 |
600 | 0.25 100 0-720 2500 1000 Φ1100 Φ900 350 |
1000 | 0.25 100 0-720 2850 1200 Φ1300 Φ1100 350 |
2000 | 0.25 100 0-720 3350 1500 Φ1500 Φ1300 350 |
3000 | 0.25 100 0-720 3700 1700 Φ1700 Φ1500 350 |
5000 | 0.25 100 0-720 4250 2000 Φ2000 Φ1800 400 |
10000 | 0.25 100 0-720 5000 2500 Φ2500 Φ2300 400 |
本公司生產的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*。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。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。根據用戶要求,稀配罐可增加充氮氣裝置和PH計。