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Can you imagine going through a surgical procedure in which the physician did not wash his hands and did not sterilize the instruments? What today may seem crazy was a common practice throughout the world. Many people have suffered until the scientific community perceived the connection between the sterilization of the environment and the success of the procedures. And that’s how the control of bacteria and microorganisms represented a great advance for medicine.
The development of sterilization techniques for instruments and everything that comes into contact with the patient meant a drastic reduction of complications and deaths caused by the lack of concern for hygiene, very common in the mid-nineteenth century. What seems so obvious today took a long time to be unveiled, and had the collaboration of many names such as Semmelweis, Pasteur, Lister, Koch and so many others who contributed anonymously.
The discoveries made primarily in health area extended to other fields and their precepts are used in different sectors, which demand for delicate processes of high precision. Today it is possible to find controlled environments - such as clean rooms - not only in hospitals, but also in the pharmaceutical, food, chemical and beverage industries, for example.
But, finally, what are the clean rooms? Clean rooms are extremely controlled spaces in order to ensure that there is no contamination of the environment and, consequently, of what is being manipulated inside that.
However, it is not just about that type of cleaning as we do at home. It is somewhat more complex... Beyond the sterilization of all the components present in the premises, there is a control of airborne particles, climatic conditions - such as temperature and humidity - and the control of all the agents that can infect the environment.
Also, think that the impurities come only from outside the clean room is a mistake. The main source of contamination is, precisely, the human resources involved in the processes carried out in its interior, since the human body is a great source of particles originating from the desquamation of the skin and hair, from the fibers of the garments used and even of the microorganisms present in the air that we breathe out.
Added to these elements, there are the particles generated by the wear of the materials in the room and those from the production process itself, such as droplets and residual dust from the raw material.
The prevention and control of contamination in clean rooms can be divided, basically, into care with the internal and with the external environment.
For the internal environment, it is necessary to create a barrier so that the particles generated by people will not pollute the air. It’s essential to use special clothing, gloves, mask and head covering, as well as care with the use of cosmetics. The furniture must be resistant, made with a smooth surface and withstand abrasion, in order to allow cleaning, avoiding the accumulation of waste and so that there is no detachment of any fragment.
With the controlled interior, it is essential to manage the interaction with the external environment. After all it is necessary to ensure that there is no contamination when there is access by people, raw materials and finished products, for example. All gaps, cracks and holes must be blocked and the air that is blown into the room needs to pass through a filtration system in order to guarantee the quality and control of the airborne particles. This system is designed according to the specifications of the process and the classification of the clean room, made through specific regulatory norms.
To prevent external air from contaminating the sterile environment, the room is kept pressurized. For example, when the door is opened, there is only air movement from inside to outside the room and not in the opposite direction. By that, only clean air leaves the room, without letting the “dirty” air enter.
With so many details to consider, it’s undisputed the fact that the project needs to be well structured by a professional who masters the peculiarities of construction, assembly and maintenance of a clean room. However, it cannot simply be isolated from all the rest, especially when the manipulation that occurs inside is part of a productive chain. It must be integrated with the process and the adjacent facilities and, nevertheless, fulfill its role of guaranteeing a sterile environment.
A big challenge that can be overcome with an in-depth study of the process, understanding the flows and looking for solutions that facilitate and enable their incorporation. That is why it is essential that all planning be done in partnership with workers who really know the process in which the clean room will be inserted. Just as in the beginnings of the discovery of the importance of sterilization, the collaboration of professionals with different knowledge is the great differential for the project be successful.
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DistribuTECH Conference & Exhibition takes place in New Orleans, LA from Feb. 5-7. You can visit NOVUS at booth 401.
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