產(chǎn)品特點(diǎn) 本系統(tǒng)采用密閉內(nèi)循環(huán)方式,按潔凈區(qū)等級(jí)配置、混合效果好。 罐體采用SUS304或316L不銹鋼制作,罐內(nèi)配有自動(dòng)噴淋清洗機(jī)頭,采用衛(wèi)生級(jí) 0.20μm呼吸器等裝置,確保生產(chǎn)過(guò)程符合GMP質(zhì)量標(biāo)準(zhǔn)要求,可根據(jù)用戶生產(chǎn)要求設(shè)計(jì)系統(tǒng)配置。 產(chǎn)品簡(jiǎn)介 該系列容器適用于制藥行業(yè)的濃/稀配之用,罐體設(shè)有夾層,可加熱、冷卻,內(nèi)表面采用電解鏡面拋光,封頭(錐形)均經(jīng)旋壓加工、符合GMP標(biāo)準(zhǔn)。本系列濃、稀配罐嚴(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,檢測(cè)驗(yàn)收。 產(chǎn)品構(gòu)造 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、接口采用國(guó)際通用標(biāo)準(zhǔn)ISO快裝卡盤(pán)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≤0.28μm,外表面拋亞光、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)、空氣呼吸口、溫度計(jì)(數(shù)顯式或表盤(pán)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10L-10000L等規(guī)格,也可根據(jù)客戶實(shí)際需要進(jìn)行設(shè)計(jì),更加貼近客戶要求。 Product characteristics The system adopts closed inner circulation mode, according to the level of clean area configuration, mixing effect is good. The tank body is made of SUS304 or 316L stainless steel. The tank is equipped with automatic spray cleaning machine head and adopts sanitary 0.20μm respirator and other devices to ensure that the production process meets the requirements of GMP quality standards. The system configuration can be designed according to the user's production requirements. Product introduction This series of containers is suitable for the concentration/dilution of the pharmaceutical industry, the tank body is equipped with a sandwich, can be heated and cooled, the inner surface is polished by electrolytic mirror, the head (cone) are spun processing, in line with GMP standards. This series of thick and thin cans strictly follow the "Drug production quality Management Standards" GMP General Provisions (1998 revised version) 31, 32 requirements, according to GB150-98 "Steel pressure vessel", JB/T4735-97 "Steel welded atmospheric pressure vessel" requirements for design, manufacturing, testing and acceptance. Product structure 1, the container insulation material is made of high temperature resistant, anti-aging polyurethane foam or pearl cotton. 2, the interface adopts the international standard ISO quick mount chuck type, the inner liner is made of imported stainless steel SUS316L or SUS304, the inner surface mirror polishing to Ra≤0.28μm, the outer surface polishing matte, mirror, sandblasting or cold rolling primary color matte, in line with GMP medical standards. 3, the seal of the agitator adopts imported sanitary mechanical mixing seal or magnetic fully sealed mixing device, mixing speed can be selected. 4, the pipe port is equipped with a liquid level gauge port (static pressure, capacitance, non-contact, ultrasonic, glass tube), air breathing port, thermometer (digital display or dial type), CIP cleaning port, sight mirror, explosion-proof light (sight mirror and light integration), SIP sterilization port, inlet and outlet and sanitary manhole. 5, the volume of 10L-10000L and other specifications, can also be designed according to the actual needs of customers, more close to customer requirements. |