AS-H1.5安瓿灭菌器SOP 1.01 ..doc

PHARMACHINE 安瓿灭菌器 AS-H1.5 AMPOULE AUTOCLAVE 1.5M3 标准操作规程 STANDARD OPERATING PROCEDURE (SOP) （供客户参考，详见使用说明书） This document is only reference for users，Refer to instruction manual for details 描述：Description 本文件由用户和 商贸有限公司双方共同确认。 This document is the approval of the protocol from both parties PHARMACHINE CHINA LTD. and user. 本文件仅适用于下面所述项目。 This documentation only applies to the project below described. 没有 商贸有限公司同意，本文件不得被复制或提供给第三方。 The documentation must not be reproduced or given to third parties without being written allowed by 。 责任: Responsible 台州惠美商贸有限公司负责编辑设备确认草案并向客户提交进行确认； 用户在执行前审核和批准本方案。 The documentation must not be reproduced or given to third parties without being written allowed by HM。 设备名称： Equipment: 设备型号： Equipment Type: 设备编号： Equipment No: 协议批准Protocol Approval: 标题Title 名字Name 签名Signature 日期Date Prepared by 工程师 Project Engineer 复核人 wed by 主管 Director 批准人Approved by 客户质量主管 Customer Director of Quality and Regulatory 审核人 Approved by 客户技术经理 Customer Technical Manager 文件协调员 Document Coordinator 客户确认 Customer Validation 协议完成（签名后，协议就完全完成了） Protocol Completion (To be signed only after protocol has been completed): 标题Title 名字Name 签名Signature 日期Date 执行人员 Executed By: 客户工程测试员 Customer testing engineers 审核 人员 Approved by 客户质量主管 Customer Director of Quality and Regulatory 审核 人员 Approved by 客户技术经理 Customer Technical Manager 文件协调员 Document Coordinator 客户确认 Customer Validation A 目录Table of Contents 1、目的PURPOSE………………………………………………………………5 2、适用范围RANGE…………… ………………………………………………责任者RESPONSIBLE……………………………………………………………………… ………………………………………………5 4.1设备描述 Equipment descripation……………………………………………………………………………………….5 4.3开机前准备：Prepartion before opening machine………………………………6 4.4开机操作程序：Open machine operation procedure……………………………6 4.5 关机程序 Close machine procedure………………………………………………6 5、注意事项与日常保养……………………………………………………………..7 一、目的：建立 AS-H1.5安瓿灭菌器标准操作规程，使操作达到规范化、标准化，