This client, instrumental in shaping cGMP (Current Good Manufacturing Practice) standards, selected Airkey to design and build three turnkey modular cleanroom solutions for their critical cell therapy production processes. This project underscores Airkey's capability to deliver international cleanroom projects that meet the most stringent global regulatory requirements.
Project Overview: Scalable Cleanrooms for Advanced Cell Therapy
The client’s need for expanding their biopharmaceutical production capacity led them to Airkey’s custom cleanroom design services. Over several years, we deployed three unique ISO 7 cleanrooms (Class 10,000), each approximately 200 square meters. Each unit was meticulously tailored to integrate seamlessly into their existing facility and optimise their specific aseptic processing workflow.
cGMP Compliance Cleanroom: Every design decision was made to ensure strict adherence to US FDA cGMP guidelines, ensuring a compliant environment for pharmaceutical manufacturing.
Custom Cleanroom Layout: The layout of each modular cleanroom was not standard. It was expertly customised to mirror and enhance the client's unique production process, minimising cross-contamination risks and maximising operational efficiency.
Corrosion-Resistant SS316 Construction: Understanding the rigorous decontamination and sanitation processes required in cell culture labs, all cleanroom frames and structures were constructed from stainless steel 316 (SS316). This material offers superior corrosion resistance against harsh cleaning agents, ensuring long-term durability and hygiene.
Precise Environmental Control: Each cleanroom is equipped with a dedicated HVAC system and strategically placed air return walls. This engineering ensures exceptionally stable temperature and humidity control, a critical factor for the viability of sensitive cell therapy products.
Integrated Clean Corridor: The inclusion of a clean corridor enhances personnel and material flow, supporting a unidirectional flow design that is essential for maintaining contamination control and ISO 7 classification.
Turnkey Modular Construction: Our prefabricated cleanroom approach allowed for fast installation and minimal disruption to the client's ongoing operations. The modular design also provides the flexibility for future expansion.
Conclusion: Your Partner for cGMP Cleanroom Projects
The successful deployment of these three GMP cleanrooms for a leading US client solidifies Airkey's position as a global provider of high-quality cleanroom solutions. We are experts in creating controlled environments for sterile manufacturing, medical device production, and life sciences.
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