About PermaSure+ and the world’s first Ph. Eur. 5.24 compliant FT-IR imaging

Importance of the Topic

Chemical imaging combines spectroscopy and microscopy to reveal spatially resolved chemical distributions within a sample. This capability is highly valuable in pharmaceutical manufacturing, materials research and quality control, but its routine application was limited by the lack of standardized performance guidelines.

Objectives and Study Overview

This work describes the development and validation of the first FT-IR imaging system fully compliant with European Pharmacopoeia Chapter 5.24. The goal was to achieve pixel-by-pixel wavenumber accuracy on par with single-element spectrometers and to demonstrate qualitative and quantitative reliability for regulatory and industrial environments.

Methodology and Instrumentation

The core innovation, termed PermaSure+, implements a laser-based calibration procedure that measures the optical path differences encountered by infrared rays reaching each pixel of the focal plane array. By assigning a calibrated wavenumber scale to every pixel, the method corrects spectral axis shifts and ensures consistent band positions across the image.

Used Instrumentation

• Bruker LUMOS II FT-IR imaging microscope with focal plane array detector
• PermaSure+ pixel-wise laser wavenumber calibration module
• INVENIO research-grade FT-IR platform covering FIR to VIS/UV
• HYPERION II FT-IR imaging microscope

Key Results and Discussion

Comparison of uncalibrated and PermaSure+ calibrated images shows dramatic reduction of wavenumber variability across pixels. Without calibration, the position of a reference water vapour band varied by several wavenumbers. After PermaSure+, all pixels exhibited identical band positions matching the accuracy of standard single-element spectrometers. This uniformity is essential for reliable qualitative interpretation and quantitative imaging.

Benefits and Practical Applications

• Enhanced spectral accuracy enables traceable and reproducible imaging data.
• Full automation and high speed acquisition (>900 spectra/s) support high-throughput screening.
• Compliance with Ph. Eur. 5.24 facilitates regulatory acceptance in pharmaceutical QC.
• Improved confidence in spatial distribution analyses for material and life-science research.

Future Trends and Opportunities

Ongoing developments may include integration of AI-driven data analysis, extension to hyperspectral and Raman imaging modalities, and tighter coupling with process analytical technology (PAT) workflows. Advances in detector technology and calibration algorithms are expected to further boost throughput and versatility in industrial settings.

Conclusion

The PermaSure+ calibration strategy successfully delivers Ph. Eur. 5.24 compliance for FT-IR imaging, achieving unprecedented wavenumber accuracy across every pixel. The resulting instrument platform meets the demands of routine manufacturing control, research applications and regulatory frameworks, marking a significant step forward in chemical imaging.

Reference

No formal literature list was provided in the source document.