J B20003.3-2004-滴眼剂联动线隧道烘干机.pdf

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1、ICS11.12030C92J日中华人民共和国制药机械行立k标准JB20003.3-2004滴眼剂联动线隧道烘干机Productionlineforeyedrops一Dryingtunnel2004-02-05发布2004-06-01实施且习舅丈卫是万和U!交鞠玺一冬改-;2r发布JBZ沉幻3.3-21义域目次前言················································。····························。·························

2、··········一221范围·······································，·············。···················································⋯⋯232规范性引用文件·..............................................................................................233型号和标记·························

3、·······································································⋯⋯234要求·····································································································。···⋯⋯245试验方法····························································。········

4、····················，·········⋯⋯256检验规则···················································································。···············⋯⋯267标志、使用说明书、包装和贮存···············。························。·······························⋯⋯27.班2沉103.3-么X娜前言本标准由中国制药装备行业协

5、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:北京航天万达高技术开发中心。本标准主要起草人:辛毅、冯瑞馨、王金燕。祀2003.3-21沉抖滴眼剂联动线隧道烘干机范围本标准规定了滴眼剂隧道烘干机的标记、要求、试验方法、检验规则和标志、使用说明书、包装和贮存。本标准适用于滴眼剂塑料瓶隧道烘干机(以下简称烘干机)。2规范性引用文件下列文件中的条款通过在本标准中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

6、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。GB/T191包装储运图示标志GB5226.1-2002机械安全机械电气设备第1部分:通用技术条件GB/T6388运输包装收发货标志GB/T9969.1工业产品使用说明书总则GB/T10111利用随机数般子进行随机抽样的方法GB/T13306标牌GB/T13384机电产品包装通用技术条件GB/T16769金属切削机床噪声声压级测量方法JG/T19层流洁净工作台检验标准YY/T0216-1995制药机械产品型号编制方法药品生产质量管理规范(

7、1998修订版)国家药品监督管理局中华人民共和国药典(2000版)国家药典委员会3型号和标记3.1型号烘干机的型号应符合YY/T0216的规定。DL·H巨口/口丁几主要参“‘’*功率’kW)一碑一一主要参数(网带宽度Inm}产品型式及特征代号(L一联动;什一烘干)产品功能代号(D-滴眼剂机械)JB20003.3-20043.2标记示例DL·H420/15加热功率15kW网带宽度420滴眼剂联动线·烘干机4要求4.1总则烘干机的设计、制造、安装、使用、维修、保养和验证应符合《药品生产质量管理规范》(1998修订版)有关

8、原则性指令。4.2工作条件环境洁净度:烘干机应安放在10万级洁净区，冷却段指向洁净化厂房的万级控制区。4.3材质要求4.3.1烘干机的箱体应采用耐腐蚀、无毒、性能稳定的不锈钢材质制造。4.3.2输送网带应采用耐潮湿、耐高温、耐磨损的不锈钢编织带制造。4.4外观要求4.4.1烘干机外表面应平整、光滑，无凸起、凹陷、裂缝和死角。4.4.2零部件外露