The must have handheld Raman solution for Pharmaceutical Industry

Significance of the Topic

Handheld Raman spectroscopy provides a rapid, non-destructive and accurate approach for identifying pharmaceutical raw materials directly through packaging. By integrating advanced fluorescence suppression and expanded spectral coverage, this technology addresses common challenges in quality control and process optimization within the pharmaceutical industry.

Study Objectives and Overview

This application note introduces the BRAVO handheld Raman solution designed for pharmaceutical material verification. It presents key performance features, fluorescence mitigation strategy, user interface design and regulatory compliance, illustrating how the instrument streamlines material inspection workflows.

Methodology

BRAVO combines:

• DuoLaser excitation covering 300–3200 cm⁻¹ Raman shift for extended spectral range including CH-stretch region.
• Sequentially Shifted Excitation (SSE™) for patented fluorescence mitigation and enhanced signal quality.
• High-quality optics (HQI approach) for benchtop-comparable spectral precision and accuracy.
• IntelliTip™ automated probe tip recognition to ensure consistent sampling conditions.

Material libraries are built and managed through Bruker’s OPUS software, enabling guided workflows for acquisition, validation and result reporting.

Used Instrumentation

The system comprises:

• BRAVO handheld Raman spectrometer (laser class 1, touchscreen interface)
• DuoLaser™ excitation source
• Integrated barcode scanner for sample identification
• OPUS software suite for library creation and data management

Main Results and Discussion

Verification of various cellulose derivatives against a microcrystalline cellulose (MCC) reference demonstrated:

• High correlation coefficients (up to 0.99) without SSE.
• Improved distinction of similar excipients when combining HQI and SSE (e.g., HPMC correlation improved from 0.58 to 0.93).
• Performance metrics (wavelength precision and accuracy) exceed regulatory limits for handheld Raman devices and rival benchtop systems.

These results confirm SSE’s effectiveness in reducing fluorescence interference and HQI’s contribution to spectral fidelity.

Benefits and Practical Applications

BRAVO supports pharmaceutical QA/QC by enabling:

• On-site, real-time identification of active ingredients and excipients through packaging.
• Reduction of false negatives and improved confidence in material verification.
• Streamlined workflows with intuitive touchscreen guidance and integrated barcode scanning.
• Compliance with 21 CFR Part 11, Ph. Eur. 2.2.48 and USP 1120 regulations, ensuring data integrity.

Future Trends and Opportunities

Emerging directions include integration of machine-learning algorithms for spectral classification, cloud-based data sharing for decentralized QC, miniaturization of components for enhanced portability and expanded spectral libraries covering novel pharmaceutical compounds.

Conclusion

The BRAVO handheld Raman solution delivers a powerful combination of fluorescence mitigation, extended spectral coverage and user-friendly operation, addressing critical needs in pharmaceutical material verification. Its compliance with stringent regulations and benchtop-level performance positions it as a key tool for modern QA/QC laboratories.

Reference

Bruker Optics GmbH & Co. KG. Product Note R35 (2021)