Identifying Raw Materials Directly Through Paper Sacks

Importance of the Topic

Pharmaceutical companies receive large volumes of excipients like lactose monohydrate, mannitol, microcrystalline cellulose, and sucrose in multilayer paper sacks. Regulatory guidelines require identity verification before these materials enter production. Conventional methods involve opening each sack, sampling, and analysis in a dedicated booth or QC laboratory, which can take days and incur high labor and consumable costs.

Objectives and Study Overview

The primary aim was to demonstrate that a handheld Vaya Raman spectrometer employing Spatially Offset Raman Spectroscopy (SORS) can identify raw materials directly through unopened paper sacks. The study compared time and resource requirements against traditional FTIR and back-scattering Raman methods in a GMP warehouse setting.

Methodology and Instrumentation

• Handheld Agilent Vaya Raman system with SORS capability.
• Materials tested: lactose monohydrate, mannitol, microcrystalline cellulose, sucrose, magnesium stearate.
• Containers: three-layer paper bags with PE liner (DFE Pharma) and two-layer bags with PE liner (Meggle).
• Reference spectra obtained through thin polyethylene film and subtracted from sample spectra to isolate material signatures.

Key Results and Discussion

The Vaya system generated container-free Raman spectra for all tested excipients. Identification times per sample through sacks were ≤90 seconds. Compared with conventional handheld Raman in a sampling booth, the SORS approach reduced total verification time by more than 3-fold; relative to FTIR in a QC lab, time savings exceeded 9-fold. Eliminating steps such as sack opening, resealing, booth cleanup, and material transfers contributed to the efficiency gains.

Benefits and Practical Applications

• Material identity confirmed within quarantine areas without opening sacks.
• Significant reduction in turnaround time—from days to hours for bulk receipts.
• Lower operational costs by removing consumables and minimizing labor-intensive handling.
• Enhanced compliance with pharmacopeia methods for raw material testing.

Future Trends and Opportunities

As SORS technology matures, integration with real-time data analytics and digital batch records can further streamline GMP processes. Expanding application to other container types (e.g., drums, flexible packaging) and a broader range of compounds will enhance supply chain efficiency. Automation of handheld scanning workflows and AI-driven spectrum interpretation are likely developments.

Conclusion

The Agilent Vaya Raman spectrometer using SORS enables rapid, non-destructive identity verification of excipients through multilayer paper sacks. This approach significantly shortens receipt workflows in pharmaceutical warehouses, reduces costs, and preserves container integrity while maintaining compliance with regulatory standards.

Reference

• EU GMP Annex 8: Sampling of Starting and Packaging Materials.
• Agilent publication 5991-8859: Application of Spatially Offset Raman Spectroscopy to In-Container Testing of Raw Materials for PIC/S GMP Annex 8 Using the Agilent RapID Raman System.