Real-Time blending process monitoring with NIR spectroscopy

Powders blending process is the most popular to achieve content uniformity in solid forms. Despite its apparent simplicity, i.e., taking advantage of shear forces for mixing APIs and excipients by merely moving the container for a certain time, any specialist in galenic does know that the real behavior of the mixture is not that simple. In fact, the final distribution results from a chaotic combination of microscopic interactions among the particles and macroscopic flow mechanics, not to mention that, once the homogeneity has been achieved, there is a real risk of demixing as a consequence of the affinity among homologous particles. That is why, regardless of the mechanical improvements in the blender’s design, systematically checking for mixture homogeneity is a key requirement in the pharmaceutical and nutraceutical sector. This is where NIR becomes important as a technique for real-time blending process monitoring.

Traditional control of the blending process vs. Blending process monitoring (PAT)

Up to now, periodically stopping the blending process after several cycles in order to take some samples from different points, which are further analysed by chromatography, has been the traditional way to do it. However, such an approach has also certain unwanted drawbacks, namely added lead time (due to the involved cumbersome lab procedures), suboptimal blending time (because of arbitrary extended blending intended for guaranteeing homogeneity) and blending artifacts (such as demixing and lumps as a consequence of keeping the load in static conditions while waiting for the lab results).


On the contrary, a PAT approach, such as a spectroscopy-based real time blending process monitoring, could be deemed the optimal way to check if the endpoint condition has been reached. In fact, both FDA and EMA have described such an approach as a recommended new paradigm.

In principle, as thoroughly described in the scientific literature, there are two ways for implementing a PAT-based endpoint determination: by using a supervised machine learning predictive model (for example, a PLS model that quantitatively predicts the API concentration) or by using an algorithm agnostic to the specific composition of the mixture. The first one usually renders more direct and accurate results but, in turn, it requires developing specific models on the basis of suitable reference samples, which is not always feasible, especially when there are too many different formulations. The agnostic approach for blending process monitoring, on the contrary, is based on spectral similarity; no ground truth data on the specific composition of each formulation is required in advance.

The agnostic approach: Moving-block Standard Deviation and the dynamic algorithm by IRIS Technology Solutions

Spectral stability is, in fact, agnostic to the specific composition of each formulation. No quantitative predictive model has to be developed for assessing the components concentrations because the underlying rationale states that, regardless of the composition, no improvement in homogeneity can be made once the spectra remain unchanged, at least for the major components. Indeed, a mixture can be deemed homogeneous once their spectra remain unchanged after several blending cycles. 

Since the NIR spectroscopy is sensitive to 0.1-1 % or higher concentrations, during during blending process monitoring the homogeneity of minor components cannot be assessed by means of such a technology. However, it can be inferred from the homogeneity of major components and opportunely validated with traditional lab methods if required.

Moving-block Standard Deviation (MBSD) is the most widely described agnostic algorithm, at least in the scientific literature. Usually, the MBSD endpoint criterion is rather arbitrary.  Even when a statistically-founded criterion is used [Critical evaluation of methods for end-point determination in pharmaceutical blending processes. M. Blanco, R. Cueva-Mestanza and J. Cruz. Anal. Methods, 2012, 4, 2694], some restrictive hypothesis on the distribution of the similarity metric should be fulfilled in order to be properly applicable. Moreover, the mean of the standard deviation has a rather “smoothing” effect that could veil to some extent the real trend of the spectral similarity.

The dynamic approach with Visum NIR In-Line™ for blending process monitoring

IRIS Technology Solutions’ proprietary algorithm, on the contrary, is based on checking for the stability of a true similarity metric (MSD: mean squared difference between two successive spectra) by using strong statistical criteria on the blending-specific MSD distribution. In fact, our moving block approach dynamically adapts the threshold to each formulation-wise spectral-similarity statistical distribution. Consequently, it provides a robust endpoint criterion for blending process monitoring regardless of the specific behavior of each formulation, which is particularly required when mixing anomalies such as demixing or lumps formation take place. 

For the sake of flexibility, the users can set both the moving block size and the statistical significance at their convenience. Whenever possible, such parameters should be tuned in the commissioning stage although the factory-set values should work for the most frequent circumstances.


Image 1: Sapphire window adapter module for Visum NIR In-Line analyser ™ manufactured by IRIS Technology Solutions S.L.

The adapter module with sapphire window allows easy integration of the Visum NIR In-Line™ analyser via a tri clamp connection. There are different sizes of the adapter module depending on the blending machine’s own configurations.

