SGW6A47FH3

Polysep^™ II 1.0/0.5 µm nominal, OptiScale^® Capsule

OptiScale^® 47, filtration area 17.7 cm², pore size 1.0/0.5 μm

• Synonym(s): Optiscale Capsule Polysep II 1.0/0.5 μm 3/4 in. TC-1/4 in. HB
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PVDF vent cap; borosilicate glass fiber (BGF) membrane; fluoroelastomer FKM seal; mixed cellulose esters (MCE) membrane; polycarbonate ; polypropylene support
• Quality Level: 400
• 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^® 47
• feature: hydrophilic
• manufacturer/tradename: OptiScale^®
• parameter: 25 °C max. inlet temp.; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psig max. inlet pressure
• technique(s): prefiltration: suitable
• diam.: 6.9 cm (2.7 in.)
• filtration area: 17.7 cm²
• inlet connection diam.: 3/4 in.
• outlet connection diam.: 1/4 in.
• impurities: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
• matrix: Polysep^™ II
• pore size: 1.0/0.5 μm nominal pore size; 1.0/0.5 μm pore size
• input: sample type liquid
• fitting: inlet sanitary flange; outlet hose barb; (19 mm (3/4 in.) Sanitary Flange Inlet and 6 mm (1/4 in.) Hose Barb Outlet)

Description

General description

Device Configuration: Capsule

Features and Benefits

Format: Double Layer

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

Sterilization Method
3 autoclave cycles of 60 min @ 121 °C; not in-line steam sterilizable

Analysis Note

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥100 mL

Legal Information

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

Polysep is a trademark of Sigma-Aldrich Co. LLC

Safety Information

• pictograms: GHS08
• signalword: Danger
• hcodes: H350i
• pcodes: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Carc. 1B Inhalation
• Storage Class: 4.1B - Flammable solid hazardous materials
• wgk_germany: WGK 2