物料
borosilicate glass fiber (BGF) prefilter
polypropylene device
polypropylene support
silicone seal
管理合规性
meets EU 1935/2004/EC (all component materials; regarding materials and articles intended to contact food)
meets FDA 21 CFR 177-182 (all component materials)
制造商/商品名称
Bevigard™
参数
3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C
纯化柱标称长度
40 in. (100 cm)
设备尺寸
40 in.
过滤器直径
2.8 in. (7.1 cm)
过滤器过滤面积
1.84 m2
杂质
≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
重量萃取物
≤140 mg/cartridge
基质
Bevigard™-P
pore size
1.0/0.5 μm pore size
代码
Code 0
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一般描述
Device configuration: Cartridge
Cartridge type: Groundwater
Cartridge type: Groundwater
应用
Food and Beverage: Beer, Bottled Water, Wine
特点和优势
Format: Double 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 ≤ 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 20 L
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 20 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 to installation and wetting sections of OPTISCALE®-25 user guide and introduction section of Mixed cellulose ester Tech Brief
- Storage Statement: Please refer to Mixed cellulose esters Tech Brief
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
法律信息
Bevigard is a trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
警示用语:
Danger
危险声明
危险分类
Carc. 1B Inhalation - Flam. Sol. 1
储存分类代码
4.1B - Flammable solid hazardous materials
WGK
WGK 3
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