LeSiever Sterilizing Capsule Filter
● Validated bacteria retention capability
✓ This sterilizing capsule filter passed the bacterial challenge test using Brevundimonas diminuta (ATCC 19146) at a minimum challenge concentration of 1x107 CFU/cm2
● Wide range of chemical compatibility (pH 1-14)
✓ Under normal filtration conditions, LeSiever sterilizing capsule filter is compatible with common aqueous solutions of pH 1-14, biochemical substances, and most solvents, except for aromatics and chlorides.
● 100% integrity test
✓ The sterilizing capsule filte assures no risk of leakage with maximum allowable positive differential pressure of 5 bar.
● High throughput and high flow rate
✓ The large filtration area with asymmetrical hydrophilic polyethersulfone (PES) membrane has advantages of high flow rate and high capacity.
● Excellent anti-fouling performance
✓ Suitable for a wide range of biopharma applications, such as bioburden reduction and sterile filtration of upstream and downstream process liquids including cell culture media, buffer, intermediate solutions, drug substance, and semi-finished products.
● Filter component materials
✓ All materials meet the requirements specified by FDA in 21 CFR and comply with USP < 87 > < 88 > Class VI test.
✓ Filter membrane: PES (Polyethersulfone)
✓ Protective layer of filter membrane: PP (polypropylene)
✓ Filter element housing: PP (polypropylene)
✓ Filter housing: PP (polypropylene)
✓ O-ring: Silicone
✓ Protective sleeves for Inlet/outle ports and vent/drain ports: Silicone
● Product specifications
LeSiever sterilizing capsule filte comes with two types of membrane structures, single layer (0.2 μm) and double layer (0.45/0.2 μm) membranes. Both are available in five different sizes, 2", 4", 5", 10" and 20”. The inlet and outlet ports of 2", 4", 5", 10" filter are available in 38 mm, 1.5"Tri-Clamp and 12.7 mm, 1 / 2" hose barb. The inlet and outlet ports of 20" filter are available in 38 mm, 1.5 "Tri-Clamp and 3/ 4" hose barb.
✓ LeSiever sterilizing capsule filter is packaged with double-layer PE plastic bags. The inner packaging is vacuum sealed, which can ensure the sterility of the filter by protecting it from microbial growth and pyrogen during transportation and storage.
✓ The validated shelf life for the filter with uncompromised packaging is 3 years.
● Quality assurance
✓ All materials comply with current regulations, FDA CFR, cGMP guidelines and other relevant requirements.
✓ The filter is qualified after being tested according to the up-to-date regulations including USP < 788 >, USP < 88 >.
✓ LeSiever sterilizing capsule filter cannot be released until all process and final quality control data meet the requirements.
Data-EN-LeSiever® Sterilizing Capsule Filter-Autoclave-20220830
Data-EN-LeSiever Sterilizing Capsule Filter-Gamma-20220830