Exods^® Fully Automatic Intelligent Ultrafiltration System

简介

Our Exods^® Fully Automatic Intelligent Ultrafiltration System combines block valves and a manifold design with hygienic stainless steel tubing to eliminate the dead legs found in conventional systems and minimize hold-up volume. Engineered strictly to cGMP principles, it integrates high-precision sensors and the AI-powered UinBio software platform to automate the entire ultrafiltration and microfiltration workflow. The system comprises a UF module and a UF tank module, handling 0.2 to 20 L of feed for UF/MF processes.

特点

• Six operating control modes: constant TMP, constant flow, constant pressure, timed run, metered run and multi-mode linked control

•        Fully unmanned operation with automatic feed and make-up, concentration, buffer exchange, product recovery and closed-loop CIP

• Built-in AI agent for auto recipe generation, intelligent parameter recommendation, real-time process optimization, automatic fault handling and continuous learning

•        Full-process compliant data traceability with SQL database, audit trail, e-signature and multi-level access control

•        Compliant across the full R&D cycle: FDA 21 CFR Part 11, GAMP5, ASME BPE and cGMP

•        Dual safety design with hardware e-stop and audible alarm shutdown

•        UniBio control platform covers the full UF workflow with nested recipe editing for easy use

•        Linear scale-up from R&D through pilot to production, covering all stages and reducing scale-up risk

  
  

应用场景

• Concentration & buffer exchange of antibodies, recombinant proteins, vaccines and biologics — from process development and pilot through commercial production.

技术参数

其他

Standard Module Configuration

• UF Module

• UF Tank Module

Optional Accessories

Optional documentation:

       full validation documentation package

• 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)

  
  

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