Product features
Extensive Experience in All Aspects of Cleanroom Construction
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
Pharmaceutical Cleanroom GMP Consulting and Validation Service
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.
Airkey One-Stop GMP Cleanroom Solutions
We has been offering turnkey cleanroom 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.
Unique Modular Clean Room Design
We have our own patented modular structure cleanrooom technology, which ensures efficient, fast and green installation while ensuring structural strength and sealing performance. The entire modular cleanroom has a simple and beautiful appearance, easy to clean surface, no dead corners, and is convenient for later maintenance, upgrades and moving.
100% personalized customization: Base on the customer’s production process and requirements, the modular cleanroom’s design, internal layout, materials and cleanroom equipment are fully customized.
Clean Room HVAC System Solution
Cleanroom HVAC system is necessary to maintain the comfort and productivity of garbed personnel. Clean room air conditioning system with humidity control can maintain steady temperature and RH level that realizes precise control of the cleanroom conditions. Accompanied with air ducting system, it can precisely control the required percentage of recirculated/make-up air according to production needs.
Our HVAC engineer will provide professional clean room HVAC design and help select module type and quantity of air conditioner, based on room size,number of FFUs, local climate conditions, production reguirements, and heat generated by personnel and process equipment.
Airkey Modular Cleanroom with 3 core modular systems
Our system is built around three core modular systems:
1. Modular Structure System
Prefabricated sandwich panels
Quick-assembly aluminum alloy frame
Specialized connection components for stable structure and easy disassembly and reassembly.
2. Modular Clean Room HVAC System
Prefabricated support frames and ductwork.
High-efficiency modular air conditioning equipment, flexibly tailored to meet various cleanroom environment requirements.
3. Intelligent Control System
Support environmental monitoring, system linkage control , and remote management.
This modular clean room design is ideal for industries seeking mobile cleanroom flexibility, clean room technology innovation, and cost-effective deployment of prefabricated clean room solutions.
Turnkey modular cleanroom solution Big or small, all fully equipped
- Ceiling Mount Cassette Air Conditioner
1.Perfect clean room HVAC solution for
smaller cleanroom with temperature control only.
2.Flush mount to the celling
3.Evenly four-way air supply
4.Easy installation into reserved ceiling grid - Constant Temp.&RH Dx Air Conditioner
1.Perfect HVAC solution control cleanroom humidity in
small and medium sized cleanroom
2.Handled air recirculated to save energy
3.Flexible air ducting system configuration and placement
4.Easy installation and space saving - Chiller and AHU
1.Ideal for large-scale cleanroom with larger air volume
and higher capacity demands.
2.Arrangement of functional sections as required to
realize required conditions by sectons including
humidification,heating, air filtration.
3.Stable clean room temperature and humidity control
attainable remote control available.
Intelligent Control Panel
Free Standing Structure
The modular cleanroom system is highly flexible:
Free standing structure: Needn’t ceiling support, self-load-bearing structure, needn’t to rely on the customer’s existing building structure, suitable for workshop, laboratories, and other complex environments.
Break through space limitations: Not restricted by the layout of existing building , the module size and combination method can be flexibly adjusted according to the site.
Diverse layout
AK-castle modular clean room use handmade color steel plates with excellent sealing and thermal insulation properties.
The modular clean room panel surface is smooth, flush and seamless, making it easy to clean and maintain. The cleanroom HVAC system can accurately control key environmental parameters such as temperature and humidity, fully meeting GMP cleanroom standards.
Diverse layout
In addition to high-quality color steel plates or glass materials, the cleanroom uses a mechanical sealing structure in the frame design and the connection between the plate and the frame, supplemented by high-performance sealing strips, which significantly improves the overall airtightness.
Meanwhile, the modular aluminum profile frame is light and easy to transport and assemble on site.
AK-castle is an ideal choice for high-cleanliness pharmaceuticals and biopharmaceuticals industries.
Modular Clean Room AssemblyComplete Model
GMP modular cleanroom color steel plates, aluminum frame, cleanroom window
and return air grilles.
Cleanroom Wall Panel ConnectionSystem
The joints of two wall panels in the modular clean room are connected by”external cylinders” and used with sealing strips to enhance the air tightness ofthe clean room.
FFU with H14 HEPA filter ISO Class 4-9 optional
The FFU (fan filter unit) on the top of the modular cleanroom adopts a high-efficiency and low-noise design, which can easily create an ISO4-9 clean space. Including ISO5, ISO7, and ISO8 cleanrooms. The FFU clean room system supports centralized group control functions,can uniformly control multiple groups of FFU through an intelligent control system, flexibly adjust the air velocity and air volume, ensure uniform and stable indoor airflow, effectively avoid airflow dead corners.Also optimizes cleanroom pressure control. Greatly improve the overall performance and operating efficiency of the clean room.
