产品名称
Viresolve® Pro Shield Micro除病毒预过滤器套件,
Quality Segment
material
molded polypropylene component(s), polyethersulfone membrane, white device (magenta band)
manufacturer/tradename
Viresolve®
parameter
3.5 bar max. inlet pressure (50 psig), 4.1 bar max. pressure (60 psid) at 25 °C (Samples were integral based on an Air/ Water Diffusion Test, before and after a forward stress.)
H × diam.
3.83 cm (1.51 in.) × 3.07 cm (1.21 in.)
H
3.83 cm (1.51 in.)
diam.
3.07 cm (1.21 in.)
filtration area
3.1 cm2
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
fitting
female Luer-Lok® inlet (inlet and vent), female Luer inlet fitting, male Luer outlet (Slip), male Luer outlet fitting
application(s)
(Process development studies, Viral clearance evaluations)
shipped in
ambient
General description
Viresolve Pro PD套件非常适合执行评估、优化和扩大化研究。每组套件包含一个膜层组合的9个Micro器件*、一份用户指南和质量证书。通风口可以防止设备内部产生气锁。
* Viresolve Pro滤器内置两层滤膜。每件Viresolve Pro Shield Micro除病毒预过滤器采用泡罩包装，并标记装置批次和顶层膜批次/卷数。
* Viresolve Pro滤器内置两层滤膜。每件Viresolve Pro Shield Micro除病毒预过滤器采用泡罩包装，并标记装置批次和顶层膜批次/卷数。
Features and Benefits
- 用于工艺开发、优化和验证研究的小规模装置
- 基于滤膜的吸附型预过滤器，去除蛋白聚集体等杂质
- 每套9个（同一滤膜批号）
Preparation Note
本品采用符合21 CFR 210.3(b)（6）中规定的“无纤维脱落”过滤器标准的材料制造。
Analysis Note
TOC/电导率
灭菌和50 L/m²受控水冲洗后，按USP <64>检测，样品TOC小于500 ppb，按USP <64>检测，电导率小于1.3 µS/cm。
灭菌和50 L/m²受控水冲洗后，按USP <64>检测，样品TOC小于500 ppb，按USP <64>检测，电导率小于1.3 µS/cm。
Other Notes
这些产品在符合FDA药品生产质量管理规范的工厂生产。
Legal Information
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany
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