Integrating Thermo Scientific LC systems into Waters Empower 3 Chromatography Data Systems in regulated environments

Importance of the Topic

High-performance liquid chromatography (HPLC) and ultra-high-performance liquid chromatography (UHPLC) are core technologies in regulated analytical laboratories. Ensuring seamless integration of modern instrumentation into established data infrastructures is vital to maintain compliance, streamline workflows, and protect data integrity.

Objectives and Study Overview

This technical note provides a clear roadmap for integrating Thermo Scientific Vanquish HPLC and UHPLC systems into Waters Empower 3 Chromatography Data System (CDS) environments. It focuses on key information technology considerations, version compatibility, and qualification requirements to support regulated operations.

Instrumentation Used

• Thermo Scientific Vanquish HPLC and UHPLC systems
• Waters Empower 3 Chromatography Data System
• Thermo Scientific Standard Instrument Integration (SII) for Empower drivers
• Waters Laboratory Acquisition Control Environment (LAC/E) modules
• Windows desktop and server operating systems, Oracle database platforms

Methodology and Instrumentation

Integration proceeds through a five-step approach:

1. Design Qualification: Define Vanquish system requirements (pressure, detection, throughput) and ensure SII driver compatibility.
2. SII Version Selection: Identify and, if necessary, update the SII for Empower driver to match the chosen hardware configuration.
3. Empower Assessment: Confirm the existing Empower architecture (stand-alone, workgroup, enterprise), version, and platform support for Oracle and Windows.
4. LAC/E Evaluation: Verify the configuration and operating system of the Waters LAC/E acquisition server, ensuring USB cabling and component limits adhere to specifications.
5. IQ/OQ Procedure: Execute Installation Qualification (IQ) and Operational Qualification (OQ) under Empower control with certified protocols and reference standards.

Main Results and Discussion

The analysis highlights:

• SII for Empower 1.1 supports Vanquish Horizon, Flex, Duo, and UltiMate 3000 SD/RS on Windows 7/10 with Empower 3 FR2–FR5 or SR3–SR5.
• SII for Empower 1.2 extends support to Vanquish Core HPLC and updated UHPLC modules on Windows 10 and Empower 3.6.x.
• Waters LAC/E Configuration 16 (post-October 2018) enables connection of up to four Vanquish components per server; earlier models support fewer devices.
• IQ captures comprehensive system details and generates automated reports; OQ validates injector, detector, pump, and compartment performance through Empower-driven test sequences.
• Certified Thermo Fisher Scientific field service personnel perform IQ/OQ and annual preventive maintenance to maintain compliance.

Benefits and Practical Applications

Integrating Vanquish systems into Empower offers:

• Centralized data storage and audit trails within a familiar CDS
• Reduced training burden through standardized software and workflows
• Enhanced flexibility to adopt best-in-class instruments without disrupting existing infrastructure
• Streamlined qualification and validation under regulatory guidelines

Future Trends and Potential Uses

Ongoing developments will likely include expanded driver support for next-generation LC modules, closer integration with cloud-based CDS solutions, enhanced automation of qualification workflows, and AI-driven data review tools. Adapting to evolving regulatory landscapes and digital lab platforms will further enhance operational efficiency.

Conclusion

Thermo Scientific Vanquish HPLC and UHPLC systems can be fully integrated into Waters Empower 3 environments using the appropriate SII drivers, LAC/E configurations, and qualification protocols. Following the outlined five-step process ensures compliant installation, reliable instrument control, and consistent data management within regulated laboratories.

References

1. Paul C, Maurer O, Shade B. Integrating Thermo Scientific LC systems into Waters Empower 3 Chromatography Data Systems in regulated environments. Thermo Fisher Scientific Technical Note 74067; 2022.
2. Thermo Fisher Scientific. Application Note 73310: LC Compendial Impurity Analysis of Chlorhexidine; 2021.
3. Thermo Fisher Scientific. Application Note 72939: UHPLC Method Transfer for Mebendazole; 2021.
4. United States Pharmacopeia–National Formulary (USP–NF) <1058> Analytical Instrument Qualification; 2018.