SMP4A25NB6

Optiscale^® 25 Milligard^® PES

filtration area 3.5 cm², pore size 1.2/0.45 μm

• Synonym(s): OptiScale 25 Milligard PES 1.2/0.45 μm NB
• UNSPSC Code: 23151806

Properties

• material: polyethersulfone membrane; polypropylene ; polypropylene support; polypropylene vent cap
• Quality Level: 400
• sterility: non-sterile
• Sterilization Compatibility: autoclavable compatible
• product line: OptiScale^®
• feature: hydrophilic
• manufacturer/tradename: OptiScale^®
• parameter: 0 bar max. differential pressure (Reverse); 4.14 bar max. differential pressure (60 psi) at 25 °C (Forward)
• 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: 1.2/0.45 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

Description

General description

Device Configuration: Capsule

Other Notes

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.

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.

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