材料
borosilicate glass fiber (BGF) prefilter
polypropylene device
polypropylene support
silicone seal
法律遵循
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)
製造商/商標名
Bevigard™
參數
3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C
柱標稱長度
40 in. (100 cm)
設備尺寸
40 in.
過濾器直徑
2.8 in. (7.1 cm)
過濾器過濾面積
1.84 m2
雜質
≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
重量法萃取物
≤140 mg/cartridge
基質
Bevigard™-P
pore size
1.0/0.2 μm pore size
代碼
Code 7
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一般說明
Device configuration: Cartridge
Cartridge type: Liquid
Cartridge type: Liquid
應用
Food and Beverage: Beer, Bottled Water, Wine
特點和優勢
Format: Double Layer
包裝
Double Easy-Open bag
準備報告
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).
分析報告
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
其他說明
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
法律資訊
Bevigard is a trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
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