ISPE+HVAC翻译(part1)

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GMP(2010年修订版)中的中英文术语

GMP(2010年修订版)中的中英文术语

ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会。

Q10:药品质量管理体系(PQS),基于QMS(质量管理体系)而来,最合适的指南应该是ICH的Q10。

Q9:质量风险管理。

Q8:药物开发。

自动化生产规范GAMP5(Good Automated Manufacturing Practice)由ISPE(International Society For Pharmaceutical Engineering国际制药工程协会。

创立于1980年,是致力于培训制药领域专家并提升制药行业水准的世界最大的非盈利性组织之一)的GAMP论坛(GAMP Forum)组织编写发布的关于制药企业计算机化系统的综合性指南。

纠正和预防措施CAPA(Corrective Action & Preventive Action)超出标准的可疑结果OOS(out of specification)质量管理 QM(Quality Management)质量保证 QA(Quality Assurance)质量控制 QC(Quality Control)生产管理 PM(Production Maanagement)工程设备管理 EM (Enginccr Equipment Managemant)销售管理 MS (Maragement Of Sales)行政人员管理AP (Administration and Personael Managemeht)工艺验证 PV (Process Validation)设备验证 EV (Equipment Validation)工艺规程 PP (Process Procedure)质量标准 QS (Quality Management)物料管理 MM (Materid Management)原料管理 RM (Raw Material Management)辅料管理 EM (Excipient Management)质量标准 QS (Quality Standard)增补和修订A.A.A Addition and Amendments空调器AC Air Conditioner药物不良反应ADR Adverse Drug Reaction食品与药品官员协会(美国)AFDO Association of Food and Drug Officials 接受ACC Accept合格质量标准AQL Acceptable Quality Level简化的新药申请ADNA Abbreviated New Drug Application物料清单BOM Bill of Material原料药BPC Bulk pharmaceutical Chemiclls生物制品评价与研究中心CBER Center for Biologics Evaluation Research 菌落形成单位CFU Colony Forming Unet药品管理档案DMF Drug Master File药物评价与研究中心CDER Cemter for Drug Evaluation amd Research企业识别(形象)CI Corporate Identity (Image)在线清洗CIP Cleaning in Place消费者安全调查员CSI Consumer Safety Insepctor在线清洗程序CLP Cleaning Line Procedure缺陷作用水平DAL Defect Action Level管制药品管理DEA Drug Enforcement Adminestration文件系统DS Documentation Systim食品与药品管理局(美国)FDA Food and Drug Administration关贸总协会GATT General Agreemernt on Tariffs and Trade药品生质量管理规范GMP Good Manufacturing Practice药品临床实验管理规范GCP Good Clinical Practice实验室管理规范GLP Good Laboratory Practice药品商业质量规范GSP Good Supply Practice药品零业质量管理规范GRP Good RaTAIL Practice药材生产管理规范GAP Good Agriculture Practice验证管理规范GVP Good Validation Prctice药品使用规范GUP Good Use Practice国际标准化组织ISO Intematonal Organization for Standardization 谅解备忘录MOU Memorandum of Understanding生产记录用表格PF Porduction File非处方药品OTC Over the Counter (Drug)产品许可申请PLA Product License Application质量管理程序QMP Quality Management Procedure国家药品监督管理局SDA State Drug Administration标准管理程序SMP Standard Managmert Procedure标准操作程序SOP Standard Operating Procedure全面质量管理TQC Tatal Quality Control美国药典USA Uneted States Pharmacopeia生产管理中的术语系统: system起始原料:starting material物料:material物料平衡:reconcilination批: batch or lot批号:batch number (lot number)批档案:batch records文件: doocument标准操作规程:standard operating processsing工艺规程:master for processing纯化水: puritied water工艺用水:water for processing蒸馏水:distilled water去离子水:deionized water注射用水:water for injection无菌:sterile灭菌:sterlization(sterilise)无菌制剂:sterile product ?(preparation,dosage from) 非无菌制剂:non-sterile product状态标志:status mark (labet)中间产品:intermediate product制造:manufacture带包装品:bulk product成品:finished product活性药物组分:active pharmaceutical ingredient理论产量:theoretical yield质量管理中的术语待验:quarantine控制点:control point质量保证:quality assurance质量控制:quality control质量管理:quality management质量体系:quality system质量监督:quality surveillance规格标准:specification生产过程中控制:in-process control返工:reprocessing退货:retured product拒收:rejected交叉污染:cross contamination放行:released质量要求:quality requirement质量管理体系:quality management system可追溯性:traceability合格(符合):conformity不合格:nonconformity预防措施:preventive action质量手册:quality manual计量确认:metrological confirmation验证术语:验证:validation空调净化系统:HVAC( heating ventilation and air conditioning) 起泡点实验:bubbling point挑战性试验:challenge test最差状况:worst case不合格限:edge-of-failure严整方案:validation protocol在线清洗:CIP(cleaning in place)在线灭菌:SIP(sterilization in place)预确认:pre qualification安装确认:IQ(instalation qualification)运行确认:OQ(operational qualitification)性能确认:PQ(performance qualificantion产品验证:PV(product validation)工艺验证:process validation前验证:prospective validation同步验证:concurrent validation回顾性验证:retrospective认证:certification其他术语:管理体系:management system组织结构:organizational structure指南:guideline销售许可证:marketing authorization计算机系统:computerized system生物反应器:biogenerator生物试剂:biological agents细胞库系统:cell bank system主细胞库:master cell bank工作细胞库:working cell bank细胞培养:cell culture种子库:seed lot主种子库:master seed lot工作种子库:working seed lot外源生物体:exotic organism放射性药品:radio pharmaceutical原植物(植物药)crude plant(vegetable drug)药用植物:medicinal plant草药品:herbal pharmaceuticalOn the Road推荐阅读:•CAPA(Corrective Action & Preventive Action)纠正2010-08-09 19:25:00•oos和偏差2010-07-09 15:27:01•车间标识中英对照2010-08-16 15:37:56•GMP文件管理常用的英文缩写2009-06-08 11:23:40。

