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Key Documents

CHVE71TF3

Millipore

Millipore Express® SHRP, Cartridge

with prefilter, cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm), Code 7

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About This Item

Codice UNSPSC:
23151806

Materiali

polypropylene support
seal (Fluorocarbon rubber)

Livello qualitativo

Conformità normativa

meets FDA 21 CFR 177-182 (all component materials)

Sterilità

non-sterile

Compatibilità con la sterilizzazione

autoclavable compatible
steam-in-place compatible

Nome Commerciale

Millipore Express®

Caratteristiche

hydrophilic
with prefilter

Produttore/marchio commerciale

Millipore Express®

Parametri

≤27.1 mL/min air diffusion at 3.45 bar (50 psig) (in water)
0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse)
0.35 bar max. differential pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psi) at 80 °C (Forward)
1000 mbar max. differential pressure (15 psi) at 135 °C (Forward)
1700 mbar max. differential pressure (25 psi) at 80 °C (Forward)
2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse)
2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse)
6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
69 mbar max. differential pressure (<1.0 psi) at 135 °C (Reverse)
6900 mbar max. differential pressure (100 psi) at 25 °C (Forward)

tecniche

sterile filtration: suitable

Lunghezza

10 in.

Larghezza

2.7 in.

Lunghezza nominale della cartuccia

10 in. (25 cm)

Diam. filtro

2.7 in. (6.9 cm)

Dimens. filtro

10 in.

Superficie filtrante

0.48 m2

Impurezze

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

Matrice

Millipore Express® SHR (w/Prefilter)

pore size

0.5/0.1 μm pore size

Punto di bolla

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

Codice cartuccia

Code 7

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Descrizione generale

Cartridge Type: Liquid
Device Configuration: Cartridge

Confezionamento

Double Easy-Open bag

Nota sulla preparazione

Sterilization Method: 25 forward or 22 forward and 3 reverse SIP cycles of 30 min at 135 °C, or 3 forward cycles, 30 min., 135 °C at ≤1000 mbar (15 psid); 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).

Risultati analitici

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

TOC/Conductivity: After sterilization and a controlled water flush of 20 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.

Altre note

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.

Note legali

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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