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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 Code
Code 0 (2-222) O-rings
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Cartridge Nominal Length
10 in. (25 cm)
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Catalogue Number
CGW901S03
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Chemistry
Mixed Cellulose Esters (MCE)
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Device Configuration
Cartridge
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Device Material
Polypropylene
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Device Size
10 in.
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Diameter
7.1 cm (2.8 in.)
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Filtration Area
0.46 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 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
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Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
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Length
10 in. (25 cm)
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Material Package
Double Easy-Open bag
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Material Size
3
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Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
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Maximum Inlet Pressure, bar (psi)
3.5 bar (50 psi) @ 25 °C
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Media
Polysep™ II
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Nominal Pore Size
2.0 / 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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Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
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Pore Size
2.0 / 1.2 µm
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Sanitization
30 min with hot water @ 80 °C
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Seal Material
Silicone (SI)
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Sterilization
10 autoclave cycles or SIP @ 121 °C for 30 min
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Support Material
Spun bonded polypropylene
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Trade Name
Polysep®
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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.
+852-3069 6950
sales@gugent.com.hk
