0 comentarios 24 - 09 - 15

The engineering involving clean rooms are divided in three main stages:



Based on the information provided by the customer and other kind of requirements, a conceptual design is stablished in order to detail all the processes, products and volume of production that will be necessary. The equipment, machinery and technology have to be defined as well as all the auxiliary services required. Also the facilities and all the interrelationship between them in order to provide production flows. Lastly a timeline has to be set in order to determine the costs associated to the project.

Conceptual Design has to cover the following chapters:

  • Definition of products
  • Definition of processes
  • Selection of technologies and equipment
  • Definition of the volume and size of the batchs
  • Definition and requirements of the products
  • Definition and scale of services
  • Layout proposal
  • Timeline of the project
  • Investment proposal





From de Conceptual Design is made the Basic and Detailed Engineering, where all the constructive aspects , facilities and equipment of the project are defined. From the detailed engineering the construction of the plant is the next step. In this particular stage a proper Project Management will avoid delays, budget diversions and technical deficiencies.

  • Integral project management: Technical/costs/timeline
  • Coordination and management of local contractors
  • Civil works
  • Indoor architecture: Clean Rooms
  • Energetic supplies
  • Air treatment
  • Electricity and control
  • Mechanical facilities
  • Services
  • Specific facilities
  • Equipments



Once the plant is built and all its facilities and equipments are done, an entire start-up , commission and validation program is required, in order to ensure all the processes, equipment and facilities are working accordinly with the stablished specifications. All the process has to be properly documented, following the international policies in order to provide the endorsement of the local and international authorities.


  • Reception and start-up of all the facilities and equipments
  • Commission
  • IQ/OQ/PQ validation
  • Technical documentation management
  • Endorsement of the local authorities: FDA, EU GMP…

Tags: ,

Did you find this article interesting?
Suscribe our newsletter

I accept the privacy policy.

Escribe tu opinión