CBR Novasome Sp. z o. o. offers wide range of analytical services for manufacturers of pharmaceuticals, cosmetics, food and chemicals.

We offer measurements tailored to the individual needs of our customers including development of analytical methods, validation and transfer to the destination place.

Good Manufacturing Practice (GMP) certificate and periodic inspections of Polish Chief Pharmaceutical Inspectorate guarantee the highest quality of our work.

Well-trained staff focuses on quality and reliable research and our customers can count on full substantive and practical support at all stages of commissioned projects.

 

Analysis of particle size distribution by laser diffraction

We offer analyses of particle size distribution in range 0,02 – 2000 µm by laser diffraction method. The obtained information allows determination of the quantitative or volumetric share of individual fractions in the entire test sample.

Measurements made by laser diffraction allow the assessment of the particle size of the tested sample, detection of anomalies in the material or a quick comparison of several batches of the same product (checking process repeatability, e.g. crystallization or comminution efficiency).

We use Mastersizer 2000 equipment (Malvern Panalytical Ltd.) with two measurements modules:

  • Hydro 2000S for “wet analysis” in aqueous or organic suspensions. The small volume of the measuring cell requires relatively little amount of the test sample. It enables measurement of products used, among others, in the pharmaceutical, cosmetics and food industries.
  • Scirocco 2000 for “dry analysis”. In this case, the measurement is based on continuous feeding of the sample to a measuring cell using a controlled air flow. The method allows testing large quantities of raw material in a short time and can be used for materials that tend to change their properties during dispersion in water or organic solvents. The “dry” dispersion method is used in the study of pharmaceutical substances, building materials (e.g. cements), dry granulates, chemical materials, feed additives, powdered metals and many more.

Analysis of droplet size distribution by laser diffraction

We offer analysis of droplets size or atomized particles by laser diffraction method in aerosols: nasal preparations, cosmetics, plant protection products and others. The measurements are made with a Spraytec apparatus (Malvern Panalytical Ltd.) allowing the determination of the size of droplets or sprayed substances in the range from 0,1 – 900 µm, including the determination of the average diameter of droplets – one of the most valuable illustrative quantities, allowing a comparative assessment of the spray quality. We can also detect the presence of harmful particles <10µm in size capable of reaching the bronchi and lungs during aerosol inhalation.

We also possess an innovative system of automatic spraying of nasal preparations allowing precise and repeatable dosing, e.g. nasal preparations in the form of an aerosol. Individual fractions can be quantified by number or by volume relative to the total dose released.

Analysis of size and shape of particles by the microscopic method

We offer particle size and shape determination using microscopic image analysis with the use of Morphologi G3S apparatus (Malvern Panalytical Ltd.), enabling measurements in the range of 0,5 to 1000 µm. Direct microscopic observations of up to several hundred thousand particles at once allow detailed characterization of the size and shape of the materials tested.

The great advantage of microscopic measurements is the need of small volume of sample for measurements with good statistics.

Thanks to the extensive capabilities of the software, it is possible to present the results in the form of particle size distribution in terms of their quantity or volume in relation to the entire sample. The program also allows us to filter particles in terms of size and shape according to preferences given.

Analysis of nanoparticle size by dynamic light scattering method (DLS)

We offer nanoparticle size analysis by dynamic light scattering using Zetasizer Nano ZS apparatus (Malvern Panalytical Ltd.). Exceptional sensitivity of the device allows the measurement of particles in the range from 0,3 nm to 10 µm.

The DLS technique is used in the measurement of nanoparticles, colloids, proteins, liposomes, microemulsions and many other materials.

An additional advantage of our device is the ability to determine the Zeta potential.

Analysis of surface area and porosity by gas sorption method

We offer determination of the surface area and porosity of materials by gas sorption technique. The method is based on analysis of the controlled gas adsorption / desorption to the material surface and enables measurement from 0,01 m2 of surface / g and a pore size determination in the range of 0,35 – 500 nm.

We use a NOVAtouch LX2 apparatus (Quantachrome Instruments) that allows surface characterization of materials used in industry, including sorbents, ceramic sinters, catalysts, soil samples, ores and metal oxides.

Measurements of water activity and water sorption curves

We offer analysis of water activity and measurement of sorption curves of DVS (Dynamic Vapor Sorption) and DDI (Dynamic Dew Point Isotherm) methods.

We use a water sorption analyzer (VSA) allowing measurement of water activity and determination of water sorption curves (adsorption and desorption). The device provides access to water activity in ingredients, intermediates and finished food and pharmaceutical products. Control of water activity allows the reduction of the probability of the unexpected reactions (e.g. Oxidation of lipids, non-enzymatic browning reactions or hydrolysis) and a growth of microorganisms (molds, yeasts and bacteria). Water activity analysis is a technique recognized by the FDA (USP <1112>) and ICH / EMA as a replacement for the Karl-Fischer water content parameter and an argument for a limited microbiological testing program.

The water sorption curves allow the determination of critical values of water activity – parameters that help in optimization of the manufacturing process, storage and selection of the finished product packaging.

Analysis using a high-resolution mass spectrometer HRMS

We use a high resolution mass spectrometer using Orbitrap approximation in combination with an HPLC system with a fraction collector, which allows us to perform qualitative (high resolution) and quantitative analyzes.

As a standard, we perform data identification and analysis of nitrosamines in water, substances and finished products.