物料
PVDF (modified)
polypropylene
polypropylene support
polypropylene vent cap
silicone seal
制造商/商品名称
Viresolve®
参数
≤10 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water)
25 °C max. inlet temp.
250 L process volume
3.4 bar max. differential pressure (50 psid) (Reverse)
5.5 bar max. differential pressure (80 psid) (Forward)
80 psig max. inlet pressure
技术
protein purification: suitable
长度
33 cm (13 in.)
设备尺寸
10 in.
过滤面积
0.42 m2
入口接头直径
9/16 in.
出口接头直径
9/16 in.
杂质
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基质
Viresolve® NFP
配件
1/4 in. drain/vent hose barb (with double O-ring Seal)
inlet hose barb
16 mm (5/8 in.) inlet/outlet hose barb
outlet hose barb
一般描述
Device Configuration: 取样皿滤膜
应用
Parvovirus removal
包装
Double Easy-Open bag
制备说明
Sterilization Method
Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min
Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min
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
TOC/Conductivity
After sterilization and a controlled water flush of 12 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
After sterilization and a controlled water flush of 12 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
其他说明
Directions for Use
- Organism Retention: Parvovirus
- Mode of Action: Filtration (size exclusion)
- Application: Protein purification
- Intended Use: Viral clearance
- Instructions for Use: Please see the user guide shipped with this product
- Storage Statement: Store at room temperature
- 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
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
VIRESOLVE is a registered trademark of Merck KGaA, Darmstadt, Germany
免责声明
EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
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