Fully automated sample preparation system FLEX EP

for the pharmaceutical industryfloor-standing

Overview
FLEX EP is a GxP-compliant workstation designed to automate eluent (mobile phase) preparation and integrate with laboratory information systems. The system removes repetitive manual tasks, reduces human error during routine operations and method transfers, increases throughput, and provides a complete digital record for audit and release processes.

Product summary
FLEX EP prepares eluents directly into standard glass bottles and supports up to 16 different eluents per run, with a typical daily throughput of 60–120 L. Tight integration with LIMS and inventory management enables recipe ownership, electronic records and signatures, and a full audit trail to support regulated environments.

Key features

• Direct production into standard 0.5 L, 1 L or 2 L glass bottles (no additional glassware required)
• Handles organic and aqueous solvents, acids/bases and solid materials
• Fully automated pH measurement and pH adjustment
• System startup routines including daily SSTs: balance verification and pH-electrode calibration
• Recipe ownership and transparency for reproducibility
• Tools and processes specified to support GMP-compliant workflow execution
• Seamless transfer from method development to routine use across sites
• Same recipes usable between laboratories, sites and partner organisations (CROs, CDMOs)
• User-rights management, electronic records and signatures
• Fully digital documentation and audit trail to facilitate review and release
• Fast qualification process aligned with GAMP category 4
• Custom integration options for LIMS and inventory management systems

Benefits

• Reduces repetitive manual work by automating eluent preparation
• Minimises human error in routine operations and method transfers
• Increases laboratory productivity by freeing staff for higher-value tasks
• Supports business continuity with a compliance-ready workstation design
• Provides comprehensive digital records for reproducibility, audit and product release

Technical specifications

• Model name: FLEX EP
• Compliance: FDA 21 CFR part 11 and GAMP category 4
• Bottle sizes supported: 0.5 L, 1 L, 2 L (standard glass bottles)
• Number of different eluents per run: up to 16
• Throughput: approximately 60–120 L per day
• pH handling: automated pH measurement and pH adjustment
• Startup SSTs: balance verification and pH-electrode calibration (daily)
• Materials handled: organic solvents, aqueous solvents, acids/bases, solids
• Integration: interfaces for LIMS and inventory management; recipe ownership and transferability across sites
• Data integrity: user-rights management, electronic records and signatures, full audit trail
• Qualification category: GAMP category 4 (fast qualification process)