蒸餾水貯罐
DISTILLED WATER STORAGE TANK
本系列臥式蒸餾水貯罐嚴格遵循《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》要求進行設(shè)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. 接口采用國際通用標準ISO快裝卡盤式,內(nèi)膽選用進口不銹鋼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、噴砂或冷軋原色亞光,符合GMP醫(yī)藥標準。
3. 管口設(shè)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、SIP滅菌口、進出液口及衛(wèi)生人孔等。
4. 容積有1000L-30000L等規(guī)格,也可根據(jù)客戶實際需要進行設(shè)計、制造。
5. 隨機附送有關(guān)GMP驗證資料(含材質(zhì)報告、外購件合格證、驗證表格等)。
The horizontal distilled water tank series strictly tally with the 31st and 32nd clauses of ' Medicine Production Quality Management Norm——GMP General Principles' (1998 Revised Edition), and is designed, manufactured and accepted according to the requirements of GB150-98 'Steel Pressure Vessel' and JB/T4735-97 ' Steel Welding Normal 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 imported stainless steel SUS316L or SUS304, internal surface is polished to Ra≤0.28μm, and external surface polishing, mirror polish, sand blasting or cold-rolled nature-color surface polishing. All is in accordance with GMP medical standards.
3. Orifice is set with level gauge (static-pressure type, capacitance type, non-contact type, ultra-sonic type and glass tube type), air respirator, thermometer (digital display type or dial plate type), CIP cleaning mouth, SIP sterilizing mouth, liquid entrance-exit gate and sanitary inlet.
4. Volume Specification: 100L-30000L or to be designed and manufac-tured at customers' actual request.
5. Relevant GMP testing data are attached in the machine.(including ma-terial report, external com-ponents certificate of quality and verification form).
衛(wèi)生級容器
SANITATION CONTAINERS
洪都所有不銹鋼容器均按GB2880-81《鋼制焊接常壓容器技術(shù)條件》或GB150-89《鋼制壓力容器技術(shù)條件及新版GMP、FDA標準進行設(shè)計、制造、試驗和驗收》采用SUS304或316L材料,內(nèi)表面采用鏡面電解拋光,拋光精度達Ra0.28μ,容器桶身與上下封頭過渡均采用旋壓R角成型,平整光滑,均無衛(wèi)生死角,確保容器始終處于衛(wèi)生無菌狀態(tài)。外表面采用拋光、噴砂、磨砂或冷軋原色啞光等多種表面處理方式,使容器在任何場地都能顯示出它的的品質(zhì)。
All stainless vessels of brand are designed, manufactured, tested and checked according to GB2880-81 "Technical Conditions For Steel Welded Normal Pressure Vessels" or "GB150-89 "Technical Conditions For Steel Pressure Vessels and GMP, FDA Standards (new versions)". Products adopt SUS304 or 316L material, and their inner surface adopts mirror surface electrolytic polishing,with polishing precision of Ra0.28μ. Transition between vessel body and upper/lower end enclosures all adopts rotary press R-angle modelling to ensure smoothness and cause no hygienic dead angles, as well as ensuring hygienic state of vessels at all times.External surface adopts many kinds of surface treatment modes such as polishing, sandblasting, frosting or cold-rolling primary color dumb lightness to embody the superior quality of vessels at any locations.