KPHLA04TH3

Durapore^® 0.45 µm, Opticap^® XL Capsule

Opticap^® XL 4, inlet connection diam. 1.5 in., cartridge nominal length 4 in. (10 cm)

• Synonim(y): Opticap XL4 Durapore 0.45 μm without prefilter TC/HB, Durapore^® 0.45 µm, Opticap^® XL Capsule
• UNSPSC Code: 23151806

Właściwości

• Nazwa produktu: Opticap^® XL 4 CapsuleMedia: Durapore^® 0.45 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 9/16 in. Hose BarbMax Operating Pressure: 80psi @ 25 °C
• Quality Segment: 400
• material: PVDF , polypropylene , polypropylene housing, polypropylene support, polypropylene vent cap, silicone seal
• 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: ≤4.5 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.8 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 3.4 bar max. differential pressure (50 psid) at 25 °C (Forward), 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent), 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure
• technique(s): bioburden reduction: suitable
• L: 7.7 in.
• W: 3.3 in.
• cartridge nominal length: 4 in. (10 cm)
• diam.: 8.4 cm (3.3 in.)
• filtration area: 0.19 m²
• inlet connection diam.: 1.5 in.
• inlet to outlet W: 19.3 cm (7.6 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: ≤10 mg/capsule
• matrix: Durapore^®
• pore size: 0.45 μm
• input: sample type liquid
• bubble point: ≥1930 mbar (28 psig), air with water at 23 °C
• fitting: 1/4 in. drain/vent hose barb (with double O-ring Seal), inlet sanitary flange, outlet hose barb, (38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Opis

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable

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

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

Other Notes

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• 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

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.

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