MFGL10SL3

Durapore^® 0.22 µm, Millipak^® Final Fill Capsule

Millipak^® Final Fill 100, sterile; γ-irradiated

• Kod UNSPSC: 23151806

Właściwości

• Materiały: polysulfone device; polysulfone support
• Poziom jakości: 400
• agency: meets EP 2.6.14; meets JP 4.01; meets USP 85
• sterylność: irradiated; sterile; γ-irradiated
• linia produktu: Millipak^® Final Fill 100
• Właściwości: hydrophilic
• producent / nazwa handlowa: Millipak^®
• Parametry: 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 100 L process volume; 3.81 L/min flow rate at 1.1 bar (ΔP); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
• metody: sterile filtration: suitable
• filter filtration area: 500 cm²
• zanieczyszczenia: <0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)
• macierz: Durapore^®
• wielkość porów: 0.22 μm pore size
• punkt pęcherzykowania: ≥50 psi (3450 mbar), air with water
• dopasowywanie: (38 mm (1 1/2 in.) Sanitary Flange Inlet and 13 mm (1/2 in.) Hose Barb Outlet)

Opis

Opis ogólny

Device Configuration: Gamma Gold Capsule

Opakowanie

Double Easy-Open bag

Uwaga dotycząca przygotowania

Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤40  kGy gamma exposure.

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), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections

Komentarz do analizy

Bacterial Grow-Through: Quantitative retention of 1 x 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per ASTM^® F838 methodology.

Inne uwagi

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 general guidelines section of user guide shipped with this product
• Storage Statement: Please refer user guide shipped with this product
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

Informacje prawne

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

ATCC is a registered trademark of American Type Culture Collection

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

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

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