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Merck

CHGE01HS

Millipore Express® SHC High Area, Cartridge

cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm)

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Informacje o tej pozycji

UNSPSC Code:
23151806
Pomoc techniczna
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material

polyethersulfone device, polypropylene device, polypropylene support, silicone seal

reg. compliance

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

sterility

non-sterile

sterilization compatibility

autoclavable compatible
steam-in-place compatible

product line

EMPROVE® Filter, Millipore Express®

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤56.4 mL/min air diffusion at 2.75 bar (40 psig) (in water), 1700 mbar max. differential pressure (25 psi) at 80 °C (Forward ), 1700 mbar max. inlet pressure (25 psi) at 80 °C (Forward ), 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse), 2100 mbar max. inlet pressure (30 psi) at 25 °C (Reverse), 340 mbar max. differential pressure (5 psi) at 135 °C (Forward ), 340 mbar max. inlet pressure (5 psi) at 135 °C (Forward ), 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse), 69 mbar max. inlet pressure (1 psi) at 135 °C (Reverse), 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward ), 6900 mbar max. inlet pressure (100 psi) at 25 °C (Forward )

technique(s)

sterile filtration: suitable

L

10 in.

W

2.8 in.

cartridge nominal length

10 in. (25 cm)

filter diam.

2.7 in. (6.9 cm)

filter filtration area

1.0 m2

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Millipore Express® SHC High Area

pore size

0.5/0.2 μm pore size

bubble point

≥4000 mbar (58 psig), air with water

cartridge code

Code 0

General description

Device Configuration: Cartridge
Cartridge Type: Liquid

Packaging

Double Easy-Open Bag

Preparation Note

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

TOC/Conductivity: After sterilization and a controlled water flush of 20 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.



Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.

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 wetting instructions of Filters with MILLIPORE EXPRESS® Membrane user guide
  • Storage Statement: Please refer Filters with MILLIPORE EXPRESS® Membrane user guide
  • 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
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
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