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物料
borosilicate glass fiber (BGF) membrane
fluoroelastomer O-ring
mixed cellulose esters (MCE) membrane
polypropylene support
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
Polysep™
特点
hydrophilic
制造商/商品名称
Polysep™
技术
prefiltration: suitable
长度
30 in.
宽度
2.7 in.
纯化柱标称长度
75 cm (30 in.)
过滤面积
1.26 m2
基质
Polysep™ II
pore size
1.0/0.2/0.1 μm nominal pore size
1.0/0.2/0.1 μm pore size
柱代码
Code 7
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一般描述
Device Configuration: Cartridge
特点和优势
Triple Layer
制备说明
Non-Fiber Releasing: This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
分析说明
Gravimetric Extractables: the extractables level was equal to or less than 140 mg per 10-inch cartridge after 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 first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
- Storage Statement: Please refer Mixed cellulose esters Tech Brief
- 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
Polysep is a trademark of Sigma-Aldrich Co. LLC
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