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文档简介

序号,中文,English

1,HEPA,HighEfficiencyParticulateAir

2,安全关注,duecare

3,安全门,EmergencyDoor

4,安全门,Emergencyescapepanel

5,安全眼镜,Safetyglass

6,搬运小车,TransportCart

7,办公室,Office

8,包衣间,CoatingRoom

9,包衣室,CoatingRoom

10,备料室,MaterialsPreparingRoom

11,壁板下侧回风口,thelowwallreturns

12,便装,thestreetclothes

13,标签管理,LabellingManagment

14,不良质量成本,costofpoorquality

15,不锈钢踏步梯,StainlessSteelStepStoolsandStep

16,材质,MaterialsofConstruction

17,层流,LaminarFlow

18,层流台,LaminarFlowBenches

19,层流罩,Fan-filterUnits

20,层流转运车,LaminarFlowTransportCart

21,拆除旧建筑,demolition

22,产品审核,productaudit

23,超额运费,premiumfreight

24,超过cGMP要求,ExceedscGMPrequirements

25,超声清洗机,UltrasonicCleaners

26,成套设备,IntegratedSystems

27,充氮的/氮气保护的,Nitrogen-Purged

28,充氮设备/系统,NitrogenPurgeSystem

29,除尘,DustRemoving

30,储柜,suppliescabinet

31,传递窗,TransferringWindow

32,传递窗/柜,TransferHatches

33,传递间,TransferRoom

34,传递间传递柜,passthrus/Pass-Through

35,传送带进/出口,Conveyorentries/exits

36,纯化水的循环管路,distributionloop

37,纯化水站,PurifiedWaterProductionPlant

38,从洁净室内更换HEPA,Roomsidereplaceable

39,存料间,StorageRoomofRawMaterials

40,存瓶室,AmpulStorageRoom

41,大屏幕LCD显示器,Large-formatLCDdisplay

42,弹簧门,SwingingDoor

43,灯检,Individualinspection

44,灯检室,VisualInspectionRoom

45,电磁阀,solenoidvalve

46,电动擦鞋机,MotorizedShoeCleaner

47,电动阀,electromotorcontrolvalve

48,电器插座,WiringStuds

49,电器接地端子,GroundingTerminals

50,吊顶,suspendedceilings

51,翻新/重新装修,refurbishment

52,反应计划,reactionplan

53,防火的,Fire-Rated

54,防火等级,Fireclassification

55,防火门,Firerateddoor

56,防火门,Firedoor

57,防火墙,Firewalls

58,房门开向(左开/右开),doormounting(leftorrightopening)

