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Bacterial Endotoxins
Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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Catalogue Number
SW19A47HH3
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Chemistry
Mixed Cellulose Esters (MCE)
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Device Configuration
Capsule
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Device Material
Polycarbonate
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Diameter
6.9 cm (2.7 in.)
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Filtration Area
17.7 cm²
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Format
Single 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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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
1/4 in.
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Material Size
3
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Maximum Inlet Pressure (psig)
80 psig
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Maximum Inlet Pressure, bar (psi)
5.5 bar (80 psi) @ 25 °C
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Maximum Inlet Temperature
25 °C
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Media
Milligard®
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Nominal Pore Size
1.2 µm
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Outlet Connection
Hose Barb
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Outlet Connection Diameter
1/4 in.
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Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥100 mL
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Pore Size
1.2 µm
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Seal Material
Fluoroelastomer (FKM)
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Sterilization
3 autoclave cycles of 60 min @ 121 °C; not in-line steam sterilizable
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Support Material
Polypropylene
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Trade Name
OptiScale®
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Vent Cap Material
Polyvinylidene fluoride (PVDF)
+852-3069 6950
css@gugent.com.hk
