MCGL10S03

Durapore^® 0.22 µm, Millidisk^® Cartridge

filtration area 500 cm², hydrophilic

• Synonim(y): Millidisk Cartridge 10-stack 0.22 μm Hydrophilic
• Kod UNSPSC: 23151806
• eCl@ss: 32031690

Właściwości

• Materiały: PVDF ; polysulfone ; polysulfone support; silicone seal
• Poziom jakości: 400
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible; steam-in-place compatible
• linia produktu: EMPROVE^® Filter; Millidisk^® 10
• Właściwości: hydrophilic
• producent / nazwa handlowa: Millidisk^®
• Parametry: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 0.7 bar max. inlet pressure (10 psi) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 15 L/min flow rate at 3.5 bar (ΔP); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 4.1 bar max. inlet pressure (60 psi) at 25 °C (Forward)
• metody: sterile filtration: suitable
• powierzchnia filtracyjna: 500 cm²
• zanieczyszczenia: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• substancje ekstrahujące się grawimetrycznie: ≤2.5 mg/device
• Matryca: Durapore^®
• wielkość porów: 0.22 μm
• moc wejściowa: sample type liquid
• punkt pęcherzykowania: ≥3450 mbar (50 psig), air with water at 23 °C
• kod wkładu: not applicable

Opis

Opis ogólny

Device Configuration: Cartridge

Stack Design: 10 Stak

Opakowanie

Double Easy-Open bag

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
5 SIP cycles of 60 min @ 135 °C; 5 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.

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL

Informacje prawne

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

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

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

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

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