The manufacturing process behind most of the world’s pharmaceuticals and advanced technology occurs in highly controlled working environments called cleanrooms. They are necessary to ensure that delicate products are worked on only in the cleanest environments.
This is crucial due to the sort of high-stake industries that rely on them. In today’s article, we are going to explore everything cleanroom-related, which might help you understand why the costs of high-end computer hardware, medicines, and aerospace products can reach sky-high figures.
What Is a Cleanroom?
Cleanrooms are controlled environments designed to minimize the amount of particulate matter and other contaminants in the air. As of 2020, cleanroom technology is a $4 billion market and is expected to grow at 5.4% over the next six years.
Cleanrooms are used in a variety of industries, including semiconductor manufacturing, pharmaceuticals, and biotechnology, to ensure that products are not contaminated during production. Cleanrooms are typically classified based on the number of particles per cubic meter of air.
The cleanliness level is measured in terms of the number of particles of a certain size that are present in one cubic foot of air.
To achieve high cleanliness levels, cleanrooms are equipped with a variety of technologies, such as HEPA filters, laminar flow systems, and airlocks. HEPA filters remove particles from the air, while laminar flow systems use a flow of filtered air to push contaminants away from the work area.
Airlocks prevent contaminants from entering the room when people or equipment are moved in or out. Personnel working in cleanrooms also wear special clothing and follow strict procedures to minimize the number of contaminants they introduce into the room.
We’ll be looking at how they work in more detail later on but for now, let’s find out where cleanrooms are most commonly used.
The Types of Industries That Use Cleanrooms
Cleanrooms are used in a variety of industries that require a controlled environment to minimize the risk of contamination. Some of the most common industries that use cleanrooms include:
- Semiconductor manufacturing: Cleanrooms are used in the production of semiconductors and other microelectronics to prevent dust and other contaminants from damaging delicate components.
- Pharmaceuticals: Cleanrooms are used in the production of drugs and other pharmaceutical products to prevent contamination and ensure the quality of the final product. Check out the infographic below to see what goes on in the pharmaceutical clean room.
Infographic provided by The Emmes Company, a vaccine trial facilitator
- Biotechnology: Cleanrooms are used in the production of biological products such as vaccines, gene therapies, and other medical treatments to protect the integrity of the living organisms involved.
- Aerospace: Cleanrooms are used in the manufacturing of aircraft components, especially for sensitive parts such as electronics, to prevent dust and other contaminants from causing damage.
- Medical devices: Cleanrooms are used in the manufacturing of medical devices such as pacemakers, artificial joints, and other implantable devices to prevent contamination during production.
- Food and Beverages: Cleanrooms are used in the production of food and beverages to prevent contamination by microorganisms and to ensure the quality of the final product.
- Research Labs: Cleanrooms are used in various research labs to perform experiments that require a high level of control over contamination, such as genetic engineering, stem cell research, and other life science research.
The Different Types of Cleanrooms
Cleanrooms are most commonly found in the medical and pharmaceutical fields but are also used by many industries where certain standards of particle cleanliness need to be met. In addition, there are different types of cleanrooms that meet certain requirements better than others.
Here are some common examples of cleanroom types and their usage scenarios:
|ISO Class cleanrooms||Semiconductor manufacturing, pharmaceuticals, and biotechnology|
|Federal Standard 209E cleanrooms||Aerospace and medical device industries|
|GMP cleanrooms||Pharmaceutical and medical device industries|
|Controlled environment rooms (CERs)||Assembly, packaging, and testing|
|Laminar flow hoods||Laboratory, biotech, and pharmaceutical applications|
|Biological safety cabinets||Handling of potentially hazardous biological materials such as pathogens|
|Compounding aseptic containment isolator (CACI)||Pharmaceutical industry|
The classification of cleanrooms is also an important aspect of maintaining standards across the industry. Cleanrooms are classified based on the number of particles per cubic meter of air. The classification system most commonly used is the Federal Standard 209E, which is used by the US government.
