JB20008.3-2004_抗生素玻璃瓶轧盖机.pdfVIP

ICS 11.120.30 C92 J日 中华人民共和国制药机械行」k标准 JB 20008.3-2004 代替YY 0234.3-1995 抗生素玻璃瓶轧盖机 Antibiotics vial capping machine 2004-02-05发布 2004-06-01实施 匡I翅丈竺 月醚不n4 tow-1Z员 鉴纷 发布 JB2口X拍.3一创14 目 次 前言···········································································································，·····一 72 1范围······································································。····。。。···。。。···。··，，·······，，，一73 2规范性引用文件·····················。。····························。··········。·。·········一，二，，.，，，，73 3分类和标记 。··。··。。。·······················································································……73 4要求 ·········································································································……74 5 试验方法 ······························································ 75 6检验规则 。·············。。。···。·。······，·，·································。·········。············。·········……76 7标志、包装和贮存······。········。·····，，，············································。·····。·······……76 正 2〕X18.3-2004 99 言 本标准是根据《药品生产质量管理规范》和GB/T 1.1-2000, GB/T 1.2-2002标准化工作导则，对 YY 0234.3-1995《抗生素玻璃瓶轧盖机》进行的修订。 本标准自实施之日起代替YY 0234.3-19950 本标准与YY 0234.3-1995相比，主要技术内容变化如下: a}删除了YY 0234.3-1995中的章、条: — 组成(3.3); — 基本参数表1(3.4.1); 「— 工作环境洁净度测定(5.1)0 b)修订了YY 0234.3-1995中的章、条: — 小瓶破损率(表2); — 轧盖合格率(4.14); — 负荷运转噪声(4.9)。 c)增加了使用说明书要求(见7.2)a 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:哈尔滨飞机工业集团药机厂。 本标准主要起草人:刘红梅、徐明堂。