Identifying Raw Materials Directly Through Paper Sacks

Significance of the Topic

Quality assurance for pharmaceutical raw materials requires rapid, noninvasive identification to meet GMP compliance and reduce operational delays.

Objectives and Study Overview

This study demonstrates the use of a handheld Raman spectrometer with spatially offset Raman spectroscopy (SORS) to identify common excipients through multilayer paper sacks, evaluating performance and time savings.

Methodology and Instrumentation

Measurements were conducted on lactose monohydrate, microcrystalline cellulose, sucrose, mannitol and magnesium stearate supplied in two-layer and three-layer paper sacks lined with polyethylene. SORS spectra were acquired through unopened sacks using the Agilent Vaya handheld Raman system. Reference spectra were collected from thin polyethylene liners and subtracted to isolate the excipient signal.

Key Results and Discussion

SORS measurements produced container-free spectra matching reference fingerprints for all materials. Scan times ranged from 30 to 90 seconds per sample. Compared to conventional handheld Raman and FTIR workflows, identity verification time was reduced by factors of over 3 and 9 respectively, eliminating lengthy sampling booth procedures.

Benefits and Practical Applications

• Same-day release of large batches directly in quarantine areas
• Preservation of packaging integrity and reduced contamination risk
• Lower labor requirements and elimination of disposable sampling tools
• Enhanced compliance and cost efficiency in warehouse operations

Future Trends and Potential Applications

Further developments may include application of SORS to diverse container types, integration with automated spectral libraries and AI-driven analysis, and broader adoption in pharmaceutical and biopharmaceutical supply chains.

Conclusion

The Agilent Vaya Raman system with SORS enables rapid, noninvasive identification of excipients through paper sacks, significantly reducing process time and cost while maintaining regulatory compliance.

Instrumentation

Agilent Vaya handheld Raman spectrometer configured for spatially offset Raman spectroscopy.

References

• European Commission. EU GMP Annex 8: Sampling of Starting and Packaging Materials.
• Agilent Technologies. 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; Publication 5991-8859.