CGW301SB1

Bevigard^™-P Cartridge Filter

pore size 1.0/0.2 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

• Synonym(s): Bevigard^™-P Cartridge Filter 10 in. 0.2 µm Code 0
• UNSPSC Code: 23151806
• eCl@ss: 32031610

Properties

• material: borosilicate glass fiber (BGF) prefilter; mixed cellulose esters (MCE) ; polypropylene ; polypropylene support (Spun bonded); 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: 10 in. (25 cm)
• diam.: 7.1 cm (2.8 in.)
• filtration area: 0.46 m²
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
• gravimetric extractables: ≤140 mg/cartridge
• matrix: Bevigard^™-P
• pore size: 1.0/0.2 μm pore size
• input: sample type liquid; sample type bottled water; sample type beer; sample type beverage(s); sample type food(s); sample type wine
• cartridge code: Code 0 (2-222; O-rings)

Description

General description

Device Configuration: Cartridge

Features and Benefits

Format: Double Layer

Packaging

Double Easy-Open bag

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

Preparation Note

Sanitization Protocol
30 min with hot water @ 80 °C

Sterilization Method
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 ≥5 L

Legal Information

Bevigard is a trademark of Merck KGaA, Darmstadt, Germany

OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety Information

• pictograms: GHS02,GHS08
• signalword: Danger
• hcodes: H228,H350i
• pcodes: P202 - P210 - P240 - P241 - P280 - P308 + P313
• Hazard Classifications: Carc. 1B Inhalation - Flam. Sol. 1
• Storage Class: 4.1B - Flammable solid hazardous materials
• wgk_germany: WGK 3