Unlike other analysers on the market, the Visum NIR In-Line™ is a self-contained analyser (embedded computer) and can communicate with multiple communication protocols. It also complies with the pharmaceutical regulation 21 CFR Part 11 (FDA), the requirements of the American (USP) and European (Ph. Eur.) Pharmacopoeia and the European Medicines Agency (EMA) Guidelines 2014 and 2023.

In its Blender version, the Visum NIR In-Line™ analyser is wireless, powered by rechargeable and replaceable batteries with a battery life of more than 3 hours and connected via Wi-Fi, as shown in the image below.


Image 2: Visum NIR In-Line™ analyser in a blending process monitoring cycle.

Table 1: Visum NIR In-Line analyser ™ technical specifications


The IRIS Technology Solutions S.L. In-Line™ NIR analyser presents a more robust and realistic dynamic method for blending process monitoring than the Moving-block Standard Deviation (MBSD) algorithm  in that it is based on the quadratic mean of two successive spectra and not on the average of the standard deviation as a similarity index used by the MBSD approach.

As it has an embedded computer, it does not need to be connected to other electronic devices or external computers, making it an excellent stand-alone tool for working at the plant production level and in GMP environments.

In addition, it has a much larger illumination and spectrum acquisition area than other NIR analysers, especially those very small ones, with a resolution of 256 pixels, obtaining more chemical information and spectral quality for optimal monitoring of each blending cycle.

By IRIS Technology Solutions
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
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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

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.


  • 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
Ai, Digitalization, Industry-4-0, Innovation, Pharma-4-0 5 September 2023

New Visum Palm™ AI-assisted handheld NIR analyser

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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
Industry-4-0, Pharma-4-0 31 March 2022

NIR technology and Raman spectroscopy: introduction and applications in the pharmaceutical industry

NIR technology and raman spectroscopy
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In the following article we will address the main applications with NIR technology and Raman spectroscopy, in real time, for the control of manufacturing and quality processes both for pilot plant – in tune with the Quality by Design (QbD) concept – and for industrial scale-up. In addition, this article is intended to be a starting point for industry professionals to raise questions about how to optimize control with process analytical technologies (PAT) for efficient management and implementation of a continuous manufacturing model.


Raman and NIR Spectroscopy


Both technologies have in common that they are photonic techniques – they take advantage of the properties of photons or light and their interaction with matter – diagnostic and non-destructive, allowing chemical and structural information to be obtained in seconds from almost any organic or inorganic material or compound. Hence, their use in laboratories is widespread in different industries and they are analytical techniques known by quality control professionals.


For those who are not laboratory professionals or are just entering the field, it is essential to start with a few brief concepts and examples to understand its applications.


Raman spectroscopy is a technique based on the inelastic scattering of light. Inelastic or Raman scattering occurs when the energy changes during the collision between the monochromatic light and the molecule and, therefore, the frequency of the scattered light also changes. These changes provide information about the molecular identity and structure of the samples or material being analyzed.


Near infrared spectroscopy (NIR) is a technique based on the interaction between electromagnetic radiation and matter, within the wavelength range of 780-2500 nm. These absorbed radiations can be related to different properties of the sample, providing qualitative and quantitative information. The near-infrared range is characterized by weak overtones and combined bands arising from the strong fundamental vibrations of O-H, C-H, C-O, C=O, C=O, N-H bonds and metal-OH groups in the mid-infrared range.


However, both Raman and NIR spectroscopy devices in real time are optical (vision) devices that work with artificial intelligence. The information they collect from the spectrum of the analyzed object is interpreted by a mathematical model – chemometrics – called a “predictive model” that tells the system what it is looking at. A very simple example: if we want to control the Paracetamol content of a 1mg. form, the mathematical model that analyzes the process must know how to correlate the spectrum corresponding to that value and for that it must know what is 0.8 – 0.9 – 1.1 and so on in the range of interest to be controlled. The predictive model is a mathematical model that essentially correlates a spectrum with a reference value. This reference value comes out of the traditional laboratory analysis.


Let’s get down to the important: What use are these systems in my factory?


Applications of real-time NIR technology:


1) Raw material identification: Identification of raw materials is a routine task in the pharmaceutical industry. These tests are carried out before the materials are processed, in order to avoid errors as much as possible and thus save time and money. This material testing applies not only to purchased materials (e.g. excipients), but also to some internal material transfers, e.g. APIs manufactured in another plant. The latter is very important to take into account when wondering why we have problems in mixing some formulations with certain raw materials.

