Sterilizing grade filter using a unique asymmetric technology coupled with a pre-filter layer. Good application with many special fluids.
Features
- Hydrophilic PES membrane has a wide range of chemical compatibility
- Unique asymmetrical structure with excellent flow rate
- Built-in pre-filtration layer, long service life, low cost
Applications
- Highly viscous fluid
- Sterile filtration
Quality
- 100% Integrity testing in manufacturing
- Each filter is fully traceable with unique serial number
- Manufactured in a facility which adheres to ISO 9001:2015 Practices
Flow Rate Characteristics
Specifications
Material of Construction
| Membrane | Hydrophilic polyethersulfone (PES) |
| Support | Polypropylene (PP) |
| Core/Cage/End Caps | Polypropylene (PP) |
| End Cap Inserts | Polybutylene terephthalate (PBT) |
| Seal Material | Silicone / EPDM / Viton FEP/ PFA encapsulated O-rings |
Operating Conditions
| Max. Operating Temperature | 80°C |
| Max.Operating Pressure | 0.69 MPa@25°C 0.40 MPa@60°C 0.24 MPa@80°C |
| Max. Differential Pressure (Forward) | 0.69 MPa@25°C 0.40 MPa@60°C 0.24 MPa@80°C |
| Max. Differential Pressure (Reverse) | 0.30 MPa@25°C 0.10 MPa@80°C |
Filtration Area
| Outer Diameter | Membrane Pore Size | Area/10″ |
| 69mm | 0.22μm | 0.58m² |
Integrity Test Standards @10inch，20°C
| Membrane Pore Size | Bubble Point |
| 0.22μm | ≥ 0.30 MPa (water), Air test |
Bacterial Retention
| Model | Content |
| DPSTF 0.22μm | Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology. |
Sterilization
| In-line steam sterilization | Up to 60 cycles (135 °C for 30 min and differential pressure < 30 kPa per cycle) |
| Autoclave | Up to 200 cycles (130 °C for 30 min per cycle) |
Regulatory Compliance
- Autoclaved filter effluent meets the USP<788> requirement of particulate matter in large volume injection.
- Component materials meet the criteria for a “Non-fiber-releasing filter” as defined in 21 CFR 210.3(b)(6).
- Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
- Meet the requirement of USP <87> In Vitro Cytotoxicity Test.
- Component materials meet the requirements of the current USP<88> for plastic class VI-121°C.
- All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
- Based on the current information from our suppliers, all component materials used in the manufacture of this product are animal-free.
End Cap
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