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Key Documents

CVEP72TE3

Millipore

Millipore Express® SHR, Cartridge

pore size 0.1 μm, cartridge nominal length 20 in. (50 cm), Code 7, EPDM rubber seal

Sinonimo/i:

Millipore Express SHR Cartridge Filter 20 in. 0.1 μm Code 7 EPDM

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About This Item

Codice UNSPSC:
23151806
eCl@ss:
32031690

Materiali

EPDM rubber seal
polyethersulfone
polypropylene
polypropylene support
polysulfone

Livello qualitativo

Conformità normativa

meets FDA Indirect Food Additive requirements cited in 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

Produttore/marchio commerciale

Millipore Express®

Parametri

≤66.6 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water)
<1.0 psi max. differential pressure (69 mbar) at 135 °C (reverse)
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)
100 psi max. differential pressure (6.9 bar) at 25 °C (forward)
2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse)
25 psi max. differential pressure (1.7 bar) at 80 °C (forward)
30 psi max. differential pressure (2.1 bar) at 25 °C (reverse)
5.0 psi max. differential pressure (340 mbar) at 135 °C (forward)
6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)

tecniche

sterile filtration: suitable

Lunghezza

20 in.

Larghezza

2.7 in.

Lunghezza nominale della cartuccia

20 in. (50 cm)

Diametro

6.9 cm (2.7 in.)

Superficie filtrante

1.2 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

Dimensione pori

0.1 μm pore size

input

sample type liquid

Punto di bolla

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

Codice cartuccia

Code 7

Descrizione generale

Device Configuration: Cartridge

Confezionamento

Double Easy-Open bag

Altre note

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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.

Nota sulla preparazione

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

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 <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

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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