水浴灭菌柜URS

水浴灭菌柜URS 编号:Q/J-URS-004 版次:第一版 安瓿水浴灭菌器用户需求 (URS) 起草人: 日期: 审核人: 日期: 审核人: 日期: 审核人: 日期: 审核人: 日期: 审核人: 日期: 批准人: 日期: 目 录 1. 目的................................................................................................................................... 3 2. 范围................................................................................................................................... 3 3. 缩写列表 ........................................................................................................................... 3 4. 设备 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 ........................................................................................................................... 3 5. 一般描述 ........................................................................................................................... 3 6. 物料规格 ........................................................................................................................... 4 7. 用户及系统要求 ................................................................................................................ 4 7.1. 概述............................................................................................................................ 4 7.2. URS要求确认 .............................................................................................................. 6 7.2.1. URS01:设备工艺或性能要求 ................................................................................ 6 7.2.2. URS02:安全要求 .................................................................................................. 6 7.2.3. URS03:安装区域及位置要求 ................................................................................ 7 7.2.4. URS04: 安装环境要求 ......................................................................................... 7 7.2.5. URS05:电力要求 .................................................................................................. 7 7.2.6. URS06:设施,公用系统要求 ................................................................................ 8 7.2.7. URS07:外观及材质要求 ....................................................................................... 8 7.2.8. URS08:技术要求 .................................................................................................. 9 7.2.9. URS09:控制系统要求 ......................................................................................... 12 7.2.10. URS10:仪表要求 ................................................................................................ 13 7.2.11. URS11:清洁要求 ................................................................................................ 13 7.2.12. URS12:润滑剂要求............................................................................................. 13 7.2.13. URS13:文件要求 ................................................................................................ 14 7.2.14. URS14:设备转运要求 ......................................................................................... 15 7.2.15. URS15:验证/确认要求 ........................................................................................ 15 7.2.16. URS16:服务与维修要求 ..................................................................................... 15 7.2.17. URS17:供应商对项目要求的确认....................................................................... 16 flattened, damage and cracks of steel pipe shall be removed, pole, vertical pole tube length the lap length is not less than 1000mm, and two rotary buckle fastened. 