Blending process monitoring with in-line NIR spectroscopy

RESCHAPE PROJECT: RESHAPING SUPPLY CHAINS FOR POSITIVE SOCIAL IMPACT

Industry-4-0, Digitalization, Pharma-4-0 3 April 2024

Control of the coating process of granular forms by NIR spectroscopy

monitoring of the pellet coating process

Control of the coating process of granular forms by NIR spectroscopy

In the pharmaceutical industry, there are many granular formulations that are coated to achieve a sustained or controlled release of the drug or active pharmaceutical ingredient (API) over time, a clear and well-known example being Omeprazole. In this paper we will discuss these extended release formulations and how it is possible to optimize the release time and potency analyses during the coating process using NIR spectroscopy.

Pelletisation process and traditional analysis

During the pelletisation process of modified release dosage forms, the correct application of the coating (e.g. an enteric release coating intended to prevent gastric digestion or degradation) will determine the subsequent efficacy of the drug and the mg/API release time of the drug and therefore controls are carried out throughout this process to ensure the quality and thus the expected pharmacological action.

Currently, this control is performed during the coating process with samples obtained from the coating equipment at different times and analysed in the laboratory using the analytical technique of HPLC or liquid chromatography and dissolution testing to demonstrate that the release of the active ingredient(s) is satisfactory. Both methods require sample preparation prior to analysis, require specialised personnel and consumables (materials), in addition to the duration (hours) of a dissolution test, whose main objective is to determine the bioavailability of the drug, meaning the relative amount of the drug that has entered the general circulation after administration, and the rate at which this access has occurred.

Therefore, the major problem with traditional analytics is that it is time-consuming to obtain the results and therefore does not allow for timely rectification of the coating process in case of failures or, in the frequent case of stopping the process for sampling, there is a risk that the quality of the semi-product will be altered.

An alternative and very effective tool that allows real-time monitoring of the coating process is NIR technology, since the spectral signature of each pellet can be related to its coating conditions, dosage and release times without the need to resort to traditional methods.

Development of an NIRS method for predicting release time and potency

In order to develop a predictive model for the real-time determination of release times and potency (mg API/g pellet) that is released at 1, 4 and 7 hours, we worked in coordination with a major Spanish pharmaceutical laboratory and the portable NIR spectroscopic analyser Visum Palm™ manufactured and marketed by IRIS Technology Solutions S.L.

The data provided by the laboratory consists of the NIR spectra of several batches of two drugs based on, on the one hand, an antihistamine which, for confidentiality reasons, we will refer to as “DS”, and on the other hand, a form of vitamin B6 which, for the same reasons, we will refer to as “PH”. In both cases, the active substance was part of the coating of the pellets constituting the vehicle.

The spectra of the pellets were acquired at different times of the coating process, from both wet and dry samples and, in parallel, the respective sample was subjected to the usual analyses in these cases to determine the drug release at 1, 4 and 7 hours and the potency mg PI/g.

The predictive models developed on the basis of the spectral data showed that it is not necessary to dry the samples for the acquisition of the spectra – so the control can be performed directly on the wet sample, saving time and handling – and that there is a clear relationship between the NIR spectra, the power and the release times of 1h, 4h and 7h, as we will see below.

PH compound - Coating process and NIR spectroscopy

^{Table 1: Quality parameters of the prediction models for the release at 1, 4, 7 hours and the potency in the samples with different stages of the PH coating process. The * symbol indicates that the model was built by using the average NIR spectra of the replicates of each sample.}

^{Figure 1: Regression curves for PH a) All samples; b) Batches 1,3,4 y 7; c) Mean spectra of batches 1,3,4 y 7; d) Batch 7.}

DS compound

^{Table 2 shows the quality parameters of the models for the analysis of wet DS samples. All samples were studied simultaneously: samples from batches 6, 8 and 10 together, and batch 6 separately. Batches 6, 8 and 10 were chosen for the study of a set of batches because they had the largest number of samples. In addition, batch 6 was chosen for individual analysis as it contained the most samples with the optimal release parameters for the case study.}

^{Table 2: Quality parameters of the prediction models for the release at 1, 4, 7 hours and the potency in the samples with different stages of the DS coating process.}

Figure 2 shows the regression curves resulting from the study for the active substance DS. The values of the quality parameters for the DS models show, in general, a good correlation. As an observation, it is noted that the error increases when data from different batches are used, probably because the process conditions of each batch are different due to the fact that the data come from the development and fine-tuning phase of the production process. The prediction of the release at 7 hours is worse than that of the other parameters, probably because the end of the release process has been reached in many cases before that time.

