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Merck
CN

KHGES1STT1

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

Fittings 1-1/2 in. TC, Sterile

别名:

Millipore Express® SHC, Opticap® XLT Capsule

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHC，Opticap® XLT囊式, Chemistry: Hydrophilic Polyethersulfone (PES)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-line with 1-1/2 in. Gauge PortMax Operating Pressure: 80 psi @ 25 °C

material

polyester support, polypropylene device, polypropylene housing, polypropylene vent cap, polysulfone device, silicone seal

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

Quality Level

400

product line

Opticap® XLT 10

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

1.0 bar max. inlet pressure (15 psi) at 80 °C, 1000 mbar max. differential pressure (15 psi) at 80 °C (Forward), 2.75 bar max. inlet pressure (40 psi) at 60 °C, 2100 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent), 25 °C max. inlet temp., 5.5 bar max. inlet pressure (80 psi) at 25 °C, 5500 mbar max. differential pressure (80 psi) at 25 °C (Forward), 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent), 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward; intermittent), 80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

cartridge nominal length

10 in. (25 cm)

device L

37.7 cm (14.8 in.)

device size

10 in.

filter diam.

14.5 cm (5.7 in.)

filter filtration area

0.54 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® SHC

pore size

0.5/0.2 μm pore size

bubble point

≥4000 mbar (58 psig), air with water

fitting

(38 mm (1½ in.) Sanitary Flange Inlet and Outlet)

sterility

irradiated, sterile

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General description

Device Configuration: Capsule
T-line/Gauge Port: T-line with 1-1/2 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 21 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 ≥ 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

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

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