5, scaffolding pole connector length must be in the joint fastener, compromise with the adjacent Rod joints should be staggered not less than 500mm, and should not be in the same step, Center distance, the joint master distance should not be less than 500mm, the same inner and outer longitudinal bars on both sides of joints should be staggered, and is not within the same distance, the Joint Centera Chapter labour plans the project consists of two units, General construction principles: underground, ground after first structure, enclosure after first subject, after renovation; civil engineering, professional General construction sequence. In the construction process to adhere to the plan, control-oriented, System clear, well-organized construction, contractors responsible. General process flow: excavation ? Foundation slab of concrete waterproof cushion ? ? ? ? ? ground structures of the underground structures of construction decoration (including plumbing, threading, heat, rain, fire, ventilation, gas installation). Main team selection of construction the same engineering team and must be of higher quality, and ensure project quality can meet the objectives and targets. Public material comes into play as far as Taiyuan select qualified vendors, material provided by material, two or three types of professional-oriented material and, if necessary, invite owners participate in bidding work of the Commissioner. 1. 目的 该文件旨在从项目和系统的角度阐述用户的需求，主要包括相关法规符合度和用户的具体需求，这份文件是构建起项目和系统的文件体系的基础，同时也是系统设计和验证的可接受标准的依据。 2. 范围 本文件的范围涉及到了山东方明药业集团股份有限公司对此定制自动化设备的最低要求，我公司需要1台安瓿水浴灭菌器，用以对我公司生产的1-20ml安瓿产品进行灭菌。供应商应以URS将作为详细设计以及报价的基础。供应商在设计、制造、组装时必须要按照URS来执行。 本选型用户需求包含工艺，其他，验证，安装，健康和安全以及文件需求等六个方面。 3. 缩写列表 Term 术语 Definition 定义 BS Black Steam / 工业蒸汽 CA Compress Air / 压缩空气 CS Clean Steam / 洁净蒸汽 FAT Factory Acceptance Test / 工厂验收测试 HMI Human Machine Interface / 人机界面 IQ Installation Qualification / 安装确认 OQ Operational Qualification运行确认 SAT Site Acceptance Test现场验收测试 SIP Sterilization In Place / 在线灭菌 SOP Standard Operating Procedure / 标准操作规程 4. 设备标准 包括以下内容但不限于: SFDA:药品生产质量管理规范(2010年修订) GB 8599-2008大型蒸汽灭菌柜技术要求-自动控制型 第 3 页 共 16 页 GB 18278-2000 医疗保健产品灭菌确认和常规控制要求-工业湿热灭菌 PDA TR 1湿热灭菌的验证:灭菌程序的设计，开发，确认和日常监控 PDA TR48 湿热灭菌系统:设计，试车，运行，确认和维护 EN 285 蒸汽灭菌柜 ISO 17665 湿热灭菌工艺验证 HTM 2010 灭菌柜的设计及确认 5. 一般描述 安瓿水浴灭菌器是一种纯蒸汽压力灭菌设备，用纯蒸汽作为灭菌介质对被灭菌物品进行高温灭菌。该种类设备能达到GMP对于灭菌设备的要求。 6. 物料规格 , 压缩空气:0.4-0.8Mpa , 工业蒸汽:0.3-0.5Mpa 7. 用户及系统要求 7.1. 概述 安瓿水浴灭菌器将从以下17个方面对用户需求进行详细的描述 编号 项目 要求内容 根据市场预测、生产条件、人力资源预计设备涉及产品的批量、URS01 设备工艺或性能要求 每日班次等，确定设备的主要运行工况。 设备功能失调或者故障的情况下，必须配备所有必要的保护措施，URS02 安全要求 保证设备和产品仍然处于一个安全状态。必须提供设施保证人员， 产品和设备安全。 URS03 安装区域及位置要求 根据工艺要求和设备的特性确定设备的安装区域和位置要求。 URS04 安装环境要求 环境空气的洁净级别要求、摆放空间要求。 flattened, damage and cracks of steel pipe shall be removed, pole, vertical pole tube length the lap length is not less than 1000mm, and two rotary buckle fastened. 