Risk-based Approach Supports Migration of Legacy Methods for Eurofins BPT Toronto

Importance of the Topic

Analytical laboratories depend on high-performance liquid chromatography (HPLC) for GMP testing in pharmaceutical and biopharmaceutical industries. Aging HPLC instruments increase downtime, maintenance costs, and risk of data variation. Implementing a risk-based migration of legacy methods to modern platforms safeguards data integrity, accelerates throughput, and ensures regulatory compliance.

Objectives and Study Overview

This case study details the collaboration between Eurofins BPT Toronto and Waters to apply a risk-based approach for migrating validated HPLC assays from aging equipment to the Waters ACQUITY Arc HPLC System. The primary aims were to confirm method equivalency, preserve validated conditions, and improve operational efficiency without full revalidation.

Methodology and Instrumentation

Risk-based analysis steps:

• Compare technical specifications of legacy HPLC systems versus ACQUITY Arc.
• Develop risk assessments and control strategies for both isocratic and gradient methods.
• Install and qualify the ACQUITY Arc HPLC System, followed by system suitability testing.
• Perform side-by-side injections using identical columns, mobile phases, and sample preparations.

Instrumentation:

• Waters ACQUITY Arc HPLC System
• Empower Chromatography Data System

Main Results and Discussion

Equivalency criteria were set at ≤1% RSD and ≤3% retention time variation. Key findings:

• Detector response and signal-to-noise ratios on the Arc system matched or exceeded legacy instrumentation.
• Retention times and injection precision met SOP requirements without parameter adjustments.
• Seamless method transfers achieved, eliminating need for extensive revalidation.

Systematic risk assessment identified potential variabilities proactively, building confidence in method performance on the new platform.

Benefits and Practical Applications

Migrating legacy methods to ACQUITY Arc HPLC delivers:

• Reduced instrument downtime and maintenance interventions.
• Cost and time savings by avoiding full method revalidation.
• Enhanced throughput through reliable, high-precision analysis.
• Improved customer satisfaction via consistent, on-time results.

Future Trends and Opportunities

Planned expansions include testing a broader range of assays over extended periods and challenging “dirty” gradients to verify robustness. Gradient SmartStart’s automated dwell volume correction offers potential for streamlined transfers across diverse HPLC platforms. Such innovations will support ongoing method lifecycle management.

Conclusion

The risk-based migration approach demonstrated that validated HPLC methods can be transferred confidently to the Waters ACQUITY Arc System in a GMP setting. This strategy preserves data quality, enhances operational efficiency, and supports regulatory compliance while modernizing analytical infrastructure.

References

1. US Pharmacopeia General Chapter <621>.