物料
polyester support
polypropylene device
silicone seal
质量水平
无菌性
non-sterile
灭菌适用性
autoclavable compatible
steam-in-place compatible
产品线
Milligard®
特点
hydrophilic
制造商/商品名称
Milligard®
参数
3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C
技术
prefiltration: suitable
长度
4 in.
宽度
2.9 in.
纯化柱标称长度
4 in. (10 cm)
过滤器直径
2.8 in. (7.1 cm)
过滤器尺寸
4 in.
过滤面积
0.34 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
Milligard® LPB
孔径
1.2 μm nominal pore size
1.2 μm pore size
柱代码
Code M ((2-118) O-rings)
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一般描述
Cartridge Type: Liquid
Device Configuration: Cartridge
Filter Grade: Low Protein Binding MILLIGARD® Media
特点和优势
Format: Single Layer
包装
Double Easy-Open bag
制备说明
Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
This product was manufactured with a 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
Gravimetric Extractables: The extractables level was ≤100 mg per 4-inch cartridge after a 2 L flush and 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L
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 installation and wetting sections of OPTISCALE® -25 user 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
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
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