5, scaffolding pole connector length must be in the joint fastener, compromise with the adjacent Rod joints should be staggered not less than 500mm, and should not be in the same step, Center distance, the joint master distance should not be less than 500mm, the same inner and outer longitudinal bars on both sides of joints should be staggered, and is not within the same distance, the Joint Centera Chapter labour plans the project consists of two units, General construction principles: underground, ground after first structure, enclosure after first subject, after renovation; civil engineering, professional General construction sequence. In the construction process to adhere to the plan, control-oriented, System clear, well-organized construction, contractors responsible. General process flow: excavation ? Foundation slab of concrete waterproof cushion ? ? ? ? ? ground structures of the underground structures of construction decoration (including plumbing, threading, heat, rain, fire, ventilation, gas installation). Main team selection of construction the same engineering team and must be of higher quality, and ensure project quality can meet the objectives and targets. Public material comes into play as far as Taiyuan select qualified vendors, material provided by material, two or three types of professional-oriented material and, if necessary, invite owners participate in bidding work of the Commissioner. 编号 项目 要求内容 提出设备的电压、电流、功率、几相几线制、接线图以及线缆要URS05 电力要求 求。 URS06 设施/公用系统 供水、压缩空气、管道等要求。 表面涂层色彩要求，表面粗糙度要求，表面平面度、直线度，表URS07 外观及材质要求 面镀铬，表面氧化处理，表面喷朔等，及关键零部件的材质、选 型要求等。 对设备提供的功能提出具体的技术要求，如:产品质量要求、关URS08 技术要求 键工艺控制、安装要求、设备功能要求、控制与保护功能要求、 其他功能要求、安装要求等。 提出控制系统软硬件的要求、控制模式、数据 分析 定性数据统计分析pdf销售业绩分析模板建筑结构震害分析销售进度分析表京东商城竞争战略分析 、存储、备份、URS09 控制系统要求 恢复、打印、安全管理等。 提出设备所需仪表、传感器、变送器等的控制模式、类型、数量、URS10 仪表要求 准确度、精度和校验等要求。 URS11 清洁要求 物料接触处无死角。 URS12 润滑剂要求 食品级、无毒 对供应商需要提供的各类图纸、文件的列表，如使用和维护手册、URS13 文件要求 图纸、接线图、备件清单、材质证明等证书、校验方法、报警清 单、备份等。 URS14 设备转运 向供应商提出设备的安装职责、试车职责、 培训 焊锡培训资料ppt免费下载焊接培训教程 ppt 下载特设培训下载班长管理培训下载培训时间表下载 职责等。 根据设备的类型，提出设备的验证和确认需求，提交必需的各类URS15 验证/确认需求 验证和确认文件。 第 5 页 共 16 页 编号 项目 要求内容 要求供应商提供设备维护、校验的建议，保质期间和保质期外的URS16 服务与维护 设备现场维护的响应速度，提供备品、备件的响应速度。 供应商的基本资质要求、供应商对URS各项目要求能否满足予以URS17 供应商确认 确认。 7.2. URS要求确认 7.2.1. URS01:设备工艺或性能要求 编号 要求内容 URS01-1 灭菌室容积约为4.0m? URS01-2 保证每天工作15小时，设备连续运行稳定可靠。 7.2.2. URS02:安全要求 编号 要求内容 URS02-1 恰当的故障 检测 工程第三方检测合同工程防雷检测合同植筋拉拔检测方案传感器技术课后答案检测机构通用要求培训 和警报 URS02-2 设备应贴有统一的设备铭牌。 设备上易对操作人员造成伤害的运动部位应有安全罩，电气控制柜装有安全锁，符 URS02-3 合零进入标准。 URS02-4 距离设备1m远的噪音在80db以下 URS02-5 设备任何部位不能有锋利的边缘和尖角。 URS02-6 优化设计，易于接近的区域安装紧急停止按钮，以减少人机 工程 路基工程安全技术交底工程项目施工成本控制工程量增项单年度零星工程技术标正投影法基本原理 伤害。 URS02-7 断电时，机器逐渐停稳，以保护操作工、设备和产品。 flattened, damage and cracks of steel pipe shall be removed, pole, vertical pole tube length the lap length is not less than 1000mm, and two rotary buckle fastened. 5, scaffolding pole connector length must be in the joint fastener, compromise with the adjacent Rod joints should be staggered not less than 500mm, and should not be in the same step, Center distance, the joint master distance should not be less than 500mm, the same inner and outer longitudinal bars on both sides of joints should be staggered, and is not within the same distance, the Joint Centera Chapter labour plans the project consists of two units, General construction principles: underground, ground after first structure, enclosure after first subject, after renovation; civil engineering, professional General construction sequence. In the construction process to adhere to the plan, control-oriented, System clear, well-organized construction, contractors responsible. General process flow: excavation ? Foundation slab of concrete waterproof cushion ? ? ? ? ? ground structures of the underground structures of construction decoration (including plumbing, threading, heat, rain, fire, ventilation, gas installation). Main team selection of construction the same engineering team and must be of higher quality, and ensure project quality can meet the objectives and targets. Public material comes into play as far as Taiyuan select qualified vendors, material provided by material, two or three types of professional-oriented material and, if necessary, invite owners participate in bidding work of the Commissioner. 