millipore,密理博,LAGRM1S02,Optiseal-M Aervent Cartridge Filter 0.2 µm hydrophobic

Description
Catalogue Number	LAGRM1S02
Trade Name	Optiseal^®
Description	Optiseal-M Aervent Cartridge Filter 0.2 µm hydrophobic

Product Information
Device Configuration	Cartridge
Maximum Differential Pressure, bar (psid)	Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 4.1 bar (60 psid)
Maximum Inlet Pressure, bar (psi)	Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 4.1 bar (60 psi)
Cartridge Code	Not Applicable
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality Level	MQ400

Biological Information
Bacterial Endotoxins	Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media	Aervent^®
Sterilization	80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C
Bacterial Retention	Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.
Wettability	Hydrophobic

Physicochemical Information
Pore Size	0.2 µm
Bubble Point at 23 °C	≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water
Gravimetric Extractables	The extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Non-Fiber Releasing	This product was manufactured with a PTFE 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.