摘要
Vacuum-assisted fabrication of EVOH nanofiber membrane with uniform nanopores for virus removal. • In-situ GA/PEG modification endows superior hydrophilicity and protein antifouling performance. • Optimized PNFM achieves high flux of 857.45 L·m −2 ·h −1 , > 95% protein recovery rate and virus LRV > 5. • The membrane breaks permeability–fouling trade-off for biopharmaceutical virus filtration. Achieving high-throughput virus clearance without compromising protein recovery remains a critical challenge in biopharmaceutical processing. This study is predicated on the hypothesis that the assembly of ultrafine nanofibers, coupled with synergistic in-situ PEG crosslinking, can create a mechanically robust membrane with precisely tailored nanopores and a good hydrophilic surface to overcome the permeability-selectivity trade-off. Herein, ultrafine ethylene vinyl alcohol (EVOH) nanofibers (∼50 nm) were produced via melt extrusion phase separation and fabricated into membranes through vacuum-assisted wet-laying. Subsequent in-situ crosslinking with glutaraldehyde (GA) and polyethylene glycol (PEG) yielded a modified membrane (PNFM-2) featuring a narrow pore size distribution (33.18 nm) and good hydrophilicity (water contact angle: 28.9°). The membrane demonstrated an exceptional steady-state water flux of 857.45 L m −2 h −1 , a 30 nm Au nanoparticle rejection rate above 99%, and a bovine serum albumin (BSA) recovery rate exceeding 95%. Crucially, PNFM-2 achieved a log reduction value (LRV) > 5 for PP7 bacteriophages in intravenous immunoglobulin solutions, fulfilling the stringent international conference on harmonization (ICH) Q5A regulatory requirements. These results validate the proposed hypothesis and offer a simple, scalable strategy for engineering high-performance, antifouling nanofibrous membranes for industrial-scale viral clearance. Download: Download high-res image (243KB) Download: Download full-size image
危险品化学品经营许可证（带存储）