CHGL01TP3

Multilayer Durapore^® 0.45/0.22 µm, Cartridge

pore size 0.45/0.22 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

• Synonim(y): Durapore Cartridge Filter 10 in. 0.45/0.22 m Code 0
• Kod UNSPSC: 23151806
• eCl@ss: 32031690

Właściwości

• Materiały: PVDF ; polypropylene ; polypropylene support; silicone seal
• Poziom jakości: 400
• zgodność regionalna: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible; steam-in-place compatible
• linia produktu: Durapore^®
• Właściwości: hydrophilic
• producent / nazwa handlowa: Durapore^®
• Parametry: ≤10.8 mL/min air diffusion at 2.75 bar (40 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; intermittent); 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse; Intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• metody: sterile filtration: suitable
• Długość: 10 in.
• Szerokość: 2.7 in.
• długość nominalna kartridża: 10 in. (25 cm)
• Średnica: 6.9 cm (2.7 in.)
• powierzchnia filtracyjna: 0.55 m²
• zanieczyszczenia: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• macierz: Multilayer Durapore^®
• pore size: 0.45/0.22 μm pore size
• moc wejściowa: sample type liquid
• punkt pęcherzykowania: ≥3450 mbar (50 psig), air with water at 23 °C
• kod wkładu: Code 0 (2-222; O-rings)

Opis

Opis ogólny

Device Configuration: Cartridge

Inne uwagi

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 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.

Uwaga dotycząca przygotowania

Sterilization Method
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 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).

Komentarz do analizy

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

TOC/Conductivity
After sterilization and a controlled water flush of 16 L per 10-inch cartridge, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1.5 L

Informacje prawne

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

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

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