MPGL2GCL3

Durapore^® 0.22 µm, Millipak^® Capsule

sterile

• Synonim(y): Sterile Millipak-200 Filter Unit 0.22 μm 1-1/2 in. TC/TC
• Kod UNSPSC: 23151806

Właściwości

• Materiały: PVDF ; PVDF vent cap; polycarbonate ; polycarbonate support
• Poziom jakości: 400
• sterylność: irradiated; sterile
• linia produktu: Millipak^®
• Właściwości: hydrophilic
• producent / nazwa handlowa: Millipak^®
• Parametry: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 100 L process volume; 19 L/min flow rate at 2.8 bar (ΔP); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 5.2 bar max. inlet pressure (75 psi) at 25 °C
• metody: sterile filtration: suitable
• powierzchnia filtracyjna: 1000 cm²
• śr. przyłącza doprowadzającego: 1.5 in.
• śr. przyłącza odprowadzającego: 1.5 in.
• 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: ≤5 mg/device
• macierz: Durapore^®
• wielkość porów: 0.22 μm
• punkt pęcherzykowania: ≥3450 mbar (50 psig), air with water at 23 °C
• dopasowywanie: inlet sanitary flange; outlet sanitary flange; (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Opis

Opis ogólny

Device Configuration: Gamma Gold Capsule

Opakowanie

Blister

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
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable

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 a 200 mL flush and 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

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

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