HVAC专业词汇中英文对照表

HVAC专业词汇中英文对照表

暖通专业词汇中英文对照air conditioning load空调负荷air distribution气流组织air handling unit 空气处理单元air shower 风淋室air wide pre.drop空气侧压降aluminum accessories in clean room 洁净室安装铝材brass stop valve 铜闸阀canvas connecting termingal 帆布接头centigrade scale 摄氏温度chiller accessories水冷机组配件chiller assembly水冷机组组装clean bench 净化工作台clean class 洁净度clean room 洁净室无尘室correction factor修正系数dry coil units 干盘管district cooling 区域供冷direct return system直接回水系统displacement ventilation置换通风drawing No.图号elevation立面图entering air temp进风温度entering water temp进水温度fahrenheit scale 华氏温度fan coil unit 风机盘管ffu fan filter units 风扇过滤网组flow velocity 流速fresh air supply 新风供给fresh air unit 新风处理机组ground source heat pump地源热泵gross weight 毛重heating ventilating and air conditioning 供热通风与空气调节hepa high efficiency particulate air 高效过滤网high efficiency particulate air filters高效空气过滤器horizontal series type水平串联式hot water supply system生活热水系统humidity 湿度hydraulic calculation水力计算isometric drawing轴测图layout 设计图leaving air temp 出风温度leaving water temp出水温度lood vacuum pump中央集尘泵mau make up air hundling unit schedule 外气空调箱natural smoke exhausting自然排烟net weight 净重noise reduction消声nominal diameter 公称直径oil-burning boiler燃油锅炉one way stop peturn valve 单向止回阀operation energy consumption运行能耗pass box 传递箱particle sizing and counting method 计径计数法Piping accessaries 水系统辅材piping assembly 配管rac recirculation air cabinet unit schedule循环组合空调单元ratio controller 比例调节器ratio flow control 流量比例控制ratio gear 变速轮ratio meter 比率计rational 合理性的,合法的;有理解能力的rationale (基本)原理;原理的阐述rationality 有理性,合理性rationalization proposal 合理化建义ratio of compression 压缩比ratio of expansion 膨胀比ratio of run-off 径流系数ratio of slope 坡度ratio of specific heat 比热比raw 生的,原状的,粗的;未加工的raw coal 原煤raw cotton 原棉raw crude producer gas 未净化的发生炉煤气raw data 原始数据raw fuel stock 粗燃料油raw gas 未净化的气体real gas 实际气体realignment 重新排列,改组;重新定线realm 区域,范围,领域real work 实际工作ream 铰孔,扩孔rear 后部,背面,后部的rear arch 后拱rear axle 后轴rear-fired boiler 后燃烧锅炉rear pass 后烟道rearrange 调整;重新安排[布置]rearrangement 调整,整顿;重新排列[布置]reason 理由,原因;推理reasonable 合理的,适当的reassembly 重新装配reaumur 列氏温度计reblading 重装叶片,修复叶片recalibration 重新校准[刻度]recapture 重新利用,恢复recarbonation 再碳化作用recast 另算;重作;重铸receiving basin 蓄水池receiving tank 贮槽recentralizing 