The filter has a hydrophilic wettability and a pore size of 0.5 / 0.2 µm. It is sterile and can withstand 3 autoclave cycles of 60 min at 123 °C. The filter is quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
The filter device meets the FDA Indirect Food Additive requirements cited in 21 CFR 177-182 and is non-fiber releasing. The aqueous extraction contains ≤0.25 EU/mL of bacterial endotoxins as determined by the Limulus Amebocyte Lysate (LAL) Test. After sterilization and a controlled water flush of 21 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
The dimensions of the filter device are 10 in. (25 cm) nominal length, 33.5 cm (13.2 in.) length, and 10.7 cm (4.2 in.) diameter. The filtration area is 0.54 m², and the maximum differential pressure is 80 psi (5.5 bar) continuous and 100 psi (6.9 bar) intermittent. The device is designed to meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L.
The materials used in the filter device include polyethersulfone (PES) chemistry for the filter media, polypropylene/polysulfone for the device material, silicone (SI) for the seal material, and polyester for the support material. The vent cap material is made of polypropylene (PP). The product is packaged in a easy-open bag.
Description
Catalogue Number KHGES10TT1
Trade Name
Millipore Express®
Description Opticap® Sterile XL 10 Millipore Express® SHC 0.5/0.2 µm 1-1/2 in. TC/TC
Product Information
Device Configuration Capsule
Connections, Inlet/Outlet 38 mm (1-1/2 in.) Sanitary Flange
Connections, Vent/Drain 1/4 in. Hose Barb with double O-ring seal
Housing Material Polypropylene (PP)
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, bar (psi) 6.9 bar (100 psi) intermittent @ 25 °C; 5.5 bar (80 psi) @ 25 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
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.
Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality Level MQ400
Biological Information
Bacterial Endotoxins Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Millipore Express® SHC
Sterility Sterile
Sterilization 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Bacterial Retention Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Wettability Hydrophilic
Physicochemical Information
Pore Size 0.5 / 0.2 µm
Inlet Connection Sanitary Flange
Outlet Connection Sanitary Flange
Air Diffusion at 23 °C ≤31.2 mL/min @ 2.8 bar (40 psig) in water
Bubble Point at 23 °C ≥4000 mbar (58 psig) air with water
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Inlet Pressure (psig) 80 psig
Maximum Differential Pressure 80 psi (5.5 bar) continuous
100 psi (6.9 bar) intermittent
Maximum Inlet Temperature 25 °C
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).
TOC/Conductivity After sterilization and a controlled water flush of 21 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
USP Bacterial Endotoxins A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Cartridge Nominal Length 10 in. (25 cm)
Length 33.5 cm (13.2 in.)
Diameter 10.7 cm (4.2 in.)
Filtration Area 0.54 m²
Inlet to Outlet Width 33.5 cm (13.2 in.)
Device Size 10 in.
Inlet Connection Diameter 1-1/2 in.
Outlet Connection Diameter 1-1/2 in.
Materials Information
Chemistry
Polyethersulfone (PES)
Device Material
Polypropylene/Polysulfone
Seal Material Silicone (SI)
Support Material Polyester
Vent Cap Material Polypropylene (PP)