JB20003.2-2004滴眼剂联动线清洗机.pdf

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1、ics11.120.30C92J.中华人民共和国制药机械行」至标准JB20003.2-2004滴眼剂联动线清洗机Productionlineforeyedrops一Cleaningmachine2004-02-05发布2004-06-01实施到}&Ew委和r定二鞠鉴导员J鉴纷发布JB20003.2-2004目次前言····························································································。··················⋯⋯121范围········

2、·································································································⋯⋯132规范性引用文件··························································································⋯⋯133型号和标记···········································································

3、·····················⋯⋯134要求·········································································································⋯⋯145试验方法···································································································⋯⋯156检验规则··································

4、·································································⋯⋯167标志、使用说明书、包装和贮存··············。·························································⋯⋯17JB20003.2-2004前言本标准由中国制药装备行业协会提出。本标准由制药装备行业标准化技术委员会归口。本标准起草单位:北京航天万达高技术开发中心。本标准主要起草人:冯瑞馨、王金燕、袁景洲。JE21义幻3.2-21义)4滴眼剂联动线清洗机范围本

5、标准规定了滴眼剂清洗机的型号和标记、要求、试验方法、检验规则和标志、使用说明书、包装和贮存。本标准适用于滴眼剂塑料瓶清洗机(以下简称清洗机)。2规范性引用文件下列文件中的条款通过在本标准中引用而成为本标准的条款。凡是注日期的引用文件，其随后所有的修改单(不包括勘误的内容)或修订版均不适用本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件，其最新版本适用于本标准。GB/T191包装储运图示标志GB5226.1-2002机械安全机械电气设备第1部分:通用技术条件GB/T6388运输包装收发货标志GB/T9969.1工业

6、产品使用说明书总则GB/T10111利用随机数般子进行随机抽样的方法GB/T13306标牌GB/T13384机电产品包装通用技术条件GB/T16769金属切削机床噪声声压级测量方法YY/T0216-1995制药机械产品型号编制方法药品生产质量管理规范(1998修订版)国家药品监督管理局中华人民共和国药典(2000版)国家药典委员会3型号和标记型号清洗机的型号应符合YY/T0216-1995的规定。规格代号:生产能力(支厄血)/适用瓶子直径(})型式及特征代号:联动线清洗机产品功能代号:滴眼剂机械扭a沉103.2-20(抖3.2标记示例DL-080/22瓶子直径为

7、22nun生产能力为80支/nvn滴眼剂联动线·清洗机4要求4.1总则清洗机的设计、制造、安装、使用、维修、保养和验证应符合《药品生产质量管理规范》(1998修订版)有关原则性指令。4.2工作条件4.2.1环境温度:正常工作的环境空气温度为18℃一28'C.4.2.2湿度:相对湿度为50%一60%.4.2.3环境洁净度:清洗机应安装在10万级的洁净区。4.2.4水源:纯化水，压力为0.2MPa一0.3MPa;注射用水，压力为0.2MPa一0.3MPao4.2.5气源:无油、无水、无杂质，经过滤的压缩空气，压力为0.4MPa一0.6MPao4.3材质要求4.3.，

8、直接接触水、气的零部件应