SHGLA25NB6

Multilayer Durapore^® 0.45/0.22 µm, OptiScale^® Capsule

OptiScale^® 25, filtration area 3.5 cm², pore size 0.45/0.22 μm

• Synonym(s): Multilayer Durapore^® 0.45 μm/0.22 μm Optiscale 25mm NB, Multilayer Durapore^® 0.45/0.22 µm, OptiScale^® Capsule
• UNSPSC Code: 23151806
• NACRES: NB.24
• eCl@ss: 32031610

Properties

• Product Name: OptiScale^® 25 Capsule Media: Multilayer Durapore^® 0.45 / 0.22 µm,
• Quality Segment: 400
• material: PVDF 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: OptiScale^®
• 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.
• 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: Multilayer Durapore^®
• pore size: 0.45/0.22 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

Description

General description

Device Configuration: Capsule

Preparation Note

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

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).

Analysis Note

TOC/Conductivity
After sterilization and a controlled water flush of 35 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

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

Other Notes

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.

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

Legal Information

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

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

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