Airkey Envirotech is a national high-tech enterprise that focuses on providing a full range of dust-free, sterile cleanroom solutions and cleanroom equipment to high-tech customers around the world. Our solutions create a high-cleanliness production environment for many high-precision industries, including medical devices, pharmaceuticals, biotechnology, semiconductors, electronics, and new energy.
With 25 years of industry experience, our business covers the customised design, manufacturing and project installation of high-end modular cleanrooms. Our products include modular cleanrooms, fan filter units (FFUs), mobile laminar flows, dispensing booths, air showers and clean benches. Modular cleanrooms are favoured by customers because of their fast installation.
Key cleanroom concerns for medical and pharmaceutical uses
Medical and pharmaceutical clients have specific requirements for cleanrooms, including:
- Compliance with CMP, EU GMP, and FDA regulations throughout the design, construction, and validation processes
- ISO 5-8 cleanliness to meet aseptic production requirements
- Equipped with air and microbial monitoring systems to strictly control contamination
- Precise temperature and humidity control from 22-24℃, with a temperature fluctuation of ±1 or ±2°C. An RH of 45%-65% is required to ensure drug stability
- Equipped with HEPA, ULPA, or FFU filters, and specific materials should be used for cleanroom wall panels and floors to ensure sufficient sealing is achieved
- Full DQ, IQ, OQ, and PQ validations and NEBB testing to validate the performance of the cleanroom
- Data traceability, real-time environment and equipment data recording, support backup, query and analysis to ensure that the drug quality is traceable
Airkey’s modular cleanrooms can perfectly meet all of these requirements.
Modular cleanrooms designed to meet client specifications
Airkey’s cleanroom solutions have been used in 50 countries worldwide and have won the trust of many well-known pharmaceutical companies, including BGI, Amcor, Winner, GE HealthCare, DuPont and Akron Biotech. We have accumulated rich experience in the design, construction and management of large-scale cleanroom projects, as well as heating, ventilation and air conditioning (HVAC) system technology, and have created a brand image of a non-standard cleanroom expert with leading speed, quality and cost.
Our cleanroom solutions follow modular designs that can be customised to suit the needs of various clients, industries and cleanroom functions. The prefabricated modules enable rapid on-site assembly and significantly shorten construction time, as well as reduce costs by an average of 20% compared with traditional cleanrooms. All our cleanrooms are strictly manufactured in accordance with ISO 14644 to ensure stable and reliable quality.
Benefits of using modular structures for cleanrooms:
- Bright visual and simple designs – Modular cleanrooms fixed using concealed locks creates a pore-free, flat surface, helping to avoid dust accumulation.
- High-strength free-standing frame – Made of SS304 stainless steel, with a self-supporting structure that is free of external support or suspension, the frame is lightweight and can be installed quickly.
- Cleanroom panel options for hardwall cleanrooms – Panel options for hardwall cleanrooms include materials such as:
– Rock wool
– PU sandwich panels
– PVC boards
– Coloured steel
– Aluminium honeycomb
– Magnesium alloy
Some benefits of using these materials include excellent fire, moisture, static, thermal, and sound resistance.
Precise manufacturing services for pharmaceutical cleanrooms
Airkey provides a series of processes, including technical consulting, engineering design, equipment manufacturing, engineering installation, project management, and system maintenance. We have undertaken more than 1,000 cleanroom projects both in China and overseas to date.
At the beginning of each project, our expert engineers visit the site for precise surveys, guaranteeing the accuracy and perfection of the construction drawings. During the construction phase, our engineers provide on-site guidance and strictly control if recessionary. All the cleanrooms we prefabricate are fast-built and well-accepted.
High-quality fan filter units for pharmaceutical facilities
Airkey independently produces core cleanroom equipment such as FFUs, placing great emphasis on customers’ personalised needs, and can customise FFU functions and appearance designs according to customers’ needs. While ensuring efficient air filtration, we effectively control cleanroom costs to create cost-effective cleanroom solutions.
Our FFUs follow a low-resistance air passage design that optimises air passage significantly, reduces operating resistance and improves energy efficiency, while their uniform damping model optimises cleanroom airflow organisation to ensure air is distributed equally across the cleanroom. They are also designed to create minimal vibration and noise, contributing to a quieter working environment.
Intelligent HVAC/BMS/EMS systems for cleanrooms
Airkey’s intelligent systems feature 24-hour, real-time temperature monitoring, as well as continuous humidity, pressure, microorganisms, ACH, air speed, and equipment status monitoring. The systems are able to automatically adjust to fix any anomalies, ensuring stable and efficient cleanroom operation.
GMP-certified cleanroom manufacturing and facilities
Airkey’s good manufacturing practice (GMP) consulting and validation team has a deep understanding and rich experience of domestic and foreign GMP regulations and guidelines. We can provide customers with various validation services, including design auditing, VMP programming, and design, installation, operational and performance qualification (DQ/IQ/OQ/PQ).
Airkey’s manufacturing centre, Airkey Cleanroom Plant, is equipped with advanced intelligent production lines and high-precision testing equipment. We currently hold more than 60 patents; our strong design and production capability make us experts in customising non-standard products and providing high-quality goods and services for clients.
We have received ISO9001 international quality management system and ISO14001 environmental management system certification, while our cleanroom equipment also holds UL, CE, Federal Communications Commission (FCC), and Restriction of Hazardous Substances (RoHS) certificates. Many of our projects have successfully met the GMP standards of the US Food and Drug Administration (FDA) and European Union (EU).
Customisable cleanroom solutions
Over 20 years of experience with cleanrooms tells us that a minor difference may significantly influence the stability and safety of an environment. Therefore, we adhere to and aim for complete self-control for core production processes, including air passage design and low-resistance structure design. All of the production processes are finished in Airkey’s factory, allowing us to strictly control the quality and quickly respond to any FFU size, structure, or configuration customisation requirements from customers.
Contact us now for a tailored cleanroom solution ‒ let us help you create a clean and efficient controlled environment for production.