SMP8A25NB6

Milligard^® PES 1.2/0.8 µm, OptiScale^® Capsule

OptiScale^® 25, filtration area 3.5 cm², pore size 1.2/0.8 μm

• Synonim(y): OptiScale 25 Milligard PES 1.2/0.8 μm NB, Milligard^® PES 1.2/0.8 µm, OptiScale^® Capsule
• UNSPSC Code: 23151806

Właściwości

• Nazwa produktu: OptiScale^® 25 CapsuleMedia: Milligard^® PES 1.2/0.8 µm Nominal,
• Quality Segment: 400
• material: polyethersulfone membrane, polypropylene , polypropylene support, polypropylene vent cap
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible
• product line: OptiScale^® 25
• feature: hydrophilic
• manufacturer/tradename: OptiScale^®
• parameter: 0 bar max. differential pressure (Reverse), 4.14 bar max. differential pressure (60 psi) at 25 °C (Forward), 60 psi max. inlet pressure (4.1 bar)
• technique(s): prefiltration: suitable
• L: 3.9 cm (1.52 in.)
• W: 1.21 in.
• diam.: 3.1 cm (1.2 in.)
• filtration area: 3.5 cm²
• impurities: <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)
• matrix: Milligard^® PES
• pore size: 1.2/0.8 μm pore size
• fitting: female Luer-Lok^® inlet connection, male Luer-Lok^® outlet connection, (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• cartridge code: not applicable

Opis

General description

Device Configuration: Capsule

Preparation Note

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.

Analysis Note

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

Other Notes

Directions for Use

• 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.

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

Legal Information

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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