Cobetter DPSHSL is a sterilizing grade filter. The unique double-layer hydrophilic PES membrane has excellent filtration performance and reliable bacterial retention ability. It can withstand repeated steam sterilization and fully meet the filtration requirements of pharmaceutical process.
Features
- The unique double-layer design ensures reliable bacterial retention
- Excellent long service time and cost effective
- Broad chemical compatibility (pH 1-14) to effectively handle a wide range of pharmaceutical filtration processes
- Double-layer design extends the service life, decreases the cost of use and guarantees that the filter safety factor is increased by more than 10 times
Applications
- Chinese medicine injection filtration
- Sterile filtration of sterile raw materials
- Sterile filtration of eye drops and liquids
- Buffer 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
Materials 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 0.55 MPa@50°C 0.40 MPa@60°C 0.24 MPa@80°C |
| Max. Differential Pressure (Forward) | 0.69 MPa@25°C 0.55 MPa@50°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 | 0.22+0.1μm | 0.60m² |
| 69mm | 0.22+0.22μm | 0.60m² |
| 69mm | 0.45+0.22μm | 0.60m² |
| 69mm | 0.65+0.22μm | 0.60m² |
| 69mm | 0.8+0.22μm | 0.60m² |
| 69mm | 1.2+0.22μm | 0.60m² |
| 69mm | 0.45+0.45μm | 0.60m² |
| 69mm | 0.65+0.45μm | 0.60m² |
| 69mm | 0.8+0.45μm | 0.60m² |
Integrity Standard @10inch，20°C
| Membrane Pore Size | Bubble Point | Diffusion Flow (Air) |
| 0.22+0.1μm | ≥ 0.38 MPa (water), Air test | ≤ 25 ml/min @ 0.30 MPa (water) |
| 0.22+0.22μm | ≥ 0.34 MPa (water), Air test | ≤ 25 ml/min @ 0.275 MPa (water) |
| 0.45+0.22μm | ≥ 0.32 MPa (water), Air test | ≤ 25 ml/min @ 0.275 MPa (water) |
| 0.65+0.22μm | ≥ 0.32 MPa (water), Air test | ≤ 25 ml/min @ 0.275 MPa (water) |
| 0.8+0.22μm | ≥ 0.32 MPa (water), Air test | ≤ 25 ml/min @ 0.275 MPa (water) |
| 1.2+0.22μm | ≥ 0.32 MPa (water), Air test | ≤ 25 ml/min @ 0.275 MPa (water) |
| 0.45+0.45μm | ≥ 0.18 MPa (water), Air test | ≤ 25 ml/min @ 0.16 MPa (water) |
| 0.65+0.45μm | ≥ 0.18 MPa (water), Air test | ≤ 25 ml/min @ 0.16 MPa (water) |
| 0.8+0.45μm | ≥ 0.18 MPa (water), Air test | ≤ 25 ml/min @ 0.16 MPa (water) |
Bacterial Retention
| Model | Content |
| DPSHSL 0.22+0.1μm | Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology. |
| DPSHSL 0.22+0.22μm | |
| DPSHSL 0.45+0.22μm | |
| DPSHSL 0.65+0.22μm | |
| DPSHSL 0.8+0.22μm | |
| DPSHSL 1.2+0.22μm | |
| DPSHSL 0.45+0.45μm | Bacterial quantitative retention of 10⁷ cfu/cm² Serratia marcescens (ATCC14756) according to ASTM F838 methodology |
| DPSHSL 0.65+0.45μm |
Sterilization
| In-line steam sterilization | Up to 100 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.
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