Dietetics and Food Supplements
Industry
Your medical devices require the highest quality. We strive to help you achieve it.
We understand the demands of the industry to supply safe products. Our goal is to offer the analytical and technical support appropriate to the level of quality required.
You will find our support for all those tests, studies, technical advice or know-how transfer that you need for your business to grow and develop.
Some of our activities and services in these sectors would be:
Physicochemical Analysis
- Physicochemical characterization parameters: moisture, density, viscosity, fat, protein, ...
- Determination of active ingredients by volumetric, spectrophotometric and chromatographic techniques: vitamins, plant extracts, ...
- Determination of additives: alcohol, caffeine, density, essential oils, fatty acid spectrum, histamine, iodine index, peroxide index, acidity index, nitrogen, trans fatty acids...
- Development and validation of analytical methods (ICH Q2 (R1))
- Determination of impurities and degradation products.
- Determination of contaminants
- Heavy metals
- Residual solvents
- Essential parameters: complexometric titrations, Karl Fischer, Kjeldahl, oxidizing substances, indexes, ...
- Reactions and identification analysis
- Quality control of raw materials
- Determination of allergens: gluten, soy, ...
- Determination of genetically modified organisms (GMO)
Microbiological Analysis
- Microbiological quality control of raw materials and final formulations
- Development and validation of microbiological methods
- Preservative System Efficacy Test (Challenge test) ISO 11930/2019 and Ph. Eur. 5.1.3 Efficacy of antimicrobial preservation
- Identification of microorganisms by:
- Advanced phenotypic methods: identification by MALDI-TOF MS (matrix-assisted laser desorption/ionization time-of-flight (maldi-tof) mass spectrometry (ms)).
- Large staining, microscopy/classical phenotypic methods (biochemical galleries)
- Sterility test (ISO 11737-2 and Ph. Eur. 2.6.12): method suitability and product control.
- Environmental and surface control ISO 14698 and NCF
Other Analysis
- Facility qualification: Environmental and surface control and cleaning validation
- ICH Q1a (R2) and ISO 18811 stability testing: Design, storage and/or analysis