JB 20003.4-2004 滴眼剂联动线 灌装压塞旋盖机.pdf

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1、ICS11.120.30C92J.,中华人民共和国制药机械行」Ik标准JB20003.4-2004滴眼剂联动线灌装压塞旋盖机Productionlineforeyedrops一Filling&closingmachine2004-02-05发布2004-06-01实施虱'-;C之灵和1X!,交青玺一寻暑步改.蛋纷发布JB20003.4-2004目次前言···························································································

2、····················⋯⋯321范围·········································································································⋯⋯332规范性引用文件··························································································⋯⋯333型号和标记························

3、········································································⋯⋯334要求·································，·······································································⋯⋯345试验方法···········································································

4、·········..·········....⋯⋯356检验规则·······················································，···········································⋯⋯367标志、使用说明书、包装和贮存········································································⋯⋯37.B20003.4-2004nil舀本标准由中国制药装备行业协会提出。本标准由制药

5、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:冯瑞馨、王金燕、袁景洲。JB20003.4-21义抖滴眼剂联动线灌装压塞旋盖机范围本标准规定了滴眼剂灌装压塞旋盖机的型号和标记、要求、试验方法、检验规则及标志、使用说明书、包装和贮存。本标准适用于滴眼剂塑料瓶灌装压塞旋盖机(以下简称灌封机)。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

6、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(20C。

7、版)国家药典委员会3型号和标记3.1型号灌封机的型号应符合、'Y/T0216的规定。DL·G〔二/C规栩弋号:生产能力(支/m园/瓶装量((ML)型式及特征代号:联动线灌封机产品功能代号:滴眼剂机械JB20003.4-20043.2标记示例DL"G8017住瓶装量7mL生产能力80支/min滴眼剂联动线·灌封机4要求41总则灌封机的设计、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)有关原则性指令。4.2工作条件4.2.1环境温度:正常工作的环境空气温度在18℃一28`1Co4.2.2湿度:相对

8、湿度50%一60%a4.2.3环境洁净度:灌封室应为1万级的洁净区。4.3材质要求4.3.1直接接触液体、气体的零部件均应用低碳奥氏体不锈钢或无毒、耐腐蚀，不与相接触的药液发生化学反应，不产生吸附作用，不产生微粒的材料。所用材料应有材质证明书。4.