Agilent RapID Raman

Importance of the Topic

Raw material verification is a critical step in ensuring the safety, purity, and efficacy of pharmaceutical products. Modern manufacturing demands rapid, accurate, and noninvasive methods to confirm container contents without compromising sterility or delaying production workflows.

Objectives and Overview of the Article

This document introduces the Agilent RapID Raman system, designed to perform through-barrier identification of raw materials using spatially offset Raman spectroscopy (SORS). Key aims include eliminating sampling steps, accelerating identity testing, reducing operator exposure, and achieving 100% container verification in high-throughput environments.

Methods and Instrumentation

The RapID Raman system integrates several innovative components and protocols:

• Spatially Offset Raman Spectroscopy (SORS): An 830 nm Class 3B laser excites samples through opaque or colored barriers, minimizing container fluorescence and capturing high-quality spectra from internal contents.
• Interchangeable Nose Adapters: Magnetic retain-and-release adapters fit common container geometries (paper sacks, cylindrical and flat bottles), enabling rapid alignment and measurement. Custom sizes are available on demand.
• Software Platform: The touch-screen interface is 21 CFR Part 11 compliant, supports barcode-driven batch workflows, network integration (Ethernet/Wi-Fi), LIMS connectivity, and automated data backup.

Key measurement times for typical container-material combinations:

• Mannitol in three-layer paper sacks: 20–30 seconds
• Lactose in one-ton supersacks: around 10 seconds
• Acetaminophen in plastic bottles: 5 seconds
• Acetic acid in 2.5 L amber glass bottles: 5 seconds

Main Results and Discussion

Comparative testing of 200 paper sacks containing lactose illustrates significant efficiency gains:

• RapID Raman workflow completes identity verification of 200 sacks in under 4 hours (<1.2 minutes per sack).
• Conventional Raman with sampling booths requires approximately 17.5 hours total (5.25 minutes per sack) and involves multiple quarantining and handling steps.

Spectral analysis demonstrates that SORS delivers clear chemical signatures through multilayer packaging, whereas traditional handheld Raman often records only container fluorescence. RapID supports a broad range of formulations, including oral solid doses (sugars, excipients, APIs), parenteral preparations (sterile liquids, salts), and biopharmaceutical components (growth media, surfactants, buffers).

Benefits and Practical Applications

• Noninvasive Testing: Eliminates container opening, preserving sterility and product shelf life.
• Operational Efficiency: Reduces QC turnaround times, minimizes laboratory bottlenecks, and lowers outsourcing costs.
• Safety and Compliance: Limits operator exposure to high-potency APIs and supports regulatory documentation through integrated software controls.
• Versatility: Compatible with diverse container types (sacks, barrels, bottles) and a wide chemical library of raw materials.

Future Trends and Opportunities

Ongoing developments are expected to expand RapID Raman capabilities and applications:

• Enhanced Spectral Libraries: Incorporating machine learning to refine identification algorithms and handle increasingly complex mixtures.
• Miniaturization and Portability: Developing lighter, field-deployable units for on-site and remote verification in supply chain settings.
• Integration with Digital Platforms: Real-time data analytics, cloud-based monitoring, and seamless LIMS/ERP interfacing for end-to-end quality management.
• Broader Container Compatibility: Adapting SORS optics to new packaging materials and shapes, including composite and multilayer plastics.

Conclusion

Agilent RapID Raman represents a significant advance in pharmaceutical raw material testing by combining SORS technology with user-friendly instrumentation and software. This system streamlines QC workflows, enhances safety, and ensures full compliance with regulatory standards while maintaining high throughput and cost-effectiveness.

References

• Agilent Technologies. RapID Raman – Through-Barrier Raw Material Identity Verification. Application Note, April 16, 2020.