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KGW3A3TTT1 MilliporeOpticap^® XLT30 Polysep^® II 1.0/0.2 µm 1-1/2 in. TC

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Overview

Description
Catalogue Number	KGW3A3TTT1
Trade Name	Opticap^®
Description	Opticap^® XLT30 Polysep^® II 1.0/0.2 µm 1-1/2 in. TC

Product Information
Format	Double Layer
Device Configuration	Capsule
Connections, Inlet/Outlet	38 mm (1-1/2 in.) Sanitary Flange
Housing Material	Polypropylene (PP)
Maximum Differential Pressure, bar (psid)	3.5 bar (50 psid) @ 25 °C
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
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Prefilter Material	Borosilicate Glass Fiber (BGF)
T-line/Gauge Port	T-line
Quality Level	MQ400

Biological Information
Bacterial Endotoxins	Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media	Polysep™ II
Sterilization	3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable

Physicochemical Information
Pore Size	1.0 / 0.2 µm
Inlet Connection	Sanitary Flange
Outlet Connection	Sanitary Flange
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.
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 Inlet Temperature	25 °C
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).
USP Bacterial Endotoxins	A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.

Dimensions
Cartridge Nominal Length	30 in. (75 cm)
Length	87.1 cm (34.3 in.)
Filtration Area	1.38 m²
Inlet to Outlet Width	15.2 cm (6.0 in.)
Device Size	30 in.
Inlet Connection Diameter	1-1/2 in.
Nominal Pore Size	1.0 / 0.2 µm
Outlet Connection Diameter	1-1/2 in.

Materials Information
Chemistry	Mixed Cellulose Esters (MCE)
Device Material	Polypropylene
Seal Material	Silicone (SI)
Support Material	Polypropylene
Vent Cap Material	Polypropylene (PP)

Packaging Information
Material Size	1
Material Package	Double Easy-Open bag

Specifications
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥15 L

Global Trade Item Number
Catalogue Number	GTIN
KGW3A3TTT1	04053252447471

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