Single-Use Tangential Flow Filtration System

 

Jiuling supplies fully integrated, Single-Use Tangential Flow Filtration (TFF) systems engineered for bioprocess applications requiring flexible scale-up, zero cleaning workload, and rapid batch turnover. Designed for laboratory, pilot, and GMP production environments, our systems deliver optimal efficiency in multi-product manufacturing by eliminating cross-contamination risks and minimizing system changeover downtime.

 

 

The Jiuling Single-Use TFF system seamlessly integrates into downstream purification lines (typically positioned post-cell culture harvest or post-chromatography steps) to perform vital separation and concentration tasks:
Cell Harvest Clarification: Efficient removal of whole cells and cell debris.
Protein & Biomolecule Concentration: High-flux concentration of mAbs, recombinant proteins, and enzymes.
Buffer Exchange (Diafiltration): Rapid desalted formulation and buffer replacement.
Viral Vector Concentration: Gentle processing of lentivirus, AAV, and adenoviruses with high recovery.
Final Formulation Preparation: Precise volume reduction prior to final filling.

 

 

Parameter	Range
Filtration mode	Tangential flow / optional single-pass
Membrane area	0.1 – 20 m²+
MWCO	1 kDa – 1,000 kDa
Operating pressure	up to 6 bar
Temperature	4–40°C
Flow system	Peristaltic pump compatible
Tubing	Bioprocess-grade silicone / TPE
Connections	TC / CPC / custom
Sterilization	Gamma compatible / pre-sterilized

 

 

Single-Use Flow Path
No CIP/SIP is required. This reduces batch turnaround time and removes cleaning validation between runs.

Stable TMP Operation
The flow loop is designed to maintain stable transmembrane pressure. This helps control flux decline during long processing times.

 

 

 

TFF Membrane Module Options: Fully compatible with cassette, hollow fiber, or spiral wound configurations.
Pre-Assembled Tubing Set: Optimized manifold geometry with minimized hold-up volume.
Recirculation Loop: Integrated with bioprocess-grade peristaltic pump tubing.
Advanced Monitoring Sensors: Non-invasive, single-use pressure sensors at critical ports (Feed, Retentate, Permeate).
Sampling & Fluid Transfer: Optional sterile sampling valves and secure single-use connectors (TC, CPC, or customized aseptic connectors).

 

 

Operational Metric	Jiuling Single-Use TFF Systems	Traditional Stainless Steel Systems
Cleaning Validation (CIP/SIP)	None. Eliminates costly assays and validation protocols.	Extensive. Requires complex chemical, WFI, and steam validation.
Batch Turnaround Time	< 2 Hours. Fast manifold replacement.	12 - 24 Hours. Long downtime for cleaning and sterilization cycles.
Cross-Contamination Risk	Zero. Single-use fluid path is dedicated to one batch/product.	Risk Present. Requires strict cross-contamination matrix monitoring.
Capital Investment (CAPEX)	Low. Minimal infrastructure and utility setup required.	High. Massive upfront costs for piping, automation, and utility plants.
Multi-Product Flexibility	Excellent. Ideal for CDMOs switching between diverse molecules.	Rigid. Long campaigns required to offset changeover costs.

 

 

To achieve optimal concentration factors and processing times, several process matrix interactions must be evaluated during development:
Feed Viscosity & Gel Layer Formation: High protein concentrations increase viscosity; optimizing cross-flow velocity helps disrupt the polarized boundary layer.
Membrane-Protein Interactions: Our low-binding membrane chemistry is engineered to minimize non-specific adsorption, preserving flux stability and achieving typical product recovery yields of 95% to 98%.
Automated TMP Maintenance: Real-time pressure monitoring prevents operation above the critical flux point, controlling membrane fouling over long filtration windows.

 

 

Jiuling ensures safe, compliant delivery to global destinations via specialized medical-grade packaging:
Double Sterile Barrier: Fluid paths are double-bagged in heavy-duty cleanroom packaging to maintain sterility up to the point of use.
Mechanical Protection: Shock-absorbing, rigid enclosures protect sensitive membrane modules from transit vibrations.
Traceable Labeling: Each tubing set features individual lot-number tracking, component labeling, and clear orientation tags.
Export-Ready Crating: Palletized, ISPM-15 compliant packaging optimized for secure international air and sea freight.
Comprehensive Documentation Package: Shipped with Certificate of Analysis (CoA), material traceability data reports, and gamma sterilization certificates.

 

 

Operating under an ISO 9001 certified quality management system, Jiuling provides extensive validation lifecycles for regulated environments:

Cleanroom Assembly: Fluid paths are assembled and packaged in certified ISO Class 7 cleanrooms.

Full Component Traceability: Lot-level traceability mapping for every fitting, sensor, and tubing section.

Regulatory Support File (RSF): Available validation data packs covering extractables data, biocompatibility (USP <88>), and particle counts (USP <788>).

Global Technical Support: Engineering assistance for hardware integration, DCS/SCADA automation connectivity, and scale-up calculations.

 

 

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