Exods^® Fully Automatic Ultrafiltration System

简介

Our Exods^® Fully Automatic Ultrafiltration System is built on a tangential-flow filtration (TFF) platform and engineered strictly to cGMP principles, covering ultrafiltration and microfiltration from pilot scale-up through commercial production. An integrated block-valve layout with fully hygienic stainless steel tubing eliminates dead legs and minimizes hold-up volume, boosting concentration efficiency and product recovery. High-precision sensors and the dedicated UniBio control platform deliver fully automated operation, multi-mode process control, and compliant data traceability, while compatibility with leading membranes and flexible multi-dimensional customization adapts to diverse biopharma process needs.

特点

1. Flexible Adaptation・Efficient Concentration

• Full membrane compatibility—Compatible with all mainstream hollow-fiber cartridges and flat-sheet cassettes, with filtration modes switchable to process needs

• Low hold-up, High concentration—Low hold-up, high concentration: TFF design optimized to process and regulatory requirements; block-valve layout minimizes minimum working volume for higher concentration factor and sample recovery.

2. Intelligent self-control・Precise operation

• Modular multi-rack architecture—flexible flow-path selection and the modular design can be expanded as needed, providing a high-level automation operation experience.

• Digital precision monitoring—based monitoring for real-time, high-precision parameter measurement and feedback supporting stable process control
  

• Multi-mode combination  control—constant TMP, constant flow, constant pressure, timed run, metered run and linked control for complex process logic

• Fully unmanned operation—automatic feed/make-up, concentration, buffer exchange, product recovery and closed-loop CIP for continuous, automated UF — reduced labor costs and fewer human errors

3. Compliance traceability・Audit compliance

• End-to-end data traceability—built-in SQL database , audit trail, e-signature and multi-level access  for biopharma compliance audits.

4. Flexible customization・Easy to use

• Dedicated UniBio control platform—covers the full UF workflow with clear nested recipe editing and a short learning curve.

• Fully customizable by scale—single-batch volumes from liters to tens of thousands of liters across bench, pilot and industrial production, with optional high-salt-resistant systems for special materials.
  

应用场景

• Concentration, buffer exchange, desalting, dealcoholization — UF/MF for antibodies, vaccines, blood products and gene therapies.

技术参数

Note: customizable to specific customer requirements.

其他

Validation&Qualification Documentation:

• Product risk assessment

  Quality Project Plan (QPP), System Classification (SC), Critical Components Assessment (CCA), Risk Assessment (RA)

• Design qualification / design review:

  Design Qualification (DQ), Functional Specification (FS), Hardware Design Specification (HDS), Software Design Specification (SDS)

• C&Q testing and documentation

  Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ)

• Certification documents

  product inspection report, wetted-parts material certificate, certificate of conformity, product quality certificate, calibration certificates

• Process documentation

  surface roughness records, pickling & passivation records, welding records

• List-type documents
  

       I/O list, alarm list (AL), parts list (PL), critical spares list (CL)

联系我们

如果您有相关采购需求，请点击上方"咨询"，我们的销售代表会尽快联系您！