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CHVE71HS1

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

Code 7 Silicone, Autoclavable and SIP

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UNSPSC Code:
23151806
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产品名称

Millipore Express® SHRP High Area, Cartridge, cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm)

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

Millipore Express®

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

6900 mbar max. differential pressure (100 psi) at 25 °C (Forward), 340 mbar max. inlet pressure (5 psi) at 135 °C (Forward), ≤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), 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

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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