_{Figure 2: Regression curves for DS a) all samples; b) Batches 6, 8 y 10; c) Mean spectra of batches 6, 8 y 10; d) Batch 6.}

Prediction of dry samples

^{Table 3: Quality parameters of the prediction models for the dry samples of DS batch 6 and PH batch 7.}

The prediction models of the dry samples for individual batches of PH and DS show a good correlation. It should be noted that the prediction error is due to the few validation samples used.

^{Figure 3: Regression curves for Dry simples of a) DS batch 6 y b) PH batch 7.}

Conclusions - Coating process and NIR spectroscopy

There is a clear correlation between NIR spectra with release times of 1h, 4h and 7h, as well as with potency, for both DS and PH, although it is slightly worse for PH.
In the case of the 7h release, the correlation seems a bit weaker, possibly because it is close to the maximum release (at the release plateau) or due to differences in the pH of the samples.
The different batch production conditions affect the robustness of this correlation, an inherent variability factor because the samples come from the development phase of the production process (fine-tuning phase) and not from the NIRS method.
Individual batch tests show a good correlation for both wet and dry samples. Since the results in both cases are similar, it can be concluded that drying is not necessary to correlate the studied parameters (release time and potency) with the NIR spectra.
Finally, from the analysis of the results analysed, it can be concluded that NIR spectroscopy can be used to optimise the control of the coating process of granular forms and that, from a technical point of view, it is a robust and evidence-based method. However, for all the cases evaluated in this document, definitive models have to be made once the production process has been fully developed.

By IRIS Technology Solutions

RESCHAPE PROJECT: RESHAPING SUPPLY CHAINS FOR POSITIVE SOCIAL IMPACT

Plastic identification, verification and classification using Visum Palm™

Industry-4-0 12 February 2024

Real-time NIR grain analysis

Near infrared spectroscopy (NIR) is a valuable analytical tool for real-time analysis of the chemical composition of a wide variety of products, including those of agricultural origin. In this article, we will address the application of NIR technology for grain analysis and in particular of two varieties of wheat grains: soft (Triticum aestivum) and hard (Triticum durum), as well as yellow corn (Zea Mays).

Grain analysis with continuous or portable NIR technology

The quality of food products depends directly on the quality of the raw materials used. Therefore, assessing their composition, purity and physicochemical characteristics is of interest to the food industry.
In grain analysis, NIR spectroscopy plays a crucial role in providing detailed information on several parameters simultaneously, with moisture being one of the critical factors in assessing grain quality. However, this technique also makes it possible to analyse other key parameters such as protein, fat, fibre, ash and starch content, thus offering a more rigorous control according to established quality criteria.
NIR spectroscopy differs from other techniques in that it is non-destructive, which means that measurements can be made continuously without compromising the integrity of the batch or sample under analysis. In addition, results are obtained in a matter of seconds, streamlining grain analysis, quality control processes and allowing instant decision making compared to conventional wet chemistry analysis.

Below we will look at two ways of performing NIR grain analysis, either fully automated and continuous on the production line or by means of a portable analyser, useful for analysis in the field, in the raw material reception warehouse or in discontinuous processes.

Continuous and real-time grain analysis: wheat and corn grains

A Visum NIR In-Line™ (900-1700 nm) continuous analyser was used to develop the grain calibration model and 30 calibration samples and 7 validation samples were used from each class. In addition, duplicate reference analyses were obtained from each sample to mitigate the inherent error in the primary method of analysis. For moisture analysis, a thermogravimetric moisture meter HE53 (Metler Toledo) was used, protein was determined by the Kjeldahl method and fat content was determined by the Soxhlet method.

