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Bacterial Endotoxins
A sample aqueous extraction contains less than 0.25 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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Cartridge Nominal Length
10 in. (25 cm)
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Catalogue Number
KHGLS10FH1
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Chemistry
Polyvinylidene Fluoride (PVDF)
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Device Configuration
Capsule
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Device Size
10 in.
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Diameter
3/4 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
Sanitary Flange
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Inlet Connection Diameter
3/4 in.
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Length
10 in. (25 cm)
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Material Size
1
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Maximum Inlet Pressure (psig)
80 psig
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Maximum Inlet Temperature
25 °C
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Media
Multilayer 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
Hose Barb
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Outlet Connection Diameter
9/16 in.
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Pore Size
0.45 / 0.22 µm
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Sterility
Sterile
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Sterilization
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
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Trade Name
Opticap®
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USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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Wettability
Hydrophilic
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