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Merck
CN

KHGES10TB1

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

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

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHC，Opticap® XL囊式, Opticap® XL 10, sterile, cartridge nominal length 10 in. (25 cm), filter diam. 10.7 cm (4.2 in.)

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)

sterility

irradiated
sterile

product line

Opticap® XL 10

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤31.2 mL/min air diffusion at 2.8 bar (40 psig) (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

cartridge nominal length

10 in. (25 cm)

device L

33.5 cm (13.2 in.)

device size

10 in.

filter diam.

10.7 cm (4.2 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 (1 ½ in.) Sanitary Flange Inlet and 25 mm (1 in.) Hose Barb Outlet)

Quality Level

400

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Legal Information

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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

General description

Device Configuration: Capsule

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).

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