产品名称
Optiscale®囊式过滤器Polygard® CN, Max Pressure: 80 psi @ 25 °C
Quality Level
material
PVDF vent cap, fluoroelastomer FKM seal, polycarbonate , polypropylene , polypropylene support
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
manufacturer/tradename
OptiScale®
parameter
25 °C max. inlet temp., 5.5 bar max. inlet pressure (80 psi) at 25 °C, 80 psig max. inlet pressure
diam.
6.9 cm (2.7 in.)
filtration area
17.7 cm2
inlet connection diam.
3/4 in.
outlet connection diam.
3/4 in.
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
matrix
Polygard®-CN
pore size
0.3 μm nominal pore size, 0.3 μm pore size
input
sample type liquid
fitting
inlet sanitary flange, 19 mm (3/4 in.) inlet/outlet sanitary flange, outlet sanitary flange
General description
设备配置:胶囊
Features and Benefits
形式:单层
Preparation Note
灭菌方法
3次高压灭菌循环,每次60 min,126°C;不可在线蒸汽灭菌
3次高压灭菌循环,每次60 min,126°C;不可在线蒸汽灭菌
Analysis Note
用水冲洗 ≥100 mL 后,将满足 USP 可氧化物质测试要求
Other Notes
使用说明:
- 生物截留:细菌
- 作用机制:过滤(体积排阻)
- 应用:蛋白纯化
- 预期用途:减少或去除微生物/生物负荷
- 使用说明:参见OptiScale® 47囊式过滤器(Polygard® CN介质)用户手册的安装和润湿部分
- 储存说明:原包装室温保存
- 处置声明:根据国家、省市和当地适用法规处置。
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
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
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全球贸易项目编号
| 货号 | GTIN |
|---|---|
| SN03A47FF3 | 04053252302961 |