编号 要求内容 URS02-8 恢复供电后机器不能自动开机，必须人工启动。 URS02-9 电气系统的安全性能应符合相应的国家标准 URS02-10 安全性能符合相关安全标准 URS02-11 设备设计、制造、安装符合国家《压力容器安全技术监察规程》 URS02-12 工业蒸汽系统配有普通安全阀 7.2.3. URS03:安装区域及位置要求 编号 要求内容 安瓿水浴灭菌器安装在我公司108针剂车间的一般区，设备安装在灭菌前室和灭菌URS03-1 后室的墙壁之间，其中房间高度为3米左右，墙壁前后的空间为4-6米。 7.2.4. URS04: 安装环境要求 编号 要求内容 本设备安装在一般区的灭菌前室和灭菌后室的墙壁之间 URS04-01 URS04-02 设备周围应有足够的空间，便于对设备进行操作和维修。 7.2.5. URS05:电力要求 编号 要求内容 URS05-1 220/380V，3 相5线制，50 Hz URS05-2 所有线缆均有标号并有连接线路图 第 7 页 共 16 页 编号 要求内容 设备具有接地线和中性线 URS05-3 URS05-4 电气系统:电气元件应选用名牌厂商的产品，例如:Siemens， GEWU，Omron。 所有的线路应密闭在接线槽内。 URS05-5 所有电缆终端应卷曲包好线头做好相应标记。 URS05-6 所有控制配线必须采用低电压控制系统，电压?36伏特 URS05-7 预留输出通讯接口，方便连接远程监控系统 URS05-8 低压接线(24VDC和通讯/信号线路)应与控制盒中的控制电压和较高的电压隔URS05-9 离开 7.2.6. URS06:设施,公用系统要求 编号 要求内容 URS06-1 压缩空气:0.4-0.8MPa 干燥、无油 工业蒸汽:过热蒸汽，>150?, 0.3-0.5 MPa URS06-2 7.2.7. URS07:外观及材质要求 编号 要求内容 任何与工业蒸汽接触的部分和管路必须采用SUS/AISI 316L不锈钢且其表面光洁度URS07-1 应小于0.8μm，并提供相关材质证明。 框架部分采用优质角钢(表面涂有防腐蚀材料)或SUS/AISI 304不锈钢制造，有URS07-2 起重吊环，设备外罩采用SUS/AISI 304制造 URS07-3 所有排水(排气)管路使用SUS/AISI 304不锈钢，并提供相关材质证明 URS07-4 所有密封材质均为制药级聚四氟乙烯或EPDM flattened, damage and cracks of steel pipe shall be removed, pole, vertical pole tube length the lap length is not less than 1000mm, and two rotary buckle fastened. 5, scaffolding pole connector length must be in the joint fastener, compromise with the adjacent Rod joints should be staggered not less than 500mm, and should not be in the same step, Center distance, the joint master distance should not be less than 500mm, the same inner and outer longitudinal bars on both sides of joints should be staggered, and is not within the same distance, the Joint Centera Chapter labour plans the project consists of two units, General construction principles: underground, ground after first structure, enclosure after first subject, after renovation; civil engineering, professional General construction sequence. In the construction process to adhere to the plan, control-oriented, System clear, well-organized construction, contractors responsible. General process flow: excavation ? Foundation slab of concrete waterproof cushion ? ? ? ? ? ground structures of the underground structures of construction decoration (including plumbing, threading, heat, rain, fire, ventilation, gas installation). Main team selection of construction the same engineering team and must be of higher quality, and ensure project quality can meet the objectives and targets. Public material comes into play as far as Taiyuan select qualified vendors, material provided by material, two or three types of professional-oriented material and, if necessary, invite owners participate in bidding work of the Commissioner. 编号 要求内容 URS07-5 除非在特殊情况下不切实际，所有紧固件都应为不锈钢材质 焊接部分必须采用高纯氩气保护自动焊接，所有焊接均经抛光、酸洗，钝化处理，URS07-6 手工焊缝必须100,经内窥境或X光检查。 所有保温结构均采用5厘米以上优质保温材料(正常开机时外表面温度不超过URS07-7 40?) URS07-8 水平管道有2-3º的斜角，以利排空 所有连接处不得采用螺纹连接，须采用法兰或快开连接，所有与纯蒸汽接触部位的URS07-9 连接必须符合GMP要求 URS07-10 系统设计应避免死角产生，符合3D要求 URS07-11 管路连接采用卫生级快接卡箍连接方式 所有需现场接线的设备内部连接电缆长度在设计院设计出图后由需方确认，电缆必URS07-12 须有不锈钢穿管保护 URS07-13 灭菌腔室内表面光滑平整，没有不易清洁的卫生死角 压缩空气滤芯采用PALL、MILLIPORE产品能够进行蒸汽灭菌，采用无菌疏水型过滤URS07-14 器，过滤精度0.01μm 7.2.8. URS08:技术要求 7.2.8.1. URS08-1:产品质量要求 编号 要求内容 腔体能够承受115-134?