KWSSA10FF1

Milligard^® 0.5/0.2 µm nominal, Opticap^® XL Capsule

inlet connection diam. 3/4 in., Opticap^® XL 10, pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm)

• Synonym(s): Opticap XL10 Milligard 0.5/0.2 μm 3/4 in. TC/TC
• UNSPSC Code: 23151806
• eCl@ss: 32031610

Properties

• material: mixed cellulose esters (MCE) membrane; polyester support; polypropylene ; polypropylene housing; polypropylene vent cap; silicone seal
• 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: Opticap^® XL 10
• feature: hydrophilic
• manufacturer/tradename: Opticap^®
• parameter: 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.5 bar max. differential pressure (50 psid) at 25 °C; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• technique(s): prefiltration: suitable
• L: 33.5 cm (13.2 in.)
• cartridge nominal length: 10 in. (25 cm)
• diam.: 14.5 cm (5.7 in.)
• filtration area: 0.69 m²
• inlet connection diam.: 3/4 in.
• inlet to outlet W: 33.5 cm (13.2 in.)
• outlet connection diam.: 3/4 in.
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤55 mg/capsule
• matrix: Milligard^®
• pore size: 0.5/0.2 μm nominal pore size; 0.5/0.2 μm pore size
• input: sample type liquid
• fitting: inlet sanitary flange; outlet sanitary flange; (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Description

General description

Device Configuration: Capsule

Features and Benefits

Format: Double Layer

Packaging

Double Easy-Open bag

Other Notes

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

Directions for Use

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer installation section of OPTICAP^® XL Capsules and OPTICAP^® XLT Capsules user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Specifications

Filter Grade: Standard Milligard^® Media

Preparation Note

Sterilization Method
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable

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

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L

Legal Information

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

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

Disclaimer

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

Safety Information

• Storage Class Code: 4.1B - Flammable solid hazardous materials
• WGK: WGK 3