2022年2022年洁净空调系统用户需求描述URS .pdf

BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 1 of 11 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_AHU11/12_URS_1.0 Revision 1.0 Name Signature Reason Function/Department Date Signature Li Xiao sheng Author Technology Manager Mark Hu Approver Project Manager Chen Huizhong Approver Construction Manager 名师资料总结-精品资料欢迎下载-名师精心整理-第 1 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 2 of 11 Table 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 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 .46.1.1Outdoor conditions室外气象条件.46.1.2Noise level 噪音等级 .46.1.3Room Performance requirements 房间性能要求.46.1.4Air 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.86.5Supporting 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 to above topics遗留条目.1015.Abbreviations 缩写.1016.Attachment 附件.11名师资料总结-精品资料欢迎下载-名师精心整理-第 2 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 3 of 11 Revision 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 Extension of RSM Facility of Beijing Austar PharmMed Consumable Packaging Ltd.,本 URS 涵盖了朗活医药耗材（北京）有限公司的年产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232。相对粉尘偏大。3.Process 工艺过程3.1 Product 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232。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 air volume will be reduced by maintaining the room pressure.名师资料总结-精品资料欢迎下载-名师精心整理-第 3 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 4 of 11 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 temperature 33 C Summer Highest Dry Bulb temperature 38.4 C Relative Humidity-High 80%Average Low Dry Bulb temperature-2.4 C Winter Lowest DB temperature-18.0 C Relative Humidity-Low 65%依据北京市怀柔区常年气象指数。6.1.2 Noise level 噪音等级Requirements GMP Relevance Max.site boundary noise level is 85 dBA Noise level due only to the HVAC plant Manufacturing areas 60 dB(A)NO 6.1.3 Room Performance requirements房间性能要求6.1.3.1 Cleanliness Zones 洁净等级要求名师资料总结-精品资料欢迎下载-名师精心整理-第 4 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 5 of 11 Room房间Cleanliness Zones 洁净等级要求GMP Relevance 挤出间 room1 10000级Yes 收卷间 room2 10000级Yes 分切间 room3 10000级Yes 6.1.3.2 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5-20Pa Yes Room1 to Room 2房间 1 对房间 2-50PaYes Room2 to Room 3房间 2 对房间 3 2Pa以内Yes Room3 to Outside房间 3 对室外5-20Pa Yes 6.1.3.3 Temperature and relative Humidity Concept温度和相对湿度的要求Room 房间Requirements要求GMP Relevance ROOM1 Temperature according the Policy:23C 3 C Relative Humidity according the Policy:55%10%YES ROOM2 Temperature according the Policy:22C 4 C Relative Humidity according the Policy:55%10%YES ROOM3 Temperature according the Policy:22C 4 C Relative Humidity according the Policy:55%10%YES 6.1.3.4 Filter concept过滤器要求Requirements GMP Relevance Generally filters shall be selected according to EN 779&EN 1822 norms.过滤器选择应符合EN779和 EN1822的要求YES 名师资料总结-精品资料欢迎下载-名师精心整理-第 5 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 6 of 11 Requirements GMP Relevance The 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,heating 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 Relevance Room1 60次/小时YES Room2 25次/小时YES Room3 25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 AHU GMP Relevance Room1 60 次/小时AHU11#(18000m3/h)，带变频YES Room1 排风66.7%热排风18000m3/h；带变频No Room2 30 次/小时AHU12#YES 名师资料总结-精品资料欢迎下载-名师精心整理-第 6 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 7 of 11 Room 房间Requirements要求对应 AHU GMP Relevance Room3 30 次/小时(28000m3/h)，带变频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ISO14644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 separate 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,pressure 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 Relevance Air flow distribution should ensure the room cleanliness and operator s 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。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。NO 名师资料总结-精品资料欢迎下载-名师精心整理-第 7 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 8 of 11 Requirements要求GMP Relevance Ductwork to be airtight and adequately insulated.风管必须完全密封和充分保温/保冷。NO 6.3 Specific HVAC design requirements特殊的洁净空调设计要求Specific requirements for the different 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：Requirements GMP 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。YES 6.4 Energy recovery能量回收All possible technical reasonable measures for energy recovery have to be implemented in the design according to the following 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 Relevance Energy 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。NO Air change rates are maintained 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。YES 名师资料总结-精品资料欢迎下载-名师精心整理-第 8 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 9 of 11 6.5 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：Requirements GMP Relevance Heating Hot Water(HHW):approx.60C/50 C 采暖热水Chilled Water(CHW):approx.7C/12 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NO 6.6 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.名师资料总结-精品资料欢迎下载-名师精心整理-第 9 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 10 of 11 全部的 cGMP的要求已经在本URS 的技术部分进行了描述。10.Documentation文件存档Refer to the Separate HVAC system Qualification Protocols for documentation.11.Exclusions/Limitations缺陷/不足本系统温湿度采用自动控制系统来保证并能集中显示；但压差系统和风机变频器靠手动调整，相关数据能够集中显示；本系统 PLC具备可远传数据的功能，但本次不予远传。12.Schedule时间计划Refer to project schedule in its current version.项目起始时间完成时间负责人提交 URS 并组织评审2010年 3 月 12日2010年 3 月 18 日李孝胜采购选择和合同签订2010年 3 月 12日2010年 3 月 28 日Amandazhang 设备采购2010年 3 月 28日2010年 5 月 10 日Amandazhang 系统建设2010年 4 月 10日2010年 6 月 10 日李孝胜13.Project Costs项目费用N.A.14.Alternatives&Open Items to above topics遗留条目N.A.15.Abbreviations缩写ACR Air Change Rates per hours 换气次数HVAC Heating,Ventilation,Air Conditioning 空调AHU Air Handling Unit 空调机组DDC Direct Digital Control 直接数字控制系统GMP Good Manufacturing Practice 名师资料总结-精品资料欢迎下载-名师精心整理-第 10 页，共 11 页 -BJMC Beijing Austar PharmMed Consumable Packaging BJMC_BWM_HVAC_AHU11/12/12_URS_1.0 User Requirement Specification(URS)for HVAC systems Page 11 of 11 HEPA High Efficiency Particulate Air 高效过滤器PLC Programmable Logic Controller URS User Requirement Specification用户需求描述PRD Pressure Diagram 压力图CLZN Cleaning Zone Diagram 洁净区域分布图16.Attachment 附件N.A.名师资料总结-精品资料欢迎下载-名师精心整理-第 11 页，共 11 页 -