The project, built in compliance with USP <797> standards, reflects the growing demand for turnkey, compliance-ready cleanroom solutions that can be installed quickly without extensive building modifications.
The cleanroom measures 7.25 meters in length, 8.48 meters in width, and 3.3 meters in height, providing approximately 61.5 square meters of workspace. The facility features a multi-zone configuration with ISO 7 (Class 10,000) airlock rooms and ISO 8 (Class 100,000) anteroom and preparation room – a layout that aligns with USP <797> requirements for sterile compounding environments.
Compliance-Driven Zoning and Workflow
The cleanroom was designed from the outset to meet USP <797> standards, which govern sterile compounding in the United States. The standard requires that compounding be performed in an ISO Class 8 controlled area, with critical areas requiring ISO Class 5 air quality provided by laminar flow workstations or biological safety cabinets.
To achieve this, the facility incorporates four distinct zones: an anteroom for gowning, a preparation room, a personnel airlock room, and a separate material airlock room. This logical zoning ensures proper personnel and material flow, minimising contamination risks and meeting pharmaceutical standards. The physical separation of personnel and material entry points prevents cross-contamination between different stages of the compounding process, a critical requirement for sterile drug preparation.
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 overhead anchorage. This approach significantly reduces installation time and eliminates the need for structural modifications - a particularly attractive feature for facilities operating within existing buildings where ceiling strength or geometry may present limitations.
The free-standing design also offers future flexibility. If production needs change or the facility relocates, the cleanroom can be disassembled, moved, and reassembled - a practical advantage for pharmacies operating under uncertain long-term space plans.
High Visibility with Large Windows
A distinctive design feature of this cleanroom is the extensive use of large, high windows on two 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 reliance on artificial lighting and creating a more comfortable environment for pharmacy technicians who may spend extended hours inside.
Quiet and Efficient FFUs with EC Motors
The cleanroom ceiling is equipped with fan filter units featuring EC motors. These motors offer significant advantages over traditional AC motors, including lower energy consumption, reduced heat generation, and quieter operation. In a sterile compounding environment, low noise is not merely a comfort issue - it supports better communication among pharmacy staff and reduces fatigue during long shifts.
All FFUs are centrally controlled through a single controller that allows operators to adjust air speed across all units simultaneously or in zones. This centralised approach simplifies daily operation and helps maintain consistent airflow throughout the workspace. The FFUs are equipped with H14-grade HEPA filters, which capture 99.995% of particles at 0.3μm, ensuring the required ISO cleanliness levels are maintained.
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, doors, pass boxes, power outlets, and control system - was installed and tested in a controlled workshop environment. The system underwent comprehensive testing, including cleanroom classification verification, air velocity measurements, and lighting level checks in accordance with ISO 14644-1 and USP requirements.
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 kilometres away. For the client, this meant a predictable installation timeline with minimal disruption to their facility operations. The cleanroom was disassembled for shipment and arrived as a standardised, factory-tested product ready for efficient on-site assembly.
Power Outlets Preinstalled to Meet US Standards
Understanding the operational requirements of US pharmacies, the cleanroom was equipped with American-type power outlets preinstalled during factory fabrication. This attention to detail eliminates the need for on-site electrical modifications, further simplifying installation and ensuring that equipment can be connected immediately upon assembly.
Project Specifications
Dimensions: 7.25 m (L) × 8.48 m (W) × 3.3 m (H)
Area: Approximately 61.5 m2 Cleanliness: ISO 7 for airlock room, ISO 8 for anteroom and preparation room
Structure: Fully free-standing, no ceiling suspension required
Configuration: Anteroom, personnel airlock, material airlock
Glass walls: Large, high windows on two walls
FFU motors: EC motors with centralised speed control
Filtration: H14 HEPA filters
Compliance: USP <797> standards
Power outlets: American-type preinstalled
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. Website: www.airkeyx.com
Click it for more details about Airkey products.
