Challenge Filair® PTFE Hydrophobic Sterile Filters: High Retention & Throughput from China Suppliers & Factory

The Challenge IM Capsule Filters are an essential solution for biopharmaceutical processes, encompassing five key series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration. With particle retention capabilities between 0.1 to 30 μm, these filters fulfill the complete spectrum of process requirements, from cell culture clarification to final product sterilization. Our filters are engineered for high-temperature steam sterilization and gamma irradiation, making them compatible with a variety of widely used biopharmaceutical solvents, As a leading China supplier and factory, we ensure that all molded parts and sealing components are free of colorants, adhering to Class VI and ISO 10993 biocompatibility standards. This commitment minimizes leachables and extractables, ensuring a hygienic processing environment. Each filter undergoes rigorous dual integrity testing during production, requiring two independent test methods for release, which guarantees a 100% factory pass rate, Our filters meet ISO 9001 quality management and GMP standards and have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, eliminating any animal-derived TSE/BSE risk. Trust in our products, validated by multiple internationally recognized agencies such as SGS and NF, to deliver reliable filtration solutions across the entire biopharmaceutical landscape