Modern industry increasingly demands strict compliance with environmental regulations.

We help our customers achieve these objectives through product analysis and testing and our specialized technical support.

Some of our activities and services in these sectors would be:

Physicochemical Analysis

  • Physicochemical characterization parameters: humidity, density, viscosity, …
    • ECHA Eu 528/2012
    • OECD
    • Regulation 440/2008
    • CIPAC
  • Determination of actives by volumetric, spectrophotometric and chromatographic techniques.
  • Development and validation of analytical methods SANCO/3030/99 rev. 4
  • Determination of impurities and degradation products
  • Determination of contaminants:
    • NIAS
    • Heavy metals
    • Residual solvents
  • Essential parameters: complexometric titrations, Karl Fischer, Kjeldahl, oxidizing substances, indexes, …
  • Reactions and identification analysis
  • Quality control of raw materials
  • Quality control of plastic materials and packaging (Ph. Eur. 3.2 Containers, USP ˂661,1˃ and <661,2> Containers – plastics).
  • Ethylene oxide sterilization residues (ISO 10993-7).
  • Chemical characterization:
    • Leachables & Extractables (ISO 10993-13/14/15/17/18)
    • Generation of medical device extracts (ISO 10993-12)

Microbiological Analysis

  • Microbiological quality control of raw materials and final formulations
    Development and validation of microbiological methods
    Bactericidal, virucidal, fungicidal and yeasticidal efficacy tests:

    • Industrial
    • Food
    • Medical-Surgical
    • Veterinary
    • Domestic
    • Antiseptic for hygienic use
  • Preservative System Efficacy Test (Challenge test) ISO 11930/2019 and Ph. Eur. 5.1.3 Efficacy of antimicrobial preservation
  • Identification of microorganisms by means of:
    • 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.

Otros Análisis

  • Estudios de estabilidad:
    • CIPAC MT 46, Accelerated Storage Procedure.
    • Long term, GIFAP (Croplife International) monograph nº 17 (Croplife, 2009)
  • Compatibilidad del envase
  • Estudios de migración
  • Calificación de instalaciones: Control ambiental y superficial y Validación de limpieza
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