Costa Rica. Grupo Clima shared an analysis on the importance of understanding and applying national standards within the concept of clean rooms. Here is the text:
Maybe we're not familiar with the concept of clean rooms, or at least not as a workspace. A clean room is a place where products are manufactured with rigorous environmental control and are designed to handle low levels of contamination, in processes that must be carried out with specific cleaning conditions. In simple words, it is a controlled environment where products are manufactured.
The idea is to minimize the introduction, generation and retention of polluting particles within the clean room and in which other parameters such as temperature and humidity are controlled. These are used in virtually all industries such as in the manufacture of pharmaceuticals, biotechnology, medical devices, as well as in critical processes, such as aerospace, optics, among others. where small particles can adversely affect the manufacturing process of the products.
Can anyone design a clean room?
The correct answer is no. It is necessary to have an expert in the subject who knows how to obtain the correct temperature, control the humidity, the particles in the environment, since due to the sensitivity of the area, the room must be completely insulated in order to ensure a totally clean environment for the processes that are carried out inside.
The Institute of Technical Standards of Costa Rica, INTECO, which is the National Standardization Organization according to Law 8279, develops through its Technical Standardization Committees (CTN) the documents that, unifying the criteria through consensus, will constitute National Technical Standards and will allow the productive and service sector to compete in international markets.
Grupo Clima and its contribution
If we are looking for a reference at the country level on knowledge, information and manufacture of clean rooms, we have no different option than looking for Grupo Clima, since they are focused on following strict rules and procedures in the construction of clean rooms to prevent pollution and thus ensure not only the user of the clean room an optimal environment in the elaboration of their products but the consumer of the product, that this was manufactured in the best conditions.
Photography Grupo Clima: design good practices for Clean Rooms.
How do we contribute?
After 3 years of work, in conjunction with INTECO and based on international standards, the CTN 55 Technical Committee has adapted, among other standards, the INTE ISO 14644 package, referring to clean rooms. Here the standards of good practices are defined to ensure that the product is free of contaminants or environments not suitable for its quality requirements. This new standard published in March of this year, will regulate the design, construction and operation of clean rooms that will benefit the medical, pharmaceutical and hospital industries.
This great work was formed by Grupo Clima as the only HVAC-Controls-Electromechanical contractor. It was led by INTECO with the participation of the medical industry, such as the federated College of Engineers and Architects and staff of the Costa Rican Social Security Fund for the part dedicated to surgery rooms.
* For more information on published national technical standards, please visit the following link.
https://www.inteco.org/en_US/shop/inte-iso-14644-1-2018-cuartos-limpios-y-ambientes-controlados-asociados-parte-1-clasificacion-de-la-limpieza-del-aire-mediante-la-concentracion-de-particulas-3001#attr=
