KGEPS05TB1

Millipore Express^® SHF, Opticap^® XL Capsule

Opticap^® XL 5, sterile, cartridge nominal length 5 in. (12.5 cm), filter diam. 10.7 cm (4.2 in.)

• UNSPSC Code: 23151806

Properties

• material: polyester support; polypropylene device (gamma stable); polypropylene housing; polypropylene vent cap; polysulfone device; silicone seal
• Quality Level: 400
• reg. compliance: meets FDA 21 CFR 177-182 (all component materials)
• sterility: irradiated; sterile
• product line: Opticap^® XL 5
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: ≤17.4 mL/min air diffusion at 2.8 bar (40 psig) (in water); 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 100 psi max. differential pressure (6.9 bar) (intermittent); 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psi max. differential pressure (5.5 bar) (continuous); 80 psig max. inlet pressure
• technique(s): sterile filtration: suitable
• cartridge nominal length: 5 in. (12.5 cm)
• device L: 21.6 cm (8.5 in.)
• device size: 5 in.
• filter diam.: 10.7 cm (4.2 in.)
• filter filtration area: 0.31 m²
• impurities: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (sample aqueous extraction)
• matrix: Millipore Express^® SHF
• pore size: 0.2 μm pore size
• bubble point: ≥4000 mbar (58 psig), air with water
• fitting: (38 mm (1 ½ in.) Sanitary Flange Inlet and 25 mm (1 in.) Hose Barb Outlet)

Description

General description

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

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of 60 min at 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 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 6.0 L, samples exhibited &#x3C 500 ppb TOC per USP &#x3C 643 &#x3C and &#x3C 1.3 μS/cm per USP &#x3C 645 &#x3C at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 L

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 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

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