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LPSL filter cartridges are specially designed for sterilizing filtration of plasma fractionation. They are featuring extremely low extractables with no more than 10mg/10”, longer service life with 40 cycles of SIP. These filters can powerfully ensure final product quality.
Features and Benefits
● Double layer hydrophilic PES Membrane
● Low protein binding
● Extensive drug compatibility for critical applications
● Extremely low extractables
Quality
● Cartridges produced in a controlled environment
● Manufactured according to ISO9001 certified Quality Management System
LPSL Low Extractable and Longer Service Life Filter Cartridge for Plasma Fractionation
Materials of Construction | |
Membrane | Double Layer Hydrophilic PES |
Support | PP |
Core, Cage and Drainage | PP |
End Caps | PP (222/226 with encapsulated stainless steel reinforcing ring) |
O-rings/Gasket | Silicone/EPDM/Viton |
Sealing technology | Thermal Bonding, No Adhesives |
Dimensions | |
Diameter | Φ70 |
Length | 5 inch, 10 inch, 20 inch, 30 inch |
Filtration Area, ft2 | |
≥ 4.9 per 10-inch cartridge | |
Pore Size, μm | |
0.45+0.22 | |
Maximum Differential Pressure | |
Forward: 4.2 bar @ 23 ℃; 1.5 bar @ 85 ℃ | |
Integrity Test at 23 ℃ | |
Water bubble point | ≥ 3500 mbar (50 psig) |
Diffusive flow | ≤ 30ml/min/10”@2.8bar |
Bacterial Retention | |
Passed the bacterial challenge testing using Brevundimonas diminuta (ATCC19146) at a minimum challenge concentration of 1 x 107 CFU/cm2. | |
Extractables, per 10-inch cartridge | |
≤ 10 mg after 24-h soak in water | |
Effluent Particle Level | |
Meets the requirements of Chinese Pharmacopoeia 2010, Volume Ⅱ, appendix Ⅸ C. | |
Non-Fiber Releasing | |
Meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). | |
Toxicity | |
Component materials meet GB/T 14233.2<2005>of Chinese National Standard for Safety Tests.!2005>!!2005>!!!2005>!!2005>!2005>!!2005>!2005> | |
TOC | |
< 500 ppb after a water flush of 60 liters per 10-inch cartridge | |
Multiple Sterilization Cycles | |
40 steam-in-place sterilization or autoclave cycles of 30 min at 123℃ | |
Oxidizable Substances | |
Meets the criteria of Chinese Pharmacopoeia 2010, volume Ⅱ for purified water. | |
Bacterial Endotoxins | |
< 0.25 EU/ml as determined by the LAL test |
LPSL Low Extractable and Longer Service Life Filter Cartridge for Plasma Fractionation