Recent Projects
How to Plan a Large-Scale Pharmaceutical Modular Cleanroom Project
2026-06-08
Airkey successfully delivered an ISO 7 modular cleanroom for a pharmaceutical company in North Carolina, USA. Designed for foam formulation manufacturing and pharmaceutical compounding applications, the cleanroom provides a controlled production environment that supports contamination control, product quality, and regulatory compliance.
Covering 11.25 square meters with an internal height of 2 meters, the project combines a transparent acrylic enclosure, customized pass box system, stainless steel furniture, and prefabricated modular construction to create a flexible and efficient pharmaceutical workspace.
RS Therapeutics specializes in advanced pharmaceutical compounding solutions and innovative topical drug delivery systems.
The production of pharmaceutical foam formulations requires strict environmental control throughout the manufacturing process. Airborne particles, microorganisms, and fibers can directly affect product stability, formulation consistency, and final product quality.
The client required a cleanroom solution that could provide reliable contamination control while remaining easy to install, operate, and maintain within an existing production facility.
Pharmaceutical foam products contain water-based ingredients that are highly sensitive to environmental contamination.
During raw material preparation and formulation processing, airborne particles may enter the production system and affect product quality. During emulsification and homogenization, microorganisms introduced from the surrounding environment can multiply within the formulation and compromise product safety.
The filling process presents another critical control point. Any contamination entering an open container can directly affect the finished product. In addition, laboratory testing and quality evaluation procedures require a clean environment to prevent false results and ensure reliable data.
For these reasons, an ISO 7 cleanroom environment was selected to provide stable airborne particle control and support GMP-oriented pharmaceutical production.
To meet the client's requirements, Airkey supplied a fully prefabricated modular cleanroom built with a high-strength aluminum alloy structure and anti-static acrylic wall panels.
The transparent acrylic enclosure allows operators to monitor production activities while maintaining a clean and controlled environment. Anti-static sealing strips improve airtightness and help prevent particle infiltration.
A large custom-built pass box was installed between the clean and non-clean areas to ensure safe material transfer. The interlocking door system minimizes contamination risks and supports pharmaceutical workflow requirements.
A dedicated gowning area was incorporated into the design to improve personnel contamination control before entering the cleanroom. Stainless steel workbenches and customized trolleys were also manufactured according to the client's operational requirements.
The project adopts Airkey's modular construction concept, with all components prefabricated and pre-assembled before shipment.
This approach significantly reduces installation time while ensuring consistent quality and performance.
The cleanroom features a transparent acrylic enclosure for enhanced visibility, customized stainless steel furniture for pharmaceutical applications, an interlocking pass box system for contamination control, and a dedicated personnel changing area to support cleanroom entry procedures.
After installation, the cleanroom successfully passed cleanliness, airflow velocity, and illumination testing, achieving an illumination level of 1000 Lux suitable for pharmaceutical production and inspection activities.
The completed ISO 7 pharmaceutical modular cleanroom now provides RS Therapeutics with a controlled production environment for foam formulation manufacturing and pharmaceutical compounding.
The project demonstrates how modular cleanroom technology can help pharmaceutical companies improve contamination control, accelerate installation schedules, and create flexible production environments that can adapt to future operational needs.
