J BT20008.1-2004-抗生素玻璃瓶粉剂分装联动线.pdf

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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机械行」尘标准JB20008.1-2004代

2、替YY0234.1-1995抗生素玻璃瓶粉剂分装联动线Antibioticsvialpowder川lingproduction2004-02-05发布2004-06-01实施习氧丈W和-TO交查薛寻导员雀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)JB20008.1---2004目次前言···································································································

3、···········⋯⋯541范围··········································。。。···。。。············。·····，·······，····，·········⋯⋯552规范性引用文件····································。，，·····················。·························⋯⋯553分类和标记··············································⋯⋯，’···········

4、··················，···········⋯⋯554要求·········································································································⋯⋯565试验方法·····················。。········································································⋯⋯576检验规则························

5、················································。。···············。。······⋯⋯57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)JB20008.1-2004月组吕本标准是根据《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YY0234.1--1995《抗生素玻璃瓶粉剂分装联动线》进行的修订。本标准自实施之日起代替YY0234.1-19950本标准与YY0234.1-1

6、995相比，主要技术内容变化如下:a)装量误差小于等于士5%改为符合《中华人民共和国药典》;b)盖胶塞失误率改为盖胶塞合格率;c)轧盖合格率改为大于等于99.5%;d)取消了输送轨道高度。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制药机械厂。本标准主要起草人:徐明堂、刘红梅。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)JB20008.1-2004抗生素玻璃瓶粉剂分装联动线范围本标准规定了抗生素玻璃瓶粉剂分装联动线的分类和

7、标记、要求、试验方法和检验规则。本标准适用于抗生素玻璃瓶粉剂分装联动线(以下简称粉剂线)。2规范性引用文件下列文件中的条款通过本标准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。GB2640模制抗生素玻璃瓶GB2641管制抗生素玻璃瓶GB5198.1抗生素玻璃瓶盖第1部分:铝盖GB5198.2抗生素玻璃瓶盖第2部分:铝塑组合盖GB5226.1-2002机械安全机械电气设备第

8、1部分:通用技术条件GB/T16769金属切削机床噪声声压级测量方法JB20007.2口服液瓶