Things You Should Know About Biological Cleanroom

As a production environment that represent the highest standard of contamination control, biological cleanrooms are specifically designed to capture the living microorganisms. Understanding their design principles and applications is crucial is crucial for industries where microbial contamination can compromise product safety and efficacy.

What Is Biological Cleanroom?

A biological cleanroom is a production environments where the concentration of airborne microorganisms is kept within specified limits. The classification of biological cleanrooms follows the standards of ISO 14644 and GMP guidelines, which specify the maximum allowable concentrations of both airborne particles and microbial colonies. These requirements make biological cleanrooms significantly more complex to design and maintain.

They are suitable for the pharmaceutical industry, hospitals (such as operating rooms, sterile wards), food, cosmetics, beverage production, animal laboratories, physical and chemical testing laboratories, blood stations, etc.

How To Design Biological Cleanroom?

The effectiveness of a biological cleanroom depends on several elements，and they are filtration system, air pressure control, airflow management and material and personnel flow control.

>>> Filtration System

Microorganisms like bacteria and viruses exist in air as colonies, often clinging to airborne dust particles as suspended bioparticles. Individual bacteria range in size from 1 to 100 μm, while viruses range from 0.008 to 0.3 μm. When these colonies cling to dust particles, their size is typically around 5 to 10 μm. The presence of these microorganisms can severely impact the proper functioning of a cleanroom. Therefore, when constructing a cleanroom, an air purification system must be designed to ensure sterile air through HEPA/ULPA filters, ensuring proper operation.

>>> Air Pressure Control

Biological cleanrooms typically maintain positive pressure relative to adjacent spaces, creating an air barrier that prevents unfiltered air from entering when doors are opened. In cases where hazardous materials are handled, negative pressure may be implemented to contain contaminants within the cleanroom.

>>> Airflow Management

Laminar airflow systems create unidirectional air movement that sweeps contaminants away from critical processes. This is typically achieved through ceiling-mounted filters that distribute clean air uniformly across the entire workspace, with return air grilles positioned at low level to maintain consistent airflow patterns.

>>> Material and Personnel Flow Control

All items entering the cleanroom must pass through dedicated transfer systems, such as pass-through windows with interlocking systems. Personnel access is strictly controlled through airlock systems where workers don specialized cleanroom garments in a sequenced dressing process.

Advanced Filtration Technologies

Modern biological cleanrooms adapt multi-stage filtration systems to ensure the cleanliness level.  The whole filtration are usually start from the pre-filters, they can capture larger particles, and extend the lifespan of the HEPA or ULPA filters.

Using appropriate filter media is important in biological applications. Many biological cleanrooms utilize filters with anti-microbial coatings that inhibit the growth of microorganisms on the filter surface itself. This prevents the filters from becoming secondary contamination sources and helps maintain long-term filtration efficiency in humid environments where microbial growth might otherwise thrive.

Operational Considerations

For biological cleanroom, daily maintenance is even more important than the initial design and construction. The company should establish the comprehensive maintenance SOP. And here are some basic things we should know :

>>> Establish a comprehensive cleanroom monitoring system to ensure prompt response to any abnormalities.

>>> Regularly inspect key equipment (such as FFUs and air filters).

>>> Strictly control the entry and exit of personnel and equipment to the cleanroom to prevent contaminants from entering.

Biological cleanrooms has an extremely high requirements of contamination control technology.As a professional supplier in air filtration line, Amorair is familiar with all items you need. Please free free to contact us if you have any questions.