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.