Cobetter SPSHR series filters have ultra-low diffusion flow levels, establishing integrity values associated with bacterial challenges to ensure sterile effectiveness. Each filter element is strictly tested for bubble point and diffusion flow during manufacturing, providing a complete set of verification guidelines for customer verification. The SPSHR series of filters has a full line of scalable products, suitable for all stages from research and development to production, to accelerate the product to market.
Features
- Good hydrophilicity for easy wetting test
- Each filter cartridge has an independent serial number, which can fully trace the production history of the product
- Excellent temperature resistance
- 100% integrity test before delivery to ensure the integrity of the filter and sterilizing effect
Applications
- Sterile filtration of LVP, SVP
- Sterile filtration of large quantities of liquid medicine
- Buffer sterile filtration
- Sterile filtration of water-based antibiotic materials
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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