CLEAN ROOMS

We are experts in the design and construction of clean rooms. We provide specialized solutions for each of the projects in containment areas, controlled environment areas, biosecurity, and critical environments.

We execute turnkey GMP clean room projects for different industries such as pharmaceutical, biotechnological, hospital, veterinary, cosmetic, food or for research and development. Our clean rooms are also perfectly designed to carry out cell therapy, tissue therapy or gene therapy processes.

IN-HOUSE PRODUCTION

All the manufacturing of our enclosures such as panels, doors, windows, or ceilings is carried out in our factory located in Vizcaya, in the north of Spain. Likewise, all our equipment is of our own design and manufacture: pass boxes, bio decontamination equipment, isolators, decontamination showers, laminar flow cabinets or modular portable laboratories.

In addition, we have our own team of assemblers, so we offer greater control, organization and management when handling the execution times of the work.

DESIGN & PROJECT

DESIGN: We have a technical department made up of a multidisciplinary professional team of engineers, pharmacists, biologists, etc.… with more than 35 years of experience. We prepare the conceptual and functional design project of your critical area, according to the user’s requirements

PROJECT CONSTRUCTION ENGINEERING: The engineering department prepares the detail and construction project. (Architecture of clean areas, air treatment engineering, fluid circuits, processes, electricity, special gases, automation and control, etc.). This detailed project allows us to guarantee our clients the delivery times and investment costs.

CLEAN ROOM ARCHITECTURE

We take care of the total construction of clean rooms from the layout design. A good design based on the flows of people and products is essential to maintain the commitments of containment and sterility. The architecture system used has the following characteristics:

· Enclosures specially designed for clean areas or biocontainment areas.

· Based on a modular, self-supporting, or similar construction system that is easy to clean and decontaminate, inorganic, waterproof and resistant to chemical agents that can be used for cleaning and decontamination.

· Sandwich panels for the execution of the walls, finished in phenolic resins, lacquered sheet steel or stainless steel and with a polystyrene core, aluminum honeycomb or rock wool.

· Windows perfectly flush on both sides of the panel.

· The doors and profiles have been designed with curved shapes to prevent dust accumulation and easy cleaning.

· Watertight doors with inflatable seal for biocontainment areas BSL-3

· Modular or continuous ceilings can be accessible for easy maintenance of the facilities.

· Epoxy or polyurethane resin floors. Thermo-sealed PVC sheet. In option they can be conductive to avoid static electricity.

· Wide range of solutions, products, accessories and materials.

· Flexibility, which allows adapting to the requirements and needs of the user.

HVAC & Cooling (Air conditioning and refrigeration).

The air conditioning and refrigeration system of clean rooms must respect the activity, the disinfection cycles, the behavior of the staff and respect the construction recommendations when conceiving a project.

· Ultra clean air.

· Temperature control, for comfort and processes.

· Humidity control, for comfort and processes.

· Punctual collection of dust.

· Contamination control.

· Collection and punctual extraction of dust with a centralized and filtered network.

· Laminar flows, independent or integrated equipment in the air conditioning installation.

· Industrial drying, product drying processes.

· Gas aspiration and industrial ventilation.

· Energy Recovery.

· Climatic rooms for product testing and stability, sample libraries.

· Accelerated aging chambers.

· Air quality audits.

· Water and glycol cooling for industrial processes.

· Cold rooms for conservation.

· Centralized installations with different refrigerants.

· Industrial refrigeration.

· Regulation and control validated CFR 21 part.11.

Auxiliary Services.

We design and carry out all the installations and fluid networks that intervene in the clean room, such as:

· Electricity, lighting and strength, ATEX protection areas.

· Fire protection.

· Industrial steam, thermal fluids.

· Vacuum, Compressed Air.

· Water for cooling, glycol water.

· Distribution of acids and solvents, lines of chemical products.

· Drains for spills of acids, toxics, etc.

· Vacuum networks, compressed air, special gases, double envelope networks.

WATER TREATMENT, PROCESSES.

We offer solutions for water and process treatment. The facilities are designed by our technical department according to the needs of the client and the requirements of current regulations.

· Vacuum networks, compressed air, special gases, double envelope networks.

TURNKEY CONSTRUCTION & ASSEMBLY.

We execute the turnkey construction and assembly.

Through our project managers and our site managers, resources are contracted and controlled, supervising the work on site.

In addition to the total facilities package, we offer a HOOK-UP service. Assembly of production equipment. Auxiliary service connections. Reimplantation of machinery in the new rooms. Room and equipment automation. Qualification of the equipment and validation of the rooms.

VALIDATION & QUALIFICATION

We carry out the qualification of the facilities and the validation of the processes with our specialist technicians.

Following the commissioning plan and the validation master plan.

Applying the most demanding standards, ISO, GMP (Good Manufacturing Practices of the pharmaceutical industry), GLP (Good Laboratory Practices) and FDA (Food and Drug Administration).

· Pharmaceutical fluids.

MAINTENANCE.

Our team carries out preventive and corrective maintenance tasks to extend the useful life of clean rooms. We offer technical support and after sales service.

We establish a clean room maintenance plan in accordance with the related regulations of the sector, ISO, GMP and FDA, carrying out the corresponding monitoring and documentation.