Metrohm NanoRam handheld Raman spectrometer

Significance of the Topic

Rapid, non-destructive verification of pharmaceutical and raw materials is critical in modern manufacturing to ensure product quality, regulatory compliance and supply-chain efficiency. Handheld Raman spectroscopy addresses these needs by delivering immediate identity confirmation without consuming or altering samples, enabling real-time decision making in laboratories, warehouses and production lines.

Objectives and Study Overview

This overview examines the NanoRam handheld Raman spectrometer, designed to perform through‐container analysis of APIs, excipients and intermediates. The aim is to assess its data quality, reproducibility, regulatory compliance, sampling versatility and ease of use for non-technical operators across cGMP environments.

Methodology and Instrumentation

The NanoRam employs a 785 nm excitation source and a TE-cooled linear CCD detector to collect Raman spectra from 176 to 2900 cm⁻¹. Its high dynamic range and broad spectral window improve detection of weak Raman signals. Measurements can be carried out directly through transparent vials, bottles and drums using interchangeable sampling probes, preserving sample integrity throughout the analysis.

Used Instrumentation

• Excitation wavelength: 785 nm diode laser, user-adjustable output up to 300 mW
• Spectral range: 176 cm⁻¹ to 2900 cm⁻¹ with ~9 cm⁻¹ resolution
• Detector: TE-cooled linear CCD array
• Display: High-resolution OLED touchscreen
• Sampling accessories: point-and-shoot adapter, vial holder, bottle adapter, immersion probe
• Power: rechargeable Li-ion battery (>5 h continuous operation) and DC-12 V adapter
• Data management: embedded NanoRam OS, PC-based NanoRam ID software, export formats .txt, .csv, .spc, .pdf, secure Wi-Fi/Ethernet transfer
• Environmental rating: IP64; operating temperature –20 °C to +45 °C

Main Results and Discussion

The NanoRam delivers high-quality spectra with low noise, enabling rapid identification even of weak Raman scatterers. Method and library transfer between devices ensure consistency across multiple instruments. Its multivariate classification routines yield reliable p values for identity verification, while mixture analysis algorithms detect multiple components in complex samples. Accessories and temperature-stabilized hardware maintain performance under variable conditions.

Benefits and Practical Applications

• On-site raw material screening in labs, warehouses and loading docks
• Elimination of quarantine zones by immediate pass/fail results
• Compliance with USP <858>, EP 2.2.48, Chinese Pharmacopeia and PIC/S & GMP guidelines
• Minimal training required for non-technical operators via intuitive touchscreen workflow
• Seamless integration with LIMS and secure data handling under 21 CFR Part 11

Future Trends and Opportunities

Advancements may include expanded spectral libraries for new materials, AI-driven spectral interpretation, enhanced miniaturized probes for specialized sampling and cloud-based data analytics. Integration with automated material handling and real-time quality dashboards will further streamline GMP workflows and support Industry 4.0 objectives.

Conclusion

The NanoRam handheld Raman spectrometer combines robust hardware, adaptable sampling accessories and validated software to provide rapid, reproducible identity verification of pharmaceutical and industrial materials. Its compliance with global regulatory standards, ease of use and versatile data management capabilities make it a valuable tool for quality assurance and process efficiency in cGMP environments.