The table below shows the main results and figures of merit of the soft grain (TB) and durum grain (TD) wheat for the parameters moisture and protein expressed as % dry matter. In addition, the results for fat and moisture of yellow corn are also shown. It is important to clarify that the same calibration is useful and groups both wheat classes into a single family or method of analysis. No significant spectral differences were observed for their individual treatment.

^{* Table 1: Analysis of common wheat, durum wheat and yellow corn. Main figures of merit resulting from the Visum NIR In-Line™ continuous analyser.}

Grain analysis with NIR spectroscopy is also important in animal feed manufacturing to optimise diets and yield. In the agri-food sector, the NIR technique offers numerous advantages over wet chemistry methods, mainly due to the immediacy of the result and the possibility of being able to make technological decisions on the spot, even more so if we consider the introduction of these systems such as the Visum NIR In-Line™ analyser in production lines that allow continuous monitoring of the entire product flow to ensure the ideal conditions of the process and the product, mitigating any deviation with phytosanitary consequences that may affect the safety of an entire batch, as far as moisture is concerned.

A portable NIR alternative for grain analysis

On many occasions, mainly due to the conditions and environment where grain analysis is to be performed, it can be of great use to work with a portable NIR grain analyser such as the Visum Palm™. This device, which works in the same spectral range (900 – 1700 nm) as the continuous analyser we saw earlier, is capable of determining in less than 3 seconds different parameters of interest in all types of grains, cereals and oilseeds.

Some of its main advantages, especially for field grain analysis, are:

It is a self-contained analyser (embedded computer and touch screen). It does not need to be connected to any external device, tablet or smartphone to operate.
It has a sample measurement area of 10 mm in diameter and illumination of 50 mm in diameter, which allows mitigating the heterogeneities present and obtaining more chemical information from each sample.
Unlike most portable NIR grain analysers on the market today, it has a spectral resolution of 3 nm or 256 pixels, i.e. two to three times higher, allowing spectra, and therefore results, of high reliability and quality to be obtained.
It includes factory libraries for different grain types.
And it is supported by external Visum Master™ PC software, so that the end user can develop their own NIR calibrations and extend them in an automated, AI-assisted way. In this way, the user is not dependent on third-party libraries and has full autonomy to strengthen and extend his calibrations for new parameters or products according to his current or future needs.

We hope you found this article on grain analysis with NIR technology useful. For further information, we invite you to contact us by email at info@iris-eng.com.

By IRIS Technology Solutions

Plastic identification, verification and classification using Visum Palm™

identificación, verificación y clasificación

Plastic identification, verification and classification using Visum Palm™

In this article we will address the problem of classification and plastic identification using the Visum Palm™ handheld NIR analyser as an agile, real-time and non-destructive technique useful in different processes, whether in the recycling of post-industrial plastic, in the analysis and classification of post-consumer plastic, in the identification of polymeric raw materials for their industrialisation, or even in areas of research and development of new plastic.

In all these cases, near infrared spectroscopy is presented as a valuable tool used for the characterisation of plastic compared to traditional methods of analysis.

Identification and sorting is important in plastic recycling and in manufacturing when using recycled plastic, as in both cases it must be ensured that the plastic materials are as pure and clean as possible because low levels of impurities can significantly affect the quality and performance of a recycled batch.

Although there are several portable NIR analyzers on the market, it is important to consider the spectral range that the equipment works with, the size of the measurement area (spectrum acquisition) and the spectral resolution (the quality of the spectrum obtained). The new Visum Palm™ analyser has a measuring area of 10 mm diameter, operates in the spectral range 900-1700 nm with a resolution of only 3 nm (↓ nm = ↑ spectral resolution). It is a self-contained device with an embedded computer and touchscreen and therefore does not need to be connected to a computer or smartphone to work with it.

Análise de forragens e espectroscopia nir

The new Visum Palm™, which includes a polymers library, allows readings and determinations to be made at the line without the need for sample preparation in less than 3 seconds. It is also possible to use it as a laboratory device as it has a support base that allows the attachment of different sample holders for the analysis of pellets, flakes or plastic up to 2 mm.

