Millipore Express® PHF Cartridge Filters
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Overview
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Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® |
Description
Millipore Express® PHF (Process protection, High-Flux) devices provide sterilizing-grade performance, ideal for buffers and other intermediate process fluids. These devices provide broad chemical compatibility, high flow rates and extended throughput for superior process efficiency and economy.
Developed to Enhance Buffer Filtration
Millipore Express® PHF filters use a fast flowing membrane specifically developed for the filtration of buffers, pH adjusters and other aqueous intermediate pharmaceutical and biotech solutions. Designed to offer high-flux performance and improved process economics, Millipore Express® PHF filters are compatible with a wide range of buffer chemistries, including acids and sodium hydroxide.
Filter Applications
- Buffer solutions
- Process additives and intermediates
Benefits
- Sterilizing-grade
- Faster flow rates than most sterilizing-grade filters, reducing process footprint
- Multiple steam-in-place or autoclave sterilization cycles
- Single-use, gamma ready formats
- Broad chemical compatibility, high and low pH 1–14
- Fully scalable product offering
| Cartridge Filters | ||
| 5" Cartridge Filters | Per 10-inch Filter | |
| Nominal Dimensions | ||
| Diameter | 6.9 cm (2.7 in.) | |
| Length | 12.5 cm (5 in.) | 25 cm (10 in.) |
| Weight | - | |
| Filtration Area | 0.29 m² | 0.54 m² |
| Materials of Construction | ||
| Filter Membrane | Hydrophilic Polyethersulfone (PES) | |
| Film Edge | Polypropylene | |
| Supports | Polypropylene | |
| Cage and end caps | Polypropylene | |
| Core | Polysulfone | |
| Structual Components* | - | |
| Vent cap | - | |
| O-ring | EPDM, silicone or fluorocarbon rubber | |
| Housing Vent | - | |
| Maximum Inlet | - | |
| Maximum Differential Pressure | ||
| Forward | 80 psi (5.5 bar) at 25 °C 25 psi (1.7 bar) at 80 °C 5.0 psi (340 mbar) at 135 °C |
|
| Reverse | 20 psi (1.4 bar) at 25 °C <1.0 psi (69 mbar) at 135 °C | |
| Air Diffusions at 23°C | ≤16.4 mL/min @ 2.8 bar (40 psig) in water | ≤30 mL/min @ 2.8 bar (40 psig) in water |
| Bacterial Retention | Samples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. | |
| Bacterial Endotoxin | A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. | |
| TOC/Conductivity | After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645>. | |
| Oxidizable Subtances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L | |
| Sterilization | 12 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 15 autoclave cycles of 60 min @ 126 °C | |
| USP Toxicity | Non-toxic per USP Cytotoxicity MEM Elusion Test. | |
| Particle Shedding | Passes USP test for particulates in injectables. | |
| 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). | |
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. | |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | |
| Good Manufacturing Practice | This product was manufactured in a facility which adheres to Good Manufacturing Practices. | |
| *Cage, end caps and capsule housing | ||