material
mixed cellulose esters (MCE) , polyester support, polypropylene , silicone seal
reg. compliance
meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food), meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
manufacturer/tradename
Bevigard™
parameter
3.5 bar max. differential pressure (50 psid) at 25 °C
cartridge nominal length
30 in. (75 cm)
diam.
7.1 cm (2.8 in.)
filtration area
2.07 m2
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
gravimetric extractables
≤150 mg/cartridge
matrix
Bevigard™-M
pore size
1.2/0.5 μm pore size
input
sample type beverage(s)
sample type bottled water
sample type beer
sample type food(s)
sample type liquid
sample type wine
cartridge code
Code 7 (2-226; O-ring and spear)
General description
Device Configuration: Cartridge
Features and Benefits
Filter Grade: Standard Milligard® Media
Format: Double Layer
Packaging
Double Easy-Open bag
Preparation Note
Sanitization Protocol
30 min with hot water @ 80 °C
30 min with hot water @ 80 °C
Sterilization Method
10 autoclave cycles or SIP @ 121 °C for 30 min
10 autoclave cycles or SIP @ 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).
Analysis Note
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 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 celulose 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.
Legal Information
Bevigard is a trademark of Merck KGaA, Darmstadt, Germany
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
signalword
Danger
hcodes
Hazard Classifications
Flam. Sol. 1
存储类别
4.1B - Flammable solid hazardous materials
wgk
WGK 2
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