2) Homogenization: Once identified and weighed, raw materials usually require homogenization of the different components. This is a critical step in the manufacture of solid-state pharmaceutical products, as it has a direct impact on the quality and homogeneity of the final product. The homogenization process is mainly affected by physical properties such as particle size, shape and density. Mixing endpoint and homogenization are not the same, not in terms of regulation according to the European Medicines Agency (EMA). From IRIS Technology we try to raise awareness on this point, which is sometimes confused, to provide in-line control solutions that are homologous to the control protocols established by the EU and Spanish regulations.

3) Granulation and sizing: Sometimes the different ingredients of the formulation do not mix well and segregate during homogenization. Therefore, it is desirable to granulate powdered ingredients by compression, dry granulation or in the presence of a binder under wet conditions. Most spectroscopic uses focus on the determination of water during wet granulation or drying after granulation.

4) Extrusion: NIR spectroscopy has been widely used in hot extrusion to monitor both API content and solid state of extrudates and to identify interactions between ingredients.

5) Tableting: This stage of the process is the closest to the final product. Therefore, it is sometimes easier to control the quality of the product directly in the press, especially if there is a subsequent coating step. At this point, NIR can also play an important role.

6) Coating: The coating process is a crucial step in the manufacture of solid oral preparations. In fact, the coating can act as a physical screen to avoid the effects of oxidation, moisture and lighting conditions in order to improve the stability of the final product or intermediate products in the process. The coating can also play an active role in the protection (gastroresistance) and release (modified release) of the drug in vivo. The homogeneity and thickness of the coating are important in controlling the timing of drug release. Many offline techniques are available to control the coating thickness, such as changes in weight, height or diameter of the coated granule/tablet cores during processing. In-line NIR technology is especially useful for monitoring water-based coatings and is a technique that saves hours of analysis, which we have discussed in particular in this other article.

7) Final product control: An important part of final product quality control includes the analysis of all batches produced to avoid out-of-specification results. This control point, although it is too late to avoid losses, can also be performed with portable (handheld) NIR tools and in just seconds analyze dozens of units (homogeneity, concentrations or other parameters) at the line.


Real-time Raman spectroscopy applications


As we will see below, this analysis technique has some applications similar to NIR spectroscopy and others very different because it is a technique with a much higher precision than NIR and that IRIS Technology uses in the systems we manufacture when we work with APIs with very low concentrations (typically <0.5) or in aqueous matrices where the amount of water generates a lot of noise in the analysis with NIR equipment.)


1) Raman spectroscopy for API identification: As each API has its own Raman characteristics, Raman spectroscopy can quickly and accurately identify the active ingredients, has a very low prediction error and in some cases has a detection limit as low as ppm.

2) Raman spectroscopy for the quantitative and qualitative analysis of formulations: The composition of pharmaceutical preparations is relatively complex; however, Raman spectroscopy remains one of the rapid detection methods if the excipients are simple or just an aqueous solution.

3) Raman spectroscopy for detection of illicit substances: Raman spectroscopy can be used for trace detection due to its sensitivity, speed and accuracy. In general, small amounts of illicit drugs cause drug safety incidents, and Raman spectroscopy can be used for illicit drug detection.


Benefits of applying NIR and Raman technology in production lines


In general, there are two fundamental advantages of Raman spectroscopy and NIR technology on production lines over traditional laboratory methods:


The first advantage would be the monitoring of continuous manufacturing. The pharmaceutical industry works mainly in such a way that the final drug is the result of several independent production steps. These can also take place in different geographical areas, which entails shipping and storing the different intermediate products in containers until the next manufacturing facility. This increases the risk of degradation over time or due to environmental conditions (light, humidity, etc.). One way to address this problem is to move from independent batch work to continuous manufacturing with the help of monitoring technologies such as real-time analytical control equipment.

A continuous process or continuous manufacturing is one in which materials are continuously loaded into the system, while the final product is continuously unloaded. Unlike stand-alone batch manufacturing, this concept involves the total connection of production units, with the use of PAT systems, along with process control systems to monitor and control the integrated manufacturing plant. Continuous process units are usually more efficient, more productive, with reduced volumes and less waste compared to classical process units. Therefore, these types of production units can respond more quickly to drug shortages or sudden changes in demand or needs (such as in a pandemic). In addition, their small size allows them to be transported directly to where the drugs are needed. However, a thorough understanding of the process, including the different connections between its processing units, is necessary.

The second major advantage is to reduce sampling and analysis time, and this is very important in biotech processes in their research, development and production phases. So far, most of the data are obtained with off-line instruments and methods.


