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millipore濾芯CGEP72TP3

Millipore Express® SHF Cartridge Filter 20 in. 0.2 µm Code 7 Silicone

概述

Replacement Information

規格

Description

Catalogue Number CGEP72TP3

Trade Name

Millipore Express®

Description Millipore Express® SHF Cartridge Filter 20in. 0.2µm Code 7 Silicone

References

Product Information

Device Configuration Cartridge

Maximum Inlet Pressure, bar (psi) Forward- 7 bar (100 psi) @ 25°C; 1.7 bar (25 psi) @ 80°C; 0.35 bar (5 psi) @ 135°C; Reverse- 2.07 bar (30 psi) @ 25°C; 0.07 bar (1 psi) @ 135°C

Cartridge Code Code7

Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Applications

Biological Information

Bacterial Endotoxins Aqueous extraction contains ≤0.25EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test

Media Millipore Express® SHF

Sterilization 25 forward or 22 forward and 3 reverse SIP cycles of 30min @ 135°C; 25 autoclave cycles of 60min @ 126°C

Bacterial Retention Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10?CFU/cm2 using ASTM®F838 methodology.

Wettability Hydrophilic

Physicochemical Information

Pore Size 0.2 µm

Air Diffusion at 23°C ≤60mL/min @ 2.75bar (40psig) in water

Bubble Point at 23°C ≥4000mbar (58psig) air with water

Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21CFR177-182.

Maximum Differential Pressure Forward: 6900 mbar (100 psi) @ 25°C; 1700 bar (25 psi) @ 80°C; 340 mbar (5 psi) @ 135°C. Reverse: 2100 mbar (30 psi) @ 25°C, 69 mbar (1 psi) @ 135°C

Non-Fiber Releasing This product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

TOC/Conductivity After sterilization and a controlled water flush of 20L, samples exhibited less than 500ppb TOC per USP <643> and less than 1.3µS/cm per USP <645> at 25°C.

USP Bacterial Endotoxins A sample aqueous extraction contains less than 0.25EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.

Dimensions

Cartridge Nominal Length 20 in. (50 cm)

Diameter 6.9 cm (2.7 in.)

Filtration Area 1.1 m2

Device Size 20 in.

Materials Information

Chemistry

Polyethersulfone (PES)

Device Material

Polypropylene/Polysulfone

Seal Material Silicone (SI)

Support Material Polypropylene

Packaging Information

Material Size 3

Material Package Double Easy-Open bag

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Description
Catalogue Number	CGEP72TP3
Trade Name	Millipore Express®
Description	Millipore Express® SHF Cartridge Filter 20in. 0.2µm Code 7 Silicone

Product Information
Device Configuration	Cartridge
Maximum Inlet Pressure, bar (psi)	Forward- 7 bar (100 psi) @ 25°C; 1.7 bar (25 psi) @ 80°C; 0.35 bar (5 psi) @ 135°C; Reverse- 2.07 bar (30 psi) @ 25°C; 0.07 bar (1 psi) @ 135°C
Cartridge Code	Code7
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Biological Information
Bacterial Endotoxins	Aqueous extraction contains ≤0.25EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media	Millipore Express® SHF
Sterilization	25 forward or 22 forward and 3 reverse SIP cycles of 30min @ 135°C; 25 autoclave cycles of 60min @ 126°C
Bacterial Retention	Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10?CFU/cm2 using ASTM®F838 methodology.
Wettability	Hydrophilic

Physicochemical Information
Pore Size	0.2 µm
Air Diffusion at 23°C	≤60mL/min @ 2.75bar (40psig) in water
Bubble Point at 23°C	≥4000mbar (58psig) air with water
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21CFR177-182.
Maximum Differential Pressure	Forward: 6900 mbar (100 psi) @ 25°C; 1700 bar (25 psi) @ 80°C; 340 mbar (5 psi) @ 135°C. Reverse: 2100 mbar (30 psi) @ 25°C, 69 mbar (1 psi) @ 135°C
Non-Fiber Releasing	This product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
TOC/Conductivity	After sterilization and a controlled water flush of 20L, samples exhibited less than 500ppb TOC per USP <643> and less than 1.3µS/cm per USP <645> at 25°C.
USP Bacterial Endotoxins	A sample aqueous extraction contains less than 0.25EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.

Dimensions
Cartridge Nominal Length	20 in. (50 cm)
Diameter	6.9 cm (2.7 in.)
Filtration Area	1.1 m2
Device Size	20 in.

Materials Information
Chemistry	Polyethersulfone (PES)
Device Material	Polypropylene/Polysulfone
Seal Material	Silicone (SI)
Support Material	Polypropylene

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