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Alfatestlab srl

ItalyCernusco sul Naviglio, Italy· 6:56 AM Website
ISO 17025GMP Accepts NDA

About

AlfatestLab srl is an Italian contract analytical laboratory headquartered at Via Firenze 30A, 20063 Cernusco sul Naviglio (Milan), Italy. Founded in 2014 as the Center of Excellence for Alfatest — a company that has specialized in scientific instrumentation distribution for over 30 years — AlfatestLab grew from an instrument demonstration center into a full-scale accredited laboratory offering independent contract analysis services to clients worldwide. The laboratory combines state-of-the-art instrumentation with deep application expertise inherited from its parent group, which serves as the exclusive Italian distributor for leading instrument manufacturers including Malvern Panalytical, Thermo Scientific, and Micromeritics.

The laboratory's core competency lies in solid-state characterization and materials science analytics. Services include particle size distribution analysis across a wide dynamic range (0.01 mm to 3 cm) using laser diffraction instruments such as the Malvern Panalytical Mastersizer; particle shape and chemical identity determination via Morphologically Directed Raman Spectroscopy (MDRS) using the Morphologi 4-ID platform; surface area and porosity measurement by BET (Brunauer–Emmett–Teller) gas adsorption; true and skeletal density by helium pycnometry; and powder and rotational rheology for assessing flow and processing behavior. X-ray powder diffraction (XRD) and X-ray fluorescence (XRF) are performed for phase identification, polymorph screening, and elemental composition studies. Scanning electron microscopy (SEM) with energy-dispersive X-ray spectroscopy (EDX/EDS) provides high-resolution morphological and elemental mapping of solid samples.

Thermal analysis forms another pillar of the AlfatestLab service portfolio. Differential scanning calorimetry (DSC) and simultaneous thermal analysis (STA, combining DSC and thermogravimetric analysis/TGA) are used to characterize melting and crystallization events, glass transitions, polymorphic transformations, decomposition profiles, and residual solvent content. These techniques are especially critical for pharmaceutical solid-state characterization, formulation development, and compatibility screening. Dynamic vapour sorption (DVS) measurements characterize moisture uptake and sorption isotherms, critical for predicting stability and shelf-life behavior of hygroscopic materials. Surface tension and contact angle measurements round out the physicochemical characterization toolkit.

The laboratory has developed a significant biosciences division encompassing nanosystems characterization and biomolecular analytics. Dynamic light scattering (DLS), electrophoretic light scattering (ELS), and nanoparticle tracking analysis (NTA) are applied to measure the hydrodynamic size, zeta potential, and concentration of nanoparticles, liposomes, and extracellular vesicles (EVs). Label-free biomolecular interaction studies and single-cell proteomics capabilities extend the laboratory's reach into advanced biopharmaceutical research. Confocal microscopy and live-cell imaging services support biological sample investigation. Microfluidics-based nanoparticle production and characterization, combined with in-vitro bioequivalence (IVBE) studies for inhaled and nasal spray products, position AlfatestLab as a technically sophisticated partner for drug delivery research.

Analytical method development, validation, and transfer constitute a significant share of AlfatestLab's commercial activity. The laboratory supports clients at every stage of the drug development and manufacturing lifecycle: early-stage R&D characterization, formulation and process development troubleshooting, analytical method validation to regulatory-submission standards, and method transfer between laboratories or manufacturing sites. Stability studies are conducted under defined conditions, and shelf-life assessments are supported by Multiple Light Scattering stability analysis for dispersed systems. The laboratory offers both standard turnaround (10 working days) and express reporting (2 working days on request), along with on-site and client-facility training programs.

Over 60 pharmaceutical and biopharmaceutical companies in Italy rely on AlfatestLab as a trusted contract laboratory. Beyond pharma, the laboratory serves clients in cosmetics and personal care (rheology of creams, emulsions, and lotions; particle characterization of suspensions), food and beverage (particle size, rheology, thermal profiling), specialty chemicals, inks, paints and coatings, additive manufacturing, ceramics, building materials, polymers and plastics, microplastics research, electronics, energy, petrochemicals, and nanotechnology. The breadth of industries served reflects the universal applicability of physical and physicochemical characterization across advanced manufacturing sectors.

AlfatestLab holds two significant quality credentials that distinguish it in the Italian and European analytical services market. It is accredited to ISO/IEC 17025 by ACCREDIA, the Italian national accreditation body and a full member of EA (European co-operation for Accreditation), IAF, and ILAC, ensuring international mutual recognition of test results. The laboratory is additionally certified as a GMP (Good Manufacturing Practice) laboratory by AIFA, the Italian Medicines Agency (certification IT/101/H/2024), enabling it to support pharmaceutical batch release, regulatory submissions, and quality assurance workflows under the stringent requirements of the European pharmaceutical regulatory framework. These dual accreditations — ISO 17025 for technical competence and cGMP for pharmaceutical compliance — make AlfatestLab a credible and audit-ready analytical partner for regulated industries.

Industries served

Food & BeverageCosmetics & SkincareConsumer ProductsPharmaceuticalsMaterials

Test categories

StabilityShelf lifeIdentity/purityMaterials characterization