Millipore Express(R) SHC Cartridge Filter (C15-1350-952)

General description

Millipore Express^® SHC filters have an on-board polyethersulfone membrane prefilter which protects the 0.2 μm membrane from premature plugging and extends filtration capacity, so you get sterilizing-grade performance with superior throughput. The CHGE75TS3 cartridge filter features a 0.5/0.2 μm pore size, a filtration area of 0.23 m² and a Code 7 cartridge configuration.

Millipore Express^® SHC filters provide you with a single solution for a range of process fluids, minimizing validation efforts and simplifying filter inventory and stocking requirements. With Millipore Express^® SHC filters, you increase productivity, shorten cycle-time and reduce cost.

Application

• Media additives
• Column protection
• Concentrated protein streams
• Cell harvest (post clarification)
• Caustics/pH adjusters
• Buffers
• CIP solution

Features and Benefits

• High capacity, high flux hydrophilic PES membranes
• Validated sterilizing-grade performance
• Easy wetting and integrity testing
• Superior throughput in high fouling streams, including media and protein containing solutions
• Increased capacity for improved process efficiency and economy
• Broad chemical compatibility across a wide pH range (1-14) — caustic compatible

Packaging

Double Easy-Open bag

Other Notes

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.

Preparation Note

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

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).

Analysis Note

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

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.

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

Legal Information

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