FFU with H14 HEPA filter on top ISO Class 4-9 optional
Vent diffuser
Balance air pressure inside cleanroom and maintain stable airflow.
Modular clean room design
Steel single or double doors
Entrance and exit of personnel or materials, including swing doors, sliding doors, roller shutter, optional with interlock device
Trial operation and test before delivery Ensure quality and performance
Including clean class test to ensure cleanroom maintain designed ISO class
Turnkey modular cleanroom solution Big or small, all fully equipped
Fast installation, plug-and-run mechanism
The modular clean room is equipped with pass box, air shower room，laminar air flow hood and fan filter units to achieve efficient isolation and transfer of personnel and materials, and effectively control dust particle pollution in the air of clean room.
Diverse layout
Clean corridor, air risers designed as neededHVAC system optional to control T, RH and DP
High visual clarity
Sandwich panels matching with view windowssmooth, free of crevice
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. - ISO9 Cleanroom (Class 1,000,000 cleanroom): The lowest cleanliness level, with limits of 35,200,000 particles ≥1.0μm and 8,320,000 particles ≥5.0μm. Used in industrial settings with minimal cleanliness requirements.
Specification
| Clean class | ISO 4-8 Confirm or recommend as per request or production process |
| Structure | Closed |
| Power | 1P/220V/50Hz 1P/110V/60Hz |
| Size | Customize based on customers’ demands No size, height, or span limitations |
| Control panel | Basic Type: speed control/LED light control/ pressure display Intelligent type: T/RH/pressure control, filter alarm, speed regulation |
| Frame | SS304/Aluminum Alloy |
| Walls | Sandwich panel walls with glazed glass view windows Wall panels including rock wool, glass magnesium, PU, etc. |
| Ceiling | Aluminum plastic composite panels/sandwich panels |
| FFU | Size: 1175*575*300mm HEPA filter: H14，99.995%@0.3μm Qty: determined according to clean class and dimension of cleanroom |
| Cleanroom equipment | Air shower/cargo air shower/pass through/Buffer Room/Clean Wardrobe/Cleanroom Furniture optional to be equipped |
| HVAC | HVAC optional: temperature control only/ temperature and humidity control |
Product video
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AK-castle GMP Modular Cleanroom
Gallery
Modular cleanroom door for bio-lab 1
Modular cleanroom for medical 3
Modular cleanroom for semi-conductor 2
Modular cleanroom for semi-conductor 3
Modular cleanroom for semi-conductor 4
Modular cleanroom for medical 4
Modular cleanroom for medical 5
Modular cleanroom for pharmaceutical 6
Modular cleanroom door for bio-lab 2
Modular cleanroom door for bio-lab 3
Modular cleanroom for pharmaceutical 7
Modular cleanroom for electronics 4
Modular cleanroom for medical 6
Modular cleanroom for pharmaceutical 8
Modular cleanroom door for bio-lab 4
Modular cleanroom door for bio-lab 5
Modular cleanroom door for bio-lab 6
Quick Setup Modular Cleanroom for All Industries
AIRKEY modular cleanrooms offer rapid installation,flexible expansion, and stable contamination control,
helping companies start production faster— perfect for clients with urgent project needs.
Our cleanrooms are widely used insemiconductor cleanrooms,electronics cleanrooms,
pharmaceutical clean rooms,operating rooms,hospital operating theaters,veterinary laboratories,
food processing & packaging cleanroom, and biotechnology labs.
Pharmaceutical Manutacturing
Medical Operating Room
Electronics Industry
Semiconductor Industry
Biotech Lab Cleanroom
Renewable Energy Industry
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Frequently Asked Questions
1.What is the design and installation process of modular cleanrooms?
Preliminary preparation and design calculation:Based on the customer]s production process requirements, confirm thefloor plan,perform overall design calculations、equipmentselection、make design drawings and commercial proposalsaccording to the parametersofcleanroom classification, temperature and humidity, anddifferentialpressure.
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.
2.How long does the installation time usually take?
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.
3.Which cleanroom classification level to determine?
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.
4.What is a GMP clean room?
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.
5.What certifications do clean rooms need? How do I get these certifications?
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.
6.What is the purpose of a clean room?
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.
7.Are there any standard requirements for clean room design?
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.
8.What are the cleanroom tests?
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.