The must have handheld Raman solution for Pharmaceutical Industry

BRAVO – The Must‐Have Handheld Raman Solution for the Pharmaceutical Industry

Importance of the Topic

In pharmaceutical manufacturing and quality control, rapid and non‐destructive identification of raw materials and finished products is critical. Handheld Raman spectroscopy enables on‐site verification of active pharmaceutical ingredients (APIs) and excipients without sample preparation, reducing downtime and ensuring continuous compliance with regulatory standards.

Objectives and Overview of the Study

This product note introduces BRAVO, a dedicated handheld Raman spectrometer tailored to the pharmaceutical sector. The aim is to demonstrate how BRAVO’s patented SSE™ fluorescence mitigation and DuoLaser™ excitation expand material coverage, improve spectral clarity, and deliver benchtop‐level performance in a portable format.

Methodology and Instrumentation

BRAVO integrates several advanced technologies:

• SSE™ (Sequentially Shifted Excitation): Mitigates fluorescence interference to reveal hidden Raman features.
• DuoLaser™ Excitation: Covers a wide Raman shift range from 300 cm⁻¹ to 3200 cm⁻¹, including the CH‐stretching region.
• Laser Class 1: Ensures safe operation in controlled environments.
• IntelliTip™: Automated tip recognition for consistent spectral quality during library building and verification.
• Touchscreen Interface and Barcode Scanner: Guides users through workflows and retrieves material data with a single scan.
• OPUS Software Suite: Streamlines library creation and high‐quality index (HQI) based analysis.

Main Results and Discussion

Validation studies compared spectral correlations of various cellulose derivatives against a microcrystalline cellulose (MCC) reference:

• MCC: Correlation remained near unity (1.00 without SSE vs. 0.99 with SSE), confirming system precision.
• Hydroxypropyl methylcellulose (HPMC): Correlation dropped from 0.93 to 0.58 with SSE, indicating effective fluorescence suppression uncovered distinct features.
• Hydroxypropyl cellulose (HPC): Small improvement (0.86 to 0.87) with SSE, facilitating finer discrimination.
• Sodium carboxymethylcellulose (SCMC): Correlation changed from 0.97 to 0.66, highlighting enhanced differentiation of chemically similar excipients.

Overall, the combination of HQI and SSE™ provides superior material distinction, while DuoLaser™ extends detection into high‐frequency regions essential for comprehensive fingerprinting.

Benefits and Practical Applications

BRAVO offers:

• Rapid material verification through transparent packaging, minimizing sampling errors.
• Intuitive workflows reducing operator training time.
• Regulatory compliance with 21 CFR Part 11, Ph. Eur. 2.2.48, USP 1120, and FDA data integrity guidelines.
• Benchtop‐equivalent wavelength accuracy and precision in a handheld form factor.

Future Trends and Opportunities

Emerging directions include integration with cloud‐based spectral libraries and machine‐learning algorithms for real-time anomaly detection, expansion of handheld Raman into continuous process monitoring (PAT), and development of multi-modal handheld platforms combining Raman with near‐infrared or fluorescence modalities for broader chemical coverage.

Conclusion

BRAVO represents a new standard in handheld Raman spectroscopy for pharmaceutical applications. Its patented SSE™ and DuoLaser™ technologies deliver fluorescence‐mitigated, wide-range spectra with benchtop accuracy. The instrument’s intuitive design and regulatory compliance accelerate material verification workflows and support quality assurance across the drug development and manufacturing lifecycle.

Reference

• ASTM E1840-96: Standard Guide for Raman Shift Standards.
• European Pharmacopoeia (Ph. Eur.) 2.2.48: Raman Spectroscopy.
• United States Pharmacopeia (USP) General Chapter 1120: Raman Spectroscopy.
• FDA Guidance for Industry: Data Integrity and Compliance With CGMP.
• Bruker Optics BOPT-01, BRAVO Product Note, 2021.