纯蒸汽灭菌，在灭菌阶段腔体热均匀度:??1?，能URS08-1-1 够显示。 URS08-1-2 在特定的工艺条件下能满足灭菌达到细菌降低6个数量级，生物挑战实验通过 7.2.8.2. URS08-2:关键工艺控制 第 9 页 共 16 页 编号 要求内容 灭菌柜的功能至少应包括预热、灭菌、干燥、冷却、干燥，压力平衡、数据和图谱 实时打印(时间间隔不大于1分钟)等。每次灭菌周期的打印记录至少应包含:记URS08-2-1 录或控制温度传感器(灭菌柜腔体,腔体进水,腔体排水)数据，活动穿刺温度传感 器数据，腔室内压力，装载量，起始和终止时间，升温时间，保温段时间(灭菌时 间)，冷却时间，被灭菌物品信息等。 灭菌柜前门和后门分别设在不同区域，前门和后门必须有连锁装置，防止前门和后 门同时对开。在预热、灭菌、干燥、冷却、干燥，压力平衡、补气、冷却过程(整URS08-2-2 个灭菌循环过程)未完成或灭菌消毒过程未完成前，前、后门就无法打开(自锁); 如果前、后门未关闭，灭菌柜灭菌操作就无法进行(自锁)。通过自锁装置保证有 菌区域和无菌区域的完全隔离，无二次污染。 URS08-2-3 灭菌柜前门或后门打开时，在另一侧必须有报警指示或提示 灭菌腔体为密封耐正负压力的方形结构，属于压力容器，应符合GB150-98《钢制压URS08-2-4 力容器》、GB8599-88《自动控制压力蒸汽灭菌器技术条件》加工制造规范。 疏水管路必须合理设计，保证所有冷凝水都能够顺畅排出。必须安装管路疏水阀，URS08-2-5 疏水阀应符合YY0159-1994《压力蒸汽灭菌设备用疏水阀》要求。 前、后面采用压缩空气门圈密封，确保无泄露，应符合YY0158-1194《压力蒸汽灭URS08-2-6 菌设备用密封圈》要求 URS08-2-7 PLC程序控制，微机显示和操作 URS08-2-8 能灭菌不同规格的安瓿产品并能检漏 URS08-2-9 温度传感器必须能时刻准确反应灭菌腔体温度，必须能够进行校验 灭菌腔体至少能分三个工作层面，用不锈钢隔板隔开，隔板抽拉方便，没有不易于URS08-2-10 清洁的死角 URS08-2-11 必须在操作方便的部位留有验证预留口 整个灭菌腔体(包括柜门、工艺管路、仪表管路等)密封良好，保证正压、负压腔URS08-2-12 体无泄漏 7.2.8.3. URS08-3:安装要求 编号 要求内容 flattened, damage and cracks of steel pipe shall be removed, pole, vertical pole tube length the lap length is not less than 1000mm, and two rotary buckle fastened. 5, scaffolding pole connector length must be in the joint fastener, compromise with the adjacent Rod joints should be staggered not less than 500mm, and should not be in the same step, Center distance, the joint master distance should not be less than 500mm, the same inner and outer longitudinal bars on both sides of joints should be staggered, and is not within the same distance, the Joint Centera Chapter labour plans the project consists of two units, General construction principles: underground, ground after first structure, enclosure after first subject, after renovation; civil engineering, professional General construction sequence. In the construction process to adhere to the plan, control-oriented, System clear, well-organized construction, contractors responsible. General process flow: excavation ? Foundation slab of concrete waterproof cushion ? ? ? ? ? ground structures of the underground structures of construction decoration (including plumbing, threading, heat, rain, fire, ventilation, gas installation). Main team selection of construction the same engineering team and must be of higher quality, and ensure project quality can meet the objectives and targets. Public material comes into play as far as Taiyuan select qualified vendors, material provided by material, two or three types of professional-oriented material and, if necessary, invite owners participate in bidding work of the Commissioner. 编号 要求内容 在启动订单和安装设备之前，设备供应商应提供一份工作计划。以便于公司做好相URS08-3-1 关准备工作。 URS08-3-2 控制箱与设备之间的连接管线应埋入地下，设备上的连接管线应通过穿线管连接。 URS08-3-3 设备与压缩空气、进水等管路系统的连接接头使用快拆(装)接头 供应商应提供设备所需全部公共系统的参数和链接方式，如:电力，压缩空气，工URS08-3-4 业蒸汽压力、用量等。 7.2.8.4. URS08-4:设备功能要求 编号 要求内容 能够显示工艺流程和故障以及其他控制参数，操作屏至少显示:内室温度、内室压URS08-4-1 力、工作状态、水位、温度曲线、显示报警及警示等 URS08-4-2 工作中各项参数能自动打印，至少包括:日期、时间、内室各探头温度、内室压力 URS08-4-3 用户可以根据需要设置不同的灭菌程序，灭菌程序参数可记忆 能够适应各种被灭菌安瓿产品(程序)。 URS08-4-4 7.2.8.5. URS08-5:控制与保护功能要求 编号 要求内容 URS08-5-1 灭菌内室必须配有符合GMP要求的不锈钢安全阀 URS08-5-2 当外部公共系统发生故障或达到不了要求时，设备不能启动或自动停机 7.2.8.6. URS08-6:其他功能要求 编号 要求内容 第 11 页 共 16 页 编号 要求内容 URS08-6-1 设备的故障信息应显示在显示屏上。 URS08-6-2 设备设有急停装置。 