蒲公英 - 制药技术的传播者 GMP理论的实践者»蒲公英论坛 › 教育＆平台 › 医药产业园 › ISPE指南：关键公用系统GMP合规性翻译讨论

ISPE指南：关键公用系统GMP合规性翻译讨论

查看数: 41013 | 评论数: 74 | 收藏 26

关灯 | 提示：支持键盘翻页<-左右->

帖子模式

蒲公英

发布时间: 2020-11-27 22:09

正文摘要:

本帖最后由蒲公英于 2020-11-29 13:10 编辑 ISPE发布了最新关于《关键公用系统GMP合规性》指南，为了方便蒲友学习讨论，组建了微信群讨论，同时开此帖同步，欢迎大家积极参与，将本帖收藏置顶讨论须知： ...

蒲公英 发表于 2020-12-31 06:25:13

2.7Process Gases 工艺气体
2.7.1General 通则

High purity gases intended for product-impact applications (except clean compressed air) include nitrogen, oxygen, carbon dioxide, and other suitable gases, or combinations of these gases. Often, compressed or liquid gases (e.g., nitrogen, oxygen) are delivered by external manufacturers. Bulk high purity gas supply systems may be equipped with backup bottles for critical uses. Care should be taken when automating these backup systems so that the manufacturer is notified (for example, an alarm is triggered) when the backup bottles have been engaged/used. In such an event, the batch production record should indicate the use of the bottles. Bottles should receive a similar level of scrutiny as other raw materials.
影响产品的高纯度气体（清洁的压缩空气除外）包括氮气、氧气，二氧化碳和其它合适的气体，或这些气体的组合。通常，压缩或液态气体（例如氮气、氧气）是由外部生产商提供的。散装的高纯度气体供应系统可能配有用于关键用途的备用瓶。自动化这些备用系统时应格外小心，以便在使用备用瓶时通知生产商（例如，触发警报）。在这种情况下，批生产记录应表明瓶子的使用情况。瓶子应受到与其它原材料相似的审查。

Common applications for these gases are:

这些气体的常见应用是：

•Blow down for drying pipes and equipment 吹干管道和设备

•Tank sparging (including fermentation and cell culture) 罐鼓泡（包括发酵和细胞培养）

•Incubation 培养

•Tank blanketing and transfer overpressure 罐填充和超压转移

Many points mentioned in Section 2.6 for clean compressed air also apply to other gases wherever there is direct product contact (including containers and closures) or contact with a product-contact surface not cleaned in a subsequent operation, and in all classified manufacturing space into which the process compressed air is exhausted. The gene and cell therapy medicines industry along with biotechnology manufacturing utilize medical gases and process air for product contact.

在第2.6节中提到的许多有关洁净压缩空气的要点，也适用于其它气体：无论它们与产品直接接触（包括容器和密封件），还是与在后续操作中未清洁的产品接触表面接触，以及在所有需要排出工艺压缩空气的洁净生产区域中。涉及产品接触时，基因和细胞疗法药物行业以及生物技术生产使用医用气体和工艺空气。

yhw007 发表于 2025-8-11 10:25:36