Millipore Express^® SHC Cartridge Filter

32031690

Device Configuration: Cartridge

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

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

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).
Sterilization Method
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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
TOC/Conductivity
After sterilization and a controlled water flush of 9.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

ASTM is a registered trademark of American Society for Testing and Materials
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

400

polyethersulfone
polypropylene
polypropylene support
polysulfone
silicone seal

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

sterile

EMPROVE^® Filter

hydrophilic

Millipore Express^®

≤13.3 mL/min air diffusion at 2.8 bar (40 psig) and 23 ℃ (in water)
0.07 bar max. inlet pressure (1 psi) at 135 ℃ (Reverse)
1.0 bar max. inlet pressure (15 psi) at 135 ℃ (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 ℃ (Forward)
1700 bar max. differential pressure (25 psi) at 80 ℃ (Forward)
2.07 bar max. inlet pressure (30 psi) at 25 ℃ (Reverse)
2100 mbar max. differential pressure (30 psi) at 25 ℃ (Reverse)
340 mbar max. differential pressure (5 psi) at 135 ℃ (Forward)
69 mbar max. differential pressure (1 psi) at 135 ℃ (Reverse)
6900 mbar max. differential pressure (100 psi) at 25 ℃ (Forward)
7 bar max. inlet pressure (100 psi) at 25 ℃ (Forward)

5 in. (12.5 cm)

6.9 cm (2.7 in.)

0.23 m²

5 in.

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

Millipore Express^® SHC

0.5/0.2 μm pore size

sample type liquid

≥4000 mbar (58 psig), air with water at 23 ℃

Code 7

Double Easy-Open bag