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Merck
CN

CHVE71HS3

Millipore Express® SHR High Area with prefilter 0.5/0.1µm Cartridge 20

Code 7 Silicone, Autoclavable and SIP

别名:

Millipore Express® SHRP High Area, Cartridge

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHR w/Prefilter High Area Cartridge, Chemistry: 0.5 / 0.1 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

Millipore Express®

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤54.2 mL/min air diffusion at 3.45 bar (50 psig), 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)

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® SHR (w/Prefilter High Area)

pore size

0.5/0.1 μm pore size

bubble point

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water

相关类别

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 less than 500 ppb TOC per USP 643 and less than 1.3 μS/cm per USP 645 at 25 μC.

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
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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