J B20005.2-2004-玻璃输液瓶灌装机.pdf

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1、JH中华人民共和国制药机械行」k标准JB20005.1-20005.4-2004玻璃输液瓶联动线2004-02-05发布2004-06-01实施虱舅之w万w和Xi-!交峭肖二委导员鉴纷发布ICS11.120.30C92JH中华人民共和国制药机械行立k标准JB20005.2-2004代替YY0235.2-1995玻璃输液瓶灌装机Glassinfusionbottlefillingmachine2004-02-05发布2004-06-01实施到戴丈M万K和xI!交自呈-1Z改发布.1B20005.2-2004目次前言···，。··············

2、···············································································。。·······。。·⋯201范围··········································⋯⋯‘·。···················································⋯⋯212规范性引用文件······················，················。。······························

3、················...⋯⋯213分类和标记·········。·。···，···············································································⋯⋯214要求···。。。····································································，···························，··⋯225试验方法··································

4、····························。，···，······················⋯⋯236检验规则······························。，。··································································⋯⋯257标志·使用说明书·包装和贮存···，···················。··································..............⋯⋯26附录A(资料性附录)型式检验试验记录表

5、····························································⋯⋯28祀2以力5.2-2004前言本标准是根据《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YY0235.2-1995《玻璃输液瓶灌装机》进行的修订。本标准自实施之日起代替YY0235.2-19950本标准与YY0235.2-1995相比，主要内容改变如下:a)删除了YY0235.2-1995中的3.1,3.3,4.2,4.11,4.12等条款。b)修订了、Y0235.2-19

6、95中的如下条款:—根据《药品生产质量管理规范》关于验证的四个步骤，对原标准中的技术要求条款做了重新编排。”要求”的内容按验证顺序分类提出;—试验方法与要求章节的内容一一对应，增强了试验方法的可操作性;—对原标准的检验规则条款和内容进行了修订;—强调了电气质量要求的重要性，按GB5226.1-2002进行了修订;—负荷运转的噪声降低到70dB(A)oc)本标准增加的主要条款:—外观质量要求(见4.3);—结构方面的要求(见4.4);—灌装工作条件(见4.5.1,4.5.2,4.5.3);—增加了控制功能;显示功能;保护功能(见4.6.4,4.6.5,

7、4.6.7);—试验方法中增加了与要求内容对应的条款;—检验规则中明确了工作条件的检验只在型式检验中进行;—增加了资料性附录A“型式检验试验记录表”。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:重庆江山制药机械有限公司。本标准主要起草人:孙金莲、周杰、王远平、黄云。本标准所代替标准的历次版本发布情况为:GB11753.2-1989,YY0235.2-19950JB20005.2-2004玻璃输液瓶灌装机范围本标准规定了玻璃输液瓶灌装机的分类和标记、要求、试验方法、检验规则和标志、使用说明书、包装、贮存。

8、本标准适用于玻璃输液瓶灌装机(以下简称灌装机)。规范性引用文件下列文件中的条款通过本标准中引用而成为本标准的