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The PES membranes for making cartridge filters at Lenge were developed and commercialized using its owned proprietary membrane manufacturing technologies in clean rooms in a state-of-the-art facility.The validation of bacterial B. diminuta retention for 0.22 µm rated pharmaceutical grade cartridges was performed in accordance with American Society of Testing and Materials (ASTM) method F838-05. Using this test methodology, 0.22 µm rated pharmaceutical grade filters retained greater than 1 x 107 CFU of B. diminuta per cm² of effective filter surface area.
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SEM Images of PES Flat Membrane
Detailed views of the membrane surface and cross-section structure
SEM photo of PES membrane, surface, upstream
SEM photo of PES membrane, surface, downstream
SEM photo of PES membrane, cross-section
Dirt Holding Capacity Test - 0.22 µm PES Membrane by PVP
Test by Fermentation Broth
Test By 2.5% Bovine Serum
Bubble Point Consistency - 0.22 µm PES filter cartridges
Reusability Test - 0.22 µm PES filter cartridges
Reusability Test - 0.45 µm PES filter cartridges
Features and Benefits
A01
Complies With United States Pharmacopeia (USP) Biological Reactivity Test, In Vivo For Biosafety, Cytotoxicity, And Hemolysis Testing.
A02
For 0.1.0.22µm Membrane, Lot Samples Retain A Minimum Of 10E7 CFU/CM2 Of Brevundimonas Diminuta(ATCC19146) Per Modified ASTM F838, Current Revision.
A03
The Optimized Built-In Highly Asymmetric Prefilter Layer For Maximum Flow And Throughput Performance.
A04
Hydrophilic Membrane That Wets Out Quickly And Completely Resulting In Fast Filtration With Superior Flow Rates And High Throughputs. Easily Wet For Reliable Integrity Testing.
A05
Very High Compatibility Over The Whole Ph Range Plus Very Low Protein Binding To Ensure The Maximum Transmission Of The Active Ingredients.
A06
Compatible With Eto, Gamma Irradiation, And Sip/Autoclave Methods Of Sterilization.
PES Membrane Key Properties
The LENGE PES membranes are highly asymmetric with a distinctuniform integral retention layer. The membranes have a high surfaceporosity and gradually increased pore size distribution in the directionfacing upstream of filtration. Therefore, the membranes have acapability of retaining various sized particulates and microorganisms.The LENGE PES membrane filters have the following distinguishedcharacteristics:
Highly asymmetric structure
Easily wet with water
High flux
High dirt capacity
High porosity
Low protein binding and adsorption
Low extractables
Low differential pressure
High mechanical strength
UNWAVERING
COMMITMENT TO QUALITY
At LENGE, quality is paramount. We adhere to the strictest international standards to ensure the consistent quality and reliability of our products.
