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Merck
CN

CVEP71TF3

Millipore Express® SHR 0.1µm Cartridge 10

Code 7 Fluorocarbon, Autoclavable and SIP

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHR，小柱, cartridge nominal length 10 in. (25 cm), filter diam. 6.9 cm (2.7 in.), Code 7

parameter

6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
0.34 bar max. differential pressure (5 psi) at 135 °C
1 bar max. differential pressure (15 psi) at 135 °C
1.7 bar max. differential pressure (25 psi) at 80 °C
2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse)
69 mbar max. differential pressure (1 psi) at 135 °C

Quality Level

400

material

fluoroelastomer O-ring
polyethersulfone membrane
polypropylene housing
polypropylene support
seal (Fluorocarbon rubber)

reg. compliance

meets FDA Indirect Food Additive requirements cited in 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®

technique(s)

sterile filtration: suitable

L

25.4 cm (10 in.)

W

2.7 in.

cartridge nominal length

10 in. (25 cm)

filter diam.

6.9 cm (2.7 in.)

filter filtration area

0.60 m2 (6.5 ft2)

filter size

10 in.

impurities

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

matrix

Millipore Express® SHR

pore size

0.1 μm pore size

bubble point

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C

cartridge code

Code 7

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Analysis Note

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

TOC/Conductivity: After sterilization and a controlled water flush of 10 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.

General description

Cartridge Type: Liquid
Device Configuration: Cartridge

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.

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: 25 forward or 22 forward and 3 reverse SIP cycles of 30 min at 135 °C; 25 autoclave cycles of 60 min at 126 °C

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).

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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