For pharmacies and healthcare institutions in the United States, meeting the stringent requirements of USP chapter <797> for sterile compounding and USP chapter <800> for hazardous drugs can be challenging. Off-site construction often leads to delays, added costs and uncertainty during final validation.
Airkey addresses these challenges by delivering fully pre-tested and pre-qualified USP modular cleanroom suites directly from the factory. Each system is engineered and tested to meet all critical standards before arriving on site, reducing risk and accelerating certification.
This project for a US client demonstrates a turnkey approach: a complete pharmacy compounding suite designed, assembled and functionally tested at Airkey’s facility to ensure seamless installation and a clear path to compliance.
Project overview: a compliant compounding ecosystem
The prefabricated suite is designed as a self-contained, compliant environment for both non-hazardous and hazardous drug preparation.
Anteroom (ISO 7 / class 10,000)
Maintained at +5 Pa pressure, serving as the primary personnel entry and gowning area.
Airlock room (ISO 7)
Maintained at +10 Pa, providing a buffer zone to protect the core compounding areas.
USP <797> cleanroom (ISO 7)
The main sterile compounding environment, maintained at a protective +10 Pa pressure.
USP <800> cleanroom (ISO 7)
Designed for hazardous drug compounding and maintained at –5 Pa negative pressure to contain airborne contaminants. The room incorporates a biosafety cabinet functioning as a containment segregated compounding area (C-SCA).
Engineering for space optimisation and performance
To maximise pharmacy floor space without compromising performance, several advanced design solutions were integrated.
Flush-mounted air return panels
Custom-designed 100 mm thick air return panels are integrated directly into the walls. This removes protruding ducts and bulky plenums, creating smooth, easy-to-clean surfaces while increasing usable space.
Dedicated negative pressure control
In the USP 800 cleanroom, a dedicated blower filter unit is directly connected to the return panel, actively exhausting air to maintain the required negative pressure and support operator safety.
Efficient airflow management
In positive-pressure rooms, air returns through the upper section of the panels into a service mezzanine, supporting unidirectional airflow and consistent ISO 7 performance.
Integrated material transfer
Both critical compounding rooms include pass-through chambers, allowing materials to be transferred safely without disrupting pressure differentials or room integrity.
The Airkey advantage: factory-tested, compliance-ready modules
Unlike traditional stick-built construction, every Airkey USP modular cleanroom is a standardised, factory-tested product developed for the US market.
Pre-assembly and factory acceptance testing
Each suite is fully assembled in the factory and undergoes comprehensive testing, including cleanroom classification, air velocity and lighting levels, in accordance with ISO 14644-1 and USP requirements. The system is then disassembled for shipment.
Reduced on-site risk and installation time
This plug-and-play approach significantly shortens on-site construction, reduces validation issues and speeds up the transition from delivery to operational use.
Built to recognised standards
All designs meet the architectural, engineering and control requirements of USP <797> and <800>, cGMP and ISO 14644-1, providing a single-source compliant solution.
