Automated eluent preparation under GxP

FLEX EP

Chemspeed's FLEX EP compliance-ready automated workstation, seamlessly integrated with your lab information management system. If your HPLC runs automatically, why is it necessary to make buffers yourself? Chemspeed automates the preparation of eluents under GMP, freeing up time for more important tasks.

Overview

Chemspeed's solution

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 5 cat 4.

The platform can prepare any eluent directly in Schott bottles, up to 16 per run, with a throughput of 60-120 L per day. Featuring fully digital documentation and audit trail, accelerated review process, and easy integration into your LIMS.

This solution reduces human error in everyday operations and method transfers, increases your productivity by allowing team members to focus on demanding tasks and can provide a complete digital audit trail.

A blue Chemspeed robotic Flex platform with a metal door and a glass panel housing a variety of analytical instruments for laboratories

Workflow

Example workflow

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

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FLEX EP

Benefits

Powerful advantages

Fully automatic calibration and verification of pH-electrode according to USP <791>.
Guided semi-automatic balance verification.
System calculates required reagents and guides user to load the platform, step by step.
Eluents are prepared directly in 0.5, 1 or 2 L Schott bottles, no additional glassware required.
Automatic liquid and solid dispensing, pH measurement and adjustment. Highest precision and accuracy specified for use under GMP.
Notification when the batch run is completed, to be released with an electronic signature on a pre-flagged report.
Software fully compliant with FDA 21 CFR part 11.
User rights levels, electronic records and signatures.
Complete digital audit trail and custom integration into your 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