The pharmaceutical industry is responsible for the production process and distribution of drugs that impact health around the world.
Furthermore, it is one of the most profitable areas internationally, generating billions of dollars every year.
This industry aims to produce effective and safe medicines. And for this goal to be achieved, the process needs to go through several stages and always prioritize a clean environment.
Clean rooms for the pharmaceutical industry must be extremely well maintained to avoid any type of contamination of medicines and professionals, because any failure can affect the entire process.
In this article you will understand what the Pharmaceutical Industry is, how the drug production processes work and how the clean room is extremely important for this entire scope.
Good reading.
What is the Pharmaceutical Industry and how the drug production process works
As previously mentioned, the pharmaceutical industry is the branch of production dedicated to the research, development, manufacturing , and distribution of medicines.
Drug production takes place in four basic steps:
- import;
- manufacturing;
- distribution;
- and marketing.
Knowing this, when production actually begins, a survey is conducted to identify substances that will be evaluated to determine their effects. These substances can be domestic or imported.
Next, professionals need to conduct research to formulate new drugs. For the medication to be produced subsequently, it is essential that the environment be extremely clean at this stage, because any failure can jeopardize the entire process.
In summary, the sequence of production processes is:
- Separation of inputs
- Weighing
- Manipulation
- Technical analysis
- Packing
- and Manufacturing
Now that you know how the drug production process works, it's time to understand the importance of clean rooms.
Microbiological contamination can impact drug production.
Microbiological contamination drastically impacts production by introducing unwanted biological elements that affect product quality and safety.
The main effect is interference with the desired outcome in sensitive environments, such as hospitals and manufacturing facilities for pharmaceuticals, food, cosmetics, or microelectronics. Contamination occurs due to the presence of unwanted substances, including bacteria and microorganisms, both live and dead.
The risk of microbiological contamination requires that production environments be designed to preserve the microbiological and physical qualities of the products . When control fails, the following can occur:
1. Product Alteration: Contamination prevents the product from being manufactured in the most hygienic way possible, resulting in modifications and failing to guarantee that it reaches the end consumer with quality and safety. A controlled environment is essential to prevent alterations in texture, color, and consistency (physical qualities).
2. Risk of Cross-Contamination: The absence of rigorous control leads to cross-contamination, which must be eliminated in processes such as weighing and sampling of products. In animal facilities, cross-contamination during the handling of cages can compromise the integrity of the research.
3. Production Disruption: If essential safety components, such as doors and seals, do not function correctly, the entire production process can be compromised.
To avoid these impacts, systems and equipment are adopted that guarantee a sterile and controlled environment, such as pathogen filtration systems, biological safety cabinets, and unidirectional flow chambers.
How important are clean rooms in the drug production process?
Clean rooms are environments with parameters such as temperature and pressure, humidity and air filtration controlled, where tests and/or manufacture of medicines are carried out.
In the pharmaceutical industry, clean rooms must ensure that particles present in the air do not contaminate or change the microbiological and physical qualities of inputs and medicines, equipment and also the integrity and health of the professional.
When designing a Clean Room, it is necessary to consider the flow of people, products, materials and equipment from the controlled environment and from support rooms and corridors, in order to ensure the performance of all operations safely.
And as in Brazil, clean rooms need to comply with ANVISA, ABNT and INMETRO standards, when designing your clean room, it must be done by a serious company, with qualified and experienced professionals in the market.
Asmontec Salas Limpas has been operating in the cleanroom manufacturing and installation market for over 30 years and has experience in maintaining quality and efficiency in all processes.
To learn more about Asmontec's work, click 👉 here and speak with one of our specialists.