The factory library included in the analyser has the following classes: PMMA, PE, PC, PETG, EVA, PVC, PET, PU, PS, ABS, PA, PP, VIN, PLA, PBT, PMP, POMC, PPS, PVA, PPSU, EMA, PHBV, PAEK, PBAT, PBS, TPES, TPS, MABS, HIPS, MBS, SBC, PCL, PEEK, PHB, SAN, PI, PB.

Extend and develop your own library with Visum Master™

Visum Master™ is a computer software that allows the end user to create, extend and strengthen their own identification, classification and quantification methods or libraries without the need for a specialist or technical knowledge of spectroscopy, making the analyser a truly open system to meet present and future analysis needs (new polymer classes, new suppliers, etc.).

As shown below, it is possible to incorporate spectra of new samples within an existing class or to incorporate new classes and thus keep the library as robust and up-to-date as possible in order to be able to classify or identify plastic.

Plastic identification

It is a working method that allows the plastic identification analysed within the library available in the analyser. The result obtained, as can be seen below, is the type of polymer with the highest similarity and the following (from highest to lowest similarity).

_{Image 1: Visum Palm™ screen performing plastic identification}

Plastic identification screen visum palm

Polymer Verification

As with plastic identification, it is based on a mathematical procedure of similarity but it allows choosing a type of material to be analysed within the identification library to confirm its identity. The result of the verification analysis is PASS / FAIL. In case of a negative result (FAIL), it provides the class corresponding to the type of plastic analysed. Both cases are shown below.

Plastic classification

In contrast to plastic identification analysis, classification uses machine learning algorithms to accurately analyse and classify samples that are spectrally very similar to each other, where a double check is necessary to determine the polymer class (PET/PETG, for example). Through the Visum Master™ software, the user can create his own classification libraries for the most problematic cases.

As a result of the analysis, the user obtains the corresponding class.

In conclusion, NIR spectroscopy is a very valuable and effective tool for plastic identification or classification and, although not covered in this article, it is also useful for manufacturers of plastic and new formulations to quantify blends. The open nature of the analyser through the Visum Master™ software makes the Visum Palm™ analyser an open, self-contained system that can continuously introduce new samples, spectra and generate different libraries without the need for a specialist.

By IRIS Technology Solutions

IRIS Technology Solutions at Alimentaria FoodTech 2023

At the end of September, IRIS Technology Solutions presented at Alimentaria FoodTech trade show 2023 Barcelona the various real-time quality and process control solutions for the industry that the Catalan company manufactures and markets under the Visum® brand.

Alimentaria-FoodTech is the machinery, technology and ingredients show that integrates the food processing and preservation value chain. It is a transversal fair that serves the food and beverage production industry from raw materials to commercial distribution.

Visum® Solutions

Visum® solutions optimize and digitize quality control on different production lines. They operate on the basis of NIR, Raman, Hyperspectral and Machine Vision spectroscopy, providing real-time information for decision making and rectification of production processes. In addition, trade show participants were able to see first-hand the new Visum Palm™ handheld NIR analyser.

The new Visum Palm™ analyzer has an innovative and ergonomic design, as well as the possibility to perform analysis at any time and place without the need to connect it to any external electronic device. This is possible because it incorporates an embedded touch screen and computer, which allow all the routine functionalities of the device.

In addition, it has the Visum Master™, this software, unlike the most common modeling and calibration software on the market, with which the user has to have certain technical knowledge about chemometrics or entrust such a task to a third party.

It allows to perform calibrations in an automated and agile way only by incorporating spectra and references (quantitative or qualitative), in addition to other functionalities.

Shealthy Project

IRIS Technology Solutions has also presented at FoodTech the European SHEALTHY project, which seeks to evaluate and develop an optimal combination of non-thermal sanitization, preservation and stabilization methods to improve safety (inactivation of pathogens and spoilage microorganisms) while preserving nutritional quality (up to 30%) and extending shelf life (up to 50%) of F&V products. By combining and modulating non-thermal technologies with minimal processing operations, SHEALTHY’s approach will finally be able to meet today’s growing consumer demand for healthy food.

