This high-precision tangential flow ultrafiltration system is purpose-built for vaccine concentration, diafiltration and buffer exchange procedures in biopharmaceutical downstream workflows, applicable to viral vaccines, subunit vaccines, inactivated vaccines and vector vaccine bulk solution treatment.
Constructed with biocompatible sanitary flow paths and validated wetted components passing E&L testing, the system supports automated CIP and SIP cycles, fully complying with cGMP and data integrity specifications for vaccine production. Equipped with high-accuracy flow, pressure and trans-membrane pressure (TMP) closed-loop control modules, it stabilizes cross-flow velocity and membrane loading, effectively preventing concentration polarization and membrane fouling. It achieves gentle molecule retention, minimizes viral particle fragmentation and activity loss, and delivers stable concentration fold control with exceptional batch consistency.
Fully automated operation enables unattended running, automatic volume endpoint judgment, real-time data logging and full audit trail generation, simplifying regulatory validation and filing. The skid-integrated layout allows seamless inline connection with upstream clarification and sterile filtration units. Capable of flexible scale-up from lab process development to commercial vaccine mass production, it reliably boosts bulk vaccine concentration efficiency while securing product biological activity and final product quality stability.
