What is a Biotech Cleanroom?


Biotechnology cleanrooms, also known as biopharmaceutical cleanrooms or bio-cleanrooms, are specialized controlled environments designed for the manufacturing and research of biotechnology and pharmaceutical products. These cleanrooms are essential for maintaining strict levels of cleanliness, air quality, and sterility to ensure the integrity of the products being developed.

Biotech cleanrooms are used across a wide range of industries, including medical and agricultural processes to meet the specific needs and requirements of the projects. To understand the complexity of biotechnology cleanrooms, let’s first talk about biotechnology and its applications.

biotechnology at work

Biotechnology Applications

Biotechnology is a branch of technology based on biology used to study and improve life by using plants, animals, and nature to enhance different areas of human life. Biotech cleanrooms make this study possible by creating and maintaining an extremely controlled environment free of any contamination. nothing can contaminate the experiments. There are three main biotechnology applications.

1. Medical Biotechnology

Certain medical cleanrooms can also be considered biotech cleanrooms as these two fields partake in similar studies. Diagnostics, forensics, vaccinations, and medicinal therapy productions are just a few biotechnology applications in this sector. A variety of significant health care research, such as cancer, gene therapy, and stem cell research, is conducted in biotech cleanrooms as they require the highest level of contamination prevention for the safety of staff and patients. 

2. Agricultural Biotechnology

Another primary application of biotechnology is the study of biology related to crops and food products. Agritech uses modification techniques to improve the nutritional content and flavor of food. However, other applications include developing non-food products, biodegradable materials, vegetable oils, biofuel, etc. 

3. Environmental Biotechnology

This biotech application studies our environment and how human actions affect it. For this application, biotech cleanrooms are designated to research and test biological samples, determine if products are safe for the environment, and conduct environmental cleaning and monitoring. 

scientists having a discussion in biotech cleanroom

Biotech Cleanroom ISO Classifications

The applications of biotechnology are very precise and require stringent cleanliness standards to develop and test new treatments and compounds. Almost all biotech cleanrooms must comply with ISO 14644-1 Class 5 or stricter cleanroom classifications. ISO Class 1-5 are considered to have extremely strict standards. Even though the biotech cleanrooms follow the ISO classification guidelines, they must also be outfitted appropriately for the chosen processes to operate effectively and efficiently. The air purity is of great concern, and the constant air velocity should be 40-80 feet per minute. Environmental control and air purity should be up to standards to ensure products and processes are not affected by contamination. 

biotech cleanroom worker

Biotech Cleanroom Designing

The design of the biotech cleanroom is a fundamental concept. To operate safely and efficiently, the cleanroom should be flawlessly designed to avoid interruptions and the risk of contamination. It should incorporate unique features to a given application, such as air filtration, HVAC, individual processing systems, and more. 

In order to achieve stringent standards of ISO Class1-5 classification, most biotech applications require HardWall type cleanrooms. HardWall cleanrooms consist of seamless modular wall panels, resilience flooring, and suspended ceiling grid, preventing dust or dirt particles from settling. The modular panels and other surfaces are made of non-corrosive and non-shredding materials, which could sustain harsh cleaning chemical procedures. 

Biotech Cleanroom Systems

There are many systems within a biotech cleanroom that support its everyday functions. These systems are responsible for maintaining the environment controlled, clean, and consistent so that the stringent classifications are reached at all times. Some of the systems include HVAC, air filtration, and air pressurization. 

  • Cleanroom Filtration: Air filtration is required in biotech cleanrooms to maintain a high level of air quality using a laminar airflow pattern and HEPA filtration. 
  • Cleanroom HVAC: In biotech cleanrooms, robust HVAC systems supply the cleanroom with temperature and humidity-controlled air. 
  • Cleanroom Pressurization: Some biotech cleanrooms require pressurization so that dangerous fumes or substances can be isolated to protect sensitive processes. Positive and negative pressure cleanrooms have a wide range of uses as biotech cleanrooms in many industries, from medical development and research to manufacturing food products and devices. 

A biotech cleanroom is a significant part of many industries and applications. A top-of-the-line cleanroom design, in accordance to all ISO classifications, is required for efficient and uninterrupted workflow.

If you think biotech cleanroom is right for your application, get in touch with our team of experts. We can provide biotech cleanroom design, build, and installation solutions tailored to your project’s needs. 


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