The Cobetter APSBR is a sterilizing grade filter. The unique asymmetric hydrophilic polyethersulfone membrane provides excellent filtration performance and reliable filter loading. Resistant to repeated steam sterilization. It can fully meet the filtration requirements of pharmaceutical processes.
Features
- Excellent long life and cost effective
- Broad chemical compatibility (pH 1-14) to effectively handle a wide range of pharmaceutical filtration processes
- Asymmetric membrane design for increased loading capacity
Applications
- Chinese medicine injection filtration
- Sterile filtration of sterile raw materials
- Sterile filtration for eye drops, liquid sterile filtration
- 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 0.40 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″ |
| 69 mm | 0.1 μm | 0.58 m² |
| 69 mm | 0.22 μm | 0.58 m² |
| 69 mm | 0.45 μm | 0.58 m² |
Integrity Standard @10inch，20°C
| Membrane Pore Size | Bubble Point | Diffusion Flow (Air) |
| 0.1 μm | ≥ 0.38 MPa (water), Air test | ≤ 25 ml/min @ 0.345 MPa (water) |
| 0.22 μm | ≥ 0.32 MPa (water), Air test | ≤ 25 ml/min @ 0.275 MPa (water) |
| 0.45 μm | ≥ 0.20 MPa (water), Air test | ≤ 25 ml/min @ 0.15 MPa (water) |
Bacterial Retention
| Model | Content |
| SPSHR 0.1μm | Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology. |
| SPSHR 0.22μm | |
| SPSHR 0.45μm | Bacterial quantitative retention of 10⁷ cfu/cm² Serratia marcescens (ATCC14756) according to ASTM F838 methodology |
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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