洁净空调系统用户需求描述URS(双语版)

1、User Requirement Specification (URS) for HVAC Systems洁净空调系统用户需求描述Project Name项目名称Extension of BWM Facility at BJMC北京制造中心BWM扩建(年产1800万平米)Project No.项目编号工程-BWM-2010-1-000Plant / Building工厂/建筑物BJMC-Huai Rou 北京制造中心-怀柔/ A区4#厂房内Unit单元HVAC洁净空调系统Equipment设备AHU11/12#洁净空调系统Document Code文件编号BJMC_MRS_HVAC_AHU11

2、/12_URS_1.0Revision1.0NameSignature ReasonFunction / DepartmentDateSignatureLi Xiao shengAuthorTechnology Manager Mark Hu ApproverProject ManagerChen HuizhongApproverConstruction ManagerTable of Content目录1.Objectives综述32.Demand Analysis要求分析33.Process 工艺过程33.1Product Characteristics产品特点34.Production

3、Strategy生产组织特征35.Location位置46.Technical Concepts技术要求46.1Design Basis设计基础4Outdoor conditions室外气象条件4Noise level 噪音等级4Room Performance requirements房间性能要求4Air Change Rates (ACR)换气次数66.2General HVAC design requirements洁净空调设计的一般性要求76.3Specific HVAC design requirements特殊的洁净空调设计要求86.4Energy recovery能量回收86.5

4、Supporting Utilities 动力供应96.6Controls 控制96.7Pressure & Zoning Diagram 压力和洁净区域平面图97.Authorities政府98.Health, Safety, Environment (HSE)健康，安全，环境99.cGMP Requirements cGMP的要求910.Documentation文件存档1011.Exclusions/Limitations缺陷/不足1012.Schedule时间计划1013.Project Costs项目费用1014.Alternatives & Open Items t

5、o above topics遗留条目1015.Abbreviations缩写1016.Attachment 附件11Revision History版本修订历史Reasons for changes compared to previous version版本修订的原因Revision No.版本号Date日期Name of Author作者姓名Description of Changes版本升级原因1. Objectives综述This URS covers the general requirements for the HVAC systems within the Project Ex

6、tension of RSM Facility of Beijing Austar PharmMed Consumable Packaging Ltd.,本URS涵盖了朗活医药耗材（北京）的年产1800万平米扩建工程的对洁净空调系统的一般性要求。2. Demand Analysis要求分析1、 整个生产区域均为万级；温度18-26，湿度45%-65%。2、 辅助区域利用原有BWM2的物流通道和供料间，设施按照使用量进行扩充；利用PCM2的人流通道和设施。3、 挤出间设备发热量非常大，需要特殊考虑降温措施以实现23±2。相对粉尘偏大。3. Process 工艺过程3.1Product

7、Characteristics产品特点1、 挤出间设备发热量非常大，需要特殊考虑降温措施以实现23±2。相对粉尘偏大。2、 吹膜过程对温度波动较为敏感，期望温度精度控制在±2以内，但温度变化曲线不大于1/h。3、 膜产品易产生静电，室内相对湿度应保持在45-65%之间。4、 该产品属于大输液包材，表面菌落、游离异物等应符合13号令要求。4. Production Strategy生产组织特征The HVAC systems will operate continuously (7 days / 24 hours). In non operation hours the ai

8、r volume will be reduced by maintaining the room pressure.本项目通常会连续运行；个别情况下会停机检修、待产。通常待产时间超过4小时允许停止空调运行；但在停机复产前必须提前2小时开启空调进行预净化。挤出间常规操作人员1人；收卷间常规操作人员4人。5. Location位置The location of the HVAC facilities is basically on the technical floor and installed on platforms or roofs.1、 该机组会安装到技术夹层中；2、 怀柔春秋风沙相对较

9、大；3、 现场有顶标高6米的网架梁，设计单位面积承载200kg；屋顶最低点高度8.5米。6. Technical Concepts技术要求6.1 Design Basis设计基础6.1.1 Outdoor conditions室外气象条件Average High Dry Bulb temperature33°CSummerHighest Dry Bulb temperature38.4 °CRelative Humidity - High80% Average Low Dry Bulb temperature- 2.4°CWinterLowest DB tempe

10、rature-18.0°CRelative Humidity - Low65% 依据北京市怀柔区常年气象指数。6.1.2 Noise level 噪音等级RequirementsGMP RelevanceMax. site boundary noise level is 85 dBANoise level due only to the HVAC plant· Manufacturing areas £ 60 dB(A)NO6.1.3 Room Performance requirements房间性能要求 Cleanliness Zones 洁净等级

11、要求Room房间Cleanliness Zones 洁净等级要求GMP Relevance挤出间room110000级Yes收卷间room210000级Yes分切间room310000级Yes Pressurization concept气流压力等级组织形式Room房间Pressure differential 压差GMP RelevanceRoom1 to Outside房间1对室外5-20PaYesRoom1 to Room 2房间1对房间2-50PaYesRoom2 to Room 3房间2对房间3±2Pa以内YesRoom3 to Outside房间3对室外5-

12、20PaYes Temperature and relative Humidity Concept温度和相对湿度的要求Room 房间Requirements要求GMP RelevanceROOM1Temperature according the Policy: 23°C±3°CRelative Humidity according the Policy: 55%±10%YESROOM2Temperature according the Policy: 22°C±4°CRelative Humidity acc

13、ording the Policy: 55%±10%YESROOM3Temperature according the Policy: 22°C±4°CRelative Humidity according the Policy: 55%±10%YES Filter concept过滤器要求RequirementsGMP RelevanceGenerally filters shall be selected according to EN 779 & EN 1822 norms. 过滤器选择应符合EN779和EN1822

