EXPERTS IN INTEGRAL
DEVELOPMENT OF CLEAN ROOMS
We are specialists in the comprehensive management of Clean Rooms and Classified Areas
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Clean Rooms
Iguña Pharma is an engineering company specialized in the development of engineering projects, execution, qualification and maintenance of clean rooms.
In classified areas, it is required to establish strictly controlled environmental parameters that allow knowing the amount of particles per m3 of air, temperature, humidity, air flow, interior air pressure, air hour renewals and lighting.
Normative
Also called classified areas, clean or white rooms must be designed in accordance with the strictest criteria of the GMP, ISO and FDA regulations, in order to obtain low or no contamination levels.
We offer pre-validation, qualification and validation services of the standards of the GMP, ISO-EN 14644 and FDA regulations.
Integral service
We offer all kinds of Engineering services and Technical services for Clean Rooms
Project
Sanitary architecture projects, classified facilities, HVAC, regulation and control, electricity and critical fluids.
Building
We design and execute the pharmaceutical construction of clean rooms complying with the strictest requirements.
Validation
We offer pre-validation, qualification and validation services of the standards of the GMP, ISO-EN 14644 and FDA regulations.
Maintenance
We carry out preventive and corrective maintenance, to extend the useful life of the clean rooms and their compliance with the regulations.
CLEAN ROOMS AND CLASSIFIED AREAS: KEY ASPECTS
In addition to the technical project, the three key elements of a clean room are its architecture, its air conditioning and its machinery and auxiliary equipment.
Sanitary architecture
The architecture of the room is composed of systems made up of panels, doors and smooth windows with rounded corner pieces, thus avoiding the accumulation of dust and easily cleaning the area.
Iguña recommends its own Modular Clean Panel system, endorsed and certified according to the strictest cleanroom regulations.
HVAC air conditioning installations
The air conditioning system of the rooms will be designed and configured according to the requirements of the GMP (Good Manufacturing Practices) and UNE-EN ISO 14644 regulations, which in turn will be conditioned to the activity carried out inside From the living room.
The system will ensure that the air that enters the laboratory is sterile, previously filtered to eliminate particles and microorganisms in suspension.
Auxiliary machinery and equipment
We design and manufacture auxiliary protection, containment and process equipment, such as Cabins, Laminar Flows, Isolators, SAS and Filling Machinery under our Kirhtech brand.
We have a wide range of references in accordance with GMP and ISO standards and an internal R&D team capable of developing all kinds of customized solutions.
Contact
We are manufacturers of modular systems and top quality equipment for Clean Rooms and Classified Areas.
With headquarters in Terrassa (Barcelona), and delegations in Morocco, Colombia, Algeria, Mexico and Jordan, we offer a high quality comprehensive service in multiple countries.
For more information and personalized advice, fill in the form and we will contact you as soon as possible.
For all sectors
We apply our more than 25 years of Know-How to the integral development of clean rooms and classified areas for a multitude of sectors:
Pharmaceutical industry
- Design of pharmaceutical production plants
- Design of pharmaceutical processes
- Sterile and non-sterile products
- Biocontainment areas
- Weighing areas
- R&D laboratories
Cosmetic industry
- Design of cosmetic production plants
- Design of cosmetic processes
- Primary and secondary production rooms
- Washing areas
- Weighing areas
- Heated warehouses
Veterinary industry
- Animal facilities for research
- Design of veterinary drug production plants
- Design of pharmaceutical processes
- Sterile and non-sterile products
- Biocontainment areas
- Weighing areas
- R&D laboratories
Hospitals and clinics
- Pharmacy rooms and sterile, non-sterile and biohazard medicine production
- Gene therapy rooms
- Rooms for immunosuppressed
- Biomolecular research rooms
- Biological laboratories
- Operating rooms
Biotechnology
- Laboratory for research and development for new biotechnological processes
- Facilities for the production and purification of biological products
Medical equipament
Food industry
- Design of food production plants
- Food process design
- Conservation and freezing chambers
Chemical industry
- Design of chemical production plants
- ATEX rooms (explosive atmosphere)
Plastics manufacturing
- Rooms for the control of particles in injection processes
- Auxiliary machinery for packaging process
