产品名称
Optiscale® 40 Viresolve®除病毒预过滤器,
Quality Segment
material
cellulose fiber prefilter (inorganic filter aid), mixed cellulose esters (MCE) , polypropylene , polypropylene support
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
manufacturer/tradename
OptiScale®
parameter
0.03 bar max. differential pressure (0.5 psid) (Reverse), 100 mL process volume, 2.1 bar max. differential pressure (30 psid) (Forward)
technique(s)
protein purification: suitable
filtration area
5 cm2
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Viresolve® Prefilter
fitting
female Luer-Lok® inlet connection, male Luer outlet slip
General description
设备配置：胶囊
Application
去除细小病毒前过滤
Preparation Note
本产品采用符合美国联邦法规21 CFR 210.3(b)（6）中规定的“无纤维脱落”过滤器标准的Viresolve®膜制造。
灭菌方法
在 123 °C下进行 60 分钟的 3 个高压灭菌循环
在 123 °C下进行 60 分钟的 3 个高压灭菌循环
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.
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany
存储类别
11 - Combustible Solids
wgk
WGK 3