KGEPS10TB1

Millipore Express^® SHF 0.2µm, Opticap^® XL 10 Capsule

Fittings 1-1/2 in. TC- 1 in. HB, Sterile

• Synonym(s): Millipore Express^® SHF, Opticap^® XL Capsule
• UNSPSC Code: 23151806

Properties

• Product Name: OPTICAP^® XL 10 Capsule Media: Sterile MILLIPORE EXPRESS^® SHF 0.2 µm, Chemistry: Hydrophilic Polyethersulfone (PES) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1 in. Hose Barb Max Operating Pressure: 80 psi @ 25 °C
• material: polyester support; polypropylene housing; polypropylene vent cap; silicone seal; polyethersulfone membrane; silicone O-ring
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterilization compatibility: autoclavable compatible
• product line: Opticap^® XL
• sterility: sterile
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: 1 bar max. differential pressure (15 psi) at 80 °C; 1 bar max. inlet pressure (15 psi) at 80 °C; 2.8 bar max. inlet pressure (40 psi) at 60 °C; 5.5 bar max. differential pressure (80 psi) at 25 °C; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; Intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (Intermittent)
• technique(s): sterile filtration: suitable
• L: 33.5 cm (13.2 in.)
• cartridge nominal length: 10 in. (25 cm)
• device size: 10 in.
• filter diam.: 10.7 cm (4.2 in.)
• filter filtration area: 0.57 m² (6.1 ft²)
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® SHF
• pore size: 0.2 μm pore size
• bubble point: ≥4000 mbar (58 psig), air with water at 23 °C
• fitting: 38 mm (1 1/2 in.) inlet sanitary flange; 25 mm (1 in.) outlet hose barb

Description

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 11 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 ≥ 1.5 L

General description

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

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

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).

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