文本教程成果stationgnt

1、出货站功能要求说明Docking sionGNT惠氏制药扩建项目WYETH DIAMOND PROJECT生产厂房PRODUCTION初步设计PRELIMINARY DESIGN自控专业Automation工 程 号Project No.2015-03-408共 7 页编制Edit校核Check审核Review图号Doc.No.C152408-P02-IC-GNT02-02PART 1 - GENERAL 第一部分-概述A.This specification covers the requirements for design, fabrication and delivery of XXX

2、 to includeaccessories, modifications or options mentioned herein or required to meet the project performancerequirements.此规范覆盖的要求包括设计、制造和交付的 XXX,包含配件,这里提到的修改,选择或需要满足项目性能要求。B.This document details performance requirements and various design criteria identified by the userand user representatives for

3、 weighing and dispensing operation in an OSD pharmaceutical envi-ronment under cGMP conditions. The system must be compliant to all applicable FDA, SFDA,EU, MHRA, TGA, WHO regulations, however, it is not the intent of this document to detail allmechanical, electrical and control requirements. The Ve

4、ndor shall supply all subordinate compo-nents necessary to meet the performance requirements established herein.Should the Vendorfind it necessary to deviate from the specific design and performance requirements detailed in thisdocument, the Vendor shall clearly state all deviations in the quotation

5、/proposal and give the rea-son(s) for each deviation.本文详细性能需求和各种由用户确定的设计标准，用户称重和配药操作是在 OSD 制药环境 CGMP的条件下执行。系统必须符合所有适用的美国食品药品管理局,SFDA,欧盟,MHRA,TGA,WTO 规定,然而,这不是本文的意图对所有机械、电气和控制细节的需求。卖方须提供所有从属组件必须满足性能需求。在本文档中供应商应该找到它需要偏离的具体设计和性能需求,卖方须写明报价中的所有偏差/建议和给出每个偏差的原因(S)。C.Proven Equipment Only proven equipment i

6、s acceptable.Proven equipment is defined asequipment that has been in continuous operation elsewhere on similar duties for a minimum ofthree years without major breakdowns.证明设备只有证明设备是可以接受的。设备证明已经在其他地方类似职责连续操作至少三年无重大故障。D.Permanent nameplates shall be permanently affixed on each piece of equipment. Th

7、e informationto be contained on the nameplates shall be identified by the owner.永久性的铭牌应永久地贴在每一块设备。铭牌上的信息包含由业主确定。E.Any exceptions to the URS shall be clearly highlighted in an exception section of the proposal.任何异常清晰一致的报告应突出异常部分的建议。PART 2 - HARDWARE AND INFRASTRUCTURE 第二部分-硬件和基础设施A.Use Pfizer BT stan

8、dard computer and build if feasible如果可行使用辉瑞 BT 标准的计算机和构建B.O/S shall be Windows 8, Windows Server 2008 or 2012O/S 应为Windows 8, Windows Server 2008 or 2012C.Shall have Ethernet interface at processors (PLC) workstations and servers在工艺设备工作站、服务器等应有以太网接口1.Use OPC DA or UA protocol for process and discret

9、e data使用OPC DA 或 UA 过程和离散数据的协议2.Use ODBC, OLE DB, JDBC or OPC AE or UA for alarm data使用ODBC、OLE DB JDBC 或OPC AE UA 报警数据3.Static IP address usage by each supplier shall be assigned by the site to avoid duplicationand invalid assignments.使用静态IP 地址由每个供应商应指定的网站,以避免重复和无效作业。D.May provide dual NIC cards fo

10、r SCADA nodes, one connected to the C-LAN and one totheM-LAN (put 2 cards).可以提供双网卡SCADA 节点，一点接C-LAN、一点接M-LAN。E.Between the automation layer 2 and the layer 3, there may be a firewall. The preferred brand isSiemens Scalance., RockwellStratix.自 动 化 之 间 的 第 二 层 和 第 三 层 , 应 设 置 有 防 火 墙 。 的 首 选 品 牌 是 西 门

11、 子Scalance,RockwellStratix。PART 3 -SECURITY FOR COMPUTER SYSTEMS APPLICATIONS 第三部分-安全-计算机系统应用A.The security for the application must be capable of using Microsoft Windows security model.应用程序的安全必须能够使用微软的Windows 操作系统安全模型。B.User accounts for each individual using the application shall be linked to thei

12、r domain account andkept synchronized with the same.用户帐户为每个单独的使用应用程序应与他们的域帐户和保持同步。C.Users must be capable of being assigned to security groups in the SCADA application.Usersmay have rights added in addition to those inherited from groups the user is a member of.用户必须能够被分配到安全组的SCADA 应用程序。用户可能有权利说除了这些继

