KHGES10HH1

Millipore Express^® SHC 0.5/0.2µm, Opticap^® XL 10 Capsule

Fittings 9/16 in. HB/HB, Sterile

• Synonym(s): Opticap Sterile XL 10 Millipore Express SHC 0.5/0.2 μm 9/16 in. HB/HB
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• Product Name: Millipore Express^® SHC, Opticap^® XL Capsule, Opticap^® XL, sterile, inlet connection diam. 9/16 in., pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm)
• material: polyester support; polyethersulfone membrane; polypropylene housing; 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: sterile
• Sterilization Compatibility: autoclavable compatible
• product line: Opticap^® XL
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: ≤31.2 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C ( 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
• L: 33.5 cm (13.2 in.)
• cartridge nominal length: 10 in. (25 cm)
• diam.: 10.7 cm (4.2 in.)
• filtration area: 0.54 m²
• inlet connection diam.: 9/16 in.
• inlet to outlet W: 33.5 cm (13.2 in.)
• outlet connection diam.: 9/6 in.
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® SHC
• pore size: 0.5/0.2 μm pore size
• bubble point: ≥4000 mbar (58 psig), air with water at 23 °C
• fitting: 14 mm (9/16 in.) inlet hose barb; 14 mm (9/16 in.) outlet hose barb

Description

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

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 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 21 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 ≥2 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.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.