物料
polyethersulfone
polypropylene
silicone seal
质量水平
特点
holdup volume 490 mL
制造商/商品名称
Viresolve®
参数
≤48 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water)
1800-3600 L process volume
3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
技术
protein purification: suitable
纯化柱标称长度
30 in. (75 cm)
过滤面积
1.281 m2
杂质
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量萃取物
≤105 mg/cartridge
基质
Viresolve® NFR
柱代码
Code 7
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一般描述
Device Configuration: Cartridge
应用
Retrovirus removal
包装
Double Easy-Open bag
其他说明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
- Organism Retention: Retrovirus
- Mode of Action: Filtration (size exclusion)
- Application: Protein purification
- Intended Use: Viral clearance
- Instructions for Use: Please see the user guide (pg. 3) shipped with this product
- Storage Statement: Store at room temperature
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
制备说明
Sterilization Method
After wetting, may be autoclaved for 3 cycles of up to 60 min at 125 °C,
using liquid cycle, slow exhaust.
After wetting, may be autoclaved for 3 cycles of up to 60 min at 125 °C,
using liquid cycle, slow exhaust.
This product was manufactured with a Viresolve® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
分析说明
Gravimetric Extractables: after a 10 minute 1.5 LPM/ft² flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥12 L
法律信息
VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany
法规信息
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