URS08-6-3 设备具有状态提示灯或蜂鸣报警器。 7.2.9. URS09:控制系统要求 编号 要求内容 自动控制采用 PLC 控制，选用进口PLC(Siemens或相当于)、微机(品牌电脑)、交流URS09-1 接触器(法国Schneider或相当于)、变频器(日本MITSUBISHI或相当于)，供应商应提 供详细的电器部件生产厂家的清单附在投标书当中 自控系统预留至少10,的PLC输入/输出接点。 URS09-2 URS09-3 参数设定必须通过用户权限管理保护(密码)。如果不可行，则必须采取物理安全方式。 断电时，机器逐渐停稳，以保护操作工、设备和产品。恢复供电后设备不能自动开机，URS09-4 必须人工启动。 系统应具有诊断功能以识别和阐述故障。显示导致设备停机的故障，如:工业蒸汽压力、URS09-5 内层温度、阀门状态等 URS09-6 可配置系统的设计应能够防止断电情况下数据和/或配置参数的丢失。 URS09-7 能对生产过程中的其他异常情况进行监控(投标文件中请详细列出灭菌柜的各项功能) 柜门必须有自锁、互锁功能。当自锁、互锁功能失效时设备报警，不能开启或停机。 URS09-8 设备必须设计有全自动运行模式和手动运行模式，可以根据用户需要灵活切换程序。 URS09-9 控制界面必须可以选择自动程序和手动程序。可以根据不同的需要设定灭菌温度、灭菌URS09-10 时间等。 参数设定根据需要应该包括灭菌温度、灭菌时间、检漏压力、一洗时间、二洗时间等。 URS09-11 工业蒸汽压力、纯蒸汽压力等根据不同灭菌程序(工艺参数)自动调节控制。 URS09-12 flattened, damage and cracks of steel pipe shall be removed, pole, vertical pole tube length the lap length is not less than 1000mm, and two rotary buckle fastened. 5, scaffolding pole connector length must be in the joint fastener, compromise with the adjacent Rod joints should be staggered not less than 500mm, and should not be in the same step, Center distance, the joint master distance should not be less than 500mm, the same inner and outer longitudinal bars on both sides of joints should be staggered, and is not within the same distance, the Joint Centera Chapter labour plans the project consists of two units, General construction principles: underground, ground after first structure, enclosure after first subject, after renovation; civil engineering, professional General construction sequence. In the construction process to adhere to the plan, control-oriented, System clear, well-organized construction, contractors responsible. General process flow: excavation ? Foundation slab of concrete waterproof cushion ? ? ? ? ? ground structures of the underground structures of construction decoration (including plumbing, threading, heat, rain, fire, ventilation, gas installation). Main team selection of construction the same engineering team and must be of higher quality, and ensure project quality can meet the objectives and targets. Public material comes into play as far as Taiyuan select qualified vendors, material provided by material, two or three types of professional-oriented material and, if necessary, invite owners participate in bidding work of the Commissioner. 编号 要求内容 系统工艺参数:灭菌温度、灭菌时间、日期、时间、温度曲线等可记录和打印。 URS09-13 7.2.10. URS10:仪表要求 编号 要求内容 URS10-1 设备上的测量用仪器仪表及设备联接件使用公制单位。 URS10-2 仪器仪表应提供有资质的检验合格证。 URS10-3 管路系统选用德国GEMU或Burket不锈钢气动角座阀 管路中所有传感器及电接点压力表、疏水阀、截至阀、减压阀、电磁阀等均符合GMP规 URS10-4 范(GEMU或Burket)，选用卫生设计型 7.2.11. URS11:清洁要求 编号 要求内容 URS11-1 设备表面及内部便于清洁，不能有清洁死角。 URS11-2 要求清洗的部件，须具备快接功能 URS11-3 所有密封垫圈应该易于拆卸和装回 URS11-4 压缩空气滤芯必须能进行蒸汽灭菌 7.2.12. URS12:润滑剂要求 编号 要求内容 设备上使用的任何润滑油，应该是食品级别无毒的。使用的润滑油不能和产品或可能和 URS12-1 产品接触的设备表面接触。 第 13 页 共 16 页 7.2.13. URS13:文件要求 编号 要求内容 URS13-1 供应商提供符合GMP标准文件。 URS13-2 供应商提供的确认文件包括DQ、FAT、SAT、IQ和OQ文件。 供应商应提供软件文件拷贝，最终版本的全部PLC程序和控制面板软件的拷贝，并免费提URS13-3 供程序恢复标准操作程序。 设备供应商应提供三套操作手册(中英文)，包括以下内容: A. 技术数据 , 设备技术说明 , 设备详细尺寸 , 描述 , 材质证明文件 , 单体设备、部件、仪器仪表等相关文件 B. 安装和空间要求 , 基础和空间要求 , 安装时的运输 URS13-4 C. 使用说明书 , 操作 , 检查和问题解答 D. 维护说明书 , 维护 , 润滑 E. 图纸和零件表 , 机械部分 , 电气部分 , 仪器仪表 flattened, damage and cracks of steel pipe shall be removed, pole, vertical pole tube length the lap length is not less than 1000mm, and two rotary buckle fastened. 