恢复到中心位置;重定中心;再集中receptacle 插座[孔];容器reception of heat 吸热recessed radiator 壁龛内散热器,暗装散热器recharge well 回灌井reciprocal 倒数;相互的,相反的,住复的reciprocal action 反复作用reciprocal compressor 往复式压缩机reciprocal feed pump 往复式蒸汽机reciprocal grate 往复炉排reciprocal motion 住复式动作reciprocal proportion 反比例reciprocal steam engine 往复式蒸汽机reciprocate 往复(运动),互换reciprocating 往复的,来回的,互相的,交替的reciprocating ( grate ) bar 往复式炉排片reciprocating compressor 往复式压缩机reciprocating condensing unit 往复式冷冻机reciprocating packaged liquid chiller 往复式整体型冷水机组reciprocating piston pump 往复式活塞泵reciprocating pump 往复泵,活塞泵reciprocating refrigerator 往复式制冷机recirculate 再循环recirculated 再循环的recirculated air 再循环空气[由空调场所抽出,然后通过空调装置,再送回该场所的回流空气] recirculated air by pass 循环空气旁路recircilated air intake 循环空气入口recirculated cooling system 再循环冷却系统recirculating 再循环的,回路的recirculating air duct 再循环风道recirculating fan 再循环风机recirculating line 再循环管路recirculating pump 再循环泵recirculation 再循环recirculation cooling water 再循环冷却水recirculation ratio 再循环比recirculation water 再循环水reclaim 再生,回收;翻造,修复reclaimer 回收装置;再生装置reclamation 回收,再生,再利用reclamation of condensate water蒸汽冷凝水回收recombination 再化[结]合,复合,恢复recommended level of illumination 推荐的照度标准reconnaissance 勘察,调查研究record drawing 详图、大样图、接点图recording apparatus 记录仪器recording barometer 自记气压计recording card 记录卡片recording facility 记录装置recording liquid level gauge 自动液面计recording paper of sound level 噪声级测定纸recording pressure gauge 自记压力计recording water-gauge 自记水位计recoverable 可回收的,可恢复的recoverable heat 可回收的热量recoverable oil 可回收的油recoverable waster heat 可回收的废热recovery plant 回收装置recovery rate 回收率relief damper 泄压风门return air flame plate回风百叶Seat air supply座椅送风Shaft seal 轴封Shaft storage 搁架式贮藏Shake 摇动,抖动Shakedown run 试车,调动启动,试运转Shake-out 摇动,抖动Shakeproof 防振的,抗振的Shaker 振动器Shaking 摇[摆,振]动Shaking grate 振动炉排Shaking screen 振动筛Shallow 浅层,浅的,表面的Shank 柄,杆,柱体,轴Shape 造[成]型,形状[态]模型。

医药洁净厂房的净化空调系统调试浅析

医药洁净厂房的净化空调系统调试浅析

药厂洁净室的系统调试工作药厂的净化空系统调试工作是调试人员按照业主设计的参数以及新版GMP对各种参数的要求对药厂洁净室的空调系统进行设置,这个过程是繁琐艰巨的,需要调试人员耐心有序地对系统各个参数进行控制。

随着国家对医药行业的监管力度加大,为了使我国的医药行业提高到国际水平,国家对医药洁净工业厂房的设计、施工、验收提出了更严格的要求。

为了高效地完成一个厂房的设计、施工、验收等一系列的工作,则需要工程设计人员、施工技术人员付出更多的心血。

通过长期的调试工作发现:在设计、施工的过程会出现各种各样的问题,从而影响工程的验收,最后只能通过整改或者更改设计参数才能勉强达到业主要求,问题严重的甚至会导致整个厂房无法使用从而影响工程进度给双方带来资源的浪费。

