Building a Clean Room is undoubtedly a complicated matter, with this in mind we have developed 5 steps for you and your company to implement the project of building a Clean Room.
Obviously, we are not going to mention the issue of defined national regulations and also foreign standards for production destined for the international market.
As the rules are extremely strict and each classification has its own regulations, we will talk in a generic way about a Clean Room project.
1) Project
Architectural projects for Clean Rooms must be designed and developed considering environments for activities that require controlled conditions, with different classifications and pressures. They are normally used in industries, in the production of food, pharmaceutical and hospital products, cosmetics, electronic components, biotechnology and many others.
2) Functionality
The Clean Room's function is crucial for the creation of the environment and the necessary specific controls, as well as the procedure and detailing of the activities involved in each process of operations.
3) Operation
Planning workflows, people, equipment and materials is essential for the project to include the procedures necessary to obtain the desired control of the product.
For this, it is important to plan corridors, the separation of people and materials (distinguish new materials from used ones) and also the flow of people entering and leaving the clean area.
Planning the flow of people, equipment and materials compromises the definition of cleaning classes, environmental conditions and pressure flows within the Clean Room.
4) Equipment
In order to comply with GMP/GMP, Anvisa, FDA guidelines and the Brazilian Society for Contamination Control Norms and Guidelines, it is necessary to equip Clean Rooms with specified products according to the required resistance and wear study.
Furniture should be considered smooth surface, without edges, neutral and without release of particles, made of electropolished stainless steel, powder coated or solid plastic.
We recommend that a study be carried out regarding the location of electronic equipment within a Clean Room.
5) Maintenance
In order to guarantee the proper cleaning and maintenance of the Clean Room, products that favor its hygiene must be considered, with a high standard finish, according to GMP standards: smooth, without edges and waterproof.
Rounded corners on the items that make up the Clean Room also facilitate cleaning and do not accumulate dirt. Tools used for maintenance of machinery and equipment must be selected, cleaned before entering the room and kept clean to minimize the risk of contamination.
After these 5 steps, you will be able to choose the company that will be responsible for the entire design and development of the project to build a Clean Room for your company, taking into account excellence, expertise and quality.
Since 1996, Asmontec has been working to ensure that the implementation of the Cleanroom is 100% consistent with the project, enabling a coherent delivery of the product until its final use.
Learn more at www.asmontec.com.br
