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Merck
CN

CHGE71HS1

Millipore Express® SHC High Area 0.5/0.2µm Cartridge 10

Code 7 Silicone, Autoclavable and SIP

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHC High Area, Cartridge, Chemistry: 0.5 / 0.2 µm Hydrophilic Polyethersulfone (PES) Configuration: 10 in. Code 7

material

polyethersulfone device, polypropylene device, polypropylene support, silicone seal

reg. compliance

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

Quality Level

400

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 7

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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

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 20 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 µS/cm per USP 645 at 25 °C.

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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