CVHL03PP3

Durapore^® 0.45 µm, Cartridge

pore size 0.45 μm, cartridge nominal length 30 in. (75 cm), Code 0 (2-222; O-rings)

• Synonym(e): Durapore Cartridge Filter without prefilter 30 in. 0.45 μm Code 0, Durapore^® Cartridge
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Eigenschaften

• Produktname: Durapore^®, 0,45 µm, Kartusche, Chemistry: 0.45 μm Hydrophilic Polyvinylidene Fluoride (PVDF)Configuration: 30 in. Code 0
• Quality Segment: 400
• material: PVDF , 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)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; steam-in-place compatible
• product line: Durapore^®
• feature: hydrophilic
• manufacturer/tradename: Durapore^®
• parameter: ≤45 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water), 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward), 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward), 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse), 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• technique(s): bioburden reduction: suitable
• L: 30 in.
• W: 2.7 in.
• cartridge nominal length: 30 in. (75 cm)
• diam.: 6.9 cm (2.7 in.)
• filtration area: 2.07 m²
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤60 mg/cartridge
• matrix: Durapore^®
• pore size: 0.45 μm pore size
• input: sample type liquid
• bubble point: ≥1930 mbar (28 psig), air with water at 23 °C
• cartridge code: Code 0 (2-222; O-rings)

Beschreibung

General description

Device Configuration: Filterelement

Packaging

Leicht zu öffnender Doppelbeutel

Preparation Note

Sterilization Method
30 In-situ-Dampfsterilisationszyklen von 30 min bei 135 °C; 30 Autoklavenzyklen von 60 min bei 126 °C

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Erfüllt die Anforderungen des USP-Tests auf oxidierbare Substanzen nach Durchspülen mit ≥3 l Wasser

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Other Notes

Diese Produkte werden in einem Werk hergestellt, das den GMP-Richtlinien der FDA entspricht.

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Legal Information

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