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物料
borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene device
polypropylene support (spun bonded)
silicone seal
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™ II
参数
3.5 bar max. differential pressure (50 psid) at 25 °C
技术
prefiltration: suitable
长度
10 in.
宽度
2.7 in.
纯化柱标称长度
10 in. (25 cm)
设备尺寸
10 in.
过滤器直径
2.8 in.
过滤器过滤面积
0.46 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)
基质
Polysep™ II
pore size
1.0/0.5 μm nominal pore size
1.0/0.5 μm pore size
柱代码
Code 7
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一般描述
Device Configuration: Cartridge
Cartridge Type: Liquid
Filter Grade: Prefilter
Cartridge Type: Liquid
Filter Grade: Prefilter
应用
mAb & r-protein intermediates; Plasma; Vaccines & viral vectors; SVPs LVPs; Cell Culture; Media Filtration; Colloid Removal; Lipid Removal
特点和优势
Format: Double Layer
包装
Double Easy-Open bag
制备说明
Sanitization: 30 min with hot water at 80 °C
Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min
This product was manufactured with a Millipore® media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
分析说明
After autoclaving and a 24 hour soak in ASTM® Type 1 reagent grade water at controlled room temperature, extractables level was ≤140 mg per 10-inch element after a 5000 mL flush.
Cartridges meet the requirements of the USP Oxidizable Substances Test after a water flush of 5000 mL per 10 inch Element
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
The product is manufuactured in a facility with a Quality Management System approved by an accredited registering body to an ISO 9001 Quality Systems Standard.
法律信息
ASTM is a registered trademark of American Society for Testing and Materials
Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC
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