SmartFlow® TFF for High Solids & High Viscosity Biopharmaceutical Processes
Performance, Reliability, and Control for the Most Challenging Bioprocess Streams
SmartFlow’s OptiSep® Tangential Flow Filtration (TFF) modules are engineered to deliver consistent, high performance filtration in demanding pharmaceutical and biopharmaceutical applications especially where high solids, elevated viscosity, or shear sensitive materials challenge conventional membrane systems. Built under a cGMP aligned Quality Management System and supported by full component traceability, OptiSep® modules provide the robustness and reliability required for modern drug substance manufacturing.
SmartFlow® TFF Flow Path
Engineered for High Solids and High Viscosity Feeds
Biopharmaceutical processes increasingly involve dense cell cultures, viscous intermediates, concentrated proteins, and complex formulations. SmartFlow® TFF modules are designed to maintain stable flux and predictable performance under these conditions through:
- Optimized channel geometry that minimizes pressure drop and maintains uniform shear across the membrane surface
- High‑strength polysulfone construction that resists deformation under elevated viscosities
- Consistent, linear scalability from development to production, ensuring predictable behavior during scale‑up
These design elements help maintain throughput and reduce fouling, even when processing feeds that exceed the limits of traditional TFF formats.
Materials Qualified for Biopharmaceutical Use
All wetted components are manufactured from materials that meet or exceed biopharmaceutical expectations:
- USP Class VI compliant membranes and bonding components that have been tested and passed USP Class VI requirements.
- 21 CFR 177.x compliant polymeric components
- ISO 10993 tested polysulfone structures
- No animal‑origin materials, with sourcing from regions classified as negligible BSE risk
This ensures compatibility with biologics, vaccines, plasma derivatives, and advanced therapeutics where material purity and regulatory acceptance are critical.
Factory Certification
Every OptiSep® module undergoes:
- Normalized clean water flux testing to confirm membrane performance
- Forward‑flow air diffusion integrity testing to verify membrane integrity
- Full traceability via control numbers linking all components and manufacturing steps
This ensures that each module meets its defined performance specifications before release an essential requirement for high‑viscosity and high‑value biopharmaceutical processes.
Ideal for Challenging Biopharmaceutical Applications
SmartFlow® TFF modules excel in applications where viscosity, solids loading, or shear sensitivity create operational challenges:
- Concentration of high‑titer proteins and antibodies
- Clarification of dense microbial or mammalian cell cultures
- Dewatering of fermentation broths and viscous intermediates
- Buffer exchange of concentrated biologics
- Fractionation of complex streams
The platform’s mechanical stability and controlled flow dynamics help maintain flux, reduce fouling, and improve batch‑to‑batch consistency.
cGMP Aligned Manufacturing & Documentation
SmartFlow supports biopharmaceutical validation requirements through:
- ISO 9001‑based Quality Management System
- Complete component traceability documented in batch records
- Supplier change‑notification controls
- Certificate of Conformance (CoC) for every module
- Preservation and packaging controls suitable for GMP environments
These elements provide the documentation and quality assurance expected in regulated manufacturing.
Fermentation Harvesting System
Summary
SmartFlow’s OptiSep® TFF modules offer a robust, and scalable solution for biopharmaceutical processes involving high solids and high viscosity. With proven material compliance, rigorous integrity testing, and design features optimized for challenging feeds, SmartFlow® TFF delivers the performance and reliability required for modern biologics and advanced therapeutics manufacturing.
Moving Forward With SmartFlow
So What Does The Process Look Like?
Customer Journey
SmartFlow’s Approach:
The 6-Stage Project Development Program
A structured, low-risk path from goals to full-scale deployment.
The program begins by identifying the goals, defining objectives, and prioritizing opportunities. Feasibility is then verified on actual materials through proof-of-concept testing. From there, SmartFlow develops and optimizes process conditions, membranes, and economics before confirming performance at pilot scale on a right-sized system, supported by SmartFlow’s large rental fleet. The pilot data is used to engineer the plant-scale system(s) with appropriate automation, documentation, and commissioning. Finally, the program standardizes performance across multiple facilities and sustains uptime through ongoing support.
Learn more about the six stages below.