-
Bacterial Endotoxins
Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
-
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
-
Cartridge Nominal Length
3 in. (7.5 cm)
-
Catalogue Number
KHVEA03TB3
-
Chemistry
Polyethersulfone (PES)
-
Device Configuration
Capsule
-
Device Material
Polypropylene/Polysulfone
-
Device Size
3 in.
-
Diameter
10.7 cm (4.2 in.)
-
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.
-
Filtration Area
0.13 m²
-
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
-
Housing Material
Polypropylene (PP)
-
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
-
Inlet Connection
Sanitary Flange
-
Inlet Connection Diameter
1-1/2 in.
-
Inlet to Outlet Width
17.3 cm (6.8 in.)
-
Length
3 in. (7.5 cm)
-
Material Package
Double Easy-Open bag
-
Material Size
3
-
Maximum Differential Pressure
80 psi (5.5 bar) continuous100 psi (6.9 bar) intermittent
-
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
-
Maximum Inlet Pressure (psig)
80 psig
-
Maximum Inlet Pressure, bar (psi)
6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
-
Maximum Inlet Temperature
25 °C
-
Media
Millipore Express® SHR w/Prefilter
-
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).
-
Outlet Connection
Hose Barb
-
Outlet Connection Diameter
1 in.
-
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
-
Pore Size
0.5 / 0.1 µm
-
Seal Material
Silicone (SI)
-
Sterilization
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
-
Support Material
Polypropylene
-
Trade Name
Millipore Express®
-
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
-
Vent Cap Material
Polypropylene (PP)
-
Wettability
Hydrophilic
-
Width
17.3 cm (6.8 in.)