According to this standard, cleanrooms are classified into nine different classes, with Class 1 being the cleanest and Class 9 being the least clean.
It’s worth mentioning that other classifications exist, such as ISO 14644 series, which is an International Standard for cleanrooms, it also classifies cleanrooms based on the number of particles per cubic meter of air, but it has different classes, and the limits are more strict.
The classification of a cleanroom is not only based on the number of particles per cubic meter of air but also on other factors such as temperature, humidity, and airflow.
The classification of a cleanroom will be affected by several factors, such as the type of process taking place, the type of materials and products being handled, and the specific requirements of the industry.
What Sort of Equipment and Technology Does a Cleanroom Require?
The specific components and resources needed for a cleanroom will depend on the industry, application, and cleanliness level required. However, some common components and resources that are typically used in cleanrooms include
- HEPA filters: These high-efficiency particulate air filters are used to remove particles from the air. They are typically installed in the ceiling or walls of a cleanroom and are capable of capturing particles as small as 0.3 microns.
- Laminar flow systems: These systems use a flow of filtered air to push contaminants away from the work area. This creates a “clean zone” where the air is free of particles and other pollutants.
- Airlocks: These are used to prevent contaminants from entering the room when people or equipment are moved in or out. They typically include a series of air showers and/or air curtains that are designed to blow off any dust or particles that may be present on clothing or equipment before they enter the cleanroom.
- Special clothing and equipment: Personnel working in cleanrooms typically wear special clothing and equipment, such as shoe covers, gloves, and special garments, as well as face masks and goggles, to minimize the number of contaminants they introduce into the room.
- Cleaning and maintenance supplies: Regular cleaning and maintenance are necessary to maintain the cleanliness of a cleanroom. This includes cleaning supplies, such as mops, brooms, and cleaning solutions, as well as equipment such as vacuum cleaners and air blowers.
- Monitoring and control systems: Cleanrooms require monitoring and control systems to measure air quality and make adjustments as needed. These include particle counters, temperature and humidity sensors, and airflow monitors.
- Power supply and backup systems: Cleanrooms require a reliable power supply and backup systems to ensure that the equipment and systems are functioning properly.
- HVAC (Heating, Ventilation, and Air Conditioning) systems: to control and maintain the temperature, humidity and airflow inside the cleanroom.
How Does a Cleanroom Stay Clean?
We already know the different types of equipment that cleanrooms rely on but that’s just one side of things. Engineers and those working in cleanrooms are required to follow specific protocols to minimize the number of contaminants that are generated during the production process.
Personnel working in cleanrooms have strict procedures to follow in order to minimize the number of contaminants they introduce into the room and they can be quite intensive. For example:
- Following proper gowning procedures: Cleanroom workers are required to wear special clothing and equipment such as shoe covers, gloves, and special garments to minimize the number of contaminants they introduce into the room. These clothing have to be worn correctly and have to be changed regularly.
- Using proper techniques to move materials and equipment: Cleanroom workers are trained in proper techniques for handling materials and equipment to minimize the number of contaminants that are generated during the production process.
- Following proper cleaning and maintenance procedures: This includes cleaning surfaces, equipment, and HEPA filters, as well as monitoring the air quality and making adjustments as needed.
- Following strict protocols for entering and exiting the cleanroom: Cleanroom workers are trained to follow specific protocols for entering and exiting the cleanroom to minimize the number of contaminants that are introduced into the environment. This may include showering, changing clothes, and passing through airlocks.
- Reporting any incidents or issues: Cleanroom workers are responsible for reporting any incidents or issues that may arise during their work, such as equipment malfunctions or cleanroom breaches, to their supervisor or manager.
Cleanrooms are one of the most understated yet essential elements of the modern manufacturing world. They are a part of almost every high-tech industry that creates the sort of products that change the world.
It’s easy to forget the contribution of workers and engineers who spend their lives in these environments. We hope this article helped you learn something new about the process behind the advancements and technology that you interact with on an everyday basis.