CHGL02TP3

Multilayer Durapore^® 0.45/0.22 µm, Cartridge

cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 0

• Sinónimos: Multilayer Durapore^® 0.45/0.22 µm, Cartridge
• UNSPSC Code: 23151806
• eCl@ss: 32110203

Propiedades

• Nombre del producto: Multicapa Durapore^® 0,45/0,22 µm, Cartucho, Chemistry: 0.45 / 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 20 in. Code 0
• Quality Segment: 400
• material: PVDF membrane, PVDF prefilter, polypropylene housing, polypropylene support, silicone O-ring
• reg. compliance: 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: 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
• technique(s): sterile filtration: suitable
• W: 2.7 in.
• cartridge nominal length: 20 in. (50 cm)
• device L: 20.0 in.
• device size: 20 in.
• filter filtration area: 1.11 m²
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Multilayer Durapore^®
• pore size: 0.45/0.22 μm pore size
• bubble point: ≥3450 mbar (50 psig), air with water at 23 °C
• code: Code 0

Descripción

General description

Device configuration: Cartridge
Cartridge type: Liquid

Preparation Note

Sterilization Method: 30 SIP cycles of 30 min at 135°C; 30 autoclave cycles of 60 min at 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

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm²  using ASTM^® F838 methodology.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 3L

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 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

ASTM is a registered trademark of American Society for Testing and Materials

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