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Australia Pharmaceutical R&D Laboratory Modular Cleanroom Project Case Study
2026-06-25
USP <797> and USP <800> are critical standards for pharmaceutical compounding environments in the United States.
USP <797> focuses on sterile compounding, requiring controlled environments to minimize microbial contamination during the preparation of sterile medications.
USP <800> establishes requirements for handling hazardous drugs, including containment strategies to protect healthcare workers, patients, and the environment from hazardous drug exposure.
A compliant compounding facility often requires carefully designed clean zones, pressure control, air filtration, and workflow separation.
To meet these demanding pharmaceutical requirements, Airkey designed and delivered a USP 797 and USP 800 modular cleanroom solution for a pharmacy facility in the USA, combining sterile preparation areas and hazardous drug compounding zones into one integrated system.
Airkey provided a complete modular cleanroom system designed for pharmaceutical compounding applications.
The cleanroom was engineered according to USP <797> and USP <800> requirements, with independent pressure control and contamination prevention measures to support safe medication preparation.
Location: USA
Industry: Pharmacy Industry
Application: USP 797 Sterile Compounding & USP 800 Hazardous Drug Compounding
Cleanroom Series: Castle Series
Model: FSP-I7H-A30(7.5×4)-F
Area: 24.4㎡
Internal Height: 2.5 m
Pharmaceutical compounding requires strict environmental control because contaminated medications can create serious risks for patients.
For sterile compounding, airborne particles and microorganisms must be controlled to maintain medication quality.
For hazardous drug preparation, the cleanroom must also prevent hazardous substances from escaping into surrounding areas.
A properly designed USP 797/800 cleanroom must achieve:
Airkey's solution addresses these requirements through integrated cleanroom engineering and intelligent environmental control.
One of the biggest challenges in USP 797 and USP 800 cleanroom design is balancing different pressure requirements.
Airkey established a differential pressure gradient within the cleanroom system:
This design prevents cross-contamination while maintaining safe pharmaceutical operations.
The cleanroom uses Airkey's Castle Series modular structure, combining aluminum frames and rock wool sandwich panels.
All components are prefabricated and tested in Airkey's factory before shipment, enabling faster installation while maintaining structural stability and cleanroom performance.
A three-door interlock system was integrated to maintain pressure stability between different clean zones.
This helps prevent simultaneous door opening and reduces contamination transfer during personnel movement.
The cleanroom includes an intelligent control system that displays differential pressure conditions in real time.
The system provides:
This enables operators to continuously track environmental performance.
To improve operational flexibility, Airkey designed removable wall panels that allow large equipment to be moved in and out of the cleanroom without major reconstruction.
This design balances cleanroom integrity with long-term maintenance convenience.
✅ USP <797> and USP <800> compliant cleanroom design
✅ Positive and negative pressure zoning
✅ Modular prefabricated construction
✅ Three-door interlock contamination control
✅ Intelligent differential pressure monitoring
✅ Removable wall panels for equipment access
✅ Complete cleanroom equipment package
USP <797> focuses on sterile drug compounding, while USP <800> focuses on safe handling of hazardous drugs and preventing exposure risks.
Yes. With proper zoning, pressure control, and airflow design, a modular cleanroom can integrate sterile and hazardous drug preparation areas.
Modular cleanrooms offer faster installation, easier expansion, and better quality control compared with traditional construction.
Yes. Airkey provides cleanroom design, manufacturing, installation, testing, and supporting equipment integration for pharmaceutical applications.
The completed USP 797 and USP 800 modular cleanroom provides a safe and controlled environment for pharmaceutical compounding operations in the USA.
Through precise pressure zoning, modular construction, and intelligent monitoring, Airkey delivered a cleanroom solution designed to support sterile preparation and hazardous drug handling requirements.
Airkey specializes in modular cleanrooms for pharmaceutical compounding, biotechnology, medical laboratories, and GMP manufacturing facilities.
From design and engineering to prefabrication, installation, and validation, Airkey provides turnkey cleanroom solutions worldwide.
