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CHVE72TS3 Millipore

Millipore Express SHR Cartridge Filter 20 in. 0.5/0.1 µm Code 7 Silicone

  •  eCl@ss 32031690

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Properties

Related Categories Biopharmaceutical Manufacturing, Biopharmaceutical Process Development and Manufacturing, Sterile Filtration for Biopharmaceutical Manufacturing More...
Quality Level   400
material   polyethersulfone
  polypropylene
  polypropylene support
  polysulfone
  silicone seal
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   ≤54.2  mL/min air diffusion at 3.45  bar (50  psig) and 23 °C ( 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)
  1.0 psi max. differential pressure (69 mbar) at 135 °C (reverse)
  1.7 bar max. differential pressure (25 psi) at 80 °C (Forward)
  100 psi max. differential pressure (6.9 bar) at 25 °C (forward)
  15 psi max. differential pressure (1.0 bar) at 135 °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)
  6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
application(s)   sterile filtration: suitable
cartridge nominal length   20 in. (50 cm)
diam.   6.9 cm (2.7 in.)
filtration area   0.98 m2
overall size   20 in.
impurities   ≤0.25 EU/mL (LAL test, Aqueous extraction)
  <0.25  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix   Millipore Express® SHR (w/Prefilter)
pore size   0.1 μm pore size
  0.5 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, or 3 forward cycles, 30 min., 135 °C at ≤ 1000 mbar (15 psid); 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 40 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 ≥4 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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