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
Specification
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. | |
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 |
Ordering Information
LPSL Low Extractable and Longer Service Life Filter Cartridge for Plasma Fractionation
Application:
Plasma Fractionation
Sterile Injection Powder
Vaccines
Sterile Injection Powder
Small & Large Volume Parenterals
Plasma Fractionation
Ophthalmic Solutions
Facilities Water
Cell Culture Media Preparation
Active Pharmaceutical Ingredients
Beer Filtration
Wine Filtration
Bottled Water Filtration
Soft Drink Filtration
Dairy Filtration
High Fructose Syrup Filtration
Semicon Filtration
Ultrapure/DI Water Filtration
Photoresist Filtration
Display Filtration
CMP Slurry Filtration
Inkjet Inks Filtration
Water Filtration
Chemicals Filtration
Engaged in creating a clean and fresh environment for people, Sffiltech is specialized in membrane pvdf filter cartridges. As one of the best manufacturers and suppliers, we can assure you the best quality and stable performance of our custom products. Please rest assured to buy.