Identifying Raw Materials Inside Containers Using a Handheld Raman Spectrometer

Importance of the Topic

Raw material identification is a critical cGMP requirement in pharmaceutical manufacturing to ensure product quality, safety and regulatory compliance. Traditional protocols involving off‐line sampling, container opening and laboratory analysis are time‐ and resource‐intensive, create logistical bottlenecks and increase operational costs.

Aims and Overview of the Study

This white paper examines the application of a handheld Spatially Offset Raman Spectroscopy (SORS) device, the Agilent Vaya Raman system, for non‐destructive identification of raw materials through both transparent and opaque packaging. The study evaluates process simplification, time and cost savings, and return on investment (ROI) in a warehouse environment.

Methodology

SORS leverages photon propagation in scattering media by spatially separating the laser excitation and collection zones. Subtraction of container‐rich and material‐rich spectra isolates the Raman signature of the raw material. This approach enables direct identification of APIs and excipients without sampling or package opening.

Used Instrumentation

• Agilent Vaya Raman system: handheld, SORS‐based spectrometer
• Capabilities: identification through paper sacks, FIBC/big bags, HDPE bottles, drums and tubs
• Performance: e.g., lactose monohydrate in three‐layer paper bag in 80 s; citric acid in white HDPE bottle in 15 s

Key Results and Discussion

• Process time reduction: 50 % less operator time compared to conventional handheld Raman (1 047 h vs. 2 370 h per year for 1 200 samples per month)
• Cost per sample: reduced from approximately $5.80 to $2.50
• Sampling booth elimination: no container movement or PPE consumables required for samples amenable to through‐container ID
• Throughput impact: daily raw material arrivals processed in under 5 h versus ~10 h, enabling same‐day release
• Inventory savings: reduced carrying costs (> $5 K/year for a $0.75 M stock at 5 %) and preservation of expiration dates for sensitive materials

Benefits and Practical Applications

• Immediate raw material verification in quarantine without opening containers
• Scalable solution supporting up to 100 % ID requirements without additional personnel or equipment
• Maintenance of sterile or inert packaging conditions, reducing waste and preserving material integrity
• Future‐proofing quality protocols against evolving regulatory demands and increased sample volumes

Future Trends and Opportunities

Handheld SORS Raman devices are expected to integrate with warehouse digitalization and Industry 4.0 initiatives. Advances in spectral libraries, automation of spectral matching and integration with manufacturing execution systems (MES) will further streamline raw material workflows. Expansion to new material types and container formats will broaden applicability across pharmaceutical and adjacent industries.

Conclusion

The Agilent Vaya Raman system provides a cost‐effective, rapid and non‐destructive method for raw material identification directly through containers. By eliminating sampling steps and reducing operator time by half, it delivers significant ROI (61 %–107 % over four years) and supports 100 % ID compliance at lower cost. Implementation of handheld SORS Raman accelerates supply chain operations, enhances quality control and prepares organizations for future regulatory and throughput challenges.

References

1. Title 21 Code of Federal Regulations, Part 211.84
2. EU GMP Annex 8: Sampling of Starting and Packaging Materials