material
borosilicate glass fiber (BGF) prefilter, polypropylene device, polypropylene support, silicone seal
reg. compliance
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)
manufacturer/tradename
Bevigard™
parameter
3.5 bar max. differential pressure (50 psid) at 25 °C, 3.5 bar max. inlet pressure (50 psi) at 25 °C
cartridge nominal length
40 in. (100 cm)
device size
40 in.
filter diam.
2.8 in. (7.1 cm)
filter filtration area
1.84 m2
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
gravimetric extractables
≤140 mg/cartridge
matrix
Bevigard™-P
pore size
1.0/0.5 μm pore size
code
Code 0
General description
Device configuration: Cartridge
Cartridge type: Groundwater
Cartridge type: Groundwater
Application
Food and Beverage: Beer, Bottled Water, Wine
Features and Benefits
Format: Double Layer
Packaging
Double Easy-Open bag
Preparation Note
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).
Analysis Note
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
Other Notes
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
Legal Information
Bevigard is a trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
signalword
Danger
hcodes
Hazard Classifications
Carc. 1B Inhalation - Flam. Sol. 1
存储类别
4.1B - Flammable solid hazardous materials
wgk
WGK 3
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