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Merck
CN

CGEP73TP48

Millipore Express® SHF 0.2µm Cartridge 30

Code 7 Silicone, Autoclavable and SIP

别名:

Millipore Express SHF Cartridge Filter 30 in. 0.2 μm Code 7 Silicone, 48-pack

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UNSPSC Code:
23151806

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Quality Level

400

cartridge code

Code 7

material

polyethersulfone membrane, polypropylene housing, polypropylene support, polysulfone (core), silicone O-ring

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

parameter

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

technique(s)

sterile filtration: suitable

L

76.2 cm (30 in.)

diam.

10.7 cm (8.1 in.)

filtration area

1.62 m2 (17.4 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

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General description

Device Configuration: Capsule

Application

Filters containing Millipore Express® SHF (Sterile, High Flux) sterilizing-grade membrane provide exceptionally high flow rates for low plugging streams. These filters contain a 0.2 µm polyethersulfone (PES) membrane that provides broad chemical compatibility for critical process steps that require validated sterility assurance.

Features and Benefits

  • Sterilizing-grade membranes that are easy to wet and integrity test
  • High flux PES membrane that provides superior processing efficiency
  • Broad chemical compatibility across a wide pH range
  • 100% integrity tested during the manufacturing process

Analysis Note

TOC/Conductivity
After sterilization and a controlled water flush of 30 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 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 to Millipore Express® Membrane user guide
  • Storage Statement: Please refer to 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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