产品详情
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
多点隔爆热电偶 孝感市产品质量监督检验所 光纤路由器 薄膜拉力测试仪 OS-CON QB2000F单点壁挂式气体检测仪 超声波测厚 多用户电能表 超声波气体流量检测研究 指针式高压兆欧表 二氧化碳报警器 便携式多功能校验仪 面向气体传感的多波长窄带红外探测器研究 LUGB型涡街流量计 中国制冷学会小型制冷机低温生物医学专业委员会 XBD-LG多级消防泵 NSK 6317N轴承 TLHG-9001矿用开关插件保护性能智能试验台 微型光谱仪 低温恒温振荡器 VV DK941X真空蝶阀 温升三相大电流发生器 皮革收缩温度测试仪 DC-DC转换器 步入式高低温箱 逆流式冷却塔 岗松超纯水机 无源直读水表 力学仪器 测量显微镜 缓冲气缸 CPA系列电子天平 空气电磁式交流接触器 北京市自来水集团 齐纳安全栅 仪器型真空泵 法兰管件 自动杀菌净手器 固体延时继电器 步入式恒温恒湿实验室系统 OLYMPUS MX61 数字式电参数综合测量仪/交直流功率测量仪 重物冲击试验机 ZP1000旋转式压片机 电子称仪表 屈服强度试验机 IHG不锈钢管道离心泵 抗静电薄膜 WFS22挡板式流量开关