System Validation - BRAVO

Importance of the topic

The qualification and validation of handheld Raman spectrometers for pharmaceutical applications ensure compliance with stringent cGMP/GLP regulations, data integrity requirements and pharmacopeial performance standards. Such validated tools enable rapid identification and quality control of raw materials, intermediates and finished products directly in production or warehouse environments, reducing turnaround time and increasing process safety.

Objectives and overview of the study

This whitepaper presents the system validation concept for the Bruker BRAVO handheld Raman spectrometer and its integration with the OPUS spectroscopy suite. The primary goal is to demonstrate how a portable Raman solution can meet pharmaceutical regulatory requirements (21 CFR Part 11, Ph.Eur. 2.2.48, USP <858>/<1858>), deliver automated operational and performance qualification, and maintain full data integrity.

Methodology and instrumentation

The validation approach follows the standard lifecycle from Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) to Performance Qualification (PQ). Software is prequalified for 21 CFR Part 11 compliance, featuring electronic signatures, segregation-of-duties user management, audit trails and secure data pools. Automated OQ/PQ routines in OPUS enforce pharmacopeial tests, including wavenumber accuracy, spectral resolution and signal-to-noise requirements, aligning with tighter benchtop criteria.

Used instrumentation

• BRAVO handheld Raman spectrometer with dedicated optics for high wavenumber accuracy and resolution
• OPUS spectroscopy suite with Validation Program (OVP) for automated IQ/OQ/PQ procedures
• Certified reference materials: polystyrene (NIST 1921b), ASTM E1840, USP <858>/<1858>, Ph.Eur. 2.2.48 standards

Main results and discussion

BRAVO and OPUS passed fully automated qualification tests, demonstrating compliance with European and US pharmacopeial limits for wavenumber accuracy (<±1 cm⁻¹), spectral reproducibility and signal-to-noise ratios. The system supports electronic records management under ALCOA+ principles, transferring mobile data to a protected pool. Validation documentation and ready-to-use log forms streamline on-site commissioning by certified service engineers.

Benefits and practical applications

• Rapid, in situ material verification for raw materials, intermediates and finished products
• Minimized regulatory compliance effort through preconfigured software validation and automated qualification routines
• Secure electronic records and audit trails for 21 CFR Part 11 and data integrity adherence
• Reduced downtime and operational costs by avoiding extensive manual testing

Future trends and potential applications

Advances in handheld Raman technology will focus on integration with cloud-based data management, real-time chemometric models for quantitative analysis, and AI-driven spectral interpretation. Expanded use cases include on-line process monitoring, field audits, counterfeit detection and decentralized QA/QC workflows.

Conclusion

The Bruker BRAVO handheld Raman spectrometer, coupled with the OPUS validation suite, provides a ready-to-use, fully compliant solution for pharmaceutical analysis. Its automated qualification, rigorous data integrity features and pharmacopeial performance ensure reliable, traceable results in demanding QA/QC environments.

References

• European Pharmacopeia 2.2.48 (Raman Spectroscopy)
• USP <858> & <1858> (Raman Spectroscopy Performance Standards)
• ASTM E1840 (Raman Wavenumber Calibration Standard)
• NIST 1921b (Polystyrene Wavenumber Reference)