QC/QA in Pharma

Pharmaceutical Quality Control and Assurance

FT-NIR, FTIR, and Raman spectroscopy stand as cornerstone methodologies in pharmaceuticals for research alongside QC/QA evaluations. They offer the advantage of non-invasive testing without the necessity of sample preparation or employing any solvents or chemicals. This ensures time-efficient and cost-effective analytical procedures. Even measurements through packaging materials have become standard practice.

In catering to the stringent regulatory demands of the pharmaceutical sector, Bruker Optics supplies systems that comply with cGMP/GMP standards and renowned pharmacopeias (like PhEur and USP). Concurrently, these systems operate under 21 CFR Part 11 compliant software. Bruker’s comprehensive array of instruments for such uses is bolstered by a suite of service and validation consulting offerings.

FT-NIR Spectroscopy

FT-NIR spectroscopy is adept at swiftly analyzing multiple components using a singular device. Near-infrared spectrometers can be fitted with optical probes, facilitating the direct assessment of raw materials in their respective containers. Alternatively, measurements can be conducted using an integrating sphere in Petri dishes or via vials in a transmission mode.

FT-IR Spectroscopy

Quality and input control of raw materials via mid-infrared spectroscopy (FTIR/MIR), combined with attenuated total reflection (ATR) technology, delivers infrared spectra of almost every kind of liquid, solid, or semi-solid sample within moments. This is a remarkably versatile technique, proving invaluable for straightforward quality or identity verification of compounds.

Raman Spectroscopy

The escalating interest in portable Raman systems, exemplified by the BRAVO system, stems from the expansive application range of this spectroscopic method. Bruker’s BRAVO system was designed to address certain constraints of mobile Raman spectroscopy tools, including challenges like fluorescence and safety concerns. Today, obtaining high-fidelity spectra directly from storage locations is feasible.