i-Dosi无菌灌装机应用灵活,可用于多种产品的灌装:西林瓶的灌装(2-250ml),西林瓶粉末样品灌装,片剂灌装,口服液体灌装,预充针灌装,鼻腔喷雾剂灌装等。
i-Dosi无菌灌装机特点:
●灌装速度高达200VPM
●蠕动泵和柱塞泵可选
●无甁止灌功能
●惰性气体冲洗功能
●LF层流系统
●RABS或isolator可选方案
●100%称重功能
●CIP/SIP可选
●符合GMP、FDA和CE标准
如何高效的生产出好质量的诊断试剂,以满足的供应,SP i-Dositecno给您提供整体解决方案。
(1)中试研发及小批量生产:灌装+冻干
●灌装速度达50瓶/min
●冻干面积高达2平米
●层板温度低至-70℃
●大凝冰量可达50L,凝冰效率高达20L/24h
●具备完善的PAT过程分析工具,可准确控制终产品质量
●全自动工艺优化技术可选
●满足各种诊断试剂研发和生产的需求
●控制系统及数据记录系统,满足FDA 21CFR part 11的要求
●标准机型及洁净室机型可选
●整体结构紧凑,占地面积小
(2)中速生产:灌装+冻干
●灌装速度可达100瓶/min
●Dosi-EYE视频通信技术指导和故障排除
●性能稳定,故障少
●可根据需求定制
●冻干面积1~10平米
●货期低至8个月
●控制系统及数据记录系统,满足FDA 21CFR part 11的要求
(3)高速生产:灌装+冻干
●灌装速度高达200瓶/min
●Dosi-EYE视频通信技术指导和故障排除
●性能稳定,故障少
●可根据需求定制
●冻干面积5~40平米
●货期低至8个月
●控制系统及数据记录系统,满足FDA 21CFR part 11的要求
(4)QPCR诊断试剂全自动灌装-CyBio Felix
●灌装体积0.5ul-1ml,适用于24、96、384孔板及各类试管
●经认证的一次性PCR过滤移液头,拥有12个工作板位,可实现快速批量灌装
●条形码读取
●高效空气过滤器和紫外进行系统灭菌
https://www.chem17.com/st102545/list_1536607.html
https://www.chem17.com/st102545/product_35113505.html
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