KGEPG3FBB1

Millipore Express^® SHF 0.2µm, Opticap^® XLT 30 Capsule

Fittings 1 in. HB/HB, Gamma Compatible

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

Properties

• Product Name: OPTICAP^® XLT 30 Capsule Media: MILLIPORE EXPRESS^® SHF 0.2 µm, Chemistry: Hydrophilic Polyethersulfone (PES) Inlet: 1 in. Hose Barb Outlet: 1 in. Hose Barb T-line with 3/4 in. Gauge Port Max Operating Pressure: 80psi @ 25 °C
• material: polyester support, polypropylene housing, polypropylene vent cap, silicone seal, polyethersulfone membrane, silicone O-ring
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• parameter: 1 bar max. differential pressure (15 psi) at 80 °C, 1.0 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
• W: 7.8 in.
• cartridge nominal length: 30 in. (75 cm)
• device L: 87.1 cm (34.3 in.)
• filter diam.: 10.7 cm (4.2 in.)
• filter filtration area: 1.71 m² (18.4 ft²)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; gamma compatible; x-ray compatible
• product line: Opticap^® XLT
• impurities: <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: 25 mm (1 in.) inlet hose barb, 25 mm (1 in.) outlet hose barb

Description

General description

Device Configuration: Capsule

T-line/Gauge Port: T-line with 3/4 in. Gauge Port

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of 60 min at 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 33 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 ≥ 4.5 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