RawMaterialID

Raw Material ID

One of the first steps in the manufacturing of any pharmaceutical product is the identification and validation of various incoming raw materials.

Impurities and adulterants in starting materials pose potential health threats when present in the manufacturing of pharmaceutical APIs and drug products. These same impurities and adulterants may also result in lower production yields and greater needs for product purification.

FT-NIR spectroscopy via fiber optic probes is rapidly becoming a standard method of accomplishing this crucial material validation, providing unprecedented speed and flexibility for identification of both solid materials and liquids.

Bruker offers a complete turnkey system for quick and accurate identification of raw materials. Both MPA and MATRIX-F FT-NIR spectrometers can be equipped with fiber optic probes for direct analysis of raw materials in their containers. Complete identification software guides the user through the library creation process and provides single click identification even at the loading dock. The MATRIX-F system comes with a NEMA rated enclosure enabling it to withstand the toughest plant environments.

Incoming goods inspection and quality control using Mid-IR spectroscopy are mainly performed using the so-called ATR (Attenuated Total Reflection) technique. It allows measuring IR spectra of almost all types of liquid, solid and paste-like samples within some seconds. For identity control the sample spectrum is compared against the spectrum of a reference substance.

To identify an unknown sample, e.g. in cases where the identity check failed or a contamination was detected, the measured spectrum is searched in a spectra library. The very compact ALPHA FT-IR spectrometer with the Platinum diamond ATR module has proven to be very suitable for quality control applications. With its plug-and-play operation, ease of use and all preconditions for full validation it offers the capabilities you expect for routine analysis in the pharmaceutical environment.

The growing demand for portable Raman systems for material verification is constituted in the vast capabilities of this spectroscopic technique. High selective information content and no need of sample preparation combined with the capability to probe materials directly through transparent packaging material often make Raman spectroscopy as the method of choice.

Bruker developed the BRAVO to overcome the limitations of handheld Raman spectroscopy like fluorescence or safety issues. Operated by intuitive actions on a touch screen display measurements are performed fully automated by simply touching icons. As a class 1M laser product, BRAVO combines maximum user safety with an utmost ease of use, of course fully compliant to regulations like CFR 21 Part 11. BRAVO is the lab in your hands for material verification in the pharmaceutical industry.

Screening starting materials using Assure™- Raw Material Screening identifies problem samples prior to use and prevents costly manufacturing mistakes. Designed for GMP environments, Assure™- Raw Material Screening provides a traceable record of sample analysis and results. Applications extend beyond pharmaceutical production and includes chemical analysis.