5, scaffolding pole connector length must be in the joint fastener, compromise with the adjacent Rod joints should be staggered not less than 500mm, and should not be in the same step, Center distance, the joint master distance should not be less than 500mm, the same inner and outer longitudinal bars on both sides of joints should be staggered, and is not within the same distance, the Joint Centera Chapter labour plans the project consists of two units, General construction principles: underground, ground after first structure, enclosure after first subject, after renovation; civil engineering, professional General construction sequence. In the construction process to adhere to the plan, control-oriented, System clear, well-organized construction, contractors responsible. General process flow: excavation ? Foundation slab of concrete waterproof cushion ? ? ? ? ? ground structures of the underground structures of construction decoration (including plumbing, threading, heat, rain, fire, ventilation, gas installation). Main team selection of construction the same engineering team and must be of higher quality, and ensure project quality can meet the objectives and targets. Public material comes into play as far as Taiyuan select qualified vendors, material provided by material, two or three types of professional-oriented material and, if necessary, invite owners participate in bidding work of the Commissioner. 编号 要求内容 F. 仪器仪表校准证明 G. 推荐的备件 7.2.14. URS14:设备转运要求 编号 要求内容 URS14-1 供应商应使用可靠的包装形式以保证设备转运安全。 7.2.15. URS15:验证/确认要求 编号 要求内容 URS15-1 在设备完全交付使用前，应完成下列验证:DQ、FAT、SAT、IQ、OQ、PQ(共同完成) 7.2.16. URS16:服务与维修要求 编号 要求内容 设备供应商负责所有技术指导和人员培训，包括:图纸、工艺、操作、设备维护、设备性URS16-1 能及问题解答。 URS16-2 设备供应商应提供不少于一年的设备保证期及终身维修服务; URS16-3 保证设备出现异常状态后48小时内厂家技术人员提供现场服务。 URS16-4 提供可满足一年设备运行需要的易损零部件及零部件及清单(包括报价) URS16-5 可长期提供便捷的设备零件服务 URS16-6 建立预防维修计划。 第 15 页 共 16 页 7.2.17. URS17:供应商对项目要求的确认 flattened, damage and cracks of steel pipe shall be removed, pole, vertical pole tube length the lap length is not less than 1000mm, and two rotary buckle fastened. 5, scaffolding pole connector length must be in the joint fastener, compromise with the adjacent Rod joints should be staggered not less than 500mm, and should not be in the same step, Center distance, the joint master distance should not be less than 500mm, the same inner and outer longitudinal bars on both sides of joints should be staggered, and is not within the same distance, the Joint Centera Chapter labour plans the project consists of two units, General construction principles: underground, ground after first structure, enclosure after first subject, after renovation; civil engineering, professional General construction sequence. In the construction process to adhere to the plan, control-oriented, System clear, well-organized construction, contractors responsible. General process flow: excavation ? Foundation slab of concrete waterproof cushion ? ? ? ? ? ground structures of the underground structures of construction decoration (including plumbing, threading, heat, rain, fire, ventilation, gas installation). Main team selection of construction the same engineering team and must be of higher quality, and ensure project quality can meet the objectives and targets. Public material comes into play as far as Taiyuan select qualified vendors, material provided by material, two or three types of professional-oriented material and, if necessary, invite owners participate in bidding work of the Commissioner.