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.
Catalogue Number
KEGBG003FF3
Chemistry
Polyethersulfone (PES)
Device Configuration
Capsule
Device Material
Gamma stable polypropylene/Polysulfone
Diameter
5.6 cm (2.2 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
0.048 m²
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 3 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Housing Material
Polypropylene (PP)
Inlet Connection
Sanitary Flange
Inlet Connection Diameter
3/4 in.
Inlet to Outlet Width
11.9 cm (4.7 in.)
Key Applications
Small scale single-use applications
Length
11.9 cm (4.7 in.)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure
60 psi (4.1 bar) continuous
Maximum Differential Pressure, bar (psid)
Forward: 4.2 bar (60 psid) @ 25 °C; Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
Maximum Inlet Pressure (psig)
60 psig
Maximum Inlet Pressure, bar (psi)
4.1 bar (60 psi) @ 23 °C
Maximum Inlet Temperature
25 °C
Media
Millipore Express® SPG
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
Sanitary Flange
Outlet Connection Diameter
3/4 in.
Pore Size
0.2 µm
Seal Material
Silicone (SI)
Sterility
Gamma
Sterilization
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Support Material
Polyethylene
Trade Name
Opticap®
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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