JB 20025-2004 全自动硬胶囊充填机.pdf

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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-Az员鉴纷发布ICs11.120.30C92J日中华人民共和国制药机械行Ak标准JB20025-2004代替YY0254-1997全自动硬胶囊充填机Fullyautomatichardgelatincapsuletillingmachine2004-02-05发布2004-06-01实施习氧芡竺定万璐和Ji-!交二鞠玺圣霎员雀纷发布

2、扭ZXn5-21X14目次前言·········....................................................................................................·⋯141范围·········································································································⋯⋯152规范性引用文件·······························

3、········································，··················⋯⋯153术语和定义·，····························································································⋯⋯巧4分类和标记································································································⋯⋯巧5要求·····

4、·······，·，·····················································································⋯⋯166试验方法·······························································，····················。······，·····⋯⋯177检验规则·························。···。···，，··································

5、·····························⋯⋯188标志、使用说明书、包装和贮存······································································⋯⋯19扭21艾125-21艾协.山L.，J~月9舀本标准是根据(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YY0254-1997《全自动硬胶囊充填机》进行的修订。本标准自实施之日起代替YY0254-1997,本标准与YY0254-1997相比，主要技术内容变化如下

6、:a)引用文件按现行有效的标准进行修改。b)增加了“上机率”术语。动要求中增加了基本要求与《药品生产质量管理规范》有关的内容;电气系统安全要求增加了有关按钮、指示灯、显示器、警示标志等内容;机械运转要求增加了空运转的内容和电机、真空泵、减速器温升;修改了上机率指标。d)试验方法与要求内容一一对应。增加了对工作室区、材料及润滑剂的检查方法;电气系统安全增加了对按钮、指示灯、显示器、警示标志等检查方法;机械运转试验中修改了空运转、常用转速、最高转速的试验时间;上机率试验增加了试验用物料“药用淀粉”的要求;装药差异试验改按“《中华人民共和国药典》(2000版

7、)二部中附录IE”的规定;噪声测试改为按GB/T16769的规定。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;北京航天长峰股份有限公司弘华制药机械分公司。本标准主要起草人:刘尊珊、左莉华、孙雅芳。本标准所代替标准的历次版本发布情况为:、，0254-19970JB20025---2004全自动硬胶囊充填机范围本标准规定了全自动硬胶囊充填机(以下简称充填机)的术语和定义、分类和标记、要求、试验方法、检验规则和标志、使用说明书、包装和贮存。本标准适用于为不同规格的空心胶囊充填粉剂、微丸等药物的充填机。2规范性引

8、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