Agilent RapID Raman

Significance of the Topic

Pharmaceutical raw material verification is essential for ensuring product quality, safety, and regulatory compliance. Traditional Raman spectroscopy requires opening containers and sampling, which adds time, contamination risk, and operational complexity. Through-barrier analysis offers a noninvasive alternative that accelerates workflows, preserves sterility, and minimizes operator exposure.

Objectives and Overview of the Study

This summary reviews the Agilent RapID Raman system, which integrates spatially offset Raman spectroscopy (SORS) for 100% identity testing of incoming materials through unopened packaging. The primary goals are to demonstrate rapid, accurate raw material identification, reduce QC turnaround, and streamline warehouse operations.

Methodology and Used Instrumentation

The RapID Raman system uses an 830 nm class 3B laser and SORS optics to suppress container fluorescence and acquire spectra of contents through opaque or colored barriers. Measurements employ magnetic nose adapters that align the excitation and collection optics with various container shapes. Data handling is managed by RapID software compliant with 21 CFR Part 11, featuring touchscreen controls, integrated 1D/2D barcode scanning, network connectivity (RJ-45/WiFi), and LIMS output.
Used Instrumentation

• Agilent RapID Raman system with 830 nm laser
• Spatially offset Raman spectroscopy (SORS) module
• Magnetic nose adapters for cylindrical, flat, and barcode-scannable containers
• Touchscreen workstation with integrated barcode scanner
• Network connectivity via RJ-45 and WiFi

Main Results and Discussion

Performance testing demonstrated identification times of 20–30 seconds for three-layer paper sacks of mannitol, 5 seconds for amber glass bottles with acetic acid, 10 seconds for 1 ton supersacks of lactose, and 5 seconds for plastic bottles of acetaminophen. In a head-to-head comparison for verifying 200 paper sacks, RapID reduced total analysis time from 17.5 hours (conventional Raman with sampling) to 4 hours, increasing throughput and reducing labor and quarantine delays. SORS spectra showed clear content signatures, overcoming container fluorescence that limits conventional handheld Raman.

Benefits and Practical Applications

• Noninvasive testing preserves sterility and reduces contamination risk
• Faster QC turnaround minimizes warehouse quarantine time
• Enables 100% inspection for enhanced quality assurance
• Lowers operational costs by reducing sampling booths and cleanup
• Compatible with a broad range of APIs, excipients, and container types (sacks, bottles, barrels, FIBCs)

Future Trends and Applications

Through-barrier Raman approaches are poised to extend into continuous manufacturing environments and automated material handling systems. Advances in adapter design and sensitivity may facilitate analysis of more complex packaging and lower-concentration analytes. Integration with data analytics and machine learning could further enhance material traceability and predictive quality control.

Conclusion

The Agilent RapID Raman system represents a significant advancement in raw material identity verification. By leveraging SORS for through-container analysis, it eliminates sampling steps, reduces risk, and accelerates QC workflows, delivering robust, compliant, and high-throughput testing for pharmaceutical operations.

References

• None