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Bacterial Endotoxins
Aqueous extraction contains ≤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
KHGEA10TT1
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Chemistry
Polyethersulfone (PES)
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Device Configuration
Capsule
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Device Material
Polypropylene/Polysulfone
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Device Size
10 in.
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Diameter
10.7 cm (4.2 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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Filtration Area
0.49 m²
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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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Housing Material
Polypropylene (PP)
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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
1-1/2 in.
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Inlet to Outlet Width
33.5 cm (13.2 in.)
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Length
10 in. (25 cm)
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Material Package
Double Easy-Open bag
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Material Size
1
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Maximum Differential Pressure
80 psi (5.5 bar) continuous100 psi (6.9 bar) intermittent
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Maximum Differential Pressure, bar (psid)
Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
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Maximum Inlet Pressure (psig)
80 psig
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Maximum Inlet Pressure, bar (psi)
6.9 bar (100 psi) intermittent @ 25 °C; 5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
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Maximum Inlet Temperature
25 °C
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Media
Millipore Express® SHC
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Non-Fiber Releasing
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).
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Outlet Connection
Sanitary Flange
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Outlet Connection Diameter
1-1/2 in.
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Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
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Pore Size
0.5 / 0.2 µm
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Seal Material
Silicone (SI)
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Sterilization
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
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Support Material
Polypropylene
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Trade Name
Millipore Express®
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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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Vent Cap Material
Polypropylene (PP)
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Wettability
Hydrophilic
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Width
33.5 cm (13.2 in.)
+852-3069 6950
sales@gugent.com.hk
