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CVEP71TE3 Millipore

Millipore Express SHR Cartridge Filter 10 in. 0.1 µm Code 7 EPDM

  •  eCl@ss 32031690

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Properties

Quality Level   400
material   EPDM rubber seal
  polyethersulfone
  polypropylene
  polypropylene support
  polysulfone
reg. compliance   meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility   sterile
feature   hydrophilic
mfr. no.   Millipore Express®
parameter   ≤33.3 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)
application(s)   sterile filtration: suitable
cartridge nominal length   10 in. (25 cm)
diam.   6.9 cm (2.7 in.)
filtration area   0.6 m2
overall size   10 in.
impurities   ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
  <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix   Millipore Express® SHR
pore size   0.1 μm nominal pore size
  0.1 μm pore size
input   sample type liquid
bubble point   ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
cartridge code   Code 7

Description

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Other Notes

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.

Preparation Note

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).

Analysis Note

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 10 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 ≥1 L

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

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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