VMP-HVAC-VER1系统描述文件.doc

Date 日期: 17 公用设施、HVAC系统和洁净室验证主计划 Page 页码: PAGE 1 of NUMPAGES 43 ： Document Ref: / 文件编号： 验证主计划 疫苗项目 公用设施、HVAC和洁净室  RESPONSABILITY SIGNATURES / 签署 Prepared By / 编写: Department / 部门: Date / 日期 Signature / 签署 Revised By / 修改: Department / 部门: Date / 日期 Signature / 签署 Approved by / 批准: Department / 部门: Date / 日期 Signature / 签署 MODIFICATIONS / 修改 Document Reference / 文件编号 Issue Date / 日期 Revision motive / 版本状况  INDEX OF CONTENTS TOC \o 1-3 1 INTRODUCTION前言 5 1.1 PURPOSE目的 5 1.2 SCOPE范围 7 1.3 GENERAL GUIDELINES通用指南 8 2 Organisation 组织 8 2.1 Organisation of the Owner 厂方组织 8 LIBP Validation Project Manager LIBP 方验证项目经理 8 LIBP main responsible/LIBP 方负责人 9 2.2 Organisation of CEFOC CEFOC方组织 9 VALIDATION Project Manager/验证项目经理 9 CEFOC main responsible/ CEFOC方主要责任人 9 Validation Team Responsibilities/验证小组责任： 9 2.3 Split of work工作细分 9 2.4 文件交接： 10 2.5 文件识别： 10 2.6 Sign responsibilities签名责任 10 3 SYSTEMS DESCRIPTION系统描述 12 3.1 HEATED VENTILATED AIR CONDITIONED (HVAC) SYSTEM AND CLEAN ROOM HVAC系统及洁净室 12 3.2 LAMINAR FLOWS (LF) FFU层流 16 3.3 Hot Water System热水系统 19 3.4 Process cooling water 冷却水处理 19 3.5 Air locks equipment (Wall Transfers –Pass Through or SAS) 20 3.6 Electrical services 20 4 VALIDATION APPROACH 21 Performance qualification 26 5 VALIDATION MATRIX 27 5.1 Documentation Matrix 28 6 QUALIFICATION SCHEDULE / 验证步骤和内容 29 6.1 DESIGN QUALIFICATION (DQ) / 设计确认 29 6.2 INSTALLATION QUALIFICATION (IQ) / 安装确认 29 6.3 OPERATION QUALIFICATION (OQ) / 运行确认 29 6.4 PERFORMANCE QUALIFICATION (PQ) 30 7 PLANNING AND SCHEDULING 31 8 OUTLINE OF VALIDATION METHOD 32 9 ACCEPTANCE CRITERIA 32 9.1 HVAC and FFU / HVAC系统和FFU 37 10 FINAL VALIDATION REPORT 40 11 Annex 1: Room List 附件1：房间表 41 12 Annex 2: Flow Chart 附件2：用户组织结构图 42  INTRODUCTION前言 PURPOSE目的 The Validation Master Plan of Utilities, HVAC and Heat Equipment ofxxx will provide the detailed programme for a documented audit trail to validate them. 关于xxx项目中的公用设施、暖通系统和加热设备