Clean rooms are responsible for maintaining the quality standard in the manufacture of products, in accordance with current standards and legislation, to avoid any failure that could contaminate the manufacturing process of a product.
Therefore, cleanrooms are environments that maintain complete control over air cleanliness and other parameters, such as humidity, pressure, and temperature. They are 100% sterilized and isolated environments, so the design needs to be done with care, commitment, and responsibility.
When hiring companies that provide cleanroom design services, it is essential to pay attention to the quality and safety of the service provided , because any kind of carelessness or negligence in cleanroom projects can have very serious consequences.
Companies need to have the knowledge and technical expertise to apply and comply with all legal standards and procedures . Only in this way is it possible to guarantee the safety and quality of a cleanroom.
With that in mind, we have developed this text to explain the legal risks of neglecting cleanroom assembly processes. Keep reading to find out more.
You will find
What are the main norms and regulations for the assembly of clean rooms?
Not all companies that supply cleanroom projects are 100% aware of industry standards and regulations. In Brazil, there are specific norms that guide and give legitimacy to companies that set up clean rooms.
The main technical standards in the sector are from the Brazilian Association of Technical Standards ( ABNT ), with the support of Associations and Societies such as SBCC , the Brazilian Society for Contamination Control, and ABRAVA , the Brazilian Association of Refrigeration, Air Conditioning, Ventilation and Heating.
The main rules to be followed in cleanroom assembly processes are:
- ABNT technical standards;
- ISO technical standards;
- Legislative norms of ANVISA (National Health Surveillance Agency);
- FDA (USA) and GMP (European) standards.
The most important and most used standard in the world is ISO 14644, which divides clean rooms into nine classes, according to the amount of specific particles present per cubic meter.
From this, the clean room considered “cleanest” refers to class 1 and the “least clean” belongs to class 9.
Another important standard is ISO 9001, which guarantees greater management and optimization of processes, which certainly brings more agility and seriousness in the development of any product.
Risks of neglecting cleanroom assembly projects
Clean rooms guarantee the quality and safety of several products in different segments, such as pharmaceuticals and food.
The environment is designed to maintain the ideal conditions for manufacturing the projects, and it is in this sense that there is a great concern with the responsibility of the companies that supply the service of assembling a clean room, since the products cannot be contaminated.
If a product is contaminated due to the lack of purity of a clean room, that is, due to irresponsibility in the assembly process, this can have serious consequences for both the company that supplies the clean room and the company that manufactures the products.
We are talking about serious legal consequences, such as compensation for material damages, moral damages, in addition to possible collective legal proceedings.
This is because the manufacture of medicines and food, for example, can affect people's health and well-being. Products like this are sent to stores, pharmacies, markets and will be bought and used by people all over the country.
Imagine people buying and ingesting contaminated products, due to the lack of responsibility in the construction of clean rooms?
If that happens, the companies that sold the products will certainly have their activities suspended and will be held civilly and criminally responsible for this. In addition to having to bear all the damage and harm that can be caused to people.
For these reasons, technical and legal commitment to cleanrooms, from the implementation project, construction, and equipment selection to operation, cleaning, and maintenance, is essential and non-negotiable.
To maintain safety, quality and thus avoid legal and financial problems for your company, it is a must to take the matter at hand seriously.
First and only ISO 9001 certified cleanroom engineering company
As we said, ISO 9001 is a management system with the aim of ensuring process optimization, greater agility in product development and more efficient production in order to satisfy customers and achieve sustained success.
Asmontec , a leader in the Cleanroom market for over 27 years, has earned this certification to reinforce the company's competitive advantages, becoming the first and only cleanroom engineering company to hold the ISO 9001 certification.
Therefore, when designing your clean room, trust companies that act correctly in each project.
Asmontec operates in cleanroom assembly processes, with the necessary and mandatory experience and seriousness for the sector, that is, complying with all standards and regulations, leaving no room for error.
If you have any questions, you can contact us by clicking here.
