Catalogue Number

CHGE71TS3

Trade Name

• Millipore Express^®

Description

Millipore Express^® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone

Device Configuration

Cartridge

Maximum Inlet Pressure, bar (psi)

Forward - 7 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 1.0 bar (15 psi) @ 135 °C; Reverse - 2.07 bar (30 psi) @ 25 °C; 0.07 bar (1 psi) @ 135 °C

Cartridge Code

Code 7

Good Manufacturing Practices

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

Quality Level

MQ400

Bacterial Endotoxins

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

Media

Millipore Express^® SHC

Sterilization

25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C and 0.35 bar (5) or 3 forward SIP cycles of 30 min @ 135 °C and 1 bar (15 psid); 25 autoclave cycles of 60 min @ 126 °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

Hydrophilic

Pore Size

0.5 / 0.2 µm

Air Diffusion at 23 °C

≤28.2 mL/min @ 2.8 bar (40 psig) in water

Bubble Point at 23 °C

≥4000 mbar (58 psig) air with water

Indirect Food Additive

All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.

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 21 CFR 210.3 (b) (6).

TOC/Conductivity

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

USP Bacterial Endotoxins

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

Cartridge Nominal Length

10 in. (25 cm)

Diameter

6.9 cm (2.7 in.)

Filtration Area

0.49 m²

Device Size

10 in.

Chemistry

• Polyethersulfone (PES)

Device Material

• Polypropylene/Polysulfone

Seal Material

Silicone (SI)

Support Material

Polypropylene

Material Size

3

Material Package

Double Easy-Open bag

Oxidizable Substances

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L