KPGES10TT1

Millipore Express^® PHF, Opticap^® XL Capsule

sterile, Opticap^® XL 10, inlet connection diam. 1.5 in., cartridge nominal length 10 in. (25 cm)

• Synonym(s): Opticap XL 10 Millipore Express PHF Sterile 0.2 m 1-1/2 in. TC/TC

Properties

• material: polyester support; polyethersulfone ; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: irradiated; sterile
• product line: Opticap^® XL 10
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: ≤32.7 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1000 bar max. differential pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 5500 mbar max. differential pressure (80 psi) at 25 °C; 80 psig max. inlet pressure
• technique(s): bioburden reduction: suitable
• L: 33.5 cm (13.2 in.)
• cartridge nominal length: 10 in. (25 cm)
• diam.: 10.7 cm (4.2 in.)
• filtration area: 0.57 m²
• inlet connection diam.: 1.5 in.
• inlet to outlet W: 33.5 cm (13.2 in.)
• outlet connection diam.: 1.5 in.
• impurities: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® PHF
• pore size: 0.2 μm
• fitting: 1/4 in. drain/vent hose barb (with double O-ring seal); inlet sanitary flange; outlet sanitary flange; (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Description

General description

Device Configuration: Capsule

Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

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 wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane 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 @ 123 °C; not in-line steam sterilizable

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

Analysis Note

Bacterial Retention
Samples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

TOC/Conductivity
After sterilization and a controlled water flush of 11 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1.5 L

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

MILLIPORE EXPRESS 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.