example solution
Flex

Automated eluent preparation under GxP

FLEX EP
Overview

Chemspeed's solution

Flex EP is a fully automated workstation for the autonomous preparation of eluents for liquid chromatography. Compliant with FDA 21 CFR part 11 and a fast qualification process adhering to GAMP Category 4. 

The Flex EP system produces eluents directly in standard glass bottles, up to 16 different eluents per run, with a total throughput of 60-120 L per day. Featuring fully digital documentation and audit trail, accelerated review process, and easy integration into your LIMS. 

This approach reduces human error in routine operations and method transfers, increases productivity by allowing team members to focus on demanding tasks and ensures a thorough digital record of all processes. 


Workflow

Example workflow

FLEX EP

Benefits

Powerful advantages

  • Eluents are prepared directly in standard 0.5, 1 or 2 L glass bottles - no additional glassware required.
  • Automatic liquid and solid dispensing, pH measurement and adjustment tools. Processes are developed and specified to enable full compliance with GMP guidelines, providing reproducibility and robustness in workflow execution. 
  • Seamless integration throughout entire analytical method life cycle enabling direct transfer from method development to routine use. 
  • Same recipes can be used between laboratories, sites and partnering companies (CROs, CDMOs). 
  • Total transparency and recipes ownership. 
  • User rights levels, electronic records and signatures. 
  • Fully digital documentation and audit trail, providing accelerated review process. 
  • Software fully compliant with FDA 21 CFR part 11. 
  • Fast qualification process adhering to GAMP Category 4. 
  • Custom integration into IT-environment (LIMS, inventory management system, etc.). 
  • Business continuity with ArkSuite Sofia. 
Software
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