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1、JI}J'中华人民共和国制药机械行」k标准JB20007.1-20007.5-2004JB20008.1-20008.3-2004JB20009-2004口服液瓶灌装联动线抗生素玻璃瓶粉剂分装联动线直线式柱塞灌装机2004-02-05发布2004-06-01实施144氢渡%灵和IV!交肖肖二寻导员鉴纷发布ics11.120.30U92J日中华人民共和国制药机械行」业标准JB20007.4-2004代替YY0217.4-1995口服液瓶灌装联动线轧盖机Productionlineforfillingoralliquid一Cappingmachine2004-02-
2、05发布2004-06-01实施匹习舅丈2定万蔫和I欠消蔚冬员鉴纷发布JB20007.4-204目次前言·······················。····。。。·············································································⋯⋯341范围·········································································································⋯⋯352规范性引用文件
3、··························································································⋯⋯353分类和标记·······································································。···。,·,·。············⋯⋯354要求·····,···············。················。···,·········································
4、·····················⋯⋯365试验方法。··································································································⋯⋯376检验规则·······························································································。。··。⋯387标志、使用说明书、包装和贮存····················,·······
5、························.....⋯⋯,,39JB刽X幻7.4-21X娜oli吕本标准是根据《药品生产质量管理规范》和GB/T1.1-2000,GB/T1.2-2002标准化工作导则的要求,对YY0217.4-1995《口服液瓶灌装轧盖机》进行的修订。本标准自实施之日起代替YY0217.4-19950本标准与YY0217.4-1995相比,主要技术内容变化如下:a)删除了YY0217.4-1995的主要章、条:—3.2,3.3;-4.1.2,4.3.2,4.3.3,4.5.7,4.6;-5.2,5.7;-6.2.2.2;,~一刁.3;—附
6、加说明。b)修订了YY0217.4-1995的主要章、条:—第1章;—第2章;—3.1;-4.1,4.2,4.3,4.4,4.5;-5.1,5.3,5.4,5.5,5.6,5.9,5.13,5.14;一‘-6.2.1.1,6.2.2.16,6.2.2.3;—7.1.2,7.2,7.40c)本标准主要增加的章、条:—见4.1.6,4.1.7,4.5,4.7.4一4.7.8;—见5.1,5.3.1-5.3.6;—见6.2.2.3;—见7.20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
7、主要起草人:袁景洲、辛毅、王兆利。JB么X107.冷一么义抖口服液瓶灌装联动线轧盖机范围本标准规定了口服液瓶灌装轧盖机的分类和标记、要求、试验方法、检验规则和标志、使用说明书、包装、贮存。本标准适用于口服液瓶灌装轧盖机(以下简称灌轧机)。2规范性引用文件下列文件中的条款通过本标准中的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)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究是否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
8、安全机械电气设备第1部分