By sharing our thirty years of experience with the customer, we offer feasibility studies, design, construction and validation of controlled contamination environments in concert with process equipment. When the system is functioning, we offer scheduled or extraordinary maintenance of environments and systems. All in full compliance with the European GMP (Good Manufacturing Practice) and / or FDA regulations to guarantee the required quality standards.
To carry out the processes in the chemical-pharmaceutical field, it is necessary to have environments with a change of air to exclude concentrations of volatile pollutants. For the finishing and packaging phase of the active ingredients (API), the production process will be confined in environments with a very low content of suspended dust microparticles and microbial particles to avoid any possible contamination of the products.
The manipulation of biological agents both in production and in quality analysis requires environments with a high level of contamination control of both the product and the surrounding environment through air treatment systems in confined environments where the in-out behavior of materials and personnel will be designed, in compliance with the strict containment measures.
In the field of food / supplement production, in order to obtain the highest quality of products, every processing phase must be controlled, therefore in environments designed and manufactured by us for maximum cleanliness. In the food sector, environments that allow the control of pollutants in the production phases is necessary for the success of the products and guarantees compliance with the hygiene and sanitary standards of the premises.
The need to create high-tech equipment requires environments in the absence of both particulate matter, the presence of which could negatively affect the proper functioning of the components, and in the case of spatial modules of microbiological contamination, as we could lead unconsciously forms of life terrestrials in space. These environments are made by us with HEPA or ULPA filtration systems. The personnel and the incoming materials will have a path and a method of controlling pollutants that we have studied and applied. Generally the environments are also controlled in terms of electrostaticity and control of volatile solvents (generally acetic).
The hospital environments, in particular the operating blocks for which specific experience is required in the design of the pathways, sterility and containment are designed according to specific needs. This is to prevent the risk of infections and to minimize the possibility of the spread of infectious agents. Even in this sector, the design and construction must take into account the health and hygiene regulations.
Generally the sectors where we build the factories require laboratories for analytical and microbiological quality control (QC). Having identified the analysis paths that production requires, it is our task to design and build the environments, technical furnishings, equipment and systems. This experience is often extended to research and development (R&D) laboratories.
The key to our success lies in being able to decline our preparation in the field of controlled contamination environments in very different contexts, this is because more and more sectors need services related to the sterility of the environments and its control.
Thanks to this great opportunity, we have gained unique experience and a complete knowledge of the controlled contamination sector and we are able to respond promptly to different types of specific needs for each customer.
We know well that creating a Clean Room requires a certain degree of versatility and adaptability to face all situations that arise and to find new solutions from time to time, suited to the customer's needs, which are functional to the type of process and production plant. , to the current legislation, to the constantly evolving quality standards and to the customer's internal procedures.