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Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
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Catalogue Number
KVGBA04NN3
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Chemistry
Polyvinylidene Fluoride (PVDF)
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Device Configuration
Capsule
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Device Size
4 in.
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Diameter
1/4 in.
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European Pressure Equipment Directive
EMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
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Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
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Inlet Connection
NPT
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Inlet Connection Diameter
1/4 in.
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Material Size
3
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Maximum Inlet Pressure (psig)
80 psig
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Maximum Inlet Temperature
25 °C
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Media
Durapore®
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Non-Fiber Releasing
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).
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Outlet Connection
NPT
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Outlet Connection Diameter
1/4 in.
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Pore Size
0.22 µm
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Trade Name
Durapore®
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USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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Wettability
Hydrophobic
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