Raw material identification and analysis (RMID) is a cornerstone of the pharmaceutical industry because it ensures the identity and quality of all materials and substances used in the manufacturing process. Only if the input products meet the required specifications can the final products also have the desired pharmacological properties.
NIR spectroscopy vs. Raman spectroscopy: A complementary relationship
Although Raman and NIR spectroscopy are complementary in RMID, neither method is the only solution. The variety of materials to be analyzed requires flexibility. Portable Raman analyzers are extremely sensitive, but show weaknesses with fluorescent substances. In addition, they cannot determine the moisture content (LoD) or measure the average particle size - both of which are possible with NIR spectroscopy and are also more cost-effective.
Figure 1: Visum Palm™ Handheld NIR Analyzer handheld or desktop.
Visum Palm™: The handheld NIR analyzer of the future
The Visum Palm™ portable NIR analyzer is a standalone spectrophotometer with an integrated CPU and touchscreen. The spectral range of the device is between 900 and 1700 nm. Identification, verification and classification are therefore easily possible. Thanks to a spectral resolution of 256 pixels, a measuring area of 10 mm diameter and an illumination area of 50 mm diameter, more chemical parameters can be obtained from the analyzed sample and the sensitivity to heterogeneities is significantly reduced compared to other spectrophotometers. This has a positive effect on the analysis of samples with contamination caused by particles of a similar size. The analyzer has an illumination system that emits a large amount of light onto the sample and a collection system that can use the larger amount of scattered light thus created. This technical feature is particularly important when analyzing powdery substances.
Figure 2: Visum Palm™ in the identification of pharmaceutical raw materials.
AI power for everyone: The software revolution
A unique selling point of the Visum Palm™ is its AI-supported software. It enables every user - even without specific expertise in spectroscopy or data analysis - to develop and iteratively adapt their own NIR libraries and methods. This allows new substances to be integrated or models to be expanded with samples from new suppliers.
GMP Compliance and Regulatory Requirements
The GMP version of the Visum Master™ software has been developed in accordance with “Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations” (2014) of the European Medicines Agency and the Abdomen “Defining the Scope of an NIRS Procedure” (2023). It also meets the requirements of FDA regulation 21 CFR Part 11.
Conclusion
The Visum Palm™ is more than just a portable NIR analyzer. It is a game-changer for raw material analysis (RMID) in the pharmaceutical industry. With its combination of cutting-edge technology, user-friendly AI software and GMP compliance, it sets new standards for efficiency, precision and quality assurance.
