-
Bacterial Endotoxins
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
-
Cartridge Nominal Length
10 in. (25 cm)
-
Catalogue Number
KW06A10FF1
-
Chemistry
Mixed Cellulose Esters (MCE)
-
Device Configuration
Capsule
-
Device Material
Polypropylene
-
Device Size
10 in.
-
Diameter
14.5 cm (5.7 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.
-
Filter Grade
Standard Milligard® Media
-
Filtration Area
0.8 m²
-
Format
Single Layer
-
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
-
Gravimetric Extractables
The extractables level was equal to or less than 55 mg per capsule after 24 hours in water at controlled room temperature.
-
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
3/4 in.
-
Inlet to Outlet Width
33.5 cm (13.2 in.)
-
Length
10 in. (25 cm)
-
Material Package
Double Easy-Open bag
-
Material Size
1
-
Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
-
Maximum Inlet Pressure (psig)
80 psig
-
Maximum Inlet Pressure, bar (psi)
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
Housing Material
-
Nominal Pore Size
0.5 µm
-
Non-Fiber Releasing
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
-
Outlet Connection
Sanitary Flange
-
Outlet Connection Diameter
3/4 in.
-
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
-
Pore Size
0.5 µm
-
Seal Material
Silicone (SI)
-
Sterilization
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
-
Support Material
Polyester
-
Trade Name
Opticap®
-
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
-
Vent Cap Material
Polypropylene (PP)
-
Width
33.5 cm (13.2 in.)