物料
PVDF
质量水平
管理合规性
meets FDA Indirect Food Additive requirements cited in 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®
技术
sterile filtration: suitable
长度
5 in.
宽度
2.7 in.
纯化柱标称长度
5 in. (12.5 cm)
过滤面积
0.35 m2
杂质
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量萃取物
≤10 mg/cartridge
基质
Durapore®
孔径
0.22 μm
输入
sample type liquid
柱代码
Code 7 (2-226; O-rings w/locking-tabs)
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一般描述
Device Configuration: Cartridge
其他说明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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 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.
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.
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
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
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