医药洁净厂房后期验收的主要技术参数有:风口风量、换气次数、高效过滤器是否泄漏、压差、洁净度、噪声、照度、温湿度、微生物数量、气流流型等。

其中以换气次数、高效过滤器是否泄漏、压差、洁净度、温度、湿度六个参数控制的更为严格。

下面从技术参数来分析医药工业洁净厂房的设计及施工所需要注意的一些问题:1、风口风量(换气次数)换气次数是一个医药洁净厂房是否合格的前提参数,换气次数不合格将直接影响洁净度的效果,影响业主使用。

换气次数校核测试时常见的问题有:1.1系统总风量不足分析:1)空调机组的选型不合理。

空调机组应选用可变频空调机组,空调机组选型应主要考虑机外余压、风量、电流等技术参数,以保证空调机组有足够的能力克服系统的阻力送出足够的风量。

特别注意的是有定风量阀和变风量阀的系统,空调机组的机外余压一定要保证,以确保定风量阀或变风量阀能达到其作用压力范围。

同时,空调机组选型一定要考虑地区原因,考虑空气密度的影响。

2)送风系统阻力过大。

送风管路系统设计遵循最小阻力的原则,尽可能的合理。

减少90°弯头等会减少局部阻力的情况。

90°弯头等应安装导流片,降低阻力。

ISPE HVAC翻译(part3)

ISPE HVAC翻译(part3)

6.1.8.4 Terminal Filtration 终端过滤器This level of filtration uses HEPA filters typically at the supply air terminal, and associated with cleanrooms classified as cleaner than ISO 8. A terminal filter may also be used on return/exhaust air when process room air is contaminated with environmentally sensitive particulates (hazardous airborne materials). These filters should have a silicone gel seal on the downstream side of the filter to form a positive seal to eliminate air bypass around the filter perimeter. Permanent upstream and downstream media protective screens (media guards) should be included to prevent physical damage to the media. Individual HEPA filters in filter banks should be able to be replaced without disruption of adjacent filters. H14 (99.995% @MPPS) efficient filter is recommended.此过滤等级常常使用高效过滤器,位于供风终端,房间洁净等级高于ISO 8。

ISPE HVAC指南中温度分布指南翻译

ISPE HVAC指南中温度分布指南翻译

ISPE Good Practice Guide:Heating, Ventilation, and AirConditioning (HVAC) 2009Appendix1117.7 Temperature MappingThe purpose of temperature mapping helps confirm that the area as a whole remains within its defined limits and determine the locations representing temperature extremes within the area温度分布的目的是证实该区域整体仍在其既定的限度范围内并确认区域内的极端温度位置点。

The second objective defines the locations for permanently installed sensors that provide data for the quality system of record for the area, the information from which the MKT is calculated (if required).第二个目的是规定用于长期安装,提供该区域质量系统记录的传感器的位置,记录中同时会有MKT的信息(如果需要)。

There is very little guidance on temperature mapping, the French Standard, (NF X15-140 October 2002 “Measurement of Air Moisture –Climatic and thermostatic Chambers- Characterisation and Verification”) (Reference 11, Appendix12) provides some guidance on sensor locations to be used for mapping of environmental chambers, as summarized below.关于温度分布的指南非常少,法国标准(NF X15-140 October 2002 “Measurement of Air Moisture –Climatic and thermostatic Chambers- Characterisation and Verification”)(附件12,参考11)中提供了一些环境测试室温度分布探测器点位置的指南,总结如下。