By IRIS Technology Solutions

New Visum Palm™ AI-assisted handheld NIR analyser

IRIS Technology Solutions introduces the latest version of its Visum Palm™ portable NIR analyser to complement its Visum® range of real-time process analysers for industry.

The new Visum Palm™ is a fully portable NIR spectrophotometer that allows real-time analysis of different substances, products or mixtures, without the need for traditional laboratory and sampling techniques, allowing industry to obtain results on the spot to make decisions or correct production process parameters.

The new generation Visum Palm™ brings with it an innovative design and a radical change in the way users experience NIR technology, now assisted by AI with the Visum Master™ software, so that each manufacturer can automatically create their own predictive models or calibrations according to their control and analysis needs.

Design, autonomy and robustness

The Visum Palm™ analyser offers an innovative and ergonomic design, as well as the possibility to perform analysis at any time and place without having to connect it to any external electronic device. This is possible because it incorporates an embedded touch screen and computer, which enable all the routine functionalities of the device.

The Visum Palm™ operates in the 900 to 1700 nm range, as this is the band that best combines availability of chemical information with price and technological maturity. It operates mainly in diffuse reflectance mode, for which it has specially designed and patented optics to extract as much information as possible from the sample. Specifically, it has a large illumination area (50 mm diameter) and a collection area of 10 mm. These features differentiate it from similar analysers in terms of its suitability for analysing heterogeneous samples, which is most often the case in real working conditions. In cases where heterogeneity is more evident, the device is configurable to calculate and report the average of a given number of repetitions.

The Visum Palm™ analyser is IP65 compliant, making it resistant to dust, moisture and water. It is also rugged enough to be carried and tested almost anywhere indoors or outdoors and even comes with a stand for desktop or tabletop use.

A new AI-assisted user experience

Unlike most common modelling and calibration software on the market, which requires the user to have some technical knowledge of chemometrics or entrust the task to a third party, Visum Master™ PC-based software makes NIR technology even more accessible by automating pre-processing, multivariate analysis algorithm selection and validation. This allows any user to generate models by simply inputting spectra and references (quantitative or qualitative) for routine real-time analysis to replace traditional analysis.

The new software also allows to extend and edit pre-existing models, synchronise with the portable analyser to import spectra, export models, download measurement results, automatically generate analytical method validation reports and audit reports for GMP environments, and to check the metrological performance of the device in a guided manner when needed.

For industry and GMP environments

While NIR technology has a myriad of applications in numerous industries such as plastics, food, chemical, agribusiness, wood, biofuels, to mention the most relevant but not the only ones; it is for the pharmaceutical industry and GMP environments where the new Visum Palm™ device introduces significant novelties at the level of usability and functionality. It is 21 CFR Part 11 compliant, allowing the generation and display of an automatic Audit Trail report, the record of all device activity, where comments and observations can be incorporated. It also allows the user to automatically generate the analytical method validations developed and perform metrological checks of the device when required and download the results at a later date.

“NIR technology today must be easy to use and understand, and at the same time it must give the user the freedom and autonomy to exploit it to the full and facilitate their day-to-day work. Technology must be an enabler. We will continue to take further steps in terms of automation and new functionalities because we are convinced that this is the right way forward and what the industry and the people in it need”, says Oonagh Mc Nerney, Director of IRIS Technology Solutions, S.L.

The new Visum Palm™ handheld NIR analyser is now available here, where you can also find technical information about the device, videos and contact IRIS Technology Solutions, S.L. for a demonstration or specific enquiry.

By IRIS Technology Solutions

IRIS Technology presents its solutions at Expoquimia 2023

IRIS Technology solutions at Expoquimia 2023

Barcelona – 1 June 2023 – Today, the director of IRIS Technology, Joan Puig, presented at Expoquimia 2023 the different real-time quality and process control solutions for industry that the Catalan company manufactures and markets under the Visum® brand. Expoquimia is the main meeting of the chemical industry to highlight the strategic importance of the transformation of the industry towards more energy-efficient production models and circular economy criteria.

