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, clean rooms are environments that maintain full control of air cleanliness and other parameters, such as humidity, pressure and temperature. They are 100% sterilized and isolated environments, therefore the project needs to be done with care, commitment and responsibility.
When hiring companies that supply cleanroom projects, it is necessary to pay attention to the quality and safety of the service provided., this is because any type of oversight or negligence in cleanroom projects can have very serious consequences.
Companies need to have knowledge and technical expertise to apply and comply with all legal rules and procedures. This is the only way to guarantee the safety and quality of a clean room.
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.
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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 of the sector are from the Brazilian Association of Technical Standards (ABNT) with the support of Associations and Societies, such as SBCC, Brazilian Society for Contamination Control and ABRAVA, 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, the technical and legal commitment to clean rooms, from the implementation project, construction, choice of equipment, 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.
A Asmotec, being a reference in the Clean Room market for over 27 years, achieved this certification to reinforce the company's differentials, and became the first and only clean room engineering company to have the 9001 certification.
Therefore, when designing your clean room, trust companies that act correctly in each project.
Asmontec operates in clean room assembly processes, with the experience and seriousness necessary and mandatory for the sector, that is, complying with all rules and regulations, leaving no room for errors.
If you have any questions, you can contact us by clicking here.
