Automated eluent preparation under GxP

FLEX EP

Flex EP – compliance ready workstation with assured business continuity, seamlessly integrated into your lab information management system.

Fully compliant with FDA 21 CFR part 11 and GAMP 5.

Overview

Chemspeed's solution

Your HPLC runs automatically, so why prepare mobile phase manually?

Chempeed automates eluent preparation with the Flex EP system. Eluents are produced directly in standard glass bottles, up to 16 different eluents per run, with a total throughput of 60-120 L per day. This approach leaves the repetitive task of eluent preparation to automation, 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

The interactive workflow panel below showcases example workflows for this solution. Each Chemspeed tool or module performs a set of specific actions, as in any manual lab workflow, and an almost limitless arrangement of these tools is possible.

FLEX EP

Choose pre-programmed eluents

Prompt required raw materials

Fill raw materials

Print labels / label bottles

Open screw caps

Dispense solvent target volume and measure liq. level

Aspirate solvent

Stir magnetically and control temperature

Check availability of raw materials by QR-code

Dispense solids

Dispense additional liquids

Measure / adjust pH

Compensate solvent up to target volume

Close bottles with screw-caps

Remove prepared bottles

Benefits

Powerful advantages

Eluents are prepared directly in standard 0.5, 1 or 2 L glass bottles - no additional glassware required
Flex EP handles organic and aqueous, acid/base and solid materials
Fully automated pH measurement and adjustment
System startup with required (daily) SSTs: balance verification and pH-electrode calibration
Total transparency and recipes ownership
Tools and processes 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)
User rights levels, electronic records and signatures
Fully digital documentation and audit trail, facilitating easy review and release process
Fast qualification process adhering to GAMP category 4
Custom integration into IT-environment (LIMS, inventory management system, etc.)

Software

AUTOSUITE

Chemspeed’s AUTOSUITE software packages execute and control all modules in every solution. They control all Chemspeed robotic platforms and any other integrated 3^rd-party software and hardware.

Explore AUTOSUITE

Chemspeed AutoSuite Software laptop screen