Specifically for Raman, Raman spectroscopy is a powerful instrumental technique used in various types of pharmaceutical analysis. The superiority of the technique depends on the molecule of interest, the concentration level, the matrix or solution, other interfering species present and the desired sampling method. For many applications, Raman spectroscopy may be the best answer for identification and spectroscopic control needs. The role of Raman spectroscopy as a quantitative analytical tool is increasing due to the simplicity of sampling, ease of use and applicability to aqueous systems.


As manufacturers and system integrators of systems that operate with Raman and NIR spectroscopy, IRIS Technology collaborates with numerous pharmaceutical, foodstuffs, chemicals, among others, companies in the development of analytical solutions and the implementation of control systems, in turnkey projects ranging from technology, adaptations that may be necessary, data modeling, installation, validation and even homologation.

Here you can find the complete range of Visum® analytical equipment.

We hope this article has been of interest to you and as always, if you have any questions or even suggestions, you can write to us at

By IRIS Technology Solutions
Pharma-4-0, Big-data, Digitalization 2 February 2022

Artificial Intelligence as a Predictive Maintenance tool

Predictive Maintenance
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Artificial Intelligence as a Predictive Maintenance tool

Together with the company mAbxience, specialized in the development, manufacture and marketing of biopharmaceuticals, we developed data models based on supervised machine learning techniques that after 4 years of work resulted in an AI-based Predictive Maintenance System in the plant facilities of the water for injections (WFI) process of mAbxience in Spain, published in the January-February Edition of the Pharmaceutical-Engineering Magazine.

The work demonstrates the effectiveness of machine learning models, built from the information generated by 31 sensors, 14 alarms and water quality indicators, to identify and predict anomalies within a warning time window (14 days) that is feasible for the preventive and predictive maintenance teams to make the corresponding adjustments in the areas and components of the plant identified by the algorithm.

Initial results show that the models are robust and able to identify the chosen anomalous events. In addition, the rule induction approach to machine learning (a technique that creates “if-then-else” rules from a set of input variables and one output variable) is “white box”, which means that the models are easily readable by humans and can be deployed in any programming language.

IRIS thanks mAbxience and the WFI plant technicians for their collaboration.

Read the full article here.

By IRIS Technology Solutions
Industry-4-0, Innovation, Pharma-4-0 27 October 2021

Pre-release: The new Visum Raman analyzer will go on pre-sale to a small number of pharmaceutical companies.

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IRIS Technology presents in the latest edition of Farmespaña Industrial Magazine – Farmaforum Special – its line of PAT analyzers for the pharmaceutical industry with a great novelty for the industry, the expectation for the launch of its Raman analyzer, which will be available both to work at-line or integrated to the line, for the beginning of next year, and whose official launch will begin with a pre-sale stage to a limited number of Spanish pharmaceutical companies.


“Our industry knowledge and PAT experience have led us to develop this new member of our Visum family of spectroscopic analyzers, mainly to meet many needs for in-line formulation control, where the particularities of each project and the chemometric modeling work behind each one of them is extremely complex,” said Alejandro Rosales, Science and Technology Manager at IRIS.


IRIS Technology’s technical teams are currently working on expanding Raman analyzer applications to processes at different stages of the drug manufacturing industry prior to launch, and invite pharma companies interested in particular applications to perform ad-hoc modeling at no cost.


Visum Raman achieves a signal-to-noise ratio far superior to its market competitors because, thanks to its temporal resolution, it physically mitigates the undesirable effects of fluorescence, making it possible to extend the range of applications in the pharmaceutical industry beyond identification.


“It is important to us that the Visum Raman, like its NIR siblings, is strongly oriented to the process and production industry, and helps operators and technicians in the factory to make technological decisions at the line and in real time. For this reason, we have already been collaborating with some companies in response to particular challenges, but with a strong transversality to other products and processes. In relation to the reasonable technological uncertainty that this type of industrial-scale projects always generate, at IRIS we work under the “proof of concept” scheme, i.e., we previously validate the success of the project on a reduced scale and in comparison with the criteria agreed with the client”, remarked the Deputy Director of IRIS, Joan Puig.


Do you have a challenge for our Raman analyzers? Do you want to participate in the pre-sale? Write to us here.


By IRIS Technology Solutions

IRIS Technology presents in Farmespaña Industrial applications of its PAT analyzers for the pharmaceutical and dermo-cosmetic industry.

Real-time content uniformity.

Real-time bioavailability.

Fluorescence-free Raman.

Read the complete note here.

By IRIS Technology Solutions