ISO 14644-4 is an important international standard for cleanroom design, construction and startup. The standard provides a series of guidelines and requirements for the construction of cleanrooms to ensure that they meet specific cleanliness levels to meet the needs of different industries, such as pharmaceuticals, microelectronics, aerospace, etc. According to statistics, the global cleanroom market is expected to reach US$4.16 billion by 2025, with an average annual growth rate of about 6.5%. Therefore, the implementation of ISO 14644-4 is particularly important.
Design requirements
During the design stage of the cleanroom, ISO 14644-4 emphasizes several key aspects, including air flow, temperature and humidity control, and contaminant control. Designers need to choose the appropriate air flow mode, such as laminar or turbulent, according to the purpose of the cleanroom. According to the standard, the cleanroom should be designed with a suitable ventilation system and filtration device according to its required cleanliness level. For example, for ISO Class 5 cleanrooms, the concentration of particles in the air must not exceed 3 particles/m³ (0.5 microns and above). In addition, designers need to consider the layout and flow of the cleanroom to reduce the movement of people and objects and reduce the risk of contamination.
Construction and material selection
The construction of the cleanroom must strictly follow the design plan. ISO 14644-4 stipulates that all building materials used in cleanrooms must have low clean release characteristics to reduce the release of pollutants. Commonly used materials include stainless steel, polyurethane coatings and specific composite materials. The surface roughness of these materials should usually be less than 0.8 microns to reduce the adhesion of particles. During the construction process, dust prevention measures should be taken, such as using air cleaning equipment and maintaining appropriate humidity to ensure the cleanliness of the construction environment.
Ventilation system and filtration equipment
The design and installation of the ventilation system is one of the core contents in the construction of cleanrooms. ISO 14644-4 requires that cleanrooms must be equipped with high-efficiency air filtration systems, such as HEPA filters or ULPA filters. The efficiency of HEPA filters must reach 99.97% (for 0.3 micron particles), while the efficiency of ULPA filters must reach 99.999% (for 0.12 micron particles). In addition, the standard also stipulates the requirements for air exchange rate, such as the minimum air exchange rate of ISO 7 clean rooms should be 30 times/hour to ensure timely air replacement and effective removal of pollutants.
Startup and commissioning
The startup and commissioning of clean rooms are important links to ensure their normal function. According to ISO 14644-4, the startup process must include a comprehensive inspection and testing of ventilation systems, filters, temperature and humidity control equipment, etc. Usually, a series of performance verifications are required during the startup phase, including air flow rate tests, particle counting tests, and temperature and humidity monitoring. Through these tests, it can be confirmed that the performance of the clean room meets the design requirements and ensure that it reaches the required cleanliness level before formal use.
Personnel training and management
The effective management of clean rooms not only depends on the design and installation of equipment, but also requires attention to personnel training and management. ISO 14644-4 emphasizes that all personnel entering the cleanroom should undergo special training to be familiar with the cleanroom operating procedures and cleaning standards. According to statistics, the training qualification rate of cleanroom operators directly affects the incidence of cleanroom contamination incidents, and trained personnel can reduce the risk of contamination by about 40%. Therefore, while investing in cleanroom construction, enterprises also need to pay attention to the education and management of personnel.
Related specifications and standards
During the design, construction and startup of cleanrooms, other relevant standards and specifications must also be referred to to ensure full compliance. The following are some of the main relevant standards:
ISO 14644-1
Classification of air cleanliness levels
ISO 14644-2
Air cleanliness monitoring
ISO 14644-3
Test methods
ISO 14644-5
Operating procedures
GMP (Good Manufacturing Practice)
Good manufacturing practices for pharmaceuticals
By combining these standards with ISO 14644-4, the design, construction and management of clean rooms will be more systematic and standardized, ensuring their efficient operation in various industries.
