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Bacterial Endotoxins
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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Cartridge Nominal Length
30 in. (75 cm)
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Catalogue Number
KGW2A3THH1
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Chemistry
Mixed Cellulose Esters (MCE)
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Device Configuration
Capsule
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Device Material
Polypropylene
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Device Size
30 in.
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Diameter
5/8 in.
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Filtration Area
1.38 m²
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Format
Double Layer
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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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Gravimetric Extractables
The extractables level was equal to or less than 435 mg per capsule after a 15 L flush and 24 hours in water at controlled room temperature.
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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
Hose Barb
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Inlet Connection Diameter
5/8 in.
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Inlet to Outlet Width
19.8 cm (7.8 in.)
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Length
30 in. (75 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, bar (psid)
3.5 bar (50 psid) @ 25 °C
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Maximum Inlet Pressure (psig)
80 psig
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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
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Maximum Inlet Temperature
25 °C
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Media
Polysep™ II
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Nominal Pore Size
1.0 / 1.2 µm
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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).
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Outlet Connection
Hose Barb
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Outlet Connection Diameter
5/8 in.
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Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥15 L
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Pore Size
1.0 / 1.2 µm
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Seal Material
Silicone (SI)
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Sterilization
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
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Support Material
Polypropylene
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Trade Name
Opticap®
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USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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Vent Cap Material
Polypropylene (PP)
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Width
19.8 cm (7.8 in.)
+852-3069 6950
sales@gugent.com.hk
