Development of new drugs and control of pharmaceutical manufaturing are complex processes that require accurate analytical studies. The pharmaceutical development cycle passes from the discovery in which the candidate active pharmaceutical ingredient is identified to the preclinical development in which the active ingredient must be characterized and the formulations must be developed and characterized. The subsequent stages of toxicological studies and clinical studies ensure that the drug is safe and effective. Finally, in production the quantity of material produced is increased and critical process parameters and critical material attributes must be monitored to ensure batch consistency.
Several issues related to development projects, drug safety, manufacturing, market demands for evidence-based data and increased regulatory requirements can be overcome through a better understanding of the pharmaceutical product and manufacturing process.
Alfatestlab offers a complete range of analytical capabilities and services to support pharmaceutical industry and other related markets such as medical devices, cosmetics and homeopathic products. Alfatestlab has great expertise and experience in particle, powder and dispersion analysis. As a result of our understanding of materials we can support our customers in testing from product development to manufacturing process. Our portfolio of analytical methods includes many of the techniques required to meet the quality standards for successful drug development:
Active pharmaceutical ingredient and excipient chemical-physical characterization
Quality control of finished product
Bio-equivalence assessment in vitro
Biosimilarity assessment in vitro
Affinity & Kinetic Characterization
Alfatestlab ensures the accuracy of the analytical methods used for customers projects and in addition offers:
Development and validation of analytical methods
analytical method transfer
optimization of existing methods
For any analytical project, Alfatestlab offers effective communication, using frequently scheduled phone conferences, on site face-to-face discussions and exhaustive reports.
There's no doubt that 3D printing technologies are leading to the next major industrial revolution and that Additive Manufacturing plays a key-role in the Industry 4.0, saving time and costs, being decisive for process efficiency and reducing its complexity, allowing for rapid prototyping and highly decentralized production processes. Currently, more and more industrial segments are adopting Additive manufacturing (AM) : AM allows 3D objects to be manufactured in a completely revolutionary way, adding layer upon layer instead of removing material from a master piece of material. Three main categories of materials can be used in Additive manufacturing: polymers, ceramics and metals. These materials are often produced in powder form, and the physical properties of these powders significantly influence their ability to be processed in AM machines and strongly condition the final product quality. Poor quality of the powder can produce defects in the final component such as pores, inclusions, residual tensions, cracks and surface roughness. Furthermore, a low quality of powder affects the process by compromising the uniformity and flowability of the powder bed. There is a direct correlation between the physical properties of the powder and the performance of process and final components.
The characterization of the powders physical properties therefore allows to optimize the process and improve the final product. It is crucial in different steps of the Additive manufacturing process:
powder production: characterization and quality control of powders produced with different technologies
choice of the best performing powders for processing: definition of the ideal physical characteristics of the powders according to the application field.
input raw material: control of specifications declared by the manufacturer and monitoring of supplies constancy
recycling of waste powder: evaluation of the number of process cycles on the physical characteristics of the powder, in order to reuse powders as much as possible,to lower manufacturing costs.
Which physical characteristics of the powder determine its performance? Both batch and individual particles properties! The ability to flow and to compact at best is crucial to allow consistent dosages and stratifications during process. These properties are directly, although not exclusively, influenced by the particles size and shape, as well as by their surface roughness, bulk density and electrostatic charge. Flowability, compaction density, particle size distribution and particle shape can be assessed quickly and effectively by means of powder rheology, density, laser diffraction and image analysis tests. Alfatestlab provides a complete analytical service to characterize the wide range of bulk powders and particle properties that can have a critical impact on AM processes, thanks to a latest generation technological platform.
 International Journal of Engineering and Technical Research 8(8):3-8, 2018
For any analytical project, Alfatestlab offers effective communication, using frequently scheduled phone conferences, on site face-to-face discussions and exhaustive reports.
The widespread use of plastics in everyday items and manufacturing processes has led to an ubiquitous presence of plastic particles in the environment. The poor biodegradability of plastics leads to a long residence time in nature, where they undergo different aging and degradation processes. Some microplastics are generated through the disintegration of large plastic fragments into smaller pieces due to weathering, others come from consumer products containing micrometric plastic particles. Microplastics include all polymer particles that are smaller than 5 mm in diameter. Microplastics have already been detected in water, soil, beaches, clothing, bottled water, air, fish and shellfish, but major sources are:
Personal care products
Microplastics present in our environment and in our food chain have an impact on human, animal and ecosystem health. The impact on human health of microplastics contamination is currently unknown as the discovery is relatively new, it is then fundamental to study the composition, physical properties and amount of microplastics in nature, as well as their biological and toxicological effects on humans. Information on microplastic shape, polymer type, size, density, colour, chemical composition and number of particles in a sample can be used to determine their fate in the environment and what is truly relevant to human and ecological health. In addition, some of these properties can help identify the main contamination sources.
Optical microscopy has proved to be simple, easy to perform and a very inexpensive methodology for characterizing the physical properties of microplastics coming from different environmental samples, but chemical analysis is indispensable to reduce false and negative positives and identify the nature of polymers. Therefore, optical microscopy have to be coupled to chemical analysis for polymer identification and to discern microplastics from other contaminants.
