A cleanroom is designed to contain particles of an acceptable level, usually less than 0.5 micrograms per cubic foot, or “particles per million” (PPM). The air in a clean room must also have fewer bacteria and fungi than in standard enclosures.
In addition to being used for medical devices and pharmaceuticals, cleanrooms are also used for electronics manufacturing and other industrial processes that require low-contamination environments. According to a report published by Grand View Research, Inc, the global cleanroom technology market is expected to reach $5.0 billion by 2028.
How Do You Classify Cleanrooms?
The classification of cleanrooms is done according to the standard used. The classification varies with the standard used. While there are three primary international standards for classifying cleanrooms, they have some differences in their basic principles and therefore do not entirely overlap.
- ISO 14644-1 (formerly ISO 14644-2)
- EU GMP Grade A/B/C/D
- US Federal Standard 209E: Cleanroom Standards
Federal Standard 209E
Federal Standard 209E was a U.S. government standard that defined how cleanroom environments were classified. It was the de facto international standard for cleanroom classifications and was often used in conjunction with the ISO 14644-1 series documents that define cleanrooms.
In contrast to ISO 14644-1, which uses a single number to indicate the level of contamination, Federal Standard 209E used classes named on the basis of the maximum particles of 0.5 micrometers or more. The number of particles in the air can range from 1 to 100000.
For example, a clean room rated “Class 10000” may contain anywhere between 0 to 10000 particles that are larger than 0.5 microns in a cubic foot of air. In 2001, Federal Standard 209E was canceled and superseded by International Organization for Standardization (ISO) Standards.
EU GMP Grade A/B/C/D
EU GMP Grade A: The highest level of cleanliness, with a maximum of one particle per cubic meter. These rooms are designed to prevent contamination by airborne particles and other contaminants.
EU GMP Grade B: This level of cleanliness is achieved when there are between 1 and 10 particles per cubic meter. These rooms are also designed to prevent contamination by airborne particles and other contaminants, but at a lower cost than the A-grade rooms.
EU GMP Grade C: Rooms with this classification can have up to 100 particles per cubic meter, but they still prevent contamination by airborne particles and other contaminants. They are less expensive than the A-grade and B-grade rooms but more expensive than the D-grade rooms.
EU GMP Grade D: These rooms allow up to 1000 particles per cubic meter. They are less expensive than the A-grade and B-grade rooms but more expensive than the C-grade rooms.
ISO Classes 1/2/3/4/5/6/7/8/9
The ISO classes for cleanrooms are the most commonly used system for classifying cleanrooms. They are based on the number of particles per cubic foot in the air and can be abbreviated as follows:
- ISO Class 1 (1) is not suitable for pharmaceutical applications
- ISO Class 2 (2) is ideal for pharmaceutical applications with some restrictions
- ISO Class 3 (3) is suitable for biotech applications, with no restrictions on to use
- ISO Class 4 (4) is suitable for biotech applications with some restrictions on to use
- ISO Class 5 (5), 6, 7, 8, and 9 are general-purpose classes. In other words, they do not specify what kind of application they’re suited to. Rather, they refer only to their particle count specifications.
Applications of Cleanrooms
Cleanrooms can be used for different applications. For example, they can help with pharmaceutical drug manufacturing, research, and development, production of sterile products, etc.
Pharmaceutical cleanrooms are used to produce drugs, vaccines, and other medical products. The purpose of these cleanrooms is to prevent contamination from microorganisms or other particulates that could negatively affect the quality of the product.
These rooms are constructed with special materials to prevent airflow from outside of the room. They also have special air filtration systems and high-efficiency particulate air (HEPA) filters to remove any contaminants found in the air.
In addition to having an enclosed space with controlled airflow, pharmaceutical cleanrooms also have special lighting systems that maintain a consistent amount of light during all hours of operation. This helps prevent variations in temperature and humidity, which can also cause product contamination.
The number of ISO 5-9 biopharmaceutical cleanrooms in use worldwide is estimated to be more than 8,000, according to the 16th Annual Report of Biopharmaceutical Manufacturing Capacity and Production.
McKinsey predicts that the global semiconductor industry will be a trillion-dollar industry by 2030. That’s a lot of chips, but it’s not enough for the increasingly complex devices being built today. The semiconductor industry will also need to develop new processes and materials to meet these demands.
Cleanrooms are ideal for semiconductor production because they allow companies to create a completely sterile environment free of contaminants.
In a cleanroom, the air is filtered to remove all dust particles, and the temperature and humidity are carefully controlled. The flooring is made of a non-porous material that does not retain dust, and all surfaces are wiped down regularly to maintain their cleanliness.
The purpose of using cleanrooms in semiconductor production is to prevent contamination of the devices produced by dust or other environmental factors. Contamination can cause defects in the device that could malfunction or fail when used outside the cleanroom environment.
Cleanroom applications in the food industry are a growing trend. As the world’s population grows and food prices increase, manufacturers are looking for ways to make their products more cost-effective and environmentally friendly. Cleanrooms provide just that.
Cleanrooms have been used for decades in medical applications, but they have recently begun to be applied to manufacturing processes to reduce contamination and increase efficiency. One of the most notable examples is processing fish, often done using cleanrooms with low oxygen and high humidity levels. This helps reduce bacteria growth on the fish and surfaces where it may come into contact during processing.
It is also used in packaging for food products like chips or cereal bars where there may be a risk of cross-contamination from previous products being stored near those currently being packaged. In these situations, a cleanroom can help ensure that there is no risk involved when opening packages or moving them around within the plant itself since all surfaces will already be cleaned before each new package goes through its own production process.
Another example is when Cargill and Feeding America partnered in 2020 to donate a USDA-monitored food processing cleanroom to the Houston Food Bank in Texas. The facility helped process bulk amounts of protein into smaller portions which the food banks would distribute.
It is essential to understand the difference between cleanroom classifications and what they mean for your facility. Classifications like ISO and Fed Std 209E are great starting points if you need to get a new cleanroom up and running.