Challenge Filair® PTFE Hydrophobic Sterile Filter with High Retention and High Throughput

The Challenge IM Capsule Filters cover five key series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration, with particle retention ranging from 0.1 to 30 μm, meeting the full process requirements from cell culture clarification to final product sterilization. The filters support high-temperature steam sterilization and gamma irradiation, and are compatible with a wide range of commonly used biopharmaceutical solvents. All molded parts and sealing components are free of colorants and comply with Class VI and ISO 10993 biocompatibility standards, minimizing leachables and extractables and ensuring hygienic processing. Each product undergoes dual integrity testing during production, with two independent test methods required for release, ensuring 100% factory pass rate. The filters comply with ISO 9001 quality management and GMP standards, and have passed USP <85> endotoxin, USP <87>/<88> biocompatibility, and USP <665> extractables tests, with no animal-derived TSE/BSE risk. All products are validated by multiple internationally recognized agencies such as SGS and NF, providing fully verified and reliable filtration solutions for the entire biopharmaceutical process.