Any company dedicated to production, regardless of the sector and the products that make up its catalog, must ensure that its processes are carried out in a controlled environment free of any contaminating element. In this way the maximum integrity of the product is ensured. This is especially important in the medical sector, where the relevance of the clean room for the manufacture of medical devices multiplies.
Difference between clean room and clean room for the manufacture of sanitary products
The most prestigious companies dedicated to the manufacture of sanitary products have either a clean room or, the most demanding and reliable, a clean room. If we want to compare both, a clean room for the manufacture of sanitary products has the same characteristics as a clean room, only that it goes one step further in terms of eliminating all signs of contaminants in an isolated and pressurized environment.
Delving into these differences, to establish why the clean room is much more recommended in the production of sanitary products, we can establish the following.
What is a clean room?
Generally, the clean room is used in sectors that manufacture products that are highly sensitive to contamination, such as the aerospace industry. In this case, the clean room is used for the assembly processes, since the presence of dust and other agents that could interfere with them is minimized.
The clean room is the perfect environment to implement strict control protocols and can identify polluting particles in the air. However, that is your limit: you identify them, but you cannot control them. And this is the biggest difference with the clean room.
What is a clean room for the manufacture of sanitary products?
Clean rooms represent another type of strictly controlled space and are present in sectors such as the manufacture of precision elements or sanitary products. Its preparation and characteristics are more complex and sophisticated than those of the clean room and its greatest advantage is that its protocols ensure that the entire production process is carried out in an atmosphere of zero contamination.
The clean room allows manufacturing companies to obtain their final product without running any risk of cross contamination by any type of pathogen.
Objectives and design of clean rooms
The correct installation and management of clean rooms must be subject to the fulfillment of certain objectives that cannot be waived. The clean room for the manufacture of medical devices must guarantee microbial exclusion to prevent contamination of materials, components, and sterile surfaces in aseptic operations. Along with the exclusion, it must achieve a microbial limitation in the surrounding areas, to minimize the introduction of contamination in the exclusion zone.
To achieve these objectives, the correct design project of the clean room must include all the processes and operations that the industry that requires the installation of said rooms plans to carry out, establishing the flow diagram that best adapts to the production processes. and considering all aspects of functionality, maintenance, and control. As well as reflecting the conclusions in documents and plans that must be approved by qualified personnel. The working document will be the distribution plan of the different rooms necessary for the processes or operations included in the project.
IP Triana has a clean room in its facilities that strictly complies with the ISO 13485 standard. In this article we explain how we take national and international quality and safety requirements very seriously.