In Alfatestlab we use Morphologically-Directed Raman Spectroscopic analysis (MDRS) to provide a complete fingerprint, i.e. a morphological characterization with chemical identity of each selected particle in a single automated analysis of a wide range of microplastics. In particular, the technique used in Alfatestlab provides particle size and particle shape information from automated image analysis and combines it with Raman spectroscopy to chemically identify and classify plastic particles, thus allowing us to compare particle size and shape distributions of the different plastic types. This is a fast and reliable method for comparing your microplastic samples and deliver accurate measurements. Furthermore, with this technique Alfatestlab is able to easily discern microplastics from other contaminants in your sample.
More details here below on our analytical services for Microplastics:
Failure analysis is the investigation of a failure in a product life cycle to determine the failure causes and the corrective actions needed to prevent future failures. Failure analysis allows to save money, lives and resources if done and implemented correctly. It is an important discipline in many sectors of manufacturing industry where it is used in the development of new products and for the improvement of existing ones.
The failure analysis process is based on the collection of failed products for subsequent examination of the failure causes using a wide array of techniques for observation, inspection and laboratory testing. Among the most used techniques there is the microscopy, a non-destructive test method that allows to analyze defective products without them be affected by the analysis. The high-resolution images obtained with a scanning electron microscope (SEM)are ideal to verify the presence of micro defects in products come from various industries such as microelectronics, precision mechanics, automotive / aerospace, chemical, metallurgy etc. Electron microscopy also allows to combine image analysis with compositional microanalysis using an EDS probe. Confirm chemical composition of a material and identify any contaminants through EDS analysis can help to determine if the material is of proper type and grade, whether it meet appropriate standards, and whether deviation from the specifications contributed to the fracture, wear, breaks, corrosion and failure.
The desktop SEMs present in our laboratory allow to quickly obtain high resolution images for microstructural analysis and chemical microanalysis for the quality evaluation of products and support in failure analysis.
More details here below on our analytical services for Failure analysis:
Alfatestlab has a longlasting experience in materials characterization including structural ceramics, ceramics for advanced materials or traditional ceramics, used in the construction industry, as we serve the italian ceramic industry since many years. The main types of traditional ceramics are terracotta, stoneware, porcelain and clay. This category includes both compact-paste ceramics, with low porosity and a certain impermeability to gases, as well as liquid, porous, soft and absorbent ceramic pastes. In the ceramic industry the porosity of the so-called green body depends strictly on the particle size. If the particles are too large, the structure after sintering will show too large pores resulting in structural fragility of the final product. It is recommended to use polydisperse particle sizes so that the smaller particles fill the gaps left by larger ones. Controlling the presence of agglomerates can avoid defects in the final product. However, particle size only cannot provide an exhaustive answer to the formulation and process issues. For this reason, Alfatestlab offers a complete technological platform made of orthogonal techniques for characterizing the properties of ceramic materials, slips, glazes, glass chips and their raw materials (clays, feldspars, etc.):
particle size, micro or nanometric particle size on dry powders or liquid dispersions (photo optic particle size, laser particle size, Dynamic Light Scattering)
morphology of the particles
rheology, flow properties and viscosity of liquid dispersions, slips, enamels, etc.
rheology of powders, analysis of properties under flowing conditions
stability of liquid dispersions, even very concentrated (no dilution required)
high resolution images for structural and failure analysis (verification of the presence / absence of micro-defects)
Alfatestlab can also help you optimize your formulations, providing an innovative laboratory scale homogenization (Microfluidizer technology) for uniform particle size reduction, aggregate removal and stability improvement of liquid suspensions.
More details here below on our analytical services for Ceramics:
Inks and paints
Alfatestlab can help you characterizing inks, paints and coatings properties such as coverage, leveling, adhesion properties, viscosity through rheological and particle size measurements. We also provide an objective and quick stability measurement using light scattering techniques to accelerate your product time-to-market.
At Alfatestlab we understand that the control of specific parameters is crucial also for digital printing inks to optimize the formulations and prevent flocculation phenomena that would affect the print quality. For the latter, in addition to the product properties characterization, Alfatestlab can help you in the production of stable high quality inks,providing an innovative laboratory scale homogenization (Microfluidizer technology) foruniform particle size reduction, aggregate removal and stability improvement of emulsions or suspensions.
At Alfatestlab we know the importance of a careful particle size control for the final powder coating quality. The development of such products, with a widden range of applications, has led to the introduction of ever more complex formulations (for example the metallic powder coatings) for which the particle size alone cannot be a sufficient control parameter to ensure quality. At Alfatestlab we provide orthogonal technologies such as morphology and surface area to deliver important further information to understand the performance of a powder coating and optimise formulations.
More details here below on our analytical services for inks, paints and coatings
Li-Ion batteries are rechargeable devices with higher performances and efficiency than the traditional non-rechargeable alkaline and zinc-carbon batteries, thanks to the high energy density, the resistance to self-discharge and the reduced memory effect. Li-Ion batteries are widely used for consumer electronic (mobile phones, tablet, laptop…), automotive (EV Electric Vehicles), and large scale energy storage. The characterization of the physical properties of the several components – electrodes, separator, electrolyte – is crucial in research & development to improve the performances (capacity, durability..) of the Li-Ion batteries, as well as in quality and production control.
