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Tecnalia. Inspiring Business

Tecnalia. Inspiring Business

CMO_Contract Pharmaceutical Laboratory – Laboratorium SANITATIS,

Laboratorium Sanitatis has developed core competences and knowledge tailored to provide contract manufacturing requirements with major pharmaceutical industries and more specically specialized in Generic medicines.

Laboratorium Sanitatis is authorised by AEMPS as a manufacturer and importer of pharmaceuticals and medicines under research with Registry Number  4163E and GMP Certificate.

Laboratorium Sanitatis has a unique facility (Pilot Plant / Pharmaceutical Laboratory) to provide ample opportunities for scaling and manufacturing of medicines, medical devices, cosmetics and food suplements, always in the most stricter compliance of GMP certification.

Our facilities and machinery are located at premises occupying a surface area of 1470 m2 with potential to manufacture new pharmaceuticals, new presentations and new release systems in different pharmaceutical forms: solid, semi-solid and liquid.  This is a unique differentiating factor with respect to other pharmaceutical development firms.

Pharmaceutical Laboratory – Laboratorium SANITATIS

boton-serviciostecnologicos-en

products

  • Human medicines.
  • Medical devices.
  • Food supplements.
  • Cosmetics.
  • Veterinary medicines

Manufacturing of Batches for Clinical Trials

  • Importation of active substances and medicines.
  • Manufacturing of placebos, medicines, food supplements.
  • Design of blinding strategy.
  • Labelling for primary and secondary packaging.
  • Storage Good Manufaturing Practices (GMP) conditions.
  • Shipping management to the different centers.
  • Return, reconciliation and destruction of medicines.


Pilot Batches and Registration Batches

  • Manufacture in compliance with the principles and guidelines of GMP for medicinal products.
  • Transfer of analytical techniques


Contract Manufacturing of Industrial Batches for Third Parties 

  • Quality control and certification of active substances, excipients and finished products.
  • Manufacturing in GMP conditions.
  • Validation of cleaning processes.
  • Analysis and batch release.
  • Storage in GMP conditions.

Industrial Scale 

  • Scaling up from laboratory batches to industrial batches.
  • Validation of new manufacturing and packaging processes.

AUTHORIZED DOSAGE FORMS

  • Solids (tablets, coated tablets, capsules, etc.).
  • Liquids (solutions, syrups, drops...).
  • Semi-solids (creams, emulsions, gels, etc.).

equipment

  • Mixing: Rulon, V, Vima Cyclops.
  • Granulation: High Speed, Oscillating.
  • Drying: Static, Fluid Bed.
  • Capsules filling: Manual, Macofar CD-40.
  • Tabletting machine: Kilian.
  • Tablet coating: IMA-70 drum coating.
  • Liquids: 100L, 2.400L reactors.
  • Semisolids: 10L, 300L, Mixer.
  • 1st Packaging:
    • Tube: Alu, PE.
    • Bottles: glass, PET.
    • Blister packing machine ALU/ALU PVC/ALU.
  • 2nd Packaging:
    • Cartoner.
    • Labeling.

ACREDITATIONS AND RECOGNITIONS

  • ISO 9001
  • Good Manufacturing Practices (GMP) - Pharmaceutical development and manufacturing.
  • Good Laboratory Practices (GLP) - Pharmaceutical development.
  • Spanish Medicines Agency (AEMPS) inspection with positive result - Clinical trials and Bioanalysis.
  • We work under Good Clinical Practices (GCP) - Clinical Trials Unit.

Access to our Acreditations and Recognitions

Pharmaceutical Laboratory – Laboratorium SANITATISPharmaceutical Laboratory – Laboratorium SANITATIS

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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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