SHGEA25NB6

Millipore Express^® SHC 0.5/0.2µm, Optiscale^® 25mm Capsule

Fittings NB, Autoclavable

• Sinônimo(s): Millipore Express SHC Optiscale 25mm 0.5/0.2 m NB, Millipore Express^® SHC, OptiScale^® Capsule
• UNSPSC Code: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

Propriedades

• Nome do produto: OptiScale^® 25 Capsule Media: Millipore Express^® SHC 0.5 / 0.2 µm,
• Quality Segment: 400
• material: polyethersulfone membrane, polypropylene , polypropylene support, polypropylene vent cap
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible
• product line: OptiScale^® 25
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: 4.1 bar max. inlet pressure (60 psi) at 25 °C, 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
• technique(s): sterile filtration: suitable
• L: 3.9 cm (1.52 in.)
• W: 1.21 in.
• cartridge nominal length: 1.52 in. (39 mm)
• diam.: 3.1 cm (1.2 in.)
• filtration area: 3.5 cm²
• impurities: ≤0.25 EU/mL (LAL test, Aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® SHC
• pore size: 0.5/0.2 μm pore size
• fitting: female Luer-Lok^® inlet connection, male Luer-Lok^® outlet connection, (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• shipped in: ambient

Descrição

General description

Device Configuration: Capsule

Preparation Note

Sterilization Method
1 autoclave cycle of 60 min @ 123 °C

This product was manufactured with a Millipore Express membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

This product was tested and passes the USP <78> test for particulates in injectables.

Other Notes

Directions for Use

• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• 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.

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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