Visum® solutions make it possible to optimise and digitise quality control on different production lines. They operate on the basis of NIR, Raman, Hyperspectral and Machine Vision spectroscopy, providing real-time information for decision making and rectification of production processes. “IRIS Technology is developing and improving its portfolio of products and solutions, and at the same time opening new export markets such as Latin America. We continue to invest in R&D and we are the Spanish SME with the most projects in this field within the European Union,” said Joan Puig during his presentation at the event.

IRIS has participated in Expoquimia by invitation of the Agency for Business Competitiveness of the Generalitat de Catalunya (ACCIÓ).

IRIS would like to thank all the people who attended the presentation and ACCIÓ for inviting and giving IRIS a new opportunity to present its Visum® devices with solutions for the chemical and plastic sectors.

For further information on IRIS developments, we invite you to contact us via the following email address: info@iris-eng.com.

By IRIS Technology Solutions

Raw material identification and analysis (RMID) using the Visum Palm™ handheld NIR analyser assisted by AI

Raw material identification and analysis (RMID) using the Visum Palm™ handheld NIR analyser assisted by AI

The raw materials identification and analysis (RMID) is a critical process in the pharmaceutical industry because it guarantees the identity and quality of all materials and substances to be used in the manufacturing process to ensure that they meet the specifications that the final products require to reach the consumer with the pharmacological characteristics for which they were designed.

In terms of raw material identification and analysis, both Raman and NIR are complementary techniques and neither represents a final or definitive solution due to the large number of materials, substances and casuistries involved. For example, handheld Raman analysers are sensitive to certain substances that emit fluorescence and are not the appropriate technique for moisture determination (LoD) to replace the Karl Fischer method or for the determination of the average particle size, where NIR spectroscopy is effective and at a lower cost.

^{Figure 1: Handheld NIR analyser Visum Palm™ handheld or desktop.}

Raw material identification and analysis in the pharmaceutical industry

The Visum Palm™ handheld NIR analyser is a self-contained spectrophotometer with embedded computer and touch screen that operates in the 900-1700 nm range useful for the pharmaceutical raw materials identification, verification and classification and has a spectral resolution of 256 pixels, a measuring area of 10 mm in diameter and an illumination area of 50 mm, which allows more chemical information to be obtained from the sample analysed and makes it less sensitive than other spectrophotometers to heterogeneities, even those derived from the particle size for substances that are very similar. The analyser has an illumination system that fires a large amount of light at the sample and a collection system that takes advantage of the larger amount of scattered light due to scattering, which is especially important when working with powdery substances.

^{Figure 2: Visum Palm™ performing pharmaceutical raw material identification.}

Among its particularities, it is the only NIR analyser on the market with AI-assisted software that allows any user, without specific technical knowledge in spectroscopy or multivariate data analysis, to develop their own NIRS libraries and methods and to edit them iteratively according to their needs, for example, to incorporate new substances or to strengthen a class with samples from a new supplier.

The Visum Master™ software in its GMP version has been specifically designed in compliance with the European Medicines Agency “Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations” (2014) and the Addendum “Defining the Scope of an NIRS Procedure” (2023). It is also compatible with FDA regulation 21 CFR Part 11.

^{Figure 3: Visum Master™ GMP version software for pharmaceutical users.}

Identification, verification and classification

The Visum Palm™ analyser allows the raw material identification or verification analysis of different substances to be carried out in seconds by comparing the spectrum acquired from the sample with the average typical spectrum of each substance in the library. This comparison is made on the basis of a mathematical criterion of similarity, which converts the differences into a numerical value. As a result of the raw material analysis, the Visum Palm™ analyser provides the class with the highest similarity obtained (Figure 3) and lists the other substances in order of highest to lowest similarity.

Unlike the identification analysis, which is agnostic to the material to be inspected, the verification analysis (Figure 4) allows the user to select a specific substance within the library to confirm its identity. The result is either PASS or FAIL and, in the latter case, also indicates the correct and most similar substance.

raw material identification and verification visum palm

^{Figure 4: Raw material identification Figure 5: Verification PASS/FAIL}

Classification analysis

In contrast to the above, for feedstock analysis, classification (Figure 5) is a function that uses machine learning algorithms, not similarity algorithms, and allows to properly distinguish (classify) very subtle spectral differences, such as particle size or concentration of a particular analyte, even if they are the same API or excipient. It is a very useful function to identify anomalies in the raw material or to perform a confirmation of the identification analysis in problematic or doubtful cases where the substances are spectrally very similar, thus complementing the identification or verification analysis mentioned above.

