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隔离器

 
二维码

隔离器单机正面2.jpg




设备概述:

  隔离器的种类分为防护型隔离器和无菌型隔离器,防护性隔离器是控制产品对于人体健康的危害,用于高活性API、核工业、细胞活性物质等OEB高密闭环境控制和除污;无菌型隔离是控制操作者反过来对于产品的危害,用于无菌药品生产过程中的取样、称量、微粉化、分装等。




防护隔离器:

  • 负压防护型隔离器的舱体内是高活性药物的生产操作,没有无菌要求,快速地把区域内的粉体、活性药物快速带离区域。

  • 负压设计;

  • 20次左右的换气次数;

  • 噪声、照度;

  • 对背景环境压差或对相邻舱室压差;

  • 舱门互锁或紧急时自锁;

  • 隔离器和物料接触部件的材质、手套材质;

  • 泄漏率(整机泄漏率和手套泄漏率);

  • 发生泄漏时裂隙风速;

  • 人机工程学;

  • 过滤器和手套的在线安全更换;

  • 操作者对隔离器的干预方法及其控制报警;

  • 化学灭活:WIP系统设计(包含清洗方法);

  • OEL值检测;

  • 不考察风速、气流流型、温湿度、粒子和微生物指标(浮游菌&沉降菌)、生物灭活等。



无菌型隔离器:

  • 风速、气流流型、温湿度、噪声、照度;

  • 对背景环境压差或对相邻舱室压差;

  • 粒子和微生物指标(浮游菌&沉降菌);

  • 隔离器和物料接触部件的材质、手套材质;

  • 泄漏率(整机泄漏率和手套泄漏率);

  • 发生泄漏时裂隙风速;

  • 人机工程学;

  • 过滤器和手套的在线安全更换;

  • 操作者对隔离器的干预方法及其控制报警;

  • 生物灭活:VHP程序开发及验证的相关工艺参数。


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