Qualification protocol of Compressed air system压缩空气系统验证方案.docxVIP

Qualification protocol of Compressed air system 压缩空气系统确认方案 Prepared by 起草： Date 日期： Reviewed by 审阅： Date 日期： Approved by 批准： Date 日期： Qualification protocol of Compressed air system 压缩空气系统验证方案 共 12 页 第 2 页 Table of contents 目 录 Instruction 引言 3 Summarize 概述 3 State of Equipment 设备的基本情况 3 2.0 Purpose 验证目的 4 Responsibility 验证职责 4 Validation team 验证小组 4 Equipment department 设备部 5 Quality department 质量部 5 4.0 Validation scope 验证范围 6 Validation content 验证内容 6 Installation Qualification(IQ)安装确认 6 Operation Qualification(OQ)运行确认 9 Performance Qualification 性能确认 10 Re-validation and re-validation period 拟定再验证及验证周期 11 Conclusion 验证方案结论 12 6.0 Approval of validation protocol 验证方案最终批准 12 Qualification protocol of Compressed air system 压缩空气系统验证方案 共 12 页 第 3 页 Content 正文 Instruction 引言： Summarize 概述：Compressed air met Criteria was provided for manufacturing process produced from air compressor in this Compressed air system and cleaning treated. 本压缩空气处理系统是通过空压机制取的压缩空气，经过净化处理后为生产工艺提供合格的洁净空气。 System process 系统流程： Air → Air compressor → Compressed air → Compressed air tank → pre-filter(Class C) →Refrigeration Air Dryer→Filter(Class T) →Filter(Class A) →Filter(Class H) →Cleaning air. 空气→空压机→压缩空气→贮气罐→前置过滤器（C 级）→冷冻式干燥机 →空气过滤器（T 级）→空气过滤器（A 级）→空气过滤器（H 级）→洁净空气。 State of Equipment 设备的基本情况： Item 项目 No 编号Name 名称Model 型号Series 系列号Manufacturer 生产厂家release date 出厂日期Contact 联系人Arrival date 到货日期Owner Department使用部门Position 放置地点Owner 管理员 Air compressor 空压机 Tank of compressed air 贮气罐 Refrigeration Air Dryer 冷冻式干燥机 Services name服务单位名称Services address 服务单位地址Tel联系电话Checked by 检查人：Reviewed by 复核人：Date 检查日期：Date 复核日期：Qualification Services name 服务单位名称Services address 服务单位地址 Tel联系电话 Checked by 检查人： Reviewed by 复核人： Date 检查日期： Date 复核日期： Purpose 验证目的： Checking the air compressed system and ensure the qualification of installation、operation、 performance to meet designed criteria 检查并确认该压缩空气处理系统安装、运行、性能等各项技术指标符合设计要求。 Ensure the archive of relatively data and file to meet the re