ISPE+HVAC翻译(part1) 甄选

ISPE+HVAC翻译(part1) 甄选

ISPE+HVAC翻译(part1) (优选.)rd1 INTRODUCTION 简介111.1B ACKGROUND 背景111.2S COPE OF T HIS G UIDE 指南范围111.3O BJECTIVES OF T HIS G UIDE 指南目的121.4D EFINITIONS 定义131.5R EFERENCES 参考文献132. FUNDAMENTALS OF HVAC 空气净化系统的基本原则172.1I NTRODUCTION 简介172.2W HAT IS HVAC?172.2.1 People comfort 人员的舒适182.2.2 Product and Process Considerations产品与工艺注意事项202.2.3 How does the HVAC system control these parameters? 空气净化系统如何控制这些参数?212.2.4 What can’t the HVAC System do? 空气净化系统不能做什么?212.3A IRFLOW FUNDAMENTALS气流基本原则222.3.1 Introduction简介222.3.2 Ventilation Fundamentals通风基本原则222.3.3 Contamination Control污染控制222.3.4 Airlocks气闸232.3.5 Classified Space 分类空间232.3.6 Total Airflow Volume and Ventilation Rate总风量与通风率252.3.7 Room Distribution and Quality of incoming air房间布局和进气质量272.3.8 Airflow Direction and Pressurization气流方向与增压272.4P SYCHROMETRICS 湿度测定法282.4.1 Introduction简介282.4.2 Basic Properties of Air空气的基本性质292.4.3 Psychrometric Properties of Air空气的湿度性质292.5E QUIPMENT 设备302.5.1 Introduction 简介302.5.2 Air Handing Unit (Ahu) 空气处理单元312.5.3 Fan风机312.5.4 Fume Exhaust/ Extraction System烟尘排除系统312.5.5 Heating Coil加热旋管312.5.6 Cooling Coil 冷却盘管312.5.7 Humidifier 增湿器312.5.8 Dehumidifier 除湿器312.5.9 Air Filtration 空气过滤器312.5.10 Ductwork 管道系统322.5.11 Damper And Louver 风门和天窗322.5.12 Diffuser and Register 扩散器和调风器322.5.13 Ultraviolet (UV) Light 紫外灯322.6HVAC SYSTEM CONFIGURATION HVAC系统配置332.6.1 Introduction 简介332.6.2 Basic System Types 基本系统类型342.6.3 Air Handling Unit Configurations空气处理单元的构造372.6.4 AIRLOCK STRATEGIES 气闸方案412.6.5 Ventilation/supply strategies 通风/供风方案462.6.6 EXTRACT (EXHAUST AND / OR RETURN) STRATEGIES 抽气(排气和回风)方案48 2.6.7 DISTRIBUTION 分布482.7HVAC CONTROLS AND MONITORING HVAC控制与监测482.7.1 Introduction 简介482.7.2 Controls 控制492.7.3 Actuation methods 驱动法502.7.4 Instrumentation 测量仪表522.7.5 Environmental Monitoring 环境检测572.7.6 Equipment monitoring 设备监测602.8SYSTEM ECONOMICS系统经济612.8.1 Introduction 简介612.8.2 Life Cycle Cost Analysis 生命周期成本分析632.8.3 User Requirements Specification 用户要求说明662.8.4 Life Time Operating Costs 寿命运行成本682.8.5 Comparing Options 对比选择682.9SUSTAINABILITY(TO BE WRITTEN LATER)可持续性(以后再写)错误!未定义书签。

干货分享:实施新版GMP技术性问题答疑(六)

干货分享:实施新版GMP技术性问题答疑(六)

⼲货分享:实施新版GMP技术性问题答疑(六)本⽂转载⾃GMP之家,内容仅供参考。

药品部分(六)131. ⽆菌分装(头孢类)的原料通过B级区采取何种灭菌消毒⽅式?⽤擦拭臭氧消毒是否可以?(FL1)答:GMP并没有规定采⽤何种⽅法,⽬前主要是采⽤擦拭法。

臭氧法消毒时间⽐较长,且影响因素较多,并不理想。

国外采⽤汽化过氧化氢是⼀种发展趋势。

不管采⽤什么⽅法,都应通过适当的验证,证明经处理后的表⾯,达到了⽆菌药品⽣产可接受的限度。

132. ⽆菌分装(头孢类)的原料在折分投料后不为整桶投料(如5kg/桶原料按⼯艺处⽅折分后应投料8.56kg)剩余原料退库还是在下发批⽣产指令时按整桶原料投料进⾏分装?(FL1)答:按批的定义去处理,原则是被分装应是同⼀批的“⽆菌原料药”;不应将不同批的原料药,在同⼀批分装中合并成分装的⼀个批号。

133. 过滤系统终端过滤芯的完整性测试试验⼀定需要在线监测吗?⽽压缩空⽓系统、制氮系统的滤芯如何测试和清洁?(FL1)答:GMP并没对此规定,有条件时建议在线监测,但这不是强制要求。

与液体除菌过滤器不同,压缩空⽓系统、制氮系统除菌过滤器的滤芯可按供货商提供的⽅法进⾏测试,定期检查;其前道的其它⽤处的过滤器,均应按⼯艺要求及供货商要求处理。

详见美国注射剂协会技术报告No 40.134. 空⽓净化系统的加湿蒸汽必须使⽤纯蒸汽吗?经清洗灭菌后的胶塞⽤⽆菌袋进⾏转运,其⽆菌袋如何证明其⽆菌性?(FL1)答:为防⽌⼯业蒸汽中胺、肼、醛类对产品的不利影响,国外通常采⽤纯蒸汽加湿。

