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1、J0中华人民共和国制药机械行业标准JB20024-20028-2004中药自动制丸机全自动硬胶囊充填机空心胶囊自动生产线滚模式软胶囊机胶囊药片印字机2004-02-05发布2004-06-01实施习氯灵Itt万毛不u欠肖鉴-IZ员鉴纷发布ICS11.120.30C92JH中华人民共和国制药机械行业标准JB20027-2004代替YY0224-1995滚模式软胶囊机Rotarydieencapsulator2004-02-05发布2004-06-01实施习舅丈W月延不qX-!交鞠鉴导员鉴纷发布JB20027-2
2、1X岭目次前言·····················································，·，，，，，·。，。...................·····················，··⋯341范围················，，，，，··。······，·········································································⋯⋯352规范性引用文件·····················
3、············································，·················⋯⋯，，，⋯353术语和定义······································，···，，，······，····。。·。。。·4·······，，，·，····。·····⋯⋯354分类和标记············，··，···········。···......................................................
4、.·⋯⋯365要求，··。·····。，·····‘··························································，···························⋯⋯376试验方法············································································，··，，。，···。···········，⋯387检验规则···············，···，·········
5、，·····，················，·············。····························⋯⋯398标志、包装、运输和贮存··············································································...⋯⋯39附录A(资料性附录)胶囊的形状和尺寸······，，，，，··················‘··············，··············二，，，，，41附录B(资
6、料性附录)软胶囊的装量系列及滚模的凹槽数···。·····，，··、，，，·············11‘····一42JB20027-2004前言本标准是根据《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YY0224-1995《滚模式软胶囊机》进行的修订。本标准自实施之日起代替YY0224-19950本标准与YY0224-1995相比，主要技术内容变化如下:。)删除了、'Y0224-1995的主要章、条:-3.2;—“技术要求”中的4.1,4.2,4.3
7、,4.4,4.5,4.6,4.7,4.8,4.12,4.13,4.15,4.19.2,4.19.4,4.19.5,4.20.3,4.21.3,4.23;—“试验方法”中与上述要求相对应的条款。b)修订了YY0224-1995的主要章、条:—第1章，第2章,3.1;—“技术要求”中的4.16,4.17,4.18;将对单机分别规定“技术要求”修订为对全套设备整体规定“要求”;“试验方法”中与“技术要求”相对应的条款。c)本标准增加的主要章、条:术语和定义(见第3章);材质与外观、安全要求(见5.1,5.3)0本标
8、准的附录A、附录B均为资料性附录。本标准由中国制药装备行业协会提出。本标准山制药装备行业标准化技术委员会归日。本标准主要起草单位:北京长征天民高科技有限公司。本标准主要起草人:丛喜胜、石海峰、张庆夫、范宗琪、刘玮。本标准所代替标准的历次版本发布情况为:GB10251--1988,YY0224-1995=JB20027-2004滚模式软胶囊机范围本标准规定了滚模式软胶囊机的术语和定义、分类和标记、要求
