Clean rooms in the pharmaceutical industry are essential so that substances are not contaminated and, therefore, altered during the manufacture and/or testing of products. However, for the site to function correctly, it is essential to be aware of some aspects. In this text, you will find everything you need to know about the topic.
As clean rooms in the pharmaceutical industry are undoubtedly essential spaces for safe and effective production. In these environments – whose name derives from the English term clean rooms -, every detail must be thought through to ensure that both manufacturing and testing of products not suffer interference and, therefore, possible contamination.
If the production of a drug is impacted by the presence of microorganisms, for example, there will be losses not only for the substance, but also for the company's employees who are dedicated to the manufacturing process.
To prevent these situations from occurring, the clean rooms, which can be defined as a type of controlled environment, should be spaces isolated from other facilities. In addition, the site needs to meet a series of requirements and standards to be considered, in fact, efficient and safe.
Beyond the pharmaceutical, clean rooms are usually present in places such as food and/or beverage factories, clinical analysis laboratories, chemical laboratories and surgical centers.
How do clean rooms work?
To understand the functioning of clean rooms in the pharmaceutical industry, it is first necessary to know the classifications of these spaces according to ISO 1464-4.
In general, cleanrooms are classified according to the analysis of several factors and are currently divided into two groups:
Class 1 to 5: in this classification, the cleanroom works through an airflow regime considered rolling. In this case, total air replacement takes place every six seconds and this occurs uniformly from the ceiling of the installation.
Class 6 to 9: In this classification, in turn, cleanrooms work through an air flow regime called turbulent. In this case, the air flows from diffusers installed in the lining of the room, which registers air currents inside.
Regardless of the classification, it is important to note that when building a cleanroom, it is necessary to design a space that will prevent particles present in outdoor areas from coming into contact with the controlled environment.
How to maintain the safety and effectiveness of a cleanroom?
As pointed out earlier, one of the main objectives of a clean room, especially in relation to the pharmaceutical industry, is to avoid or reduce the possibilities of contamination of the environment and, consequently, of the products that are being manufactured and/or tested inside.
For the controlled space to function correctly, however, it is essential that those responsible for maintaining the environment are aware of some factors. Investing in a technology that combines air filtration, environmental parameter control e materials with low particulate emissions, for example, is one of the top recommendations.
If you need help keeping your clean room safe and effective against contamination of outdoor environments, you can count on the Asmotec's expertise, a company founded in 1996 that is currently a reference in the market for the implementation and maintenance of clean rooms and other controlled environments.
Get in touch with one of our consultants, learn about our solutions and discover how your clean room can be even safer.
