Clean area is a controlled environment in which the cleanliness of the site and other parameters are monitored and recorded, such as temperature, humidity, pressure, particles e air flow.
Clean rooms are extremely important for Pharmaceutical Industries, as any risk of contamination can affect not only professionals, medicines and the environment, but also the entire billing flow.
To give you an idea and be able to measure the magnitude of this industry, it is that in 2020 alone, drug sales were US$ 1,74 trillion.
Therefore, clean rooms for the production, storage and even transport of medicines are very important.
Check now how a clean room should be in these environments.
Classification of Cleanrooms in the Pharmaceutical Industry
There are numerous standards, GMP guides and legislation that are used for cleanroom classifications.
- NBR ISO 14644 classifies air purity levels in classes 1 to 9.
- Based on the EU GMP, the classification is designated by grades: A, B, C or D.
- Classification by maximum number of suspended particles, 100, 10.000 and 100.000.
To know in detail how each classification works, visit the blog and read the article Cleanroom Ratings.
Normative Instruction - IN No. 35, OF AUGUST 21, 2019
What does the law say about clean rooms in Pharmaceutical Industries:
Art. 4th Clean areas must be maintained to an appropriate standard of cleanliness and receive air that has passed through appropriate efficiency filters.
Art. 5th The various material preparation, drug preparation and filling operations must be carried out in separate areas within the clean areas.
Single paragraph. Manufacturing operations are divided into two categories: first, those where the product undergoes terminal sterilization and; second, those that are conducted aseptically at some or all stages.
Art. 6th The clean areas for the manufacture of sterile medicines are classified according to the required characteristics of the environment.
Single paragraph. Each manufacturing operation requires an adequate level of environmental cleanliness in the operational state in order to minimize the risks of contamination of the drug or the materials being worked on by particulate or microbiological material.
Art. 7. To meet “in operation” conditions, clean areas must be designed to achieve certain specified levels of air cleanliness in the “at rest” state.
- 1st The “at rest” state is the condition in which the installation is assembled and in operation, with all production equipment, but no personnel present.
- 2nd The “in operation” state is the condition in which the facility is running in a defined operating mode with a specified number of employees working.
- 3 The states “in operation” and “at rest” must be defined for each cleanroom or set of cleanrooms.
Physical Structure for Clean Areas in the Pharmaceutical Industry
The construction of a clean room for this type of environment should also be ANVISA's Normative Instruction and care must be taken with the items discussed above.
Also, the parts of cleanrooms that need more attention are:
- Lining
- Paredes
- ceilings
- Doors
- Room/Apartments
- antechambers
Everyone must take care when assembling, to avoid any type of contamination when the room starts to be used, thus guaranteeing the health and well-being of professionals, the environment and the quality of the products.
To carry out the design and work of the clean room in the Pharmaceutical Industry, the customer must choose a company that understands the business and that already has experience in the market.
And of experience and authority, Asmotec understands well! We have been promoting clean environments, with more security and in accordance with the client's project, for over 26 years.
Discover our products and projects already carried out by pressing 👉 here.
