Metrohm NanoRam-1064 handheld Raman spectrometer

Significance of the Topic

Handheld Raman spectroscopy has become a critical tool in pharmaceutical and materials industries for rapid, non-destructive identification of raw materials. The ability to verify APIs, excipients and intermediates without opening containers accelerates workflows, minimizes quarantine handling and supports regulatory compliance under cGMP guidelines and multiple pharmacopeia standards. By reducing fluorescence interference and enabling on-site verification, modern handheld Raman devices improve supply chain security and analytical efficiency.

Objectives and Overview of the Study

This article examines the NanoRam-1064, a compact handheld Raman spectrometer designed for non-technical users to perform fast and reliable material verification. Key goals include assessing its performance in identifying various sample types, evaluating data quality and reproducibility, and verifying compliance with international regulatory requirements for raw material identification.

Methodology and Instrumentation

The NanoRam-1064 employs a 1064 nm laser to minimize sample fluorescence and enable through-container measurements. Temperature stabilization via TE cooling ensures instrument stability under variable environmental conditions. The device supports multiple sampling accessories for liquids, gels, powders and solids, facilitating rapid adapter changes. Onboard software (NOS-1064) allows direct library creation, method development and validation, while PC-based NID EX software manages data, audit trails and report generation. Robust multivariate algorithms generate p-values for statistically sound pass/fail decisions, and mixture analysis routines enable detection of multiple components.

Used Instrumentation

• NanoRam-1064 handheld Raman spectrometer
• 1064 nm laser excitation, 420 ± 30 mW output
• Spectral range: 176 cm⁻¹ to 2500 cm⁻¹
• High-resolution touch screen, 1D/2D barcode reader, optional camera
• Sampling accessories: point & shoot, vial holder, polystyrene cap, immersion probe, bottle and right-angle adaptors, large-spot adaptor
• Embedded NOS-1064 software and PC-based NID EX data management suite

Main Results and Discussion

The NanoRam-1064 delivers high-quality spectra with low noise and fast acquisition times, even for highly fluorescent or colored samples. It effectively distinguishes chemically similar materials, including different cellulose types, polysorbates and Opadry® coatings. Through-container analysis maintains sample integrity and reduces handling steps. Secure Wi-Fi and USB connectivity enable streamlined data synchronization with LIMS. The built-in library of 110 USP reference materials speeds method deployment, while customizable libraries and method transfer features facilitate new material qualification.

Benefits and Practical Applications

• Rapid, non-destructive ID of raw materials at lab, warehouse or field locations
• Reduced quarantine areas and accelerated material release
• Compliance with 21 CFR Part 11, USP <858>, EP 2.2.48, JP 2.26, and Chinese pharmacopeia guidelines
• Intuitive single-touch workflow for non-technical operators
• Secure data integrity and audit trails for cGMP environments

Future Trends and Applications

Advances in handheld Raman technology are expected to include expanded and AI-augmented spectral libraries, improved multivariate analysis algorithms, and deeper integration with digital lab ecosystems. Miniaturization and enhanced sensitivity will open applications in forensics, environmental monitoring and on-line process analytics. Cloud-based data management and real-time remote diagnostics will further streamline quality control workflows.

Conclusion

The NanoRam-1064 represents a versatile, user-friendly solution for fast and reliable material verification in pharmaceutical and related industries. Its robust hardware, advanced software and regulatory compliance features make it an essential tool for modern QA/QC laboratories. By enabling non-destructive through-container analysis and offering comprehensive data management, it supports efficient supply chain operations and stringent identity assurance.

Reference

1. B&W Tek, NanoRam-1064 Handheld Raman Spectrometer Documentation, Doc-Rev: 280001290-D (2021).