Awareness of the importance of a contamination-free environment is very old. It dates back to ancient times, when drug manufacturers understood that it was essential to perform microbiological cleaning of the products they handled. Even back then, the importance of hygiene in such environments was understood. Today, clean rooms are essential in several sectors, ensuring the integrity of processes and products.
From that point onwards, the issue of “invisible” critical contamination began to be looked at with different eyes. That is, the contaminants that we cannot see, but that must be controlled. The first scientific approaches to the subject occurred with doctors Semmelweis and Lister. They used some disinfection methods in hospital environments and operating rooms and, as a result, resulted in a drastic reduction in infection, as well as in the mortality rate of patients who were treated in those environments.
Table of contents
Initially, the objective of implementing controlled environments was exclusively concerned with people's health. However, it did not take long to understand the importance of being careful with products that are sensitive to contamination. Care began in the middle of the last century, then they began to be handled in controlled environments:
- Pharmaceutical products;
- Medical devices;
- Automotive turbo compressors;
- Photovoltaic modules;
- Hard disk drives;
- Flat screen displays and integrated circuits;
- Among others.
Several sectors understood the importance and started to adopt Clean Room technologies in their production processes. This just points to the daily growth of applications of controlled environments with the objective of reducing harmful contamination in manipulated products, and also, preserving human health.
In order for the risks and problems with internal contamination to reach controlled levels, that is, non-critical, the mechanisms and technologies of clean rooms were developed and became fundamental for the proper functioning and preservation of the quality of the materials, after all, through the filtration constant air exchange and circulation, it was possible to remove biotic and abiotic particles from the production environment.
Clean rooms in medicine
Currently, what emerges as a trend in the medical industries is totally focused on innovative products, with high durability and excellent quality, aiming to optimize all the benefits provided to patients, reduce physical or psychological stress and also provide cost reductions.
The industry in this sector constantly needs high potential for innovative measures. And for them to be really competitive in the market, it is necessary that the products are of high quality, so that the health of the people who will come into contact with them is preserved (from patients to doctors, nurses, etc.).
It is also important to emphasize that maintaining the hygiene of medical equipment, such as appliances, reusable surgical instruments, implants, among others, is essential.
However, even though everyone knows that maintaining a clean environment is essential, it turns out that there are still several problems in the “cleanliness” aspect of medical devices, caused by poor hygiene. Therefore, it is essential to raise awareness that investing in clean rooms is necessary for the proper functioning of all processes and the safety of all.
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Cleanrooms in the aerospace sector
In the space sector, some rigid standards of durability, reliability and performance of satellites and spacecraft are very important. These standards must be strictly followed in order for the equipment to withstand extremely stressful conditions in space. And, for this to be possible, it is important to have the best cleaning technologies so that everything is done and produced in the safest and most assertive way possible.
By following these regulatory policies, the possibilities of transmitting terrestrial contamination in space or vice versa are eliminated. That is, not even terrestrial life forms, such as microorganisms (bacteria, spores, etc.), for example, can contaminate space, just as land is not allowed to be contaminated by unknown life forms, which would be brought from samples on return from missions.
Cleanliness standards and norms are established to minimize any types of false results and misinterpretations. In this way, this segment meets the contamination control requirements of the semiconductor industry and the pharmaceutical industry, which are extremely challenging.
So, in order for the hygienic levels to be guaranteed in the flight hardware, it is necessary that cleaning processes are carried out. In other words, good cleaning technologies must be adopted, after all, once cleaning is carried out, it is essential to adopt adequate concepts so that hardware recontamination does not happen during the entire assembly and integration phase.
Validation of cleaning technologies
In order to avoid cross-contamination of the environment and the operator, the validation steps need to be performed in an AMC (Airborne Molecular Contamination) that is controlled in an ISO Class 1 Clean Room, in accordance with ISO 14644, by trained and qualified operators. to perform that function.
In this cleaning technology verification test process, it is necessary to determine the quantitative contamination before and after the cleaning procedure and this can be done in the following ways:
- In order to detect particles on surfaces, mechanisms that automatically count particles on a surface can be used;
- Now, for organic molecular contamination to be detected, it is possible to use a gas chromatograph, combined with a mass spectrometer (GCMS-TD).
All the techniques that are used must be installed in a clean and controlled environment, so that the processes are done correctly.
There is also a very promising and extremely effective cleaning technology: CO2 snow. In addition to being precise, it is very suitable for space applications, after all, it can remove contamination from biotic/abiotic and molecular (organic) particles at the same time.
Clean rooms in the automotive industry
In recent years, some quality problems have been observed in this sector, such as contamination by residual particles (mainly metallic >50μm). They caused numerous functional impairments in automobiles, among them, impairment of the fuel system, brake circuits, lubrication, hydraulic, refrigeration, air conditioning systems, among others. They also harm mechanical and electronic units. Even small amounts of particles can cause serious problems.
cleaning inspections
The VDA guideline 19 (2004) has as main objective to describe the necessary conditions for the application of inspection methods so that it is possible to determine the state of contamination by particles of the components. There are three steps that must be performed and are performed in environments with established cleaning classes, check:
- Particle extraction;
- filtering;
- Analysis.
The state of cleanliness of the particles of a given component indicates the functional quality characteristics.
clean assembly
Guideline 19,2 of the VDA aims to assist in the planning of assembly areas and environments, in addition to optimizing those that already exist, in relation to contamination control. They must follow the following approaches:
- Prevent contamination by critical particles from occurring in sensitive locations;
- Remove unavoidable particles;
- It must protect components and assembly systems against ingress of particles;
- Avoid recontamination of cleaned components.
These guidelines are intended to cite relevant sources. This is so that the right measures are taken and unnecessary costs are reduced.
Conclusion
It is extremely common for new markets to learn about the advantages of achieving high levels of cleanliness and how this impacts product quality and reliability. By transferring cleanroom technologies that are already known and established in various industrial sectors, it is possible to diversify cleaning technologies, leading to the joint evolution of already established cleaning concepts and methods. In this way, cleanrooms will continue to be a market of constant evolution, improvement and extremely positive for the industrial sectors.
