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
§211.72 Filters.Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use shall not release fibers into such products. Fiber-releasing filters may be used when it is not possible to manufacture such products without the use of these filters. If use of a fiber-releasing filter is necessary, an additional nonfiber-releasing filter having a maximum nominal pore size rating of 0.2 micron (现在表述）(0.45 micron if the manufacturing conditions so dictate) shall subsequently be used to reduce the content of particles in the injectable drug product. The use of an asbestos-containing filter is prohibited. [73 FR 51932, Sept. 8, 2008]
(Comment 18) Four comments recommended revising the following provision in proposed § 211.72: "If use of a fiber-releasing filter is necessary, an additional nonfiber-releasing filter of 0.22 micron maximum mean porosity (原先表述）(0.45 micron if the manufacturing conditions so dictate) shall subsequently be used to reduce the content of particles in the injectabledrug product." Each of these comments stated that it is technically more accurate to describe a filter in terms of its nominal pore size rating than its mean porosity. One comment stated that the filter pore size standard of 0.22 micron is outdated and should be changed to 0.2 micron. （每个的建议都阐明在技术层面使用nominal pore size rating 比mean porosity更加准确，并且一个建议称过滤孔径使用0.22micro已经过时了，应该使用0.2micro）
(Response) These suggested technical changes are consistent with statements in our guidances for industry (e.g., the Aseptic Processing Guidance) concerning filters. Therefore, we have revised § 211.72 to require that if use of a fiber-releasing filter is necessary, an additional nonfiber-releasing filter having a maximum nominal pore size rating of 0.2 micron be used.
| 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2017-8-4 16:09:17
置顶卡
变色卡
楼主