Alfatestlab has the technologies and the competences to support your Li-Ion batteries characterization needs:
Electrodes properties characterization
Porosity, Particle Size and Shape, Packing Density, viscosity: all these characteristics influence the performances (life, charge cycling) and the capacity of the electrodes of a Li-Ion battery. Porosity for instance, influences the interactions between the active material and the conductive diluent and is essential for the transport of Li-Ion between the electrodes. Particle Size and shape have to be controlled in order to ensure a high packing density (polydisperse size and circular shape) and high power. Electrodes showing high surface area have a better efficiency in the electrochemical reactions and a better ion exchange between electrolyte and electrode, at the same time electrodes showing low surface area and high density materials normally offer a longer lifetime.
Regarding the initial slurry, its quality will strongly depend on the properties of the powder, mixed with solvents and binder, to get the correct fineness of the grain, solid content and viscosity for the process. The rheological properties of the powder will rule the mixing dispersion to create the slurry. Viscosity of the slurry itself will have a meaningful influence to obtain a proper coating and a correct calendering and therefore to ensure the quality of the final electrodes.
Calendering process is the most important part in the process of electrodes production, i.e. the common compaction process for lithium-ion battery electrodes. Calendering has a substantial impact on the pore structure and therefore the electrochemical performance of Lithium-ion battery cells. Increasing the calendaring will decrease the thickness and by consequence the percentage of porosity of the electrode. Above the correct level of calendering, the pore size and the porosity can be reduced to the point to cause a loss of capacity and a bad longevity in cycle performance.
In Alfatestlab technological platform includes:
Porosity and BET surface area measurements by Gas adsorption
Density by Helium pycnometer
Porosity, Surface Roughness, Failure Analysis by Scanning Electron Microscopy (SEM) and elemental analysis (EDX)
Particle Size and Particle Shape Analysis by Laser diffraction, DLS Dynamic Light Scattering, Automated Image Analysis (Static and Dynamic)
Powder rheology using FT4 Powder rheometer
Viscosity using Rotational Rheometer
Separator and Electrolyte characterization
The separator has the function to isolate the cathode from the anode, at the same time the separator has to promote as a catalyst the flow of the ions from cathode to anode during the charge and oppositely during discharge. The separator membrane is normally made of a highly porous material, like polyolefins and is wetted with the electrolyte.
The porosity is by default a fundamental parameter to be measured and controlled, since a high porosity tend to keep the electrolyte entrapped within the pores that helps the ionic movement from cathode to the anode and gives a higher energy density. On the other hand a too high porosity can limit the capacity of the separator to shut down and generate overheating of the battery closing the pores.
Alfatestlab can support you to achieve uniform porosity, constant flow of ions and an homogeneous current distribution by controlling the porosity. The pore size distribution of the membrane has to be smaller than the particle size of the electrodes material to prevent from entering the separator pores.
The affinity between the material used in the separator membrane and the electrolyte, that will affect the mechanism of transport, can be evaluated measuring the Zeta Potential.
In Alfatestlab we provide:
Porosity and BET surface area measurements by Gas adsorption and SEM with Porometric software
Density by Helium Pycnometer
Zeta Potential by Electrophoretic Light Scattering
More details here below on our analytical services for Li-ion batteries:
At Alfatestlab we are experts in materials characterization and this includes specialty chemicals such as catalyts, adhesives and sealents, detergents and surfactants, lubrificants, etc. Optimising a formulation or formulating an innovative chemical product may require characterization techniques not yet available in your lab. Alfatestlab can provide a unique technological platform and the related expertise to support your project on:
In Alfatest we can analyse properties such as porosity (micro, meso and macro pores), surface area and particle size (for example in the case where the porous structure uses nanoparticles as precursors) to improve catalyst activity and efficiency.
Adhesives and sealents
In Alfatest our experts can perform rheology measurements (viscosity and viscoelasticity), particle size analysis and provide high-resolution images (SEM images) to help you understand the influence of formulation parameters on the product behavior such as coverage property and / or stability.
Detergents and Surfactants
Alfatestlab can provide orthogonal techniques such as zeta potential and rheology analysis to determine the CMC (critical micellar concentration) of surfactants, and understand the influence of pH and concentration on the micellar size. With high resolution images such as SEM images we can help checking precisely the detergent ability to remove dirt and preserve the tissues. Particle size and surface area parameters are useful to characterize final formulations or raw materials of powder detergent.
In Alfatestlab we are experts in liquid dispersions characterization. Our technical platform allow us to study lubricants based on emulsions controlling the size of the emulsion droplets and their stability (avoiding coalescence and creaming), as we understand these are fundamental aspects for the efficiency of these products. Alfatestlab can also help you optimize your formulations, providing an innovative laboratory scale homogenization (Microfluidizer technology) for uniform particle size reduction, aggregate removal and stability improvement of emulsions.