Identifying Raw Materials Inside Containers Using a Handheld Raman Spectrometer

Significance of the Topic

The identification of raw pharmaceutical materials at receipt is critical to comply with cGMP regulations and ensure first-time quality (FTQ). Traditional sampling and laboratory analyses are time-consuming and resource-intensive, leading to increased costs and operational bottlenecks. Handheld spatially offset Raman spectroscopy (SORS) offers a non-destructive approach to verify material identity through both transparent and opaque containers, streamlining warehouse workflows and reducing labor.

Objectives and Study Overview

This study evaluates the deployment of the Agilent Vaya handheld SORS-based Raman spectrometer in a pharmaceutical warehouse. It compares cost and time performance against a conventional handheld Raman device for verifying up to 1,200 raw material samples per month across multiple container types.

• Assess time and cost savings achieved by in-quarantine identification without container opening.
• Analyze throughput improvements and scalability for meeting 100% identity verification mandates.
• Calculate return on investment (ROI) over a four-year period.

Methodology and Instrumentation

A time–cost analysis was conducted on 150 monthly consignments, each comprising eight containers. Two workflows were benchmarked:

• Conventional Raman: manual container handling, opening, sampling in a booth, and off-line analysis.
• Vaya SORS-based approach: non-invasive in-quarantine scans through opaque and multilayer packaging.

Used Instrumentation

• Agilent Vaya handheld Raman spectrometer with Spatially Offset Raman Spectroscopy (SORS) capability.

Main Results and Discussion

Using Vaya reduced total annual operator time by approximately 56% (from 2,370 to 1,047 hours) and cut cost per sample by over 50% (from $5.80 to $2.50). More than 60% of containers were verified without opening, eliminating container movements, PPE use, and booth cleanup. Daily throughput improved: all arrivals could be ID-verified in 35 minutes with Vaya versus 75 minutes with conventional Raman. A four-year ROI analysis yielded a net present value of $114,000 and a 61% ROI; scaling to full 100% identity verification nearly doubled ROI to 107%.

Benefits and Practical Applications

• Non-destructive testing through multilayer and opaque containers without sampling.
• Reduced labor, PPE, and consumables by eliminating sampling booths.
• Accelerated raw material availability for production, enabling same-day release.
• Lower inventory carrying costs through faster turnover and preserved package integrity.

Future Trends and Opportunities

Handheld SORS Raman instruments are set to expand in pharmaceutical, chemical, and logistics sectors. Future advances may include expanded spectral libraries, deeper penetration through composite materials, and digital integration with warehouse management systems. The scalability of SORS supports stricter global regulations and higher sample volumes without added personnel or equipment.

Conclusion

The Agilent Vaya SORS-based Raman spectrometer enables rapid, accurate raw material identification directly in quarantine, reducing process time and cost by over 50%. This non-invasive solution ensures compliance with cGMP mandates, enhances throughput, and delivers a compelling ROI, future-proofing quality operations against evolving regulatory demands.

References

• 21 CFR Part 211.84. United States Code of Federal Regulations.
• EU GMP Annex 8: Sampling of Starting and Packaging Materials.