The biotechnology cleanroom is specially designed spacethat isdesignedandcontrolled to maintainproper conditions to support biotechnology research and production activities. This cleanroom ensures sterility and consistency of experiments and production by strictly controlling thenumber of airborne particles, microorganisms and other potential contaminants.
Biotechnology cleanrooms are widely used in a variety of industries that require a highly sterile and pure environment due to their strict environmental control capabilities. The following are several major application areas:
1.Pharmaceutical industry
2.Applications in medical treatment and research
3.Biotechnology research
4.Food industry
5.Cosmetics production
6.Other applications
Biotechnology cleanrooms are mainly divided into two categories: general biological cleanrooms and biosafety cleanrooms.
1.General biological cleanroom
General biological cleanrooms are mainly used for the production of most drugs and biological products, some foods, healthcare products and medicaldevices. The main feature of this type of cleanroom is that the interior is usually kept at a positive pressure to prevent external contamination from entering. It mainly controls inanimateairborne particles and microorganisms. The design and construction of general biological cleanrooms need to follow strict specifications to ensure the cleanliness of the production environment, thereby ensuring the quality and safety of the products.
2.Biosafety cleanroom
Biosafety cleanrooms are mainly used in situations where a high degree of control over the leakage of microorganisms is required, such as research and production of highly pathogenic microorganisms. Such cleanrooms usually maintain negative pressureinsideto prevent internal microorganisms from leakingto the external environment. The design of biosafety cleanrooms mustconsider not only theair purification, but also the configuration of facilities such as biosafety cabinets, protective clothing, and disinfection equipment to ensure the safety of operators and protection of cleanroom environment.
The cleanliness requirements of biotechnology cleanrooms depend on the specific productionprocess and application: For high-precision operations such as clinical manufacturing facilities for cell and gene management, vaccine production facilities, and stem cell manufacturing: Class B cleanliness are usually required. Class B cleanrooms are equivalent to ISO7cleanliness whenin operation and ISO5 cleanrooms whenunder static status. In a stationary state, a Class B cleanroom needs to meetthe requirement ofno more than 3,520 particles (0.5μm) per cubic meter;while running, the number of airborne particles allowed per cubic meter of air increases to 352,000 (0.5μm).
Biotech cleanroom refers to a limited space where suspended microorganisms in the air of acleanroom are controlled within a specified value. Compared with industrialcleanrooms, biologicalcleanrooms not only control the indoor dust value, but also focus on controlling the number of suspended microorganisms in the indoor air. This type of cleanroom is widely used, mainly in hospital operating rooms and wards, pharmaceutical factories, biosafety laboratories,laboratoryanimal rooms and other fields.
The requirements for biotechnology cleanrooms mainly include the following aspects:
1.Cleanliness level classification
2.Microbiological control
3.Temperature, humidity and pressure
4.Principleof airflow
5.Materials and Construction
In summary, the requirements for biotechnology cleanrooms are very strict, covering cleanliness level classification, microbial control, environmental parameter control, principles of airflow, materials and construction, etc. These requirements are designed to ensure the high quality of the cleanroom environment to meet the specialized needs of biotechnology research and production.
1.Prevention and control measures on airflow
Filtration and sterilization:
Air purification technology uses filtration as the most common way to control microorganisms in the air. Filter media include cellulose, glass wool or artificial fibers. Filtering the air in the entire room (such as a sterile operating room) or a local operating area (such as a clean bench) through an air purification device can effectively remove microorganisms. TheHEPA filterhas a filtration efficiency of 99.97% - 99.99% orhigher, which can effectively remove microbial particles in the air. It is usually installed at the air inlet and outlet of the clean bench.
Chemical disinfection:
Using disinfectants to act on indoor air, such as using appropriate chemical disinfectants to disinfect the air in biotechnology cleanrooms, can reduce the number of microorganisms. However, attention should be paid to the safety of the utilizing disinfectants and residual issues.
Ultraviolet irradiation:Use ultraviolet rays to irradiate and disinfect indoor air. When the equipment is not in use or during work breaks, turningon the ultraviolet lamp to irradiate the indoor air. Ultraviolet rays have a killing effect on microorganisms and can reduce the content of microorganisms in the air. However, ultraviolet irradiation has certain limitations, such as ineffective disinfection of places that cannot be irradiated, etc.
2.Water prevention and control measures
Chemical disinfectants: Chemical disinfectants are commonly used to disinfect process water and have better effects, such as sodium hypochlorite or chlorine gas disinfection. However, it should be noted that there should be no dead corners in the water system that cannot be disinfected.
Membrane filtration method: It is suitable for continuous circulation treatment of water systems, which can effectively remove microorganisms in water and ensure that the microbial indicators of process water are qualified.
Ultraviolet irradiation method: Ultraviolet irradiation disinfection is applied in water systems. It is suitable for water that requires special treatment (such as high optical transparency requirements), generally before the end. The water treated by this method is odorless and tasteless, and there will be no phenomenon of microorganisms migrating to the filter.In actual water systems, these methods are often used in combination and designed and installed in appropriate locations.