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KVVLG3ZTH1 MilliporeOpticap^® Gamma Compatible XLT30 Durapore^® 0.1 µm 1.5 in TC-5/8 in HB w/gauge port

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Overview

Description
Catalogue Number	KVVLG3ZTH1
Trade Name	Opticap^®
Description	Opticap^® Gamma Compatible XLT30 Durapore^® 0.1 µm 1.5 in TC-5/8 in HB w/gauge port

Product Information
Device Configuration	Capsule
Connections, Inlet/Outlet	Sanitary Flange/Hose Barb
Connections, Vent/Drain	1/4 in. Hose Barb with double O-ring Seal; 3/4 in. Gauge Port
Housing Material	Polypropylene (PP)
Maximum Differential Pressure, bar (psid)	Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C. Reverse: 2.8 bar (40 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)	5.5 bar (80 psi) @ 25 °C; 2.8 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.
T-line/Gauge Port	T-line with 3/4 in. Gauge Port T-line side
Quality Level	MQ400

Biological Information
Media	Durapore^®
Sterility	Gamma
Sterilization	3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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	0.1 µm
Inlet Connection	Sanitary Flange
Outlet Connection	Hose Barb
Air Diffusion at 23 °C	≤60 mL/min @ 3.9 bar (56 psig) in water
Bubble Point at 23 °C	≥4830 mbar (70 psig) air with water
Gravimetric Extractables	The extractables level was equal to or less than 75 mg per capsule after 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 Durapore^® membrane 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)
Device Size	30 in.
Inlet Connection Diameter	1-1/2 in.
Outlet Connection Diameter	5/8 in.

Materials Information
Chemistry	Polyvinylidene Fluoride (PVDF)
Device Material	Gamma-stable polypropylene
Seal Material	Silicone (SI)
Support Material	Polyester
Vent Cap Material	Polypropylene (PP)

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

Global Trade Item Number
Catalogue Number	GTIN
KVVLG3ZTH1	04053252563614

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