JB20003.1-2004滴眼剂联动线.pdf

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1、ICS11.120.30C92J//J,中华人民共和国制药机械行」k标准JB20003.1-2004滴眼剂联动线Productionlineforeyedrops2004-02-05发布2004-06-01实施D416CW灵和rI!-,交鞠玺AZ员雀纷发布JB20003.1-2004目次前言···············································································································⋯⋯41范围······················

2、······················································································⋯⋯52规范性引用文件·····························································································⋯⋯53分类和标记····················································································..

3、·.··.·.......⋯⋯54要求············································································································⋯⋯65试验方法·····································································································⋯⋯76检验规则·········································

4、···························································⋯⋯7JB20003.1-2004前言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:北京航天万达高技术开发中心。本标准主要起草人:王金燕、冯瑞馨、袁景洲。.田20003.1-21义抖滴眼剂联动线范围本标准规定了滴眼剂联动线的分类和标记、要求、试验方法和检验规则。本标准适用于滴眼剂塑料瓶联动线(以下简称联动线)。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

5、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。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JB20003.2滴眼剂联动线清洗机JB20003.3滴

6、眼剂联动线隧道烘干机JB20003.4滴眼剂联动线灌装压塞旋盖机JB20003.5滴眼剂联动线贴标机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(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分类和标记3.1型式由清洗机、隧道烘干机、灌装压塞旋盖机、贴标机四机组成联动线并配有单机间衔接机构。3.2型号联动线的型号应符合、TIT0216-1995的规定。JB20003.1-2004DL!口八口主要参数(适用装量规格，ML)主要参数(生产能力，支/mm)产品型式及特征代号(L一联动线)产品功能代号(D-滴眼

7、剂机械)3.3标记示例DL适用装量规格为7mL生产能力为80支/mm滴眼剂联动线4要求4.1总则联动线各单机应符合下列相应标准规定:a)清洗机应符合JB20003.2的规定;b)隧道烘干机应符合JB20003.3的规定;c)灌装压塞旋盖机应符合JB20003.4的规定;d)贴标机应符合JB20003.5的规定。4.2外观要求联动线应符合各单机要求。4.3结构要求4.3.1联动线应符合各单机要求。4.3.2联动线的传送装置不得穿越不同级别的洁净区。4.4性能要求联动线在运行过程中，各单机连接应和谐匹配、稳定可靠和监控系统协调准确;对缺瓶、积瓶有自动调节控制装置。4.

8、4.1空载