JB 20014-2004 药用沸腾制粒器.pdf

JH 中华 人 民共和 国制 药机 械 行 k4标准 JB20014--20018-2004 药用沸腾制粒器 湿法混合制粒机 高效包衣机 革莽式包衣机 摇摆式颗粒机 2004-02-05发布 2004-06-01实施 虱 Ilic另 月录手口己交肖艾寻导员 雀纷 发布 ICS 11.120.30 C92 JB 中华 人 民共 和 国制 药机 械 行 」kI标准 JB20014-2004 药用沸腾制粒器 Fluidbedgranulatorforpharmaceutics 2004-02-05发布 2004-06--01实施 .垂月氢鼠一竺定费和Ii!交鞠玺寻导员‘鉴纷 发布 .阳 20014-2004 目 次 前言 ···，·······························································································，········……4 1 范围 ·······································································································… … 5 2 规范性引用文件 ························，·····················································…·…，，.…。.‘…5 3分类和标记 ·························································。。····································。。…·…5 4要求 ··········································································································…·…6 5试验方法 ·····························。。，，7 6检验规则 ··········································。········。。，······，······································…·…8 7标志、使用说明书、包装、运输和贮存 ······。······················································，，……二‘9 8附录A(规范性附录)设备密封性能测试方法 ···········，·，········。······，·，···················…… 11 JB 20014- 2004 前 言 本标准是根据药《品生产质量管理规范》和(B:/T1.1-2000标《准化工作导则第1部分:标准的 结构和编写规则》,GB/T1.2-2002标《准化工作导则 第2部分:标准中规范性技术要素内容的确 定方法》的规定对 《药用沸腾制粒器》进行的修订。 本标准