59,非洁净区,Non-cleanroomareas

60,非生产区域,non-productionareas

61,废弃物箱,Wastereceptacle

62,分筛间,SievingRoom

63,粉碎室,PulverizingRoom

64,粉针室,LyophilizedSterilePowderRoom

65,风管制作安装,Ductworkandinsulation

66,风淋,airshower

67,风淋室,AirShower

68,风淋通道,AirTunnel

69,风速,airvelocity

70,风速监测表,airvelocitymonitor

71,风速上下限,high/lowairspeedthresholds

72,服装,apparel

73,符合国家标准的,traceabletonationalstandards

74,负压洁净室,negativepressurecleanroom

75,干燥柜,DesiccatorCabinets

76,干燥器,Desiccator

77,钢化玻璃,temperedglass

78,高效过滤器,HEPAFilters

79,高压气瓶室,CylinderStore

80,更鞋,ShoesChangingRoom

81,更衣规则,gowningprocedure

82,更衣柜,Storagelockers

83,更衣镜,Cleanroommirror

84,更衣室,Gowningroom

85,更衣室,ChangeRoom

86,更衣室,Changingroom

87,工程批准的授权,engineeringapprovedauthorization

88,工具/工装,tool/tooling

89,工具车,UtilityCarts

90,工具储柜,ToolStockers

91,工具间,FacilityRoom

92,工具箱,Toolscabinet

93,工艺配管,Pipeworkandinsulation

94,工作台,Worktables

95,公认的检定机关,accreditedtesthouses

96,公用设施连接,Utilitiesconnections

97,功能验证,functionalverification

98,挂壁式,Wall-Mount

99,管道井,CavityWalls

100,灌封室,FillingandSealingRoom

101,滚筒式拖布,Rollermops

102,过程流程图,processflowdiagramflowchart

103,过程审核,processaudit

104,海绵,Sponges

105,海绵夹层抹布,CoatedSpunlaceWiper

106,横向职能方法,cross-functionalapproach

107,弧形墙脚,RadiusFloorCoving

108,互锁门,Interlockingdoors

109,护墙管架,Wallguardrails

110,滑动门,SlidingDoor

111,化学清洗剂,chemicals

112,环保型,environmentallyfriendly

113,缓冲间,airlock

114,缓冲间,BufferRoom

115,换气次数,airchangerates

116,回风格栅/回风口,returnairgrille

117,回风夹道,returnairwalls

118,回风墙,returnairwalls

119,火灾感应系统,FireDetectionSystem

120,机房,ManchineRoom

121,基准确定,benchmarking

122,计算机辅助工程,computeraidedengineering(CAE)

123,计算机辅助设计,computeraideddesign(CAD)

124,技术改造,modificationofexistingfacilities.

125,技术改造/改建,ExistingFacilityModification

126,夹心彩钢板,WallSandwichPanels

127,架空地板,raisedfloors

128,洁净服,Cleanroomapparel

129,洁净服,CleanroomGarments

130,洁净室壁板,Cleanroompartitions

131,洁净室出入通道,AccesstotheCleanroom

132,洁净室地面清洗机,CleanroomFloorMachine

133,洁净室级别,CleanroomClass

134,洁净室用头罩,CleanroomHood

135,洁净室运行状况,cleanroomperformance

136,洁净室专用鞋,dedicatedcleanroomshoes

137,洁净头套柜,Headweardispenser

138,洁具/清洁用具,cleaningproducts

139,洁具室,CleaningToolsRoom

140,解决问题,problemsolving

141,进入洁净室,EntertheCleanroom

142,进入洁净室,togettothecleanroom

143,经过校准的测试仪器,calibratedtestinstruments

144,经营计划,businessplan

145,纠正措施计划,correctiveactionplan

146,卷闸门,roll-updoor

147,可拆式检修们,RemovableServicePanel

148,可调式喷咀,adjustablenozzles

149,可弃式蹭鞋垫,Disposablemats

150,可行性,feasibility

151,可行走式天花板,walk-onCeiling

152,空气洁净级别,aircleanliness

153,空气粒子计数器,airborneparticlecounter

154,空气自净时间,aircleanlinessrecoveryperiods

155,控制计划,controlplan

156,垃圾桶,WasteReceptacle

157,垃圾桶里面的塑料内桶,plasticliner

158,冷冻干燥机,Lyophilizer

159,冷冻水,chilledwater

160,冷库,ColdRoom

161,冷水机组,chillerplant

162,粒子异物,Particulate

163,凉片间,CoolingTabletsRoom

164,铝塑包装间,PackingRoom

165,铝型材门,aluminum-framedoor

166,密封剂,Sealant

167,密封门,Gastightdoors

168,密封门,Airtightdoors

169,灭菌间,SterilizingRoom

170,模具间,ModulesRoom

171,模具室,DiesRoom

172,抹布,Wipers

173,抹布柜,Wiperdispenser

174,末件比较,lastoffpartcomparison

175,内包装区,"primary

primarypackagingrooms"

