Analytical Diagnostic & Pharmaceutical Validation Tool

The Bran+Luebbe InfraProver is a polarization interferometer Fourier transform NIR instrument based on principles of HPCS (High Performance Crystal Spectroscopy). The system uses a moving crystal wedge to obtain FT Interferograms for the materials being tested, resulting in a substantial reduction in sensitivity to vibration compared to traditional lab grating and FT instruments.

The design of the instrument allows presentation of a wide variety of sample forms to the system via software control without changing the hardware. Two options are available for solids. A 2-meter fiber optic probe enables "probing" of containers in the reflectance mode. Materials can be scanned directly in the containers or through plastic packaging material. Alternatively, the Solid Presentation Accessory (SPA) permits spectroscopic interrogation through the base of a vial when the vial is placed on the optical window of the SPA. Tablets or capsules can also be analyzed with this accessory. Liquids were scanned in the transmission cell, a "built-in" cuvette chamber located in the center of the InfraProver.

Long term stability of the instrument is achieved via internal laser referencing for all wavelengths ensuring wavelength accuracy and reproducibility.

Near Infrared technology scans the product in its entirety. Mathematical algorithms then separate the chemical or physical properties of interest from the rest of the matrix. Samples are therefore analyzed "as -is" with no sample preparation

The InfraProver was specifically developed for the pharmaceutical industry so it is designed to meet GLP, GMP, GSP principles, and FDA & Pharmacopeia guidelines. Many pharmaceutical companies have validated the instrument for their applications.

Assay methods have been developed. Purity can be determined, giving the information if raw materials have been spiked or doped. In some cases, NIR has shown that similar materials were substituted or co-mingled with incoming raw materials.

Method development can be turned around to adapt the technology to new products or new formulations.

Library Identification Method -

Identification is performed using a Library model. Several batches of each raw material are placed in glass vials, which are placed on the optical window of the Sample Presentation Accessory (SPA). The InfraProver scans the raw materials through the glass vial. Mathematical modelling is used to determine acceptable radii and residual for each material in factor space. When an unknown sample is scanned, the Mahalanobis distance radii and spectral residual are evaluated in relation to those used to develop the library model. If the radii and residual are within the established criteria for a material, the InfraProver will confirm that the identity is ok. If the radii and residual are not within the established criteria, the InfraProver will inform the user that the identity is not ok, will print out a list of nearest materials to the one scanned.