Purcise SLE Sterilizing-Grade Bricap L Series Capsule Filters
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Polyethersulfone (PES) material, optimal filter for final filtration.
Specifications
| Materials | Membrane | Hydrophilic Polyethersulfone(PES) |
| Support | Polypropylene(PP) | |
| Core/Cage/End Cap | Polypropylene(PP) | |
| Capsule Housing | Polypropylene(PP) | |
| Capsule Vent O-rings | Silicone | |
| Filtration Area | L02-0.12m² L03-0.16m² L05-0.28m² L10-0.55m² L20-1.1m² L30-1.65m² |
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| Operating Conditions | Max. Operating Temperature | 80°C |
| Max. Differential Pressure (Forward) | 0.55 MPa @25°C 0.10 MPa @80°C |
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| Max. Differential Pressure (Reverse) | 0.21 MPa @25°C |
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| Quality Standards | Integrity | 100% Integrity testing |
| Traceability | Each filter with a unique serial number | |
| QMS | ISO 9001:2015 | |
| Sterility | Delivery Condition | Non-sterile |
| Sterilization Method | Can be autoclaved 25 cycles for 30 minutes at 130°C (Can not be steam sterilized in-line) | |
| Package | Pack Size | 1/pk |
| Packaging | Double PE bag |
*Note: Cobetter also provides filters with different sterilization methods:
1. Gamma compatible filters: can be sterilized by gamma irradiation at 25-45 kGy or can be autoclaved 5 cycles for 60 minutes at 126 °C. (Can not be steamed in-line);
2. Pre-sterilized filters by gamma irradiation at 25-45 kGy (Gamma-sterilized products cannot be re-sterilized with gamma irradiation or steam sterilization);
3. Pre-sterilized filters by autoclaved for 30 minutes at 121°C (Packed in sterile breathable bags).
Features
- Low adsorption and low leachables
- Unwetted filter can be steam sterilized directly
Applications
- Sterile filtration of terminal products
- Sterile filtration of biological products
- Blood and serum products
- Sterile filtration of vaccine products
- Pre-column/ultra-filtration protection
- Filtration of intermediate products/stock solutions
Regulatory Compliance
- 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).
- Retention of 10⁷ cfu/cm² Brevundimonas diminuta(ATCC 19146) according to ASTM F838.
- Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
- Components meet the requirement of USP <87> In Vitro Biological Reactivity Test.
- Components meet the criteria of the USP <88> Biological Reactivity Test for Class V-121 °C plastics.
- Components meet the FDA indirect Food Additive requirements cited in 21 CFR177-182.
- Based on the current information from our suppliers, all components used in the manufacture of this product are animal-free.
*Contact us for more specification details.