The cleanroom measures 9,422 mm in length, 5,636 mm in width, and 3,000 mm in internal height, providing approximately 53 square meters of workspace. It achieves ISO 7 (Class 10,000) cleanliness ,which is the standard requirement for many sterile compounding operations under USP797guidelines.
A Truly Free-Standing Structure
Unlike conventional cleanrooms that require suspension from building ceilings or reinforcement of existing structures, this unit is entirely free-standing. Its self-supporting aluminium framework carries all mechanical and airflow loads, allowing it to sit on a standard industrial floor without any over head anchorage. This approach significantly reduces installation time and eliminates the need for structural
modifications, making it particularly attractive for facilities operating within existing buildings where ceiling strength or geometry may present limitations.
High Visibility with Glass Walls on Three Sides
A distinctive design feature of this cleanroom is the extensive use of high-glass windows on three walls.This configuration provides exceptional visibility into the workspace, allowing supervisors and quality assurance personnel to observe compounding activities without entering the cleanroom. The high transparency also brings natural light into the workspace, reducing the reliance on artificial lighting and creating a more comfortable environment for pharmacy technicians who may spend extended hours inside.
Flush-Mounted Air Return Walls Simplify Installation
The cleanroom incorporates flush-mounted air return walls that connect directly to the air duct system.This design eliminates the need for protruding air risers, which typically take up valuable floor space and create awkward corners that are difficult to clean. By keeping the return air path within the wall profile, Airkey maximised the usable interior space and created a cleaner, more streamlined appearance.Theflush design also reduces potential contamination points, as there are fewer crevices where particles could accumulate.
HVAC System with 80% Air Recirculation
To achieve the tight temperature and humidity control required for sterile compounding, the clean room is equipped with a dedicated HVAC system integrated with the air return walls. The system is designed to recirculate 80% of the conditioned air, maintaining temperature between 16°C and 20°C and relative humidity between 40% and 50%. These parameters align with USP 797 requirements, which specify that sterile compounding areas must maintain appropriate environmental conditions to prevent microbial growth and ensure product stability.
The high recirculation rate also contributes to energy efficiency. By reusing 80%of the conditioned air rather than bringing in 100% fresh outdoor air, the system reduces the load on the heating and cooling coils, lowering both energy consumption and operating costs.
USP 797 Compliance from the Ground Up
The cleanroom was designed from the outset to meet USP 797 standards, which govern sterile compounding in the United States. Key design elements include:
A separate changing room allows personnel to transition from street clothing into clean room garments in a controlled sequence. The changing room is configured to prevent contamination from following the natural path of personnel movement from dirtier to cleaner areas.
A dedicated material room handles the transfer of raw materials and finished products. Three separate pass boxes are installed - two for incoming materials and another for outgoing finished products. This physical separation prevents cross-contamination between materials at different stages of the compounding process.
The pass boxes are interlocked, ensuring that only one door can be opened at any time, maintaining pressure differentials and minimising the exchange of air between the cleanroom and the surrounding environment.
Factory Pre-Assembly and Testing
Before shipment, the entire cleanroom was pre-assembled at Airkey's factory. Every component -walls, glass panels, ceiling grid, FFUs, air return walls, HVAC connections, pass boxes, and control system-was installed and tested in a controlled workshop environment.
By completing these tests before disassembly for shipment, Airkey identified and resolved any fit or performance issues in the factory rather than on the customer's site thousands of kilometers away. For the client, this meant a predictable installation timeline with minimal disruption to their facility operations.
Project Takeaways
Dimensions: 9,422 mm (L) × 5,636 mm (W) × 3,000 mm (H)
Area: Approximately 53 m²
Cleanliness: ISO 7 (Class 10,000)
Structure: Fully free-standing, no ceiling suspension required
Glass walls: High-visibility glass on three sides
Air return: Flush-mounted walls connected directly to duct system HVAC recirculation rate: 80%
Temperature control: 16°C – 20°C
Humidity control: 40% – 50% RH
FFU motors: EC motors with centralised speed control
Compliance: USP 797 with separate changing room and material room
Material transfer: Separate pass boxes for incoming and outgoing items
Quality assurance: Factory pre-assembly and full system testing before shipment
Contact Airkey today to discuss how our ISO-certified modular cleanrooms can enhance your production quality and efficiency.
