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SHVEA25NB6 Millipore

Millipore Express SHR w/Prefilter Optiscale 25mm 0.5/0.1 µm NB

  •  eCl@ss 32031690

  •  NACRES NB.24

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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 membrane
  polypropylene
  polypropylene support
  polypropylene vent cap
feature   hydrophilic
mfr. no.   Millipore Express®
parameter   4.1 bar max. inlet pressure (60 psi) at 25 °C
  60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
L   3.9 cm (1.52 in.)
cartridge nominal length   1.52 in. (39 mm)
diam.   3.1 cm (1.2 in.)
filtration area   3.5 cm2
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
fitting   inlet connection female Luer-Lok®
  outlet connection male Luer-Lok®
Agency/Method   meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
shipped in   ambient

Description

General description

Device Configuration: Capsule

Other Notes

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

Preparation Note

Sterilization Method
1 autoclave cycle of 60 min @ 123 °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

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64>> and less than 1.3 µS/cm per USP <64>>.

This product was tested and passes the USP <78>> test for particulates in injectables.

Legal Information

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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.
Protocols & Articles

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