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物料
PVDF membrane
polypropylene support
silicone O-ring
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
steam-in-place compatible
产品线
Durapore®
特点
hydrophilic
制造商/商品名称
Durapore® II
技术
sterile filtration: suitable
长度
30 in.
宽度
2.7 in.
纯化柱标称长度
30 in. (75 cm)
device size
30 in.
过滤面积
3.3 m2
杂质
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量萃取物
≤30 mg/cartridge
基质
Durapore® High Area
孔径
0.22 μm pore size
代码
Code 0
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一般描述
Device configuration: Cartridge
Cartridge type: Liquid
Cartridge type: Liquid
制备说明
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
分析说明
Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.
Gravimetric Extractables: The extractables level was ≤ 30 mg per 10-inch cartridge after a 1.5 L flush and 24 hours in water at controlled room temperature.
其他说明
Directions for Use:
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer to Wetting Instructions for Filter Units with Durapore® Membrane user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
法律信息
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
法规信息
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