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翻译文件中需统一的内容:1、 粉针项目各设备的统一英文名称中文英文设备厂家(中文)英文洗瓶机Vial washerBOSCHBOSCH隧道烘箱Sterilizing tunnelBOSCHBOSCH蒸汽灭菌柜全称:saturated steam sterilizer 常用简写:autoclaveFEDEGARIFEDEGARI脉动真空灭菌器Pulse vacuum autoclave山东新华干热灭菌柜Dry heat sterilizer LYTZENLYTZEN烘干机Dryer洗衣机Washing machine分装机Filling machine BOSCHBOSCH压盖机Vial capping machine高宁格GRONINGER贴签机Labeling machineIMAIMA蒸馏水机Still 上海九洲医药成套设备厂制冷机Refrigerator 番禺市速能冷暖设备有限公司空调柜AHU 广东吉荣 喷码机Printer厦门依玛士IMAJE纯化水储罐PW storage tank 上海九洲医药成套设备厂注射用水储罐WFI storage tank 上海九洲医药成套设备厂酒精储罐Alcohol storage tank上海九洲医药成套设备厂消毒剂储罐Disinfectant storage tank 飞拓激光灯检台inspection booth激光喷码机 Laser printer深圳大族激光自动折纸机Automatic folding mahine 浙江华联纯蒸汽发生器Clean steam generator 实验室QC lab恒温恒湿箱/稳定性箱Constant climate chamber高效液相色谱仪HPLC微粒分析仪PARTICLE COUNTER气相色谱仪GC/GAS CHROMATOGRAPH生物安全柜BIOLOGICAL SAFETY CABINET2、 各设备部件的统一英文名称(粉针车间)中文英文中文英文不锈钢桶Stainless steel bucket大粉箱搅拌Stirrer of the powder charging hopper称量器具Weighing utensil 不锈钢盘Stainless steel tray大粉箱Powder charging hopper小粉箱胶块Non-metallic parts of filling chamber分装轮罩Filling wheel cover 空气分配盘Air distribution manifold 活塞piston真空软管Vacuum hose 分装轮Filling wheel 压缩空气管Compressed air hose 小粉箱Filling chamber镊子tweezer不锈钢夹Stainless steel mop head不锈钢盒Stainless steel box续上表:中文英文硅胶密封圈silicone ring硅胶垫silicone gasket安装工具Tools used for installation充惰性气体装置inert gases device胶塞振荡器Stopper Vibrator过滤器Filter 滤芯cartridge轨道conveyor星轮starwheel传送带Conveyor隧道烘箱网带Sterilizing Tunnel conveyor belt配电柜Electrical cabinet机器外表面External surface of equipment 转盘turntable3、 各消毒剂的统一英文名称中文英文0.1%新洁尔灭0.1% benzalkonium bromide1.5%雷克特合能消毒剂1.5% hydrogen peroxide75%酒精75% alcohol 4、 各岗位及操作工的统一英文名称 中文英文中文英文洗瓶岗位Vial washing line ?动力岗位Mechanical technician 洗消岗位(工序)Washing and sterilization line辅助岗位Supporting personnel 分装岗位Filling line 洁净区Clean area无菌辅助岗位aseptic supporting personnel操作工Operator 压盖岗位Capping line 保洁工Cleaner包装岗位Packaging line 机修工Technician 空调制水岗位Mechanical technician组长/班长Line leader 中文英文中文英文组长Team leader一般区工装清洗工Support staff 车间材料员support staff车间工艺技术专员Process engineer生产QA Site QA车间主任Workshop manager 生产QCSite QC车间主管Workshop supervisor 质量管理部Quality management Dept 粉针车间Powder for injection workshop质量统计员Quality statistician 机修班长maintenance group leader 文件管理员Document controller 机修工maintenance technician机修岗位maintenance engineer 5、 各房间的统一英文名称中 文英 文编 号中 文英 文编 号合成车间API WorkshopB02质量受权人Qualified PersonR1315制剂大楼Formulation PlantB01生产部Production DepartmentR1304液体物料库Liquid Material StoreB05设备办Equipment departmentR4101安全环保办EHS officeR3106卫生间(男)Toilet (Men)QA/QC办公室QA/QC OfficeR1316卫生间(女)Toilet (Women)包装间APacking Room AR1516洗瓶间BVial Washing Room BR1518包装间BPacking Room BR1532消毒剂配制室Disinfectant Preparation RoomR1539理瓶间AVial Preparation Room AR1501压盖一更A1st Changing Room AR1511理瓶间BVial Preparation Room BR1517压盖一更 B1st Changing Room BR1527胶塞准备间Stopper Preparation RoomR1533压盖二更A2nd Changing Room AR1512洗消一更1st Changing RoomR1534压盖缓冲间ABuffer Room AR1513洗消二更2nd