Drug manufacturing plant - Laboratorium SANITATIS

Infraestructuras
Áreas de investigación
  • Life & Medical Sciences
Contacto

946 430 850

(+34) 946 430 850 (International calls)

¿Disponible para usuarios externos?
Yes
Descripción

LABSAN is a pharmaceutical manufacturing plant and pharmaceutical infrastructure certified by the Spanish Agency of Medicines and Medical Devices (AEMPS) in accordance with Good Manufacturing Practice (GMP) standards, under registration number 4163E.

It is authorised to operate with human and veterinary medicinal products, medical devices, food supplements, and cosmetics.

The facility is particularly focused on contract manufacturing (CDMO) and the industrial development of medicinal products, including clinical trial batches, pilot batches, and industrial-scale production. It offers extensive scale-up capabilities and flexibility to adapt to customer requirements.

The plant has dedicated areas for solid, liquid, and semi-solid dosage forms, as well as complete primary and secondary packaging lines.

Equipment
 

Certified GMP Areas for the Following Dosage Forms

  • Solid forms (tablets and capsules)
  • Liquid forms (syrups and solutions)
  • Semi-solid forms (gels and ointments)
     

Manufacturing Equipment

  • Mixing: Rulon, V-blender, Cyclops Vima
  • Granulation: High-speed and oscillating granulators
  • Drying: Static dryers and fluidised-bed dryers
  • Capsule filling: Manual and automatic (Macofar CD-40)
  • Compression: Kilian tablet press
  • Coating: IMA-70 coating pan
  • Liquid processing reactors: 100–2,400 L
  • Semi-solid mixers: 10 L and 300 L
     

Packaging Equipment

  • Primary packaging: Tubes (aluminium and polyethylene), bottles (glass and PET), and blister packs
  • Secondary packaging: Cartoning machine, labelling machine, and ALU/ALU and PVC/ALU blister packaging
     

Certifications and Specialised Facilities

  • GMP certification and ISO 13485 certification for medical devices
  • Dedicated manufacturing area for controlled substances (psychotropic substances and narcotics)
Servicios
  • Manufacturing of human and veterinary medicinal products (clinical trial, pilot, and industrial batches)
  • Pharmaceutical formulation development and industrial scale-up
  • Manufacturing and importation of non-sterile medicinal products, including psychotropic substances and narcotics
  • Quality control of active pharmaceutical ingredients (APIs), excipients, and finished products
  • Manufacturing of placebos and masking products for clinical trials
  • GMP labelling and primary and secondary packaging
  • Comprehensive clinical trial logistics management, including storage, shipping, returns, and destruction
  • Outsourcing of manufacturing processes for pharmaceutical laboratories
  • Technology transfer and industrial process validation
  • Support for spin-offs and start-ups during clinical and regulatory development stages

Aimed at:

  • Pharmaceutical laboratories that want a partner to manufacture their drugs.
Localización

TECNALIA

Alava Science and Technology Park, Leonardo Da Vinci, 11, E-01510, Vitoria-Gasteiz (Araba/Álava)

Otra información
Pharmaceutical Development and Manufacturing (GxP):
- Biotechnology, Biological Processes and Systems
- Healthcare Technologies

Application sectors

  • Food supplements
  • Regulated cosmetics
  • Contract Research Organisations (CROs) and Contract Development and Manufacturing Organisations (CDMOs)
  • Biotechnology and advanced pharmaceutical companies
  • Medical device manufacturers
  • Pharmaceutical and genetics sector
  • Human and veterinary pharmaceutical industry
  • Laboratories conducting clinical trials
  • Biopharmaceutical start-ups undertaking industrial scale-up

Industrial plan

  • HAZI · Healthcare and Biosanitary Sector