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质量水平
管理合规性
meets FDA 21 CFR 177-182 (all component materials)
无菌性
non-sterile
灭菌适用性
autoclavable compatible
产品线
OptiScale® 47
特点
hydrophilic
with prefilter
制造商/商品名称
OptiScale®
参数
25 °C max. inlet pressure
3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C
80 psig max. inlet pressure
技术
sterile filtration: suitable
过滤器直径
2.7 in. (6.9 cm)
过滤器过滤面积
17.7 cm2
杂质
≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
基质
Multimedia Durapore®
pore size
1.2/0.2/0.22 μm pore size
泡点
≥3450 mbar (50 psig), air with water
配件
(19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)
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一般描述
Cartridge Type: Liquid
Device Configuration: Capsule
制备说明
Sterilization Method: 3 autoclave cycles of 60 min at 123 °C
分析说明
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 100 mL
其他说明
Directions for Use
- Organism Retention: Bacterial
- Mode of Action: Filtration (size exclusion)
- Application: Protein purification
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer installation and wetting sections of OPTISCALE®-25 user guide
- Storage Statement: Please refer OPTISCALE®-25 user guide
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
法律信息
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
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