Cobetter APSEA cartridge is a double-layer membrane filter: polypropylene pre-filtration layer and asymmetric PES membranes for bacterial reduction, LRV/cm² > 6
Features
- Excellent long life and cost-effective
- Asymmetric, high loading capacity, bacterial reduction pre-filtration
Applications
- Bacterial reduction before final sterilization and filtration
- Reduces bioburden
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 | 0.22 μm | 0.66 m² |
| 69 mm | 0.45 μm | 0.66 m² |
| 69 mm | 0.65 μm | 0.66 m² |
| 69 mm | 0.8 μm | 0.66 m² |
| 69 mm | 1.0 μm | 0.66 m² |
| 69 mm | 1.2 μm | 0.66 m² |
| 69 mm | 3.0 μm | 0.66 m² |
| 69 mm | 5.0 μm | 0.66 m² |
| 69 mm | 8.0 μm | 0.66 m² |
| 69 mm | 10.0 μm | 0.66 m² |
Integrity Test Standards @10inch，20°C
| Membrane Pore Size | Bubble Point |
| 0.22 μm | ≥ 0.11 MPa，60% IPA, 40% Water, Air test |
| 0.45 μm | ≥ 0.07 MPa，60% IPA, 40% Water, Air test |
| 0.65 μm | ≥ 0.04 MPa，60% IPA, 40% Water, Air test |
Bacterial Retention
| Model | Content |
| APSEA 0.22 μm | LRV/cm² ＞6 for 10⁷ cfu/cm² Brevundimonas diminuta（ATCC 19146） |
| APSEA 0.45 μm | LRV/cm² ＞6 for 10⁷ cfu/cm² Serratia marcescens (ATCC 14756) |
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.
End Cap
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