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Merck
CN

CGEP75TF3

Millipore Express® SHF 0.2µm Cartridge 5

Code 7 Fluorocarbon, Autoclavable and SIP

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHF，小柱, Chemistry: 0.2 µm Hydrophilic Polyethersulfone (PES) Configuration: 5 in. Code 7

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®

parameter

1.7 bar max. differential pressure (25 psi) at 80 °C, 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse), 340 mbar max. differential pressure (5 psi) at 135 °C, 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward), 69 mbar max. differential pressure (1 psi) at 135 °C

technique(s)

sterile filtration: suitable

W

2.7 in.

cartridge nominal length

5 in. (12.5 cm)

device L

12.5 cm (5 in.)

filter diam.

2.7 in. (6.9 cm)

filter filtration area

0.29 m2 (3.1 ft2)

impurities

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

matrix

Millipore Express® SHF

pore size

0.2 μm pore size

bubble point

≥4000 mbar (58 psig), air with water at 23 °C

cartridge code

Code 7

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General description

Cartridge Type: Liquid
Device Configuration: Cartridge

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).

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 5.5 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
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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