System Validation ALPHA II · INVENIO · LUMOS II

Importance of FT-IR System Validation

FT-IR spectroscopy is widely applied in pharmaceutical development and manufacturing to characterize molecular structures, verify raw materials, and monitor production processes.
Validating instruments and software underlies reliable data generation, supports regulatory compliance (GMP/GLP/cGMP, 21 CFR Part 11) and minimizes risk in product quality control.

Study Objectives and Overview

This document outlines Bruker’s end-to-end validation solutions for FT-IR systems, covering the ALPHA II, INVENIO, and LUMOS II platforms.
It details qualification phases (DQ, IQ, OQ, PQ), automated test routines, integrated reference standards, and documentation practices to streamline compliance.

Methodology and Instrumentation

The validation framework combines hardware, software, and certified reference materials:

• Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) procedures
• OPUS spectroscopic software with Validation Program (OVP) protocols for PhEur 2.2.24, PhJP 2.25, USP <854>
• Internal Validation Unit (IVU) with certified polystyrene standard to automate OQ/PQ routines
• LUMOS II FT-IR microscope supporting FPA imaging per Ph.Eur. 5.24 with PermaSure+ technology for enhanced wavenumber accuracy

Instrument qualification is automated, producing non-editable reports, audit trails, and performance alerts before expiry.

Main Results and Discussion

Automated validation procedures demonstrate consistent compliance across global pharmacopeia requirements.
Integrated software ensures GLP and 21 CFR Part 11 adherence via electronic signatures, secure data archiving, and user authentication.
Performance tests and recertification options (e.g., S030/M protocols) maintain long-term instrument integrity and traceability.

Benefits and Practical Applications

• Reduced manual effort through fully automated qualification routines
• Enhanced data security and integrity via single-file storage and audit trails
• Flexible validation intervals and user alerts for timely recertification
• Worldwide support from certified Bruker service engineers and comprehensive manuals

Future Trends and Potential Applications

Expanding integration of cloud-based data management and real-time monitoring.
Advances in imaging spectroscopy and machine learning for predictive quality control.
Broader adoption of automated qualification in regulated industries beyond pharmaceuticals, such as food safety and materials science.

Conclusion

Bruker’s system validation solutions for FT-IR spectroscopy offer a comprehensive, automated approach to meet stringent regulatory demands.
The combination of hardware qualification, validated software, and certified reference materials ensures reliable performance, minimizes compliance risks, and streamlines laboratory workflows.

Reference

• US Patent 7,034,944
• DE Patent 19,940,981