Built-in LED light strips preinstalled for simple assembly and operation
Entrance and exit of personnel or materials,
including swing doors, sliding doors, roller shutter,
optional with interlock device
Balance air pressure inside cleanroom and maintain stable airflow.
Including clean class test to ensure cleanroom maintain designed ISO class
Engineering Procurement Construction Management
Airkey provides turnkey solution in compliance with GMP regulations and guarantees the quality, performance and construction schedule by providing detailed construction plan and technical guidance and be respohsible for the whole process.
Consultation - Design - Manufacturing - Installation - Commissioning - Training- Delivery
We are a professional biological cleanroom manufacturer, has been dedicated to providing integrated cleanroom solutions for pharmaceutical companies.
AlRKEY's GMP consulting and validation team has a deep understanding and rich experience of domestic and foreign GMP regulations and guidelines. Can provide customers with various validation services from design auditing, VMP programming, and DQ/10/00/P0.
We has been offering tumkey ceanroom project services, including GMP consultation,design, construction, commissioning and testing of cleanroom, HvAc system, and utility part of pharmaceutical plant.
Providing a complete of consulting services in terms of design, installation. operation and performance as wellas documents identification and approval, testing plan, testing procedures and testing reports.
The cleanliness levels of ISO Class 1-9 cleanrooms are classified based on the number of particles per cubic meter of air. This chart provides a quick overview of the cleanliness levels from the highest cleanliness (ISO 1) to the lowest cleanliness (ISO 9).
● ISO1 Cleanroom: The highest cleanliness level, with a limit of 10 particles ≥0.5μm per cubic meter. Higher particle sizes (≥1.0μm and ≥5.0μm) have no specified limit, but can be considered almost zero. Used for ultra-precise manufacturing or scientific research, such as high-end semiconductor lithography.
● ISO2 Cleanroom: The upper limit of the number of particles with a particle size ≥0.5μm per cubic meter of air is 100, and the upper limit of the number of particles with a particle size ≥1.0μm is 24. For particles with a particle size ≥5.0μm, the number is also extremely small due to the high cleanliness level. This level is suitable for fields with high requirements for environmental cleanliness, such as high-end optical lens manufacturing.
● ISO3 Cleanroom: Limit of 1,000 particles ≥0.5μm, 237 particles ≥1.0μm, and 10 particles ≥5.0μm per cubic meter. Common in sensitive electronic chip manufacturing.
● ISO4 Cleanroom (Class 10 cleanroom): Limit of 10,000 particles ≥0.5μm, 2,370 particles ≥1.0μm, and 102 particles ≥5.0μm. Used in high-precision semiconductor manufacturing and sterile pharmaceutical production.
● ISO5 Cleanroom (Class 100 cleanroom): The upper limit of the number of particles with a diameter of ≥0.5μm per cubic meter of air is 100,000, the upper limit of the number of particles with a diameter of ≥1.0μm is 23,700, and the upper limit of the number of particles with a diameter of ≥5.0μm is 1020.
It is commonly used in industries such as pharmaceuticals, biotech and precision instrument manufacturing.
● ISO6 Cleanroom (Class 1000 cleanroom): Limit of 1,000,000 particles ≥0.5μm, 237,000 particles ≥1.0μm, and 10,200 particles ≥5.0μm. Suitable for electronics assembly and medical device manufacturing.
● ISO7 Cleanroom (Class 10,000 cleanroom): Limit of 352,000 particles ≥1.0μm, and 83,200 particles ≥5.0μm per cubic meter. Often used in general electronic component production and some food processing.
● ISO 8 Cleanroom (Class 100,000 cleanroom): The upper limit of the number of particles with a diameter of ≥1.0μm per cubic meter of air is 3,520,000, and the upper limit of the number of particles with a diameter of ≥5.0μm is 832,000.
The cleanliness is relatively low and can be used for some general industrial production, such as general mechanical processing, assembly of general electronic equipment, etc.
Factory production:According to theconfirmeddesign drawings, various prefabricated components are produced and processed.
Testing and transportation:After production is completed, the modular cleanroom is assembledin Airkey factoryand various parameters are testedbefore delivery. After the test is qualified, it is dismantled, packaged, and transported to the installation site.
The modular cleanroom is assembled on site.
Debugging and acceptance:After assembly, the modular cleanroom is debugged and tested for operation to ensure that the ventilation system, filters, air conditioners and other equipment are operating normally and meet the requirements, and then tested, accepted, and delivered for use.