In all the above cases, in addition to the result, the spectrum of the analysed substance is obtained for each measurement (Figure 6).

^{Figure 6: Classification analysis Figure 7: Spectrum of each measurement}

NIRS method generation: advantages of automation for raw material identification and analysis

Visum Palm™ is the only NIR analyser on the market that allows end users to develop their own NIRS libraries or methods for identification, classification and quantification without the intermediary of technicians or specialists. Let’s see graphically below how existing market software for multivariate data analysis – or also called chemometrics – for NIRS method development and calibration differs from IRIS Technology Solutions’ Visum Master™ software.

Identification et analyse des matières premières

^{Figure 8: (Left) Chemometrics software for method development and NIRS calibrations.}^{(Right) Development of NIRS methods for identification, classification and quantification with Visum Master™ software.}

The above is a graphical example to quickly differentiate how Visum Master™ simplifies a large number of scientific and technological tasks that until now had to be performed by chemometrics experts or specialists during the development phase of a NIRS method. Moreover, the software makes it accessible to any analyst to autonomously perform these tasks and edit the created methods when necessary, making the Visum Palm™ NIR analyser an open system that can cover different analytical needs with proper user training, thus radically changing the accessibility and usability of the NIR technique in the industry.

The Visum Master™ software automatically generates a large number of successive predictive models by applying each time a certain combination of pre-treatments, algorithms and parameterisations. In all cases, it chooses the one with the lowest RMSE and risk of overfitting. It also automatically runs a spectral quality test to identify and remove spectral outliers, i.e. those spectra considered atypical in relation to a predefined range of variation for each class or value, and automatically produces a report of the developed NIRS method with all the technical information on how the model was generated, a document especially useful for external validation of a quantitative NIRS method for release and as supporting documentation for audits.

Development and edition of an raw material identification/verification or classification library

To generate a library or identification raw material method for raw material analysis (analogue for classification and quantification), it is only necessary to import the acquired spectra of each substance or calibration sample and enter its reference value, name or class. At the end of the data upload, Visum Master™ will generate the library automatically.

It is also possible to edit and iteratively strengthen the library to incorporate new substances or sample spectra from a new supplier. For each edition, a new version (v1, v2, …) is generated as a backup copy of the changes made. At the end of the process, the NIRS library or methods are exported to the Visum Palm™ portable analyser for use in the routine raw material identification, classification and quantification.

^{Figure 9: (left)Development of a NIRS raw material identification or classification method or library. (right). Edit raw material identification or classification library. Add new spectra to an existing class or add a new one and its reference (name or class).}

Conclusions

Raw material identification and qualification is an essential step in any GMP environment and unlike other technologies, the NIRS technique can identify and classify materials or substances or quantify different analytes of interest, thus reducing the workload in the laboratory or raw material receiving warehouse.

Visum Palm™ offers a unique value unlike any other device on the market in that the creation or editing of NIRS libraries and methods is automated and can be performed without specific knowledge of chemometrics, although it has an “Expert Mode” for advanced users that allows the choice of preprocessing and algorithms during the method generation phase and is activated by licence. It also has the differential of offering automated reports that facilitate the work of any analyst vis-à-vis potential auditors in terms of supporting documentation and external validation of the NIRS method used, even for release.

