System Validation - BRAVO

Importance of the Topic

The validation of handheld Raman spectrometers for pharmaceutical use addresses critical requirements in quality control and regulatory compliance. With increasing adoption of portable analytical tools in manufacturing environments, ensuring adherence to (c)GMP and GLP guidelines is essential for reliable identification of raw materials, in-process monitoring, and release testing.

Study Objectives and Overview

This whitepaper presents Bruker’s comprehensive system qualification package for the handheld Raman spectrometer BRAVO. The aims are to demonstrate full alignment with European and US Pharmacopeia performance requirements, to streamline (c)GMP/GLP compliance through automated qualification workflows, and to secure data integrity in line with FDA guidance.

Methodology and Instrumentation

The validation concept mirrors that of benchtop FT-IR/NIR and Raman systems within the OPUS spectroscopy suite. It integrates fully validated instrument software, automated operational and performance qualification (OQ/PQ) tests, and advanced user and signature management to enforce segregation of duties (SOD) and the four-eyes principle. The OPUS Validation Program (OVP) executes routine tests per Ph.Eur. 2.2.48, USP <858>/<1858> and ASTM E1840 standards. Data integrity follows the ALCOA+ framework, with electronic records stored in a Protected Data Pool and synchronized to prevent local data loss.

Key Findings and Discussion

• BRAVO optics achieve wavenumber accuracy and resolution comparable to benchtop instruments, satisfying strict acceptance limits for quantitative and identification applications.
• Fully automated OQ and PQ routines reduce manual effort and risk of procedural errors, ensuring reproducible performance qualification.
• 21 CFR Part 11 compliance including audit trails, electronic signatures and user rights management addresses current FDA data integrity guidance.

Benefits and Practical Applications

The ready-to-use System Validation and Qualification Package accelerates installation and commissioning with minimal preparatory work. Certified reference materials, including NIST-traceable polystyrene, support traceable performance tests. Comprehensive documentation and step-by-step manuals simplify qualification tasks, making BRAVO an efficient solution for pharmaceutical laboratories involved in raw material verification, counterfeit detection, and in-line process control.

Future Trends and Application Possibilities

Integration of cloud-based data management and IoT connectivity will enhance real-time monitoring and centralized audit capabilities. Advances in chemometric models and AI-driven spectral interpretation could further expand the utility of handheld Raman devices for complex formulations and low-concentration analyses. Portable instruments may soon support at-line screening of biologicals and controlled substances with enhanced sensitivity.

Conclusion

Bruker’s BRAVO handheld Raman spectrometer, together with the OPUS validation framework, establishes a new benchmark for compliant, high-performance portable analysis in the pharmaceutical industry. The turnkey qualification package, rigorous data integrity measures and automated workflows reduce compliance costs, minimize manual errors and maintain regulatory confidence.

References

• European Pharmacopeia 2.2.48 (Handheld Raman Instruments)
• United States Pharmacopeia <858> & <1858> (Raman Spectroscopy)
• ASTM E1840 (Standard Practice for Performance Qualification of Raman Spectrometers)
• NIST SRM 1921b (Polystyrene Reference Material)