Hyperspectral imaging solution for the pharmaceutical and biotech industry

The measurement of powder or lyocake substances is a frequently encountered and demanding task in the pharmaceutical and biotech industry. The Chauvin Arnoux company Indatech solved it with its HypeReal system based on hyperspectral cameras from the Finnish manufacturer Specim.

To optimize their processes and detect counterfeiting of products, pharmaceutical, and biotech companies are often faced with the challenge of checking freeze-dried products or powder-like substances and analyzing their exact composition. This task is more complicated than it seems at first glance. “This is especially true if the material is contained in glass vials during the production process and has to be inspected in powder or cake-like lyophilisate form,” explains Fabien Chauchard, who founded the French company Indatech in 2009 together with Dr. Sylvie Roussel. The pharmaceutical expert mentions the fact that the materials to be examined usually have no flat surface, and the substances can be present in different densities as a particular difficulty. So far, if the analysis is to be carried out through a vial, good advice was hard to get.

Chauchard and his team wanted to develop a solution to this problem with a system that was as easy to use as possible, based on a hyperspectral camera. “Our goal was to make the analysis of powder-like substances as easy as operating a photocopier: it should be enough to place a sample on a microtiter plate and click a button to get the results!”

According to Chauchard, a major challenge was to analyze through the glass vials that contain the substances. “We decided to measure the powder-like substances from below because this perspective offers the best overview of a flat surface and the largest possible volume. Checking from the side of the vials usually used in the pharmaceutical and biotech industry would be difficult because of the stickers that are usually placed there to identify the samples. The top view was also out of the question due to the plastic or metal caps used.”

As the basic technology for the actual analysis of the materials, Indatech decided early on to use hyperspectral cameras. These cameras work in the near-infrared range (NIR) and, combined with a spectrograph, enable the identification of the spectral characteristics of the substances to be examined by recording their reactions to electromagnetic waves of different wavelengths. Depending on their chemical and molecular composition, substances show different reactions how they absorb, reflect or let light pass through. With the help of suitable classification algorithms, it is possible to evaluate exactly which substances are present after the image has been captured.

When choosing the suitable hyperspectral camera, Chauchard relied on the Finnish manufacturer Specim, with whom he already had a good experience in various projects for about 15 years. “The camera is at the heart of such a system. Its quality is crucial for the accuracy of the results that can be achieved with the analysis, which is why we turned to Specim for the implementation of this system. Since our analyzer should be as small as possible, we looked for a compact and powerful camera. We quickly identified the Specim FX17 as a good candidate for our application after competent advice from experts at Specim.”

The first tests already showed that Indatech had made the right choice, Chauchard recalls: “The tests were very encouraging right from the start and showed that the FX17 in combination with the associated lens delivered really good image quality. We also carried out several tests to assess the robustness, e.g., by changing the temperature in the housing. However, the FX17 always provided reliable information, even under difficult conditions.” The Indatech founder mentions the GigE interface of the camera as a further advantage, which made controlling of the camera very easy.

With the selection of a suitable hyperspectral camera, the essential step towards the development of the analysis system was taken. HypeReal is the name of the solution that Indatech presented for the first time at the beginning of 2020 and has since caused a sensation as a unique inspection solution in the pharmaceutical and biotech industry. With the help of the system, a large number of lyophilized products can automatically be tested quickly, non-destructively, and reliably using contactless measurements from underneath the sample. Typical tasks include evaluating the residual humidity content of lyophilized products, identifying the active pharmaceutical ingredients, recognizing physical defects in the lyophilisate, such as cracks or melts, or checking the homogeneity of lyophilized products.

As a special advantage of HypeReal, Chauchard emphasizes the accurate inspection and preservation of samples, which is carried out without any contact and without toxic reagents. “The system is a very robust instrument with excellent repeatability that works without major adjustments. It allows the use of customized plates for each sample with built-in references and different flask sizes and has an easy-to-use interface to acquire data, create models and generate reports.”

Outstanding, however, are the significantly reduced analysis times, which ensure a relevant return on investment, as Chauchard illustrates by using the example of a typical industrial application: “For the investigation of the residual humidity content of lyophilized products, these are usually filled into the wells of a 96-well microtiter plate. Typically, the research and development department of the pharmaceutical company must then carry out Karl Fischer titrations on each well, which can take several weeks. With HypeReal, the results and the associated report of all 96 wells are available within just 2 minutes!” In addition to the residual humidity in each well, the user also receives additional quality-related data such as information about existing cracks or shrinkage of the lyophilisate thanks to the images taken.” This makes HypeReal the ideal tool for fast, economical testing of lyophilized products,” emphasizes Chauchard.

The advantages of HypeReal have already convinced some of the world’s leading vaccine manufacturers, the Indatech founder says, once again emphasizing the share of Specim in the implementation of this solution:” The expertise of our partner was very valuable during the development phase of HypeReal and has helped us to quickly find the optimal hyperspectral camera for this application. I was impressed by the comprehensive understanding of our contacts at Specim on all questions related to hyperspectral imaging and the reliable advice they gave. The fact that we chose Specim as the supplier for the camera used made the implementation of the HypeReal project considerably easier.”

For these reasons, Indatech will also work with Specim on upcoming projects, Chauchard declares: “It is currently our priority to establish HypeReal on the market and to test other applications in the pharmaceutical industry as well. In addition, we are already carrying out tests in the agricultural industry, for example, for the analysis of plant seeds and the food industry. We were able to achieve very positive results, for example, when examining flour. Another interesting field of application could also be the analysis of old documents or paintings. Specim’s hyperspectral cameras will then most likely also be the basis of such systems.”