Visum Palm™ offers the following advantages:

It is useful for the identification and qualification of materials, including fluorescent materials, which cannot be analysed by Raman spectroscopy.
In addition to identification raw material analysis it can perform quantitative analysis, e.g. to replace Karl Fischer (LoD) analysis on raw materials.
It is a self-contained analyser with embedded computer and touch screen and does not require connection to other electronic devices.
It has a spectral resolution of 3 nm or 256 pixels, a measuring area of 10 mm diameter and a sample illumination area of 50 mm. Its high spectral resolution is very similar to that of laboratory NIRS devices.
It can be used as a handheld or benchtop analyser.
It allows customised reports of measurement results in tabular form, comparison of spectra (for raw materials) and incorporation of the company logo.
It is also capable of automatically generating NIRS libraries or methods and downloading reports for each of them. The Visum Master™ software in its GMP version also allows the possibility to generate the operational qualifications of the device through a guided wizard and an Audit Trail report with all the information about the use of the device in compliance with 21 CFR Part 11.

By IRIS Technology Solutions

Forage and feed analysis with NIR spectroscopy

Forage and feed analysis with NIR spectroscopy

NIR spectroscopy is a powerful analytical method to determine in real time the chemical composition of a wide variety of materials and mixtures. In this article we will discuss some applications of near infrared spectroscopy ranging from the analysis of forage to the feed analysis, its manufacturing process and finished products for animal feed and nutrition.

NIR analysis of alfalfa

Alfalfa is a legume that is grown all over the world because of its high protein content and rapid digestibility for animal feed, mainly for livestock. Nowadays, due to the nature of the primary activity itself, various controls are carried out to determine the quality of the product, especially for export to the Chinese and Persian Gulf markets. One of the main parameters determining the quality of alfalfa is crude protein (CP), but other parameters such as acid detergent fibre (ADF) and neutral detergent fibre (NDF) determine the nutritional value of the fodder and the terms of trade in its commercialisation.

Table 1. Quality of alfalfa (less than 10% grasses) for marketable forage according to USDA Livestock, Hay & Grain Market News (Putnam and Undersander, 2006).

Feed analysis with NIR spectroscopy

NIR spectroscopy and animal nutrition

In conclusion, the use of real-time NIR spectroscopy is becoming more and more widespread in the animal feed sector and particularly in feed analysis, applications which are now extending to the introduction of this technology online for the monitoring of the entire manufacturing process.

By IRIS Technology Solutions

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Control of the coating process of granular forms by NIR spectroscopy

Control of the coating process of granular forms by NIR spectroscopy

Pelletisation process and traditional analysis

Development of an NIRS method for predicting release time and potency

PH compound - Coating process and NIR spectroscopy

DS compound

Prediction of dry samples

Conclusions - Coating process and NIR spectroscopy

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RESCHAPE PROJECT: RESHAPING SUPPLY CHAINS FOR POSITIVE SOCIAL IMPACT

RESCHAPE PROJECT: RESHAPING SUPPLY CHAINS FOR POSITIVE SOCIAL IMPACT

ReSChape's main objectives are:

The ReSChape project has been distributed in 5 different Work Packages:

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Real-time NIR grain analysis

Grain analysis with continuous or portable NIR technology

Continuous and real-time grain analysis: wheat and corn grains

A portable NIR alternative for grain analysis

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Plastic identification, verification and classification using Visum Palm™

Plastic identification, verification and classification using Visum Palm™

Extend and develop your own library with Visum Master™

Plastic identification

Polymer Verification

Plastic classification

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IRIS Technology Solutions at Alimentaria FoodTech 2023

IRIS Technology Solutions at Alimentaria FoodTech 2023

Visum® Solutions

Shealthy Project

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New Visum Palm™ AI-assisted handheld NIR analyser

New Visum Palm™ AI-assisted handheld NIR analyser

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IRIS Technology presents its solutions at Expoquimia 2023

IRIS Technology solutions at Expoquimia 2023

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Raw material identification and analysis (RMID) using the Visum Palm™ handheld NIR analyser assisted by AI

Raw material identification and analysis (RMID) using the Visum Palm™ handheld NIR analyser assisted by AI

Raw material identification and analysis in the pharmaceutical industry

Identification, verification and classification

Classification analysis

NIRS method generation: advantages of automation for raw material identification and analysis

Development and edition of an raw material identification/verification or classification library

Conclusions

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Forage and feed analysis with NIR spectroscopy

Forage and feed analysis with NIR spectroscopy

NIR analysis of alfalfa

Feed analysis with NIR spectroscopy

NIR spectroscopy and animal nutrition

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