如能证明⼯业蒸汽对产品⽆不良影响,也可使⽤⼯业蒸汽。

胶塞如⽤呼吸袋密封后灭菌,其灭菌过程需验证,呼吸袋和胶塞是⼀起灭菌的。

⾄于转移过程是否可能出现污染,取决于操作⽅式,⽓流⽅向等因素。

WHO 6.5中提到:如果被灭菌品不是装在密封容器中,则应使⽤合适的材料将其适当包扎,所⽤材料及包扎⽅式应有利于去除空⽓和蒸汽穿透并能防⽌灭菌后被污染…,也可使⽤特别设计的,既可进蒸汽,⼜可排除空⽓的可湿热灭菌不锈钢容器。

exchange的汉语是什么意思

exchange的汉语是什么意思

exchange的汉语是什么意思exchange的汉语是什么意思英文exchange是一个重点单词,我们必须要掌握它的几种汉语意思。

店铺为大家精心准备了英语单词exchange表达的汉语意思,欢迎大家前来阅读。

exchange的汉语意思英 [kstend] 美 [kstend]第三人称单数:exchanges第三人称复数:exchanges现在分词:exchanging过去分词:exchanged过去式:exchanged名词交换; 交易所; 交易; 兑换(率)及物动词兑换; 交换,互换; 交换,调换不及物动词交换,替换; 进行易货贸易,作物物交换; [金融业](货币)交换,兑换相关例句及物动词1. I'd like to exchange some pounds for dollars.我想把一些英镑兑换成美金。

2. She didn't really like the hat, but it couldn't be exchanged.她并不十分喜欢那顶帽子,但却无法退换。

3. John exchanged gifts with Mary.约翰与玛丽交换礼物。

exchange的单语例句1. The goal of the park is to form a sports leisure and entertainment center, as well as a sports business exchange center.2. Many of these students have already become the backbone force to carry on the cultural exchange and the business intercourse with China.3. Soaring gold prices and better business managementhelped boost its profits, the company said in a statement filed with the Shanghai Stock Exchange.4. The Prime Minister expressed the hope that both countries would exchange parliamentary, business and cultural delegations to further strengthen the relations.5. Banks welcomed the move which represented fresh business opportunities and the chance to utilize soaring foreign exchange savings deposits more efficiently.6. With regard to business scope, the Regulations stipulate the scope for business of foreign exchange and RMB.7. The two sides will also launch a newsletter to facilitate information exchange and business partnership between Guangzhou and Hong Kong software sectors.8. This exchange also makes business rules for steel transaction, manages the steel market information and regulates the steel trading activities.exchange的词典解释1. 交换;互换If two or more people exchange things of a particular kind, they give them to each other at the same time.e.g. We exchanged addresses and Christmas cards...我们交换了地址和圣诞贺卡。