14、的要求YESThe frames for the HEPA filter housings shall be testable for tightness by a test groove.高效过滤器安装后应对安装框架的密封性进行试验，以确保密封良好YES高效静压箱（或高效风口）要求有检测孔，以便检测滤效、压差等Yes通常空调机箱内选配G3、F7；末端高效选配H13（AAF、苏净等知名品牌）。6.1.4 Air Change Rates (ACR)换气次数The required ACRs will be determined based on required cooling load, h

15、eating load, relative humidity, pressurization, recovery times, particulate control etc. 要求的换气次数取决于冷负荷，热负荷，相对湿度，压力等级分布，自净时间，尘埃粒子控制等。Generally for corridors and other rooms where the product is closed the ACRs should be reduced to an acceptable minimum for reasons of energy saving. 一般情况下，走廊和产品是封闭状态的生

16、产车间，换气次数可以减少到可以接受的最小值，以节约能源。Minimum air changes per hours in normal production mode of each areas are the following:生产房间最小的换气次数如下：Room 房间Requirements要求GMP RelevanceRoom160次/小时YESRoom225次/小时YESRoom325次/小时YES人流、物流通道等同BWM2的，在此不做描述设计选择参数如下：Room 房间Requirements要求对应AHUGMP RelevanceRoom160次/小时AHU11#(18000m3

17、/h)，带变频YESRoom1排风66.7%热排风18000m3/h；带变频NoRoom230次/小时AHU12#(28000m3/h)，带变频YESRoom330次/小时YES人流、物流通道等同BWM2的，在此不做描述6.2 General HVAC design requirements洁净空调设计的一般性要求Generally the HVAC systems have to be designed to fulfill the requirements for the cleanliness zones according to ISO14644.洁净空调系统的设计必须完全满足ISO1

18、4644对洁净室的要求。以及GB50457-2008医药工业洁净厂房设计规范对洁净室的要求。如果两个标准不一致时，以国标为准。General requirement is to design the HVAC systems in the buildings for high flexibility with regard to maintenance and re-qualification activities in parallel to running production operations (e.g. differential function areas with separa

19、te air handling units, etc.).空调设计应该有很高的维护保养和回顾确认的灵活性，同时也应方便生产工艺的操作。（例如：不同的功能区域分别设计空气处理单元；挤出间因高热而单独设计空气处理单元。由于冬季Room2、Room3需要加热，应将Room1排出的热风通过F5过滤后作为AHU12#的一部分新风）Cross contamination between dust generating processes in different rooms must be avoided by design (closed cabins, terminal filters, pressu

20、re difference etc.)在不同房间的产尘工艺之间的交叉污染必须通过设计避免。（封闭小间，终端过滤器，压差等）Requirements要求GMP RelevanceAir flow distribution should ensure the room cleanliness and operators protection空气流的分布组织要保证房间的洁净等级和操作者的保护。YESAll technical areas accessing from cleanliness zone must separated by an airlock.从洁净区间进入的技术区域必须通过风闸间分离

21、。YESCooling coils sections of air handling unit must be drained completely to avoid stagnant water in the AHU. 冷盘管的冷凝水必须能及时地，完全地排出，避免在空调机组内部积水。NODuctwork to be airtight and adequately insulated. 风管必须完全密封和充分保温/保冷。NO6.3 Specific HVAC design requirements特殊的洁净空调设计要求Specific requirements for the differen

22、t building HVAC systems for the clean-rooms are following:个别洁净空调系统的特殊设计要求如下：RequirementsGMP Relevance由于冬季Room2、Room3需要加热，应将Room1排出的热风通过F5过滤后作为AHU12#的一部分新风。YES6.4 Energy recovery能量回收All possible technical reasonable measures for energy recovery have to be implemented in the design according to the fo

23、llowing principles:在设计过程中要尽可能地使用新的能量回收技术，以下是基本原则：Requirements要求GMP RelevanceEnergy recovering is to be installed where ever feasible. 可能的地方就安装能量回收装置。1、 由于冬季Room2、Room3需要加热，应将Room1排出的热风通过F5过滤后作为AHU12#的一部分新风2、 充分满足二次回风与一次回风比例的调整，以保证季节变化时的低能耗运行。3、 冬季冷却水可以直接进入空调冷热盘管实现降温功能。NOAir change rates are maintain

24、ed for room pressure requirements during non-production time.在非生产时间，换气次数仅能满足保持压差。YES6.5 Supporting Utilities 动力供应HVAC systems will utilize following utilities:洁净空调系统需要下列动力供应：RequirementsGMP RelevanceHeating Hot Water (HHW): approx. 60°C/50°C采暖热水Chilled Water (CHW): approx. 7°C /12

25、6;C冷冻水 Compressed Air (CA) oil free: min. 5bar for instruments无油仪用压缩空气Power supply: 380/3ph 220V/1ph (±10%)电加湿软化水或纯化水 常温NO6.6 Controls 控制简述控制的基本原理，包括温度，湿度，压差关键参数的控制。This will be described in FS in the future.6.7 Pressure & Zoning Diagram 压力和洁净区域平面图7. Authorities政府描述是否与当地政府的环保局，供电局等机构是否发生关系的

26、一些信息。该系统的排污、噪声、排气应符合环保局及相关政府机关的要求；必要时进行预处理确保符合法规要求8. Health, Safety, Environment (HSE)健康，安全，环境1、 设备采购应关注行业规范，减少、降低健康、安全、环境风险，满足相关行规；2、 设备安装使用应关注行业规范，减少、降低健康、安全、环境风险，满足相关行规；例如吊顶安装应通过EHS的评估审核。9. cGMP Requirements cGMP的要求All cGMP requirements are specified in the Technical Concept section of this URS.全部的cGMP的要求已经在本URS的技术部分进行了描述。10.