供应
供应
产品详情
在线式BFS类产品全自动检漏机Annex 1 of the EU GMP guidance requires a 99% CCIT of fusion sealed sterile pharmaceutical containers. This includes blow-fill-seal ampoules and bottles. Besides that, USP <1207> provides guidance for sterile drug product packaging for small and large volume parenterals including BFS and FFS containers. Our integrity testing solutions for BFS containers allow to fully meet those requirements.
Our automated CCI testers for blow-fill-seal containers use the latest generation of vacuum decay testing procedures allowing a highly sensitive and robust measurement for multiple product types.
One advantage is that the entire sample is tested at once while for instance, the HVLD methods allow only a partial measurement and therefore do not provide fully accountable test results.
Wide range BFS sizes and shapesThe test method can be applied for non-conductive contents as well as for different shapes and sizes of the packaging on the same system. Therefore, the versatile use of the equipment helps CMOs to run multiple presentations on one line therefore reducing investment costs for multiple systems.
Up to 60.000/h
Sensitivity of down to 5 microns
Testing of entire BFS container at once
Applicable for various shapes and sizes of BFS containers
Applicable for oily and non-conductive liquids in BFS containers
Applicable for BFS with low filling volume
Non-destructive test method
Deterministic test method preferred acc. USP1207
Test method according ASTM – F 2338
Design according GMP guidelines
Data Handling in compliance with 21 CFR part 11
Reliable product handling
Easy and tool-less format changeover
摘要:便携式顶空气体分析仪基础
[详细]
摘要:医药包材-激光打孔机4
[详细]
摘要:[目的]验证现有的色水法、
[详细]
摘要:CCIT测试腔体定制/样品支架
[详细]
摘要:实验室玻璃层析柱产品特性
[详细]
学生气象站 校园科普气象站 全自动天空成像仪 水质在线监测仪器 便携式能见度监测仪 校园科普自动气象站 自动校园气象站 便携式能见度检测仪 便携野外气象监测系统 五要素田间气象站 6要素自动气象站 智慧灯杆环境监测传感器 8要素气象站 火灾监测预警系统 污水在线监测设备 水质cod在线监测设备 地表位移监测系统 一体式六要素自动气象站 气象局六要素自动气象站 便携式直读流速仪 超声波风速风向仪传感器 风速测量仪器 病虫害测报系统 智慧农业农业四情监测系统 手持电波流速监测仪 并网式光伏环境监测仪 交通气象环境监测设备 水稻虫情测报灯 虫情测报灯 雨滴谱仪 水质悬浮物检测仪 中尺寸核磁共振成像分析仪 大口径核磁共振成像分析仪 一体式水深水温仪 低场核磁技术 全自动太阳光谱仪 手持气象参数测定仪 雷达生命探测仪 非金属管线探测仪 探地雷达探测仪 地质雷达探地仪 高速公路边坡监测系统 边坡稳定监测雷达 边坡监测雷达 地质雷达探测仪 水深水温测量仪 水流测速仪 电子气象仪 便携式明渠流量计 三维风速仪
