Compliance and Convenience at Every Point
Compliance and Convenience at Every Point
Our advanced FT-IR, FT-NIR, and Raman solutions deliver fast, precise chemical analysis at every stage of QC and QA. They ensure consistent quality, detect contaminants, and verify raw materials efficiently. By providing immediate insights into composition and material integrity, they help maintain reliable results throughout the entire quality control process.
For QA/QC Managers:
Simplified operation, reduced training time, and full workflow coverage.
For Validation Experts:
Complete documentation, audit readiness, and regulatory alignment.
For Scientists:
High spectral quality, flexible sampling, and robust performance.
For Procurement Teams:
Low total cost of ownership, long-term reliability, and cross-departmental value.
Bruker’s instruments support QA/QC across the full lifecycle:
Incoming Goods Inspection
Our instruments verify the chemical identity of active pharmaceutical ingredients directly upon arrival. This prevents mix-ups and ensures only compliant materials enter production. It streamlines quality control and reduces reliance on lab-based confirmation.
Counterfeit Detection
Suspect tablets or packaging from external sources are analyzed for material inconsistencies. Even subtle deviations in excipient composition or coating can reveal counterfeits. This safeguards patient safety and regulatory compliance.
Production Monitoring
During batch manufacturing, Bruker’s instruments are used to analyze intermediate samples at defined checkpoints. This ensures blend uniformity, correct moisture levels, and compliance with formulation specifications. The data supports timely adjustments and documentation without requiring inline integration.
Testing of Solid Dosage Forms
Tablets are scanned non-destructively to assess active ingredient distribution and coating integrity. Variations in spectral profiles highlight potential formulation issues. This ensures consistent therapeutic performance across units.
Final Product Release
Before shipment, each batch is checked against its reference spectrum to confirm identity and purity. The rapid analysis accelerates release timelines without compromising quality. It supports lean operations and reliable delivery.
Deviation Investigations
Unexpected changes in color, texture, or performance trigger targeted spectral analysis. The system helps pinpoint contamination sources or process anomalies. This speeds up root cause analysis and corrective action.
Returned Goods Analysis
Returned pharmaceuticals are examined for degradation, tampering, or improper storage. Spectral comparison with original batch data reveals any chemical shifts. This informs decisions on reprocessing, disposal, or investigation.
Validation with Integrity
Bruker’s spectroscopy portfolio is built for regulated environments, combining cutting-edge technology with full compliance support.
- Validated for cGMP, FDA, EMA, WHO standards
- Full support for 21 CFR Part 11 and ALCOA+ principles
- Trusted by pharmaceutical QA/QC teams worldwide
Please find here more information about comprehensive compliance to pharmaceutical regulations:
Explore Our Solutions
ALPHA II – Lab-Based QA/QC Backbone
Compact FT-IR spectrometer for high-precision analysis in laboratory settings.
ALPHA II delivers validated FT-IR precision for every lab task, with OPUS TOUCH software that guides even untrained users through compliant workflows and minimizes the risk of user error. Its QuickSnap modules and robust hardware allow fast adaptation to any sample type, so labs can switch between raw materials, intermediates, and finished products without downtime. ALPHA II is ready for audit at any time, with built-in validation, secure user management, and full support for electronic records and 21 CFR Part 11 compliance.
- OPUS TOUCH interface with guided workflows
- Internal Validation Unit (IVU) for automated OQ/PQ
- 10-year warranty on key components
Additional Highlight
Intelligent Spectra Identification – OPUS A.I.D.
Automate IR spectra identification with fast, reliable results for both pure substances and complex mixtures.
- AI-driven evaluation with no user input
- Visual diagnostics including residual spectra and hit quality graphs
- Intuitive library creation, validation, and advanced search
Please find here more information about our validation solutions for FT-IR spectroscopy:
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MPA III – FT-NIR for Solid Dosage Analysis
Modular FT-NIR spectrometer configured for tablet analysis in QA/QC
MPA III is the only FT-NIR analyzer that combines modular sampling (solids, liquids, tablets) with robust, state-of-the-art optics and automation, so you can develop sophisticated calibration methods and run routine QC with the same instrument. Its long-life light source and permanently aligned RockSolid interferometer ensure high stability and low maintenance, even in demanding environments. This flexibility and reliability mean you can adapt to any pharma QC routine or advanced analysis without switching systems or sacrificing data integrity.
- Automated sample wheel enables high-throughput, non-destructive tablet testing
- Applications include: Quantification of API Content & excipients, Content Uniformity, Real-Time Release Testing, Tablet Identification.
Additional Highlight
High-Throughput Sampling – MPA III Multi Purpose Analyzer
Streamline sample handling with automated, flexible configurations suitable for QA/QC and method development.
- 30-position automated sample wheel for consistent analysis
- Custom tablet nests for reliable positioning
- Modular design adaptable to laboratories, production floors, and mobile setups
Please find here more information about Brukers Multi Purpose Analyzer:
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BRAVO – Handheld Raman for Raw Material QC
BRAVO is rugged, validated, and designed for raw material QC through packaging. It combines handheld flexibility with dual-laser excitation and patented SSE™ fluorescence mitigation. With it's QR and barcode reader, material info is easily integrated in the workflows, making it ideal for routine pharmaceutical tasks.
Unified Message: Complements ALPHA II and MOBILE-IR II to deliver a complete material QC solution. A portable Raman spectrometer for fast, non-destructive raw material verification.
- Dual-laser excitation with patented fluorescence mitigation (SSETM)
- Through-packaging analysis with customizable tips
- Ideal for routine tasks with QR- and Barcode reader
- Full Pharma Validation Package (possibly add video link)
Additional Highlight
Pharmaceutical Compliance – BRAVO Raman Spectrometer
Ensure traceable, accurate measurements fully compliant with pharmaceutical regulations in validated environments.
- Full GMP/GLP and 21 CFR Part 11 compliance
- Protected raw and processed data with complete audit trails
- Advanced optics deliver benchtop-level accuracy in a handheld device
Please find more information of compliance to pharmaceutical guidelines & regulations:
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Ready to Upgrade Your QA/QC Strategy?
Please read more about the Quality Control of Bulk Materials with Bruker Instruments:
Please find here more information about Brukers Raman solution for Pharmaceutical Industry:
