Solutions

Engineering
projects

cacbecera-ingenieria

Specialists
in cleanroom design

We design 100% validated cleanrooms, thanks to our teams’ knowledge and expertise.

As experts in pharmaceutical engineering, our designs are approved by the most demanding medical agencies for all type of plants: high-activity, sterile, biotechnological, and dry, liquid, and topical forms.

We know that a good design is the key to success in any project. We offer a specialized and comprehensive service, customized to the clients’ needs. Our solutions go from the conceptual to the detailed phase, including EPC or EPCM modalities if you wish.

Our activity focuses on the design of all the specialties: cleanroom architecture, air systems (HVAC), electricity, steam, dust collection, compressed air, hot and cold water, firefighting, etc. All the above, in compliance with the process and packaging technologies to obtain the correct dimension of the area.

Cocenptual
engineering

We shape the project based on your initial idea.

We lay the foundations from a normative and functional point of view, and define the technical, economic, and planning characteristics on a large scale.

Thanks to our long experience in the pharmaceutical industry, and consolidated knowledge on the GMP/FDA regulations, we do all the preliminary studies, which
allow us to start to define the project’s requirements without losing focus on each client’s needs.

The Conceptual Engineering phase development provides us with the tools to determine the project’s feasibility. From a technical point of view, it defines the necessary space and installations for the pharmaceutical plant to guarantee the required production units. From an economic point of view, it gives us an idea of the investment, with an approximate deviation of 20%. All this with an estimated implementation timeline for the different phases required by each project.

  • Project’s general definition
  • Areas needs
  • Production processes to be considered
  • Estimated annual production
  • Definition of the type of products to manufacture
  • Future growth/set-aside space
  • User requirements (URS)
  • Manufacturing technologies and packaging to be considered.
  • Containment strategy
  • Preliminary space distribution
  • Investment economic estimate ±20%
  • Project planning

Basic
engineering

We assure your project’s feasibility

We take into account all the basic needs of the new area, considering equipment forecast, production, space needed to operate, and basic description of main installations. The main deliverable in this phase is a comprehensive cleanroom layout, which complies with the regulations in force and each client’s needs.

Through the development of the basic engineering phase, we refine the concepts to obtain a result as real as possible in all respects. We study the different options in detail to select the best one for the project. From here on, the critical elements are defined in a basic way to obtain the investment magnitude with an approximate deviation of 10%.

  • Layout definition
  • GMP criteria definition: air classification, pressure escalating
  • Personnel and material flow charts
  • Main equipment location
  • Basic definition of the features of each facility
  • Manufacturing technology definition and packaging. URS.
  • Project timeline planning
  • Basic measurement status (by line items)
  • Investment economic estimate ±10%
  • Assistance and accompaniment before the health authorities

Detailed
engineering

We guarantee your project implementation

All the project’s needs are detailed for its successful implementation. The achievement of this phase allows a close cost for the implementation. Our commitment is to offer a project with no deviation in time or cost, which ensures quality.

Starting with the basic engineering and a global view of the project, we develop all the facilities in detail so that any installer from the sector could implement them without any unexpected issues. It is because of this phase that a detailed measurement status is obtained and tender packages to obtain an assessment with a ±0% deviation. We work with BIM Technology with a LOD400 definition level.

  • Civil works
  • Cleanroom architecture
  • Air treatment
  • Electricity
  • Compressed air (steam, hot and cold water)
  • Purified water
  • Extraction
  • Waste treatment
  • Special gases
  • Firefighting System
  • Safety
  • Communications
  • Other installations

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