资源描述:
《J BT20007.3-2004-口服液瓶灌装联动线隧道式灭菌干燥机.pdf》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
1、免费标准下载网(www.freebz.net)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免费标准下载网(www.freebz.net)无需注册,即可下载免费标准下载网(www.freebz.net)ICS11.120.30C92JH中华人民共和国制药
2、机械行」Ik标准JB20007.3-2004代替YY0217.3-1995口服液瓶灌装联动线隧道式灭菌干燥机Productionlineforfillingoralliquid一Tunneltypesterilizingdryer2004-02-05发布2004-06-01实施匡剑舅之定左和百鹉交与鉴导员鉴纷发布免费标准下载网(www.freebz.net)无需注册,即可下载免费标准下载网(www.freebz.net)JB20007.3--2004目次前言·························。
3、。····。·,······································································⋯⋯241范围···。·············································································,·····················⋯⋯252规范性引用文件·······························,·························
4、·。。,····,,,·,··················。··⋯253分类和标记·············,·························,·,·。··············。·····,,,···,。······················⋯⋯254要求··············....................................................................................-····一265试验方法··
5、····,··1·······················································································⋯⋯276检验规则···········································,···,································。。,···。,····,··⋯⋯297标志、使用说明书、包装和贮存·······································
6、·········⋯⋯,,,.,......⋯⋯29免费标准下载网(www.freebz.net)无需注册,即可下载免费标准下载网(www.freebz.net)JB20007.3-2004.盆J‘.曰‘.目9青本标准是根据《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YY0217.3-1995《隧道式灭菌千燥机》进行的修订。本标准自实施之日起代替YY0217.3-19950本标准与YY0217.3-1995相比,主要技术内容变化如下:a)删除了YY021
7、7.3-1995的主要章、条:-3.2,3.3;4.1.2,4.3.2,4.5.7,4.6;—5.2,5.4,5.5;-6.2.2.2;-7.3;—附加说明。b)修订了YY0217.3-1995的主要章、条:—第1章;—第2章;-3.1;4.1,4.2,4.3,4.4,4.5;5.1,5.3,5.11,5.12,5.13;6.2.1.1,6.2.2Ab,6.2.23;—7.1.2,7.2,7.40c)本标准主要增加的章、条:—见4.2,4.4,4.5,4.7.4一4.7.8;—见5.1,5.3.1,5.3.2
8、,5.3.3,5.3.4;—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:北京航夭万达高技术开发中心。本标准主要起草人:袁景洲、辛毅、王兆利。免费标准下载网(www.freebz.net)无需注册,即可下载免费标准下载网(www.freebz.net)犯20007.3-2004口服液瓶灌装联动线隧道式灭菌干燥机范围本标准规定