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Stability studies

TECNALIA offers a wide spectrum of services under contract, such as formulation and analytical development, scaling and manufacture of pilot batches, quality control and batch release, stability studies, pharmacogenetics, clinical trials from phase I to IV and manufacturing to third parties.

The Pharmaceutical Development Laboratory of TECNALIA is authorized by the Spanish Agency for Medicines and Health Products (AEMPS) in Standards of Correct Manufacturing (NCF).

 

 Estudios Estabilidad_Medicamentos_TECNALIA_1

SERVICES STABILITY STUDIES 

  • Stability studies according to (International Conference on Harmonization) regulations under controlled temperature and humidity conditions (Zone I to IV).
  • Stability studies in use to determine the period of use both in multi-dose formulations and in formulations that require reconstitution.
  • Stability studies ongoing in commercialized products.
  • Accelerated studies
  • Photo-stability studies
  • External management of stabilities

All stability chambers are certified and monitored by an alarm system that continuously controls the relative humidity and temperature of each one of them..

We have the following temperature and humidity conditions:

  • 25°C/60 % RH
  • 30°C/65 % RH
  • 40°C/75 % RH
  • 30°C/75 % RH (climatic zone IV)

FACILITIES AND EQUIPMENT

TECNALIA has more than 3,000 M2 of laboratories for the pharmaceutical industry. Our Pharmaceutical Development Laboratory has numerous climatic chambers for stability studies:

  • Walk-in Temperature and Humidity Stability Chamber-ARALAB Fitoclima 12000 PH (2 units)
  • Constant climate chamber BINDER KBF-720 (5 units)
  • Constant climate chamber BINDER KWF-720 (1 unit)

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Parque Científico y Tecnológico de Bizkaia. Astondo Bidea, Edificio 700. E-48160 Derio. Bizkaia (Spain). Tel.: 902.760.000 - International Calls: (+34) 946.430.850


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