MPSL06CL1

Durapore^® 5.0 µm, Millipak^® Capsule

Millipak^® 60, sterile, filtration area 300 cm², matrix Durapore^®

• Synonim(y): Millipak-60 Filling Machine Filter Unit 5.0 μm 1-1/2 in. TC-1/4 in.HB
• Kod UNSPSC: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

Właściwości

• Materiały: PVDF membrane; PVDF vent cap; polycarbonate ; polycarbonate support
• Poziom jakości: 400
• sterylność: irradiated; sterile
• linia produktu: Millipak^® 60
• 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); 30 L process volume; 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 5.2 bar max. inlet pressure (75 psi) at 25 °C; 7.6 L/min flow rate at 700 mbar (ΔP)
• metody: prefiltration: suitable
• powierzchnia filtracyjna: 300 cm²
• śr. przyłącza doprowadzającego: 1-1/2 in.
• śr. przyłącza odprowadzającego: 1/4 in.
• zanieczyszczenia: ≤0.5 EU/mL (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• macierz: Durapore^®
• wielkość porów: 5.0 μm pore size
• punkt pęcherzykowania: ≥138 mbar (2 psig), air with water at 23 °C
• dopasowywanie: inlet sanitary flange; outlet hose barb; (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)
• Warunki transportu: ambient

Opis

Opis ogólny

Device Configuration: Capsule

Number of stacked discs: 60 discs

Opakowanie

Double Easy-Open bag

Inne uwagi

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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

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

Informacje prawne

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

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

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