Optimize raw material identification and verification (RMID) with MIRA P

Significance of the Topic

Raw material identification and verification is a critical step in quality assurance, enabling rapid incoming material release and preventing production delays. Implementing robust chemometric models across multiple instruments ensures consistent performance, operational flexibility, and compliance with regulatory standards such as 21 CFR Part 11.

Objectives and Overview of the Application Note

This Application Note describes a protocol for transferring principal component analysis based verification models from one MIRA P Raman spectrometer to another. It outlines steps for model export, transfer, validation, and expansion, aiming to scale RMID capabilities across locations and operators while maintaining method performance and traceability.

Methodology and Instrumentation

Model development uses Training Set data and operating parameters in MIRA Cal P software to generate PCA based models. Key steps include:

• Model export from the source instrument
• Import into the target instrument
• Validation using positive and negative control samples
• Parameter optimization and inclusion of additional spectra if required
• Application of a transfer matrix to align instrument variance

All metadata and audit trails are preserved to satisfy document control requirements under 21 CFR Part 11.

Main Results and Discussion

Validation experiments demonstrate three scenarios:

• Sodium bicarbonate: Direct transfer produced high p values for positive samples and appropriate failure of negatives, indicating a robust model requiring no further adjustments.
• Lactose: Fluorescence effects at 785 nm increased variance; parameter tuning in MIRA Cal P and inclusion of a few additional spectra from the second instrument restored performance.
• Microcrystalline cellulose: High fluorescence required use of a transfer matrix and parameter optimization, yielding a narrow p value distribution and reliable pass/fail outcomes on the new unit.

Benefits and Practical Applications

Transferring verification models between MIRA P devices enables:

• Faster turnaround of incoming inspections and reduced hold times
• Uniform RMID protocols across global sites
• Minimized downtime by using any instrument for verification
• Regulatory compliance with full traceability of model metadata

Future Trends and Potential Applications

Advancements may include automated transfer workflows integrated with laboratory information management systems, enhanced chemometric algorithms for complex or highly fluorescent materials, and cloud based sharing of verification models to facilitate global standardization and continuous learning.

Conclusion

Model transfer between MIRA P spectrometers is a straightforward yet powerful strategy for scaling raw material verification. With proper validation, parameter optimization, and transfer matrix application, chemometric models maintain robustness across instruments, supporting efficient quality control and compliance.

Instrumentation Used

MIRA P Basic package, MIRA P Advanced package, MIRA P Flex package

References

1. Metrohm AG. Simplified RMID Model Building Mira Cal P and ModelExpert AN-RS-031 Herisau Switzerland 2021
2. Gelwicks MJ Real World Raman Simplifying Incoming Raw Material Inspection Analyze This The Metrohm Blog