New technologies bring with them new horizons and opportunities for evolution. In all areas this is very real. At Pharmaceutical industry, is no different. Especially in the moment we live in. A scenario in which public health has become the main agenda around the world.
Ensuring the health of the population is a priority. Precisely for this reason, all sectors related to health are in evidence, including the Pharmaceutical Industry. The production of medicines has always been something relevant and studied, however, in recent years, it has gained even more prominence.
Everyday the new is sought. And that's where the Industry 4.0 goes into. With it, important impacts reach the market. From the production of the medicines themselves, to the way medicines are distributed in pharmaceutical retail. In some parts of the world, even, some of these advances are already very visible. In Portugal, several pharmacies have adopted automated means of dispensing medicines.
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This is just one example of market evolution and the impact new technologies can have on the pharmaceutical industry as a whole. From the beginning, in production, to the end, in the sale to the population, everything is done with great care and responsibility, to guarantee everyone's safety.
The importance of using Clean Rooms in the production of medicines
A drug production for the population, it needs to be carried out in a totally safe environment and without any type of contamination. Because they are extremely important products, it takes a very hygienic condition to operate.
And it is in this scenario that the Clean Rooms become fundamental. After all, these environments have peculiar characteristics, especially with regard to sterility and isolation. They meet the parameters of access, air control, pressure, temperature and humidity. All so that the medicines are not modified.
There is high hygienic rigor within these places. From the materials chosen for the composition of the workplace, doors, lighting and even people's clothing, everything is designed so that there is no type of contamination in the place.
This strict control is determined and regulated. There are health authorities that set standards and inspect the Clean Rooms to ensure efficacy and safety in the production of medicines. Therefore, medicines need a favorable environment to be produced, tested and, later, delivered to the population.
Cleanroom Classifications in the Pharmaceutical Industry
Clean Rooms have their own ratings according to the role assigned to them. Depending on operations needs, the environment may have a certain classification. And this also occurs when the controlled environment is intended to serve the Pharmaceutical Industry.
In this scenario, the classes of Clean Rooms established in the sets of Norms NBR ISO 14644 that contain 14 parts and cover all the literature of classified areas. article that we have prepared, especially on the subject.
Clean Room Regulations and Standards in the Pharmaceutical Industry
For every controlled environment, there are specific rules and regulations for the proper functioning of the site as a whole. There are specific bodies that make and apply these determinations. And, in the case of Clean Rooms for the Pharmaceutical Industry, the rules followed are in Anvisa regulations and also follow international bodies such as FDA Americano
The organization sees two important scenarios: the critical area and the support cleanrooms. Understand better below:
- Critical Area: an environment in which sterilized medicine, containers and buttons are exposed to environmental conditions that must, essentially, be designed to ensure the sterility of the products.
Within these environments the air sample is seen at representative points, at most, one foot away from the working position. It must have a particle count of _> 0,5 µm not greater than 3520/m³ during operations among other factors such as unidirectional airflow, air changes per hour and so on.
- Support Clean Rooms: function as zones in which non-sterile components, formulated products, materials in process, equipment and botoques are prepared, maintained or transferred.
Anvisa's recommendation is that, in these cases, the breakout rooms meet at least Iso Class 7 - Grade D.
The fact is that, with each passing day, the pharmaceutical sector evolves and gains even greater relevance in society. Therefore, understanding how processes work and ensuring greater operational safety is essential.
Asmontec is a specialist in Clean Room Engineering and acts with extreme competence. Know more about work carried out on our website.