Changing RoomR1535压盖间ACapping Room AR1514洗消缓冲间Buffer RoomR1536压盖二更 B2nd Changing Room BR1528洗消间Washing&Disinfecting RoomR1537压盖缓冲间BBuffer Room BR1529胶塞储存间Stopper StorageR1538压盖间BCapping Room BR1530洗瓶间AVial Washing Room AR1502铝盖准备间ACap Preparation Room AR1515铝盖准备间BCap Preparation Room BR1531分装间AFilling Room AR1503分装一更1st Changing RoomR1540分装间BFilling Room BR1519分装二更(进)2nd Changing EntranceR1541分装三更(出)A3rd Changing Exit AR1508分装缓冲间1Buffer Room 1R1542分装三更(出)B3rd Changing Exit BR1524分装缓冲间A(出)Buffer Room A(Exit)R1509分装二更(出)A2nd Changing Exit AR1510分装缓冲间B(出)Buffer Room B(Exit)R1525分装二更(出)B2nd Changing Exit BR1526分装缓冲间2Buffer Room 2R1544无菌原料间ASterile Raw Material Store AR1505分装三更(进)3rd Changing EntranceR1543无菌原料间BSterile Raw Material Store BR1521无菌贮存间Sterile Storage RoomR1545递料间AMaterial Staging Room AR1507无菌走廊ASterile Area Corridor AR1504递料间BMaterial Staging Room BR1523无菌走廊BSterile Area Corridor BR1520总更衣室General Changing RoomR1546货梯1Material Elevator 1洗手间女Toilet(Women)-货梯2Material Elevator 2五楼粉针车间Powder for injection Workshop (5th floor) -男更衣室Changing Room (Men)R1549六楼粉针车间Powder for injection (6th floor) -女更衣室Changing Room (Women)R1550洁净区洗衣间Laundry (Clean Area)R1564配电室3Electrical Room 3R1551QA办公室QA OfficeR1559中 文英 文编 号中 文英 文编 号管井Pipe well-总更衣间General Changing RoomR1601一般区洁具间Cleaning Tool Storage (General Area)R1553男更衣室Changing Room (Men)R1602空调/制水间HVAC and Water generation RoomR1554女更衣室Changing Room (Women)R1603空调机房AHU RoomR1556一般区工装清洗间Laundry (General Area)R1604控制室Control RoomR1555储物间Storage RoomR1605洗手间男Toilet(Men)-办公室OfficeR1606万级暂存间AStorage AR1506配电室4Power Distribution Room 4R1607制水间Water generation RoomR1610管井Pipe well-空调机房AHU RoomR1612一般区洁具间Cleaning Tool Storage (General Area)R1609控制室Control RoomR1611货梯1Material Elevator 1洗手间男Toilet(Men)-货梯2Material Elevator 2洗手间女Toilet(Women)-工装传递间Garment TransferR1566万级暂存间BClass 10,000 Storage BR1522压盖三更A3rd Changing AR1560气闸AAir lock AR1562压盖三更B3rd Changing BR1561气闸BAir lock BR1563洗消三更3rd ChangingR15656、 还有个别物料、物品统一英文名称中文英文中文英文原料Starting material 铝塑组合盖Flip-off 原料药API说明书leaflet瓶子Vial 大箱carton模制瓶Tubular Vial管制瓶Molded Vial胶塞Stopper 一般区工作服Working clothes/suits for general area小盒box瓶签label铝盖Aluminum capB级区工装Working gown for Grade B无菌内衣Inner garment无菌外衣Sterile garment丝光毛巾Lint free clothA级区Grade A一般区工鞋Working shoes for general areaB级区Grade B一般生产区General production area 鞋套Shoe cover传递窗Passbox (缩写PB)手消毒Hand disinfection 地漏Floor drain天平balance天花板ceiling清洁消毒cleaning and disinfection 送风口Air supply设备内表面Inner surface of equipment回风口Air Extract 设备外表面External surface of equipment卫生工具cleaning tool容器具container小推车Trolley 操作台Operating station 物料卡Material inventory card不锈钢桶Stainless steel bucket进水口Water inlet回水口Water return中文英文中文英文新风fresh air压差表DPI再生风Makeup air压力表Gauge 回风return air阀门Valve排风exhaust air止回阀Non-return Valve送风Air supply双向阀Two-way Valve风量flow volume三通阀Tree-way Valve新风比Ratio of fresh air球阀Ball Valve新风进风风阀dampe
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