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SVGLA25NB6 Millipore

Durapore® 0.22 µm Optiscale 25mm NB

  •  eCl@ss 32031610

  •  NACRES NB.24

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Properties

Quality Level   400
material   PVDF membrane
  polypropylene
  polypropylene support
  polypropylene vent cap
feature   hydrophilic
mfr. no.   OptiScale®
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.)
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   Durapore®
pore size   0.22 μm pore size
input   sample type liquid
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 Durapore® 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

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

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

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

Documents

Certificate of Analysis (COA)

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Protocols & Articles

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