ISO 5 Modular Cleanroom for Medical Research and Cell Therapy

Medical research and cell therapy applications require highly controlled environments to minimize airborne contamination and prevent cross-contamination between different biological samples.

For a medical biotechnology company in Singapore, Airkey designed and manufactured a 10㎡ ISO Class 5 modular cleanroom for cancer therapy research. The Castle Series system was developed to support sensitive cell manipulation workflows while integrating controlled personnel and material transfer, temperature and humidity management, and factory-based performance verification.

Project Overview

Medical Research Application

The customer is a biotechnology company focused on innovative disease-treatment technologies, including targeted molecular biotechnology, polymer molecules, and radio frequency technology. Its research activities include the development of drug products with therapeutic value.

The cleanroom is designed around cancer therapy and cell manipulation workflows, where contamination control is particularly important.

Cell Manipulation

The Class A modular cleanroom environment is intended to support workflows including:

• CAR-T cell processing
• TIL workflows
• NK cell workflows
• Primary tumor cell isolation
• Cell transfection
• Cell expansion
• Cell preparation filling
• Viral vector transient transfection

Controlled Buffer Zones

Class B and Class C modular cleanroom areas serve as buffer zones around Class A operating areas.

Secondary gowning rooms and sample pass-through windows help reduce the risk of external aerosols entering sensitive cell manipulation areas.

Supporting Laboratory Areas

Class D areas support primary gowning, equipment cleaning, consumable storage, and low-temperature cell banking activities.

Engineering Challenges

Cross-Contamination Control

Cancer therapy research involves the manipulation of tumor samples and primary patient cells. The project therefore required strict contamination control and separation of different operational zones.

Space Optimization

The laboratory required a compact cleanroom while maintaining sufficient usable space for equipment and personnel movement.

Stable Environmental Conditions

Temperature and humidity needed to remain stable during laboratory operations.

Controlled Personnel and Material Transfer

Personnel and samples needed controlled entry and transfer routes to reduce contamination risks.

Airkey Engineering Solution

Integrated Return Air Panels

Instead of conventional return air columns, Airkey integrated return air panels directly with the wall panels.

This flush-mounted design improves the overall appearance, simplifies installation, and saves valuable cleanroom floor space.

Factory-Prefabricated Modular Structure

The cleanroom uses high-strength, corrosion-resistant aluminum alloy frames combined with rock wool sandwich panels.

The components were prefabricated and pre-assembled at the Airkey factory before shipment, allowing rapid modular installation while maintaining structural stability.

Integrated Air Shower and Pass Box

The system includes an air shower for personnel and a pass box for material transfer.

Both are equipped with interlock systems to standardize operating procedures and reduce the introduction of contaminants into the cleanroom.

Integrated Temperature and Humidity Control

Split air conditioning and industrial dehumidifiers are integrated into the system to provide controlled temperature and humidity conditions.

This creates a stable and comfortable environment for laboratory operations.

Post-Experiment UV Sterilization

Ceiling-mounted UV sterilization lamps can be activated after experiments to disinfect the space and support a clean laboratory environment.

Customized Laboratory Power Supply

British-standard power sockets were customized for the analytical instruments used in the overseas laboratory environment.

Factory-Proven Performance

All components were 100% pre-built and 100% pre-tested at the Airkey factory before delivery.

Key performance parameters, including cleanliness, airflow velocity, and illuminance, passed factory performance verification.

Engineering Highlights

• ISO Class 5 medical research cleanroom
• Modular cleanroom for cell manipulation
• Castle Series modular structure
• Integrated return air panels
• Space-saving flush-mounted return air design
• High-strength aluminum alloy frame
• Rock wool sandwich panels
• Personnel air shower
• Material pass box with interlock
• Temperature and humidity control
• Ceiling UV sterilization
• Customized laboratory power sockets
• 100% factory pre-built
• 100% factory pre-tested

Why Choose Airkey as Your Modular Cleanroom Manufacturer?

Airkey designs and manufactures factory-prefabricated modular cleanroom systems for medical research, biotechnology, cell therapy, pharmaceutical manufacturing, medical devices, and life science laboratories.

Our modular systems can be customized according to ISO classification, workflow, equipment requirements, environmental conditions, and available space.

Explore Airkey's modular cleanroom solutions:
Modular Cleanroom Solutions

Project Outcome

The completed ISO 5 modular cleanroom provides a controlled environment for medical research and cell manipulation activities in Singapore.

By integrating space-efficient return air panels, controlled personnel and material transfer, environmental control, and factory performance testing, Airkey delivered a factory-built and factory-proven modular cleanroom system for a contamination-sensitive life science application.

FAQ

What cleanroom class is used for the Singapore medical laboratory?

The project uses an ISO Class 5 modular cleanroom with a 10㎡ cleanroom area.

What applications does the cleanroom support?

The documented applications include CAR-T, TIL and NK cell workflows, tumor cell isolation, transfection, cell expansion, cell preparation filling, and viral vector transfection.

How are personnel and materials transferred?

An air shower is provided for personnel, while a pass box is used for material transfer. Both systems incorporate interlocks.

Is the modular cleanroom tested before shipment?

Yes. The components are pre-built and pre-tested at Airkey's factory, with cleanliness, airflow velocity, and illuminance verified before delivery.