Durapore® Membrane in Millipak® and Millidisk® Barrier Filters
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Categorias
| Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic |
Millidisk® Barrier and Millipak® Barrier Filters were developed to faciliate in-line pre-use integrity testing of a sterilized liquid filter system. All Millidisk® Barrier and Millipak® Barrier Filters are made with Durapore® PVDF membranes, providing high flow rates and throughputs, low extractables, broad chemical compatibility and the lowest protein binding of any membrane available.
The unique stacked disc design allows separate layers of hydrophilic and hydrophobic sterilizing-grade 0.22μm Durapore® membrane to be incorporated into a single filter to allow the sterile flow of liquid and gas. This permeable sterile barrier facilitates sterilization of an assembly, and simplifies wetting, flushing, and integrity testing of an upstream sterile filter by maintaining the sterility of the system while removing the restraint of a flush bag or flush can.
Millidisk® Barrier and Millipak® Barrier Filters are available in Millipak Barrier Capsule and Millidisk Barrier Cartridge formats.
Typical Applications
- Pre-Use Post Sterilization Integrity Testing (PUPSIT) of a single or redundant liquid filter systems
- Extractables flushing through a sterile boundary to drain
- Venting a cooling system post-sterilization
- Venting a sterile system during filter drying post-flushing
Millidisk® Barrier Filter
| Materials of Construction | |
| Membrane: | Hydrophilic and hydrophobic Durapore® PVDF |
| Structural Components/Housing: | Polysulfone |
| O-rings: | Silicone |
| Filtration Area | |
| Millidisk 40 Format | 2000 cm2 (310 in2) |
| Operating Conditions | |
| Maximum Differential Pressure (Forward) | |
| 4.1 bar (60 psi) at 25 °C | |
| 1.7 bar (25 psi) at 80 °C | |
| Maximum Differential Pressure (Reverse) | |
| 690 mbar (10 psi) at 25 °C | |
| Maximum Recommended Operational Pressure | The maximum forward differential pressure during this operation should not exceed 0.5 bar (7.25 psi) at 25 °C to prevent wetting of hydrophobic membrane |
| Sterilization | May be autoclaved at 126 °C for 60 minutes up to 4 times or steamed-in-place at 135 °C for 60 minutes up to 4 times |
| Bubble Point | ≥1280 mbar (18.5 psi) in 70/30% IPA/water at 23 °C |
| Bubble Retention | Millidisk Barrier Filter units are qualified for quantitative retention of Brevundimonas diminuta at a challenge level of 107 cfu/cm2 when tested in accordance to ASTM F838 methodology |
| Bubble Endotoxin | An aqueous extraction contains |
| Toxicity | Component materials meet the requirements of USP <88> Biological Reactivity Tests for Plastics Class VI-70°C and the USP <88> Safety Test Utilizing a 0.9% Sodium Chloride extraction. |
| Flow Rate | 15.1 L/min (4.0 GPM) at ≤ 1050 mbar (15.3 psi) with water at 25°C |
Millipak® Barrier Filter
| Materials of Construction | |
| Filter Media: | Hydrophilic and hydrophobic Durapore® PVDF membrane |
| Structural Components/Housings: | Polycarbonate |
| Filtration Area | |
| Millipak 200 Format | 1000 cm2 (1.08 ft2) |
| Operating Conditions | |
| Maximum Differential Pressure (Forward) | |
| 4.1 bar (60 psi) at 25 °C | |
| 1.7 bar (25 psi) at 80 °C | |
| Maximum Differential Pressure (Reverse) | |
| 690 mbar (10 psi) at 25 °C | |
| Maximum Recommended Operational Pressure | The maximum forward differential pressure during this operation should not exceed 0.5 bar (7.25 psi) at 25 °C to prevent wetting of hydrophobic membrane |
| Sterilization | May be autoclaved at 123 °C for 90 minutes up to 3 times, not in-line steam sterilizable |
| Bubble Point | Bubble Point >1280 mbar (18.5 psi) in 70/30% IPA/water at 23 °C |
| Bacterial Retention | Millipak Barrier Filter units are qualified for quantitative retention of Brevundimonas diminuta at a challenge level of 107 cfu/cm2 when tested in accordance to ASTM F838-83 methodology |
| Bacterial Endotoxin | An aqueous extraction contains |
| Toxicity | Component materials meet the requirements of USP <88> Biological Reactivity Tests for Plastics Class VI-70°C , the USP <88> Safety Test Utilizing a 0.9% Sodium Chloride extraction, and the USP <87> L929 MEM Elution Test. |
| Flow Rate | 7.6 L/min (2.0 GPM) at ≤1140 mbar (16.5 psi) with water at 25°C |