The on-site installation time of modular cleanrooms depends on cleanroom area size. Usually, it only takes 3 to 5 days to assemble a small modular cleanroom on site, while it takes about 7 to 10 days to assemble a larger modular cleanroom.
The selection of the appropriate cleanroom classification level is mainly based on the requirements of the production process and the characteristics of the product. Different products have different requirements for air cleanliness. Therefore, when considering the cleanroomclass, we must first look at the requirements of the product production process for the surrounding environment. If the surrounding environment isdusty, it will have a greater impact on product quality and safety, so we need to choose a high classcleanroom; secondly, we need to consider the number of staff. Personnel is an important source of pollution to the cleanroom. The static and dynamic distinction between cleanliness levels is mainly based on whether there are staff operating in the clean area. Therefore, in order to ensure that the product quality is not affected, clean areas with a large number of staff are recommended to be designed according to the dynamic cleanliness level; clean areas with fewer staff and mainly for equipment operation can be designed according to the static cleanliness level. Finally, the operating energy consumption of the cleanroom needs to be considered. The higher the cleanliness level of a clean room, the greater the circulating air volume and the higher the operating energy consumption. Therefore, the cleanroom level should be reasonably selected according to actual needs to avoid unnecessary energy waste.
GMP clean room refers to a clean room that meets GMP standards. GMP is a set of management systems that guarantee the quality of drugs from the quality of personnel and production operators responsible for guiding the quality control of drug production to the quality of production plants, facilities, buildings, equipment, warehousing, production process, quality management, process hygiene, packaging materials and labeling, to the storage and sale or recall of finished products. The design and construction of GMP clean rooms follow strict specifications to minimize the risk of contamination, cross-contamination, confusion and error in the drug production process, and ensure the quality of drugs continuously and stably.
The main certifications of clean room include NEBB certification, ISO17025 management system certification,GMP certification and so on.
NEBB's testingprograms include but are not limited to wind speed and wind speed uniformity test, filterintegrity test, cleanliness test, temperature and humiditymeasurement,illuminance level test, noise test anddifferential pressure measurement.
The ISO17025 Management System certification is a standard ofquality management system for testing and calibration of laboratories to ensure that the laboratory's operations meet international standards and provide reliable and effective services.
GMP certification includes the complete set of system documents for drug production, DQ, IQ, OQ, PQ verification, to ensure the quality of drug production.
To pass these certifications, it is necessary todotests according to the standards of these certificationagencies(which requires the design and construction to meet the correspondingregulations), while attending the training courses provided by theagencies, improving the quality of practitioners, and meeting other certification conditions.
By controlling indoor cleanliness,temperature,humidity, pressure, noise and other parameters,cleanroomprovides the necessarycleanenvironment forproduction and research for various industries, ensuring product quality and safety. In the field of electronic manufacturing,micro dusts and particles may have a serious impact on electronic components and chips. Therefore,the highly purified environment of clean room can effectively protect electronic products from pollution, improving product quality and reliability; In the pharmaceutical, medical, food and biotechnology fields, clean rooms can provide a dust-free, sterile environment to ensure the quality and safety of products, while providing effective protection for workers and the surrounding environment.
In order to meet the technical needs of the production process, the clean roomneeds to be designed in accordance with strict requirements, mainly including the following aspects:
Cleanliness, temperature and humidity,floor plan, selection of equipment and materials, energy saving and environmental protection and other special requirements. Factors also need to beconsidered, including anti-static, anti-vibration, anti-electromagnetic interference, to meet the specific requirements of production or research.
In addition, the clean room design also needs toadhere tothe relevant national standards and specifications and the technical requirements specified by industry norms.
Clean room testing includes a number oftests and measurements to ensure the cleanliness and safety of the indoor environment to meet production needs. The tests mainly include: suspended particle detection (to ensure the cleanliness of indoor air), temperature and humidity detection,air speed andair speed uniformity detection, filter leakage detection, light intensity detection, noise detection, differential pressure detection, colony detection (detection of floating bacteria and settling bacteria to assess the microbial control level of clean room), water quality detection.
Customize based on customers’ demands
No size, height, or span limitations
Basic type
Intelligent type optional
HVAC: Temperature Control
Temperature&Humidity Control
Customize based on customers' demands
No size, height, or span limitations
Basic type
Intelligent type optional
Temperature Control
Temperature&Humidity Control
Customize based on customers’ demands
No size, height, or span limitations
Basic type
Intelligent type optional
Temperature Control
