KGW9A04HH3

Polysep^™ II 2.0/1.2 µm nominal, Opticap^® XL Capsule

inlet connection diam. 9/16 in., Opticap^® XL 4, pore size 2.0/1.2 μm, cartridge nominal length 4 in. (10 cm)

• Synonym(s): Opticap XL4 Polysep II 2.0/1.2 μm 9/16 in. HB/HB
• eCl@ss: 32031610

Properties

• material: borosilicate glass fiber (BGF) prefilter; mixed cellulose esters (MCE) ; polypropylene ; polypropylene housing; polypropylene support; 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 4
• 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: 19.6 cm (7.7 in.)
• W: 3.3 in.
• cartridge nominal length: 4 in. (10 cm)
• diam.: 14.5 cm (5.7 in.)
• filtration area: 0.11 m²
• inlet connection diam.: 9/16 in.
• inlet to outlet W: 19.6 cm (7.7 in.)
• outlet connection diam.: 9/16 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: ≤85 mg/capsule
• matrix: Polysep^™ II
• pore size: 2.0/1.2 μm nominal pore size; 2.0/1.2 μm pore size
• input: sample type liquid
• fitting: inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb 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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
• Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

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 a 1200 mL flush and 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

Legal Information

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

Polysep is a 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: 11 - Combustible Solids
• WGK: WGK 2