The project, built in compliance with ISO and GMP standards, demonstrates how thoughtful engineering can accommodate both current site limitations and future
operational flexibility.
The cleanroom measures 8 meters in length, 4 meters in width, and 3.3 meters in internal height, providing approximately 32 square meters of workspace. It achieves ISO 7 (Class 10,000) cleanliness, which is suitable for a range of plastics technology applications including medical device manufacturing, pharmaceutical packaging, and other industries requiring controlled environments.
Compliance-Driven Design with Personnel and Material Airlocks
The cleanroom was designed from the outset to meet ISO and GMP standards, which
govern contamination control in regulated industries. The facility incorporates a change room for gowning, a personnel air shower, and a dedicated cargo air shower for materials. This three-stage entry allows personnel to progress from street clothing to cleanroom garments while gradually reducing the risk of bringing particles into the sensitive workspace. The physical separation of personnel and material entry points prevents cross-contamination, a critical requirement for GMP-compliant operations.
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.
Lightweight and Anti-Static Materials
The cleanroom is constructed using lightweight aluminium frames combined with transparent and anti-static organic panels. The aluminium frames offer excellent structural strength while keeping the overall weight low, making transportation and on-site assembly more efficient. The transparent panels allow natural light penetration, creating a brighter and more comfortable workspace. The anti-static properties are particularly important for plastics technology applications where static electricity can attract dust particles or interfere with sensitive manufacturing processes.
Future-Ready Design with Removable Structures
One of the most distinctive features of this project is its future-ready design. The client's current facility has space constraints at the installation location. To address this, Airkey designed the cleanroom with removable wall structures at the location where the cargo air shower would eventually be installed.
In the initial phase, the cleanroom will be installed in a space-limited area with removable walls in place.This allows the cleanroom to operate with the required personnel air shower while temporarily omitting the cargo air shower to fit the available space. When the client later moves the cleanroom to a more spacious area, the removable wall sections can be taken out and the cargo air shower installed in their place.
This forward-thinking design ensures that the client does not need to purchase a new cleanroom or undertake expensive modifications when their facility expands. The cleanroom adapts to their changing needs, providing long-term value and flexibility.
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 manufacturing environment where personnel spend extended hours inside,low noise supports better communication and reduces fatigue.
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 HEPA filters, ensuring the required ISO 7 cleanliness level is 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 kilometers 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
Project Specifications
Dimensions: 8 m (L) × 4 m (W) × 3.3 m (H)
Area: Approximately 32 m²
Cleanliness: ISO 7 (Class 10,000)
Structure: Fully free-standing, no ceiling suspension required
Configuration: Change room, personnel air shower, cargo air shower
Material: Lightweight aluminium frames with transparent and anti-static organic panels
FFU motors: EC motors with centralised speed control
Compliance: ISO and GMP standards
Removable structures: Designed for future cargo air shower installation
Power outlets: European type preinstalled
Quality assurance: Factory pre-assembly and full system testing before shipment
