SMP2A25NB6

Milligard^® PES 1.2/0.2 µm nominal, OptiScale^® Capsule

filtration area 3.5 cm², OptiScale^® 25, pore size 1.2/0.2 μm

• Synonim(y): OptiScale 25 Milligard PES 1.2/0.2 m nominal NB
• Kod UNSPSC: 23151806

Właściwości

• Materiały: polyethersulfone membrane; polypropylene ; polypropylene support; polypropylene vent cap
• Poziom jakości: 400
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible
• linia produktu: OptiScale^® 25
• Właściwości: hydrophilic
• producent / nazwa handlowa: OptiScale^®
• Parametry: 0 bar max. differential pressure (Reverse); 4.14 bar max. differential pressure (60 psi) at 25 °C (Forward)
• metody: bioburden reduction: suitable
• Długość: 3.9 cm (1.52 in.)
• Szerokość: 1.21 in.
• Średnica: 3.1 cm (1.2 in.)
• powierzchnia filtracyjna: 3.5 cm²
• zanieczyszczenia: <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)
• macierz: Milligard^® PES
• pore size: 1.2/0.2 μm nominal pore size; 1.2/0.2 μm pore size
• dopasowywanie: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• kod wkładu: not applicable

Opis

Opis ogólny

Device Configuration: Capsule

Inne uwagi

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

Directions for Use

• Organism Retention: Bacterial
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer installation and wetting sections of OPTISCALE^®-25 user guide
• Storage Statement: Please refer OPTISCALE^®-25 user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Uwaga dotycząca przygotowania

Devices tested and meet requirements of USP <78> for large volume parenterals.

Sterilization Method
Capsule integrity was maintained after 1 autoclave cycle of 60 minutes at 123 °C.

Komentarz do analizy

This product was tested and passes the USP test for particulates in injectables.

Informacje prawne

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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

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

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