蒲公英 - 制药技术的传播者 GMP理论的实践者

搜索
查看: 2145|回复: 3
收起左侧

[质量保证QA] (亚))高效过滤器的更换周期

[复制链接]
药士
发表于 2016-8-31 18:54:08 | 显示全部楼层 |阅读模式

欢迎您注册蒲公英

您需要 登录 才可以下载或查看,没有帐号?立即注册

x
14. At what frequency do manufacturers have to clean or change filters such as G4, F9 and H13 filters?
Manufacturers should establish the intervals for cleaning, replacement and testing of filters based on risk assessment. Risk assessment should take various factors into consideration such as suppliers’ recommendations, process steps, product range and properties, hours of use, history, maintenance schedule, pressure differentials over filters, outcomes on tests such as installed filter leakage testing and others.


23. What is the maximum allowable time before a H13 filter is replaced?
There is no prescribed timeframe for the replacement of HEPA filters. Manufacturers should define the intervals at which H-type filters are replaced. This may be based on supplier recommendations and other risks identified. Contributing factors may include the overall design of the AHU (with pre-filters), dust loads (as a result of the environment, product type, processing step, type of equipment used such as open or closed systems), pressure differential over the filter, results of installed filter leakage test, preventive maintenance and quality attribute checks. Filter media may also deteriorate over time. The interval defined by a manufacturer should be appropriate and there should be no risk of filter failure (where the filter failure can have a significant negative effect on for example, but not limited to areas, conditions, operations, materials or products) prior to replacement of the filter.


实际操作过程中,请问大家是怎样风险评估相应的高效过滤器的更换周期的呢????

回复

使用道具 举报

大师
发表于 2016-8-31 20:47:25 | 显示全部楼层
根据厂家建议以及公司历史使用情况来评估的
回复

使用道具 举报

药徒
发表于 2016-9-2 15:34:39 | 显示全部楼层
自己定期检漏,SOP规定
回复

使用道具 举报

发表于 2016-9-2 17:59:05 | 显示全部楼层
作为英语学习不错
回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

×发帖声明
1、本站为技术交流论坛,发帖的内容具有互动属性。您在本站发布的内容:
①在无人回复的情况下,可以通过自助删帖功能随时删除(自助删帖功能关闭期间,可以联系管理员微信:8542508 处理。)
②在有人回复和讨论的情况下,主题帖和回复内容已构成一个不可分割的整体,您将不能直接删除该帖。
2、禁止发布任何涉政、涉黄赌毒及其他违反国家相关法律、法规、及本站版规的内容,详情请参阅《蒲公英论坛总版规》。
3、您在本站发表、转载的任何作品仅代表您个人观点,不代表本站观点。不要盗用有版权要求的作品,转贴请注明来源,否则文责自负。
4、请认真阅读上述条款,您发帖即代表接受上述条款。

QQ|手机版|蒲公英|ouryao|蒲公英 ( 京ICP备14042168号-1 )  京ICP证150354号  互联网药品信息服务证书编号: (京)-非经营性-2024-0033

GMT+8, 2024-11-12 00:13

Powered by Discuz! X3.4运维单位:苏州豚鼠科技有限公司

Copyright © 2001-2020, Tencent Cloud.

声明:蒲公英网站所涉及的原创文章、文字内容、视频图片及首发资料,版权归作者及蒲公英网站所有,转载要在显著位置标明来源“蒲公英”;禁止任何形式的商业用途。违反上述声明的,本站及作者将追究法律责任。
快速回复 返回顶部 返回列表