6 Considerations to Design a Static Cleanroom for Your Pharmaceutical CompanyMay 6, 2023
A cleanroom is an essential element of any pharmaceutical manufacturing facility where the quality and safety of the products are of utmost importance. The air is filtered and purified to a high standard in a static cleanroom. It ensures that the environment is free from contaminants that could affect the quality and efficacy of the drugs being produced.
Designing a static cleanroom requires careful consideration of several factors. The list includes:
- The size of the facility.
- The type of products being manufactured.
- The specific requirements of the manufacturing process.
This article will discuss six key considerations every pharmaceutical business must remember when designing a static cleanroom. These considerations will ensure it meets the industry’s strict regulatory requirements and standards.
1. Regulatory Requirements
The pharmaceutical industry is subject to strict regulations governing the production of drugs, and these regulations extend to the design and operation of cleanrooms. In the United States, the regulatory agency responsible for overseeing pharmaceutical manufacturing is the Food and Drug Administration (FDA).
The FDA has established regulations for cleanroom design and operation to ensure that pharmaceutical products are manufactured in a safe and controlled environment. These guidelines include requirements for air quality, cleanliness, and monitoring, and standards for gowning and personnel training.
Compliance with these regulations is essential for pharmaceutical businesses to maintain their licenses and approvals to operate.
2. Cleanroom Classification
The classification is based on the number and size of particles present in the air. The goal is to minimize the potential contamination during the manufacturing process. The classification system is based on the International Organization for Standardization (ISO) standards, widely recognized in the pharmaceutical industry.
The ISO classification system is based on the number of particles per cubic meter of air at a specified particle size. For example, ISO Class 5 means no more than 3,520 particles of size 0.5 microns or larger per cubic meter of air. The ISO standard also specifies the maximum allowable concentration of viable particles, such as bacteria and fungi, in the air.
The classification of a cleanroom will depend on the specific requirements of the manufacturing process and the products being produced. Therefore, pharmaceutical businesses must carefully consider the cleanroom classification needed for their operations and design it accordingly. Factors that influence the classification include:
- The type of product being produced.
- The level of cleanliness required.
- The number of employees working.
3. Airflow and Filtration
The design must ensure that the air is filtered and purified to a high standard, providing a safe and controlled environment for the manufacturing process.
The airflow within the static cleanrooms should be designed in such a way that it ensures the air moves in a unidirectional flow. The air typically moves from the ceiling to the floor. Therefore, it helps to prevent the accumulation of particles in the cleanroom and ensures that any particles generated during the manufacturing process are quickly removed.
In addition, the design should minimize the number of obstacles in the airflow path, such as equipment or personnel.
Filtration is another critical consideration. The air entering the room must be filtered to remove particles and contaminants that could affect the quality and safety of the products.
Typically, high-efficiency particulate air (HEPA) filters are used in cleanrooms to achieve the required level of air purity. According to EPA, HEPA filters can remove particles as small as 0.3 microns, ensuring that the cleanroom air is as pure as possible.
4. Materials and Finishes
Materials and finishes are another necessary consideration when designing a static cleanroom for a pharmaceutical business. The materials and finishes used must be compatible with the manufacturing process. In addition, it should be easy to clean and maintain to ensure a high level of cleanliness.
The material to construct walls, floors, and ceilings must be durable, non-shedding, and resistant to chemicals and disinfectants. Common materials used in cleanroom construction include stainless steel, epoxy-coated steel, and vinyl tiles, as per American Cleanroom System. They also recommend laying of copper conducting strip under vinyl flooring.
5. Layout and Design
The design should ensure that the cleanroom minimizes the risk of contamination and allows for efficient movement of personnel and materials.
One crucial aspect of the layout and design is the placement of equipment and fixtures. Equipment should be arranged for easy access and maintenance while minimizing airflow obstruction. In addition, fixtures such as lights, outlets, and HVAC vents should be placed to mitigate the potential generation and accumulation of particles.
Recent news in the pharmaceutical industry has highlighted the importance of layout and design in cleanroom operations. Recently, Pfizer announced plans to invest $465 million in a new manufacturing facility in Michigan that will include a state-of-the-art cleanroom. The cleanroom will feature advanced technology for monitoring air quality and controlling temperature and humidity.
6. Equipment and Technology
The selection of appropriate equipment and technology is a critical consideration when designing a static cleanroom for a pharmaceutical business. The equipment and technology must be compatible with the manufacturing process and designed to meet the high standards of cleanliness required in the pharmaceutical industry.
One important consideration when selecting equipment is the risk of generating particles or contaminants. All equipment used in the cleanroom should be designed to minimize the generation of particles. If possible, it should be enclosed to prevent the release of contaminants into the air.
Recent statistics from the pharmaceutical industry underscore the importance of equipment and technology in cleanroom design. Recent news highlights the importance of equipment and technology in cleanroom design. For example, in May 2021, Pfizer announced plans to invest $800 million in a new gene therapy manufacturing facility. The facility will feature advanced equipment and technology.
The design and construction of a static cleanroom are critical considerations for any pharmaceutical business. The cleanroom must maintain a controlled environment that meets the high standards of cleanliness required in the pharmaceutical industry.
Recent news and statistics in the pharmaceutical industry demonstrate the ongoing investment in cleanroom technology and design. Furthermore, it highlights the importance of these considerations for pharmaceutical businesses.
By carefully considering the key factors, a pharmaceutical company can design a static cleanroom that meets the required standards of cleanliness and optimize manufacturing processes.