KHGES3FTT1

Millipore Express^® SHR with prefilter 0.5/0.1µm, Opticap^® XLT 30 Capsule

Fittings 1-1/2 in. TC, Sterile

• Synonym(s): Sterile Opticap XLT 30 Millipore Express SHR 0.5/0.1 μm TC/TC 1pk w/3/4" TC top, Opticap XLT 30 CapsuleMedia: Sterile Millipore Express SHC 0.5 / 0.2 µm
• UNSPSC Code: 23151806

Properties

• Product Name: Millipore Express^® SHC, Opticap^® XLT Capsule, Chemistry: Hydrophilic Polyethersulfone (PES)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-line with 3/4 in. Gauge PortMax Operating Pressure: 80 psi @ 25 °C, sterile, Opticap^® XLT, inlet connection diam. 1.5 in., pore size 0.5/0.2 μm, cartridge nominal length 30 in. (75 cm)
• material: polyester support, polyethersulfone membrane, polypropylene housing, polypropylene vent cap, silicone seal
• Quality Level: 400
• sterility: sterile
• sterilization compatibility: autoclavable compatible
• product line: Opticap^® XLT
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: 1 bar max. differential pressure (15 psi) at 80 °C, 1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent), 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
• cartridge nominal length: 30 in. (75 cm)
• device L: 87.1 cm (34.3 in.)
• filter diam.: 10.7 cm (4.2 in.)
• filtration area: 1.63 m² (17.4 ft²)
• inlet connection diam.: 1.5 in.
• outlet connection diam.: 1.5 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: 38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet sanitary flange
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

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 @ 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 63 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 ≥6 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