Lagap SA
When the Swiss pharmaceutical company Lagap SA turned to CRT Sterile Solutions it needed to transfer production from several production plants in internal Switzerland to...
Clean Rooms are now essential in industrial production and scientific research: they allow you to work in a limited area containing air with a reduced number of suspended dust microparticles, and to control the atmospheric pressure and the particle/microbial pollution.
CRT Sterile Solutions SA offers its expertise in design and building of Clean Rooms, guaranteeing high standard quality , in compliance with current regulations and cycles production and the control bodies' requirements. CRT Sterile Solutions provides complete assistance to meet all the project requests and establish an active collaboration with the customers. The company supports the customers in every phase of the project (conceptual and executive), from the idea to its implementation, from commissioning, validation according to the most restrictive standards to maintenance and revalidation.
The final aim is providing our customers with clean rooms characterized by an excellent level of safety, hygiene and comfort.
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.
When the Swiss pharmaceutical company Lagap SA turned to CRT Sterile Solutions it needed to transfer production from several production plants in internal Switzerland to...
For this case study, the starting point was an empty warehouse in an industrial condominium, while the arrival point was transformed into an area of 2,000 square meters in which...
CRT Sterile Solutions is working on the design and construction of a clean room of 250 square meters which will be used in the production of plastic parts for medical /...
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