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What Are Biotech Cleanrooms?

  • 2024-01-04
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Biotech cleanrooms are used in a wide range of industries to meet unique needs and project requirements. They can be utilized in a variety of ways, but have to meet strict standards of quality and control. Let’s talk about biotechnology and cleanrooms used to perform its complex applications.


Biotechnology applies the principles of biology to improve life through the use of plants, animals, and the natural world to enhance food sources, the environment, and human health. Biotech cleanrooms make the study of biotechnology possible by maintaining extremely controlled spaces that allow the science to be the only variable. 

Biotech cleanrooms must often meet stringent cleanroom classifications while also complying with industry-specific regulations for product quality and processes. To better understand the demands and requirements for biotech cleanrooms, let’s explore a few common biotechnology applications.


Biotechnology reaches across many fields and industries, but has particularly important applications in medical, agricultural, and environmental fields.


Many medical cleanrooms can also be biotech cleanrooms, as the two fields often intersect. Medical applications for biotechnology include forensics and diagnostics, vaccinations, and medicinal therapy production and testing. Cleanrooms used to conduct important research such as cancer studies and therapy development, gene therapy, stem cell research, and many other critical applications in health care, all require the extreme control of biotech cleanrooms to mitigate contamination risks for the purpose of study and safety of patients.


The study of biological processes, especially related to food and food products, are another major application of biotechnology. Agricultural applications of biotech cleanrooms are widespread, and also include the development and testing of agricultural products for non food uses, such as biodegradable materials, biofuel, vegetable oils, etc.


Biotechnology is an important field for studying our environment and how human actions affect its quality. Biotech cleanrooms are used to study biological samples, test products for environmental safety, and conduct environmental monitoring and cleaning. 


Because of the delicacy of each of these applications, strict standards must be in place to maintain the cleanest possible environment to conduct tests, develop new treatments, or discover new compounds.

Most biotech cleanrooms must comply with the ISO 14644-1 cleanroom classifications of Class 5 or less. (As the Classes 9-1 descend, the cleanroom must be more and more “clean”, with ISO Class 1 being the strictest standard with the cleanest possible environment.) 

ISO Class 5 is considered to be an extremely stringent classification standard. Most cleanrooms fall in ISO Classes 7 or 8, which require moderate control over particle count and size. They must routinely change the air to cleanse it for particulate matter and regulate other environmental factors like temperature and humidity. ISO Class 5 must do all these things to a higher degree. They only allow a maximum of 3,520 particles 5 µm or larger, and must change the air so many times per hour, the constant flow is described as the air velocity of 40-80 feet per minute. 

Biotech cleanroom classifications exist to hold facilities to a minimum standard of cleanliness to ensure products and processes can exist within the cleanroom with an acceptable level of risk for contamination. Even biotech cleanrooms that meet their classification requirements must be properly outfitted to operate safely, effectively, and efficiently. The difference between an inefficient biotech cleanroom and a high performance biotech cleanroom is an exceptional cleanroom design.


To achieve the high level of control needed in a biotech cleanroom, the cleanroom design must be flawless, and be outfitted with everything the applications will need to conduct its work without interruption or risk of contamination. The special features of cleanroom design work together to make this possible, including the type of cleanroom and its unique systems, such as filtration, HVAC, and more.


Biotech cleanrooms require a cleanroom type that is able to achieve the highest level of control, which is why most are HardWall Cleanrooms. HardWall cleanrooms are able to reach all ISO cleanroom classifications — and can even match the demands of Class 1. Biotech HardWall cleanrooms feature seamless wall panels, flooring, and ceiling grid to prevent particles from settling. All components of the cleanroom build are made using non corrosive and non particle-shedding materials, that can withstand thorough cleaning to keep them contaminant-free at all times.


The systems within a biotech cleanroom support its everyday functions. They are responsible for keeping the environment clean, controlled, and consistent, and make sure the facility always reaches its stringent cleanroom classifications. A few of these systems include cleanroom filtration, cleanroom HVAC, and cleanroom pressurization.

Cleanroom filtration: Filtration in a biotech cleanroom produces a high level of air quality control using multi-stage HEPA filtration and a laminar air flow pattern.

Cleanroom HVAC: Biotech cleanrooms often require a powerful cleanroom HVAC system to supply the cleanroom with temperature and humidity-controlled air.

Cleanroom pressurization: Some biotech cleanrooms may require pressurization to isolate dangerous substances or fumes, or to protect sensitive processes. Positive pressure cleanrooms and negative pressure cleanrooms have many uses as biotech cleanrooms across a diverse range of industries, from medical research cleanrooms to manufacturing cleanrooms for devices and food products.

Biotech cleanrooms play a very important role in many applications across various industries. To be successful and meet stringent classification requirements, they require a top-of-the-line cleanroom design.

Think a biotech cleanroom is right for your application? Get in touch with Kwang Cleanroom! We can design, build, and install a biotech cleanroom that complies with your classification requirements and keeps your products and staff protected.

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