13、承自组用户的一员。D.The system shall be capable of auto logoff at a configured timeout period. The timer shall be re-set when any input from the operator is detected.The logoff time must be configurable.系统应能自动下线配置超时时间。应当重置计时器,当任何检测到操作符的输入。下线时间必须是可配置的。E.Assess to the O/S and other non-essential applications s

14、hall be prevented by a secure desktop,group policies or similar functionality.O / S 和评估其他不必要的应用程序由一个安全桌面，防止政策或类似的功能。PART 4 - DATA 第四部分-数据A.Alarms 报警1.Shall have configurable priorities and/or levels (critical, safety, etc.)有可配置的优先级和/或水平(关键、安全等)。2.The system shall provide real time and historical dis

15、plays of alarms系统应提供实时和历史警报。3.Shall provide local archival capability and ability to send to external file server, databaseor historian应提供当地档案功能和能力发送到外部文件服务器,数据库或历史学家。4.Alarms and Events shall be logged with the full user name, date, time, tag, descriptionand action (acknowledged, return to normal,

16、etc.), as a minimum.警报和事件应当记录完整的用户名称,日期,时间,标签,描述和行动(承认,恢复正常等),作为最低。5.Alarm set points shall be configurable by product (via a recipe function) or equipment asapplicable报警设置点应可配置的产品(通过配方功能)或设备适用。B.Process Data 过程数据1.Shall be configurable as to what data points are collected. Default is all analog inp

17、uts andall discrete device statuses (valves, motors, etc.)应配置收集什么数据点。默认是所有模拟输入和分立器件状态(阀门、电机等)。2.The system shall provide real time and historical displays系统应提供实时和历史显示。3.Shall provide local archival capability and ability to send to external historian应提供发送到外部历史数据能力。4.Scaling All process variables, se

18、t points and limits shall be scaled at the PLC level, notat the SCADA. This will allow data to be sent directly from the PLC OPC server to ahistorian扩展所有过程变量,设置点和限制应当在公司层面上,不是在 SCADA。这将允许直接从PLC OPC 服务器发送数据到历史站。C.Run Time/Condition Based Maintenance 基于维护的运行时间和状态1.Machines / processes Shall expose the

19、 following information for use in Pfizers assetmanagement system:Running status of all motors and other significant equipment components that preventativemaintenance (PM) is typically performed on.Any sensor or instrumentation signals that can indicate the condition of significant compo-nents. This

20、can include vibration, temperature, pressure and levels.机器/流程应当呈现以下信息用于辉瑞的资产管理系统:马达的运行状态和其他重要设备预防性维护的组件(PM)通常上执行。任何传感器和仪表信号,可以显示重要组件的状态。这可以包括振动、温度、压力和水平。2.The supplier should provide a cost option for any signals not in the standard offering ifnecessary.供应商应该提供一个对任何信号的成本选择，不是标准提供,如果必要的话。D.When forwa

21、rding any data to an external source, the system shall provide local buffering capabil-ity of a minimum of 3 days转发任何数据外部源时,系统应提供当地的缓冲能力至少 3 天E.Local Recipe Management就地配方管理Recipes for the specific Unit Operation shall be maintained locally with the capability toback-up to a network server. The syst

22、em shall provide the ability to create, edit and delete recipeversions for different products, doses or other variations.配方的具体单元操作应保持在本地备份到网络服务器的能力。系统应提供能够创建、编辑和删除配方为不同的产品版本,剂量或其他变化。PART 5 - AUTOMATION PLATFORM 第五部分-自动化平台A.Select preferred platforms for historian, SCADA, HMI and PLC based onpreferre

23、d platforms are: Rockwell,Honeywell, OSI, GE .Siemens.为历史站选择最优平台，SCADA、HMI 和 PLC 的首选厂家有:罗克韦尔、霍尼韦尔、OSI通用电气、西门子。1.Site staff experience, support tools and spare parts stock.现场工作人员的经验,支持工具和备件库存。2.Overall support model and supplier support proximity to the site整体支持模型以及供应商最接近的支持地点。3.Suppliers with Pfizer

24、 agreements(we have Pfizer agreements with Honeywell, Rockwell,Emerson and Siemens)供应商与辉瑞协议(辉瑞与霍尼韦尔,罗克韦尔,爱默生和西门子的协议)B.Request equipment bids with an option for the preferred platforms and evaluate based on cost dif-ferential and TCO savings estimates.请求设备报价为首选平台选择和评估基于微分和TCO 储蓄成本估计。C.TCO factors include: TCO 因素1.External support is not available or prohibitively expensive or distant to respond effec-tively vs. the cost of customizing standard supplier offerings to facilitate internal