Solutions for Accelerated Raw Materials Identification

Significance of the topic

Ensuring the correct identity of pharmaceutical raw materials is a regulatory requirement and a critical step to maintain product quality and patient safety. Traditional sampling and laboratory analysis can take days, involve extensive handling, and incur high costs and safety risks.

Objectives and Study Overview

This whitepaper examines the use of the Agilent Vaya handheld Raman spectrometer equipped with Spatially Offset Raman Spectroscopy SORS for rapid through-container identification of raw materials in a cGMP warehouse. The study aims to compare testing throughput cost and safety between conventional methods and Vaya-enabled workflows.

Methodology and Instrumentation

The Vaya system integrates SORS to separate container signals from material signals by acquiring both zero-offset and offset spectra and subtracting container contributions. Key hardware features include an 830 nm laser to reduce fluorescence an ergonomic design barcode scanner Wi-Fi connectivity and a NIST-traceable test piece for performance checks. The software offers guided workflows pass/fail results batch processing work-in-progress management and compliance with FDA 21 CFR Part 11 USP and EP requirements.

Key Results and Discussion

• Through-container testing through multilayer paper sacks plastic drums and flexible intermediate bulk containers was completed in 15 to 90 seconds per sample
• Comparison with conventional handheld Raman and FTIR showed a reduction in total identification time from days to hours and a more than 55% decrease in annual labor costs
• Benchmark case a pharmaceutical operation processing 1200 samples per month saw annual labor costs drop from $83 320 to $36 808 when adopting Vaya
• Container opening sampling sealing and laboratory queuing steps were eliminated reducing operator exposure and preserving material integrity

Benefits and Practical Applications

• Accelerated raw material release to production supporting just-in-time inventory and reduced stock levels
• Enhanced safety by keeping containers sealed and minimizing PPE and sampling consumables
• Scalable testing capacity to meet 100% identity verification without additional personnel or equipment
• Smooth integration with warehouse LIMS and audit-ready data management

Future Trends and Potential Applications

Advances in handheld SORS Raman systems may drive broader adoption across pharmaceuticals food and chemical industries for noninvasive quality control. Integration with machine learning for automated spectral interpretation expansion of spectral libraries and miniaturized photonics could further improve sensitivity throughput and ease of use.

Conclusion

The Agilent Vaya handheld Raman spectrometer with SORS transforms raw material identification by enabling rapid through-container testing with minimal training and full compliance with pharmaceutical regulations. This approach significantly reduces turnaround time and costs enhances safety and supports agile supply chain operations.

References

• FDA 21 CFR Part 11 and Part 2.11.84
• USP General Chapters 1225 and 1858
• EP Chapter 2.2.48