Clean Room Classification and Design Principles
The rationality of clean room classification directly affects production environment safety and product quality. Standards such as ISO 14644 and GMP impose strict requirements on cleanliness levels, air velocity, pressure differentials, and air changes per hour. Even minor errors may result in inadequate cleanliness performance, impacting production compliance.
Amber specializes in clean room classification and design, providing one-stop clean room services, including on-site measurement, grade determination, layout design, construction and installation, and other technical services to ensure that all clean room parameters comply with international standards.
Why choose us?
1.Support customisation on demand to meet the cleanliness requirements of different industries.
2. Professional technical team for fast delivery.
3. All materials are CE and ISO certified.
4. After-sales maintenance service guarantee.
Contact Amber Team for more detailed advice on clean room classification and design solutions.
What is Clean Room Classification?
The clean room classification depends on the quantity of suspended particles in the indoor air in order to define the cleanliness grade of the cleanroom. Examples of common international standards are the ISO 14644, GMP, and the U.S. Federal Standard FS 209E. Various grades require stringent levels of particle concentration in the air, air changes per hour, control of pressure differentials, and others. As an illustration, a cleanliness grade of ISO 5 stipulates that the particle count of more than 0.5 μm in size per cubic meter of air should not exceed 3520, whereas the ISO 7 grade can comprise 352000. The classification of cleanrooms serves as an important foundation for the designing, building, and acceptance of clean spaces, and it has a direct influence on the quality of products, environmental control during production, and future audits of certification. Thus, cleanroom classification can assist companies in rationalizing the planning of clean rooms depending on their industrial standards and process needs and prevent waste and blind construction-related risks.
Why is Clean Room Classification So Important?
What is the importance of clean room classification? Because cleanroom classification directly determines whether the workshop environment can meet the cleanliness requirements for product production, testing, and inspection. When cleanliness is not achieved, the impact may be on product rework and production delay, and more embarrassing compliance and safety issues, in the case of high-tech products, involving pharmaceuticals, medical devices, and chips, it could result in production shutdown and product quality issues. Different products and processes have varying requirements for particle counts, microbial counts, and air changes per hour. Determining the appropriate cleanroom classification ensures product quality while optimizing investment costs, avoiding over-engineering or under-classification. With the help of professional clean room classification design, companies are able to raise the level of management of the production environment, raise the acceptance rates, and pass the ISO and GMP certification audit, which fully supports the export of products, tenders, and customer factory visits.
Comparison of Clean Room Classification Standards
Currently, clean room classifications primarily utilise two standards: the U.S. Federal Standard FS 209E and ISO 14644-1. The FS 209E standard defines cleanrooms by the particle count of ≥0.5 μm per cubic foot of air, with classifications including Class 100, Class 1,000, Class 10000, and Class 100000. The lower the number, the higher the cleanliness level. Some electronics and semiconductor industries still use this standard.
However, ISO 14644-1 standardicies the cleanroom grades according to the concentration of particles per unit volume of air, with nine grades denoted ISO 1 through ISO 9. The smaller the figure the greater the level of cleanliness. GMP standards are mainly applied to the pharmaceutical sector and besides the requirements of particle count they also outline a microbial monitoring standards and a dynamic monitoring standards. Among these, ISO 5 corresponds to FS 209E's Class 100, while ISO 7 is comparable to Class 10000.
Clean Room Classification Standards and Applications
Various levels of clean room classification apply to varied industries and production processes. For example, the pharmaceutical and biomedical industries primarily adopt GMP cleanroom standards to ensure that pharmaceuticals and medical devices are produced in a sterile environment. In precision instrument, electronics, and semiconductor industries it is common practice to comply with ISO 5-7 standards in assuring that particle counts are kept to process-acceptable levels, preventing the damage of precision components by static electricity and dust. ISO 7-8 cleanroom environments are usually applied in the food and beverage, personal care products and medical aesthetics industries to assure the hygiene and safety of products. We will custom the cleanroom grade solution based on your industry characteristics, production processes, and certification requirements, ensuring that the cleanroom design is scientifically sound and reasonable, construction is efficient and standardised, and operation is safe and stable, helping your business easily pass relevant acceptance certifications.
The Future of Cleanroom Classification: Technological Advances and Innovation
With the manufacturing industry being upgraded and the high-end industries growing, the clean room classification is changing too. The trend in the future will be the smart and digital cleanroom, which will combine particle monitoring, dynamic control of air quality, automatic alarming, and remote maintenance. The classification standards of clean rooms will also be combined with AI and big data to realize dynamic monitoring of cleanliness in real-time and intelligent control, which will increase the stability of the clean environment and energy efficiency. Moreover, modular and prefabricated cleanroom technology will be more adopted, which can cut down the construction schedule and budgets remarkably. Whatever, Amber will remain at the cutting edge of the industry, keeping up with the times, constantly optimizing solutions related to the design of clean room classification, using new energy-saving and environmentally friendly materials, and fitting them with intelligent monitoring systems that will help businesses in various industries to build safe, efficient, and low-energy cleanrooms.
Conclusion
Clean room classification is the most critical aspect of cleanroom construction, directly impacting production safety, product quality, industry compliance, project investment, and post-construction operational costs. A reasonable and scientifically sound clean room classification design can effectively ensure that the production environment meets standards, smoothly pass certifications such as GMP and ISO 14644, and avoid excessive construction and wasteful investment. Amber has over 17 years of experience in clean room classification and design across multiple industries, offering one-stop cleanroom services, including on-site measurements, customised solutions, construction and installation, as well as after-sales support. Our services cover industries such as pharmaceuticals, healthcare, electronics, biotechnology, food, and medical devices. Our mission is to help companies efficiently create cleanroom environments that meet international standards.
FAQ
The core working principles of a cleanroom: 1) Purify the air through high-efficiency filtration equipment to control the amount of dust and microorganisms. 2) Use positive pressure protection to prevent contaminated air from flowing back in. 3) Use a reasonable zoning layout to avoid cross-contamination. 4) Maintain cleanliness standards even in dynamic conditions by equipping the room with a real-time monitoring system.
Recent Posts
-
In fields such as pharmaceuticals, biotechnology, electronics and medical device construction, Cleanroom is playing an increasingly important role in the development of industrial production. This is because Cleanrooms are able to provide a tightly controlled environment that minimizes dust and micr -
Definition of Pass BoxAccording to different self-locking interlocking methods, thePass Box Clean Room can be divided into electronic device self-locking interlocking Pass Boxand mechanical equipment self-locking interlocking Pass Box. According to the role of purification treatment, Pass Box can be -
The standards for Cleanroom cleanliness operate on a scale determined by the needs of specific industrial or research activities. Different levels of cleaning quality measure air suspension particle count where lower numbers relate to better cleanliness standards. The standards set by ISO 14644-1 and Chinese GMP specify complete guidelines regarding Cleanroom cleanliness levels. The classification of cleanroom environments consists of seven stages known as ISO 1 to ISO 9 whereas ISO 1 represents the highest level of cleanliness and ISO 9 represents the lowest. -
In modern industrial production, especially in the pharmaceutical, food, and semiconductor industries, Clean Room standards are of paramount importance. ISO and GMP are two oft-repeated concepts, each with different requirements for Clean Rooms. -
Single Person Double Blowing Air Shower Room, is a type of Air Shower Room that is designed for single-person access with high efficiency blowing and dust removal from both sides. Unlike traditional single side or one-way blowing equipment, the double blowing design can simultaneously spray high-speed clean airflow from both sides, more thoroughly removing dust particles from the surface of personnel and reducing the risk of contamination of the clean room.