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1 INTRODUCTION 简介 (7)1.1B ACKGROUND 背景 (7)1.2S COPE OF T HIS G UIDE 指南范围 (7)1.3O BJECTIVES OF T HIS G UIDE 指南目的 (9)1.4D EFINITIONS 定义 (9)1.5R EFERENCES 参考文献 (10)2. FUNDAMENTALS OF HVAC 空气净化系统的基本原则 (13)2.1I NTRODUC TION 简介 (13)2.2W HA T IS HV AC? (14)2.2.1 People comfort 人员的舒适 (14)2.2.2 Product and Process Considerations产品与工艺注意事项 (16)2.2.3 How does the HVAC system control these parameters? 空气净化系统如何控制这些参数? (18)2.2.4 What can’t the HVAC System do? 空气净化系统不能做什么? (18)2.3A IRFLOW FUNDAMENTALS气流基本原则 (19)2.3.1 Introduction简介 (19)2.3.2 Ventilation Fundamentals通风基本原则 (19)2.3.3 Contamination Control污染控制 (20)2.3.4 Airlocks气闸 (21)2.3.5 Classified Space 分类空间 (21)2.3.6 Total Airflow V olume and Ventilation Rate总风量与通风率 (23)2.3.7 Room Distribution and Quality of incoming air房间布局和进气质量 (26)2.3.8 Airflow Direction and Pressurization气流方向与增压 (26)2.4P SYCHROMETR ICS 湿度测定法 (27)2.4.1 Introduction简介 (27)2.4.2 Basic Properties of Air空气的基本性质 (28)2.4.3 Psychrometric Properties of Air空气的湿度性质 (29)2.5E QUIPMENT 设备 (30)2.5.1 Introduction 简介 (30)2.5.2 Air Handing Unit (Ahu) 空气处理单元 (30)2.5.3 Fan风机 (30)2.5.4 Fume Exhaust/ Extraction System烟尘排除系统 (31)2.5.5 Heating Coil加热旋管 (31)2.5.6 Cooling Coil 冷却盘管 (31)2.5.7 Humidifier 增湿器 (31)2.5.8 Dehumidifier 除湿器 (31)2.5.9 Air Filtration 空气过滤器 (31)2.5.10 Ductwork 管道系统 (31)2.5.11 Damper And Louver 风门和天窗 (32)2.5.12 Diffuser and Register 扩散器和调风器 (32)2.5.13 Ultraviolet (UV) Light 紫外灯 (32)2.6HV AC SYSTEM CONFIGURA TION HV A C系统配置 (33)2.6.1 Introduction 简介 (33)2.6.2 Basic System Types 基本系统类型 (34)2.6.3 Air Handling Unit Configurations空气处理单元的构造 (38)2.6.4 AIRLOCK STRATEGIES 气闸方案 (44)2.6.5 Ventilation/supply strategies 通风/供风方案 (51)2.6.6 EXTRACT (EXHAUST AND / OR RETURN) STRATEGIES 抽气(排气和回风)方案 (54)2.6.7 DISTRIBUTION 分布 (55)2.7HVA C CONTROLS AND MONITORING HVA C控制与监测 (55)2.7.1 Introduction 简介 (55)2.7.2 Controls 控制 (55)2.7.3 Actuation methods 驱动法 (57)2.7.4 Instrumentation 测量仪表 (59)2.7.5 Environmental Monitoring 环境检测 (66)2.7.6 Equipment monitoring 设备监测 (70)2.8SYSTEM ECONOMICS系统经济 (71)2.8.1 Introduction 简介 (71)2.8.2 Life Cycle Cost Analysis 生命周期成本分析 (74)2.8.3 User Requirements Specification 用户要求说明 (78)2.8.4 Life Time Operating Costs 寿命运行成本 (81)2.8.5 Comparing Options 对比选择 (81)2.9SUSTAINABILITY(TO BE WRITTEN LATER)可持续性(以后再写)............... 错误!未定义书签。

3 THE DE S IGN PROCE SS 设计过程 ........................................................................................错误!未定义书签。

3.1INTRODUCTION简介......................................................................................................... 错误!未定义书签。

3.1.1 System Design Process 系统设计工艺....................................................................... 错误!未定义书签。

3.1.2 Regulatory Considerations 监管事宜......................................................................... 错误!未定义书签。

3.2DEVELOPING THE USER REQUIREMENTS SPECIFICATION(URS)发展用户需求说明书错误!未定义书签。

3.2.1 Introduction 简介 ........................................................................................................... 错误!未定义书签。

3.2.2 References for User Requirements 用户需求参考................................................... 错误!未定义书签。

3.2.3 HVAC Parameters HVAC系统参数....................................................................... 错误!未定义书签。

3.2.4 Critical Parameters 关键参数..................................................................................... 错误!未定义书签。

3.2.5 Programming and Layout Considerations 规划和布局注意事项........................ 错误!未定义书签。

3.2.6 Architectural Considerations 建筑注意事项............................................................ 错误!未定义书签。

3.3HVA C SYSTEM RISK ASSESSMENT HVA C系统风险评估 .................................... 错误!未定义书签。

3.3.1 Introduction 简介 ........................................................................................................... 错误!未定义书签。

4 HVAC APPLICATIONS BY PROCESS AND CLASSIFICATION HVAC在工艺与不同洁净度分类中的运用...............................................................................................................................................错误!未定义书签。

4.1INTRODUCTION简介......................................................................................................... 错误!未定义书签。

4.2SYSTEM APPLICATIONS系统的运用........................................................................... 错误!未定义书签。

4.2.1 ISPE Grade 7 or ISPE Grade 8 W ith local protection or ISPE grade 5 含局部保护或ISPE 5级的ISPE 7级和ISPE 8级............................................................................................................. 错误!未定义书签。

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