176,内包装室,ImmediatePackageRoom

177,内毒素超标,excessivebacterialendotoxins

178,内衣,undergarments

179,男更洁净衣,Malegarment

180,男脱外衣洗手,Malegarment

181,浓配室,ConcentratedSolutionRoom

182,女更衣间,Femalgarment

183,女脱外衣间,Femalgarment

184,排风速率,Exhaustairflowrates

185,排风系统,Exhaustsystems

186,配浆间,CoatingMixturePreparingRoom

187,配液间,SolutionRoom

188,喷壶,SprayBottles

189,喷塑铁皮,epoxy-finishedsteel

190,平面布置,Layout

191,平面布置图,FloorPlan

192,气体钢瓶搬运车,BottleCart

193,气闸室,airlock

194,气闸室,Airlock

195,器具洗涤间,ToolWashingRoom

196,器具箱,suppliescabinet

197,前室,FrontStation

198,墙/墙交界处的圆角,Roundedsnap-incove

199,墙的贴面,LinerWall

200,墙或屋顶的开洞,openings

201,清除浮尘,toremoveloosecontaminants

202,清外包室,OuterPackageRemovingRoom

203,清洗池,Wetbenches

204,清洗池,wetcleaningstation

205,清洗设备,cleaningproducts

206,清洗室,CleaningRoom

207,清洗台,WetBench

208,全尺寸检验,layoutinspection

209,热风干手器,HandDryer

210,认可的实验室,accreditedlaboratory

211,入口,thefrontentrance

212,软胶室,SoftCapsulesRoom

213,设计纪录,designrecord

214,设计责任供方,design-responsiblesuppliers

215,生产区扩建,ManufacturingAreaExpansion

216,实验设计,designofexperiment(DOE)

217,实验室,laboratory

218,实验室范围,laboratoryscope

219,试剂储柜,ChemicalSafetyCabinet

220,室外穿的衣物,Outdoorclothing

221,手套,Gloves

222,手提式,Hand-heldmodel

223,手消室,HandsDisinfectionRoom

224,台式,benchtopmodel

225,天花板骨架,CeilingGrid

226,停电,断电,powerfailure

227,土建工程,civilconstruction

228,托盘包装机,palletwrappers

229,拖布,Mops

230,拖布把手,Mophandles

231,拖布挤水器,Squeegees

232,拖布涮洗桶,Mopwringers

233,脱去外衣,Removeoutergarments

234,外包装区,secondarypackagingarea

235,外包装室,OuterPackingRoom

236,外部场所,remotelocation

237,外开门,Doorswingisoutward(awayfromroom)

238,违反洁净更衣规程,theviolationofcleanroomgarments!

239,卫生洁具间,CleaningToolsRoom

240,温湿度监测,temperatureandhumiditymonitoring

241,无菌操作,asepticmanipulations

242,无菌洁净室,AsepticCleanrooms

243,无菌洁净室,Sterilecleanroom

244,无菌培养基传送和灌装挑战试验,sterilemicrobialculturemediumtransferandfillchallenges

245,无菌区,AsepticArea

246,无沿平滑玻璃窗,flushledge-freewindows

247,吸尘器,VacuumCleaner

248,吸尘器,vacuums

249,稀配室,DilutedSolutionRoom

250,洗瓶室,AmpulCleaningRoom

251,洗手台,Handwashingstation

252,洗眼器,eyewash

253,系统配套,systemintegration

254,下降管,DescendTube

255,先进先出,firstinfirstout(FIFO)

256,现场,field

257,现场,site

258,现场调校,fieldcalibrate

259,现场经理,sitemanager

260,项目管理,projectmanagement

261,项目组,theprojectteam

262,鞋套,CleanroomBoot

263,休息室,RestingRoom

264,袖套,Sleevecovers

265,压差计,Differentialpressuregauge

266,压降小,低压降,LowPressureDrop

267,压片间,TablettingRoom

268,压片室,TabletsRoom/CompressionRoom

269,药品包装,medicationpackaging

270,一次性洁净服,DisposableCleanroomGarments

271,一更室,FirstChangeRoom

272,衣架/衣钩,Garmenthamper

273,衣物形式,GarmentType

274,移动式衣架,FreestandingGarmentRack

275,易燃品转运车,FlammableMaterialsCart

276,应急冲淋器,SafetyShower

277,应急计划,contingencyplan

278,荧光灯,Fluorescentlighting

279,硬胶室,HardCapsu

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