Cleanrooms are environments in which air cleanliness and parameters such as temperature, humidity, pressure, particles e air flow, are controlled, monitored and recorded.
In this way, clean rooms guarantee the most hygienic environment possible to avoid any type of contamination, whether through the air, equipment, products or the place itself.
In this article you will understand the importance of clean rooms in pharmaceutical and how it should be structured according to current regulations.
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The importance of the Clean Room in the Pharmaceutical Industry
As stated earlier, clean rooms are essential for environments that need extreme hygiene, such as handling medicines, laboratories, hospitals, among others.
For the pharmaceutical industry, clean rooms become even more important due to the complexity of the processes in the handling of medicines.
The pharmaceutical industry moves billions of dollars a year on the world market and medicines have a great impact on the entire world population. Therefore, an environment that is within the required standards, with strict control of contamination and pollutants is essential.
And for the clean room project to be within the required standards, it is necessary to pay attention to bodies such as:
- ABNT technical standards
- ISO technical standards
- ANVISA's Legislative Rules
- FDA (USA) and GMP (Europe) standard.
The most widely used standard in the world is the ISO 14644, which divides cleanrooms into nine classes, with class 1 considered the “cleanest” and class 9 considered the “dirtiest”.
You can read more about the Clean Room Rating by pressing 👉 here.
Now check out what the basic structure of a clean room looks like.
Physical structure of Clean Rooms
According to Normative Instruction - IN No. 35, of August 21, 2019 by ANVISA, clean areas must be kept to an appropriate standard of cleanliness, in addition to other standards of Good Manufacturing Practices complementary to Sterile Medicines.
Taking into account the standards addressed in the ANVISA Normative Instruction, the structure of the cleanroom project starts with the panels isothermal that will keep the temperature lower than the external environment.
Os materials they must not generate or retain contaminating particles or microorganisms, they must be resistant to impacts, oxidation and be compatible with the disinfectants used for maintenance and cleaning.
Os linings are elements of the construction that separate the utility structures and technical floor from the production areas, making all equipment such as the air conditioning system, ducts and lighting accessible through it.
walls, ceilings e doors must be smooth, without edges, neutral and free of particles.
Os floors they must be strong, free of fissures and cracks, prepared to receive heavy loads and have enough space for cleaning and correct maintenance.
Nas antechambers, which are areas that precede the main production environment, interlocking is mandatory so that the pressure differential in other areas is maintained.
Asmontec Salas Limpas has all the equipment for each type of project. In addition to the ones mentioned above, you will find:
- Pass Through
- Vitreous Line
- Lighting
- Accessories
- Compact Rooms
- and stainless steel
And if you are looking for a complete project, led from start to finish by the same company, at Asmotec you will find the turn key operation.
Now that you know what a Clean Room project for the Pharmaceutical Industry is like and how it works, contact Asmontec to speak with one of our experts to design your clean room with quality and safety.
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