material
borosilicate glass fiber (BGF) , polypropylene , polypropylene support, 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.
7.4 cm (2.9 in.)
filtration area
1.38 m2
impurities
≤1.0 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
gravimetric extractables
≤660 mg/cartridge
matrix
Bevigard™-L
pore size
2.0 μm nominal pore size, 2.0 μm pore size
input
sample type bottled water
sample type beverage(s)
sample type food(s)
sample type beer
sample type wine
sample type liquid
cartridge code
Code 0 (2-222; O-rings)
General description
Device Configuration: Cartridge
Features and Benefits
Filter Grade: AP20
Format: Single 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
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 ≥5 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
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
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