Flexible cleanroom solution for pharmaceutical research and development

The Chair of Biohybrids & Medical Textiles (BioTex) at RWTH Aachen University faced a complex challenge: a GMP-compliant environment was needed at short notice for the development of innovative drugs – in a new building whose space would remain flexible for future use. The goal was to meet the GMP requirements for drug manufacturing while creating a solution that remained modular and adaptable.

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Challenge: GMP compliance and multi-stage airlock concepts

Pharmaceutical research has particularly high requirements for environmental conditions—especially with regard to cleanliness, contamination protection, and regulatory safety. The required cleanroom tent had to meet GMP Class B criteria and enable safe production under sterile conditions. A key element in this was the implementation of a multi-stage airlock chain to meet the requirements of GMP Annex 1.

inside view of the round cleanroom. At the ceiling is a blue textile air dukt and lamps are placed in the center and around the ceiling. The walls are partly transparent and printed with blue stripes.
Inside view

Solution: Customized cleanroom tent with high transparency and mobility

Sphairlab developed a custom-designed GMP-compliant cleanroom tent with an area of 40 m². The textile-based, transparent construction allows for optimal visual inspection while creating a pleasant, light-filled working environment. The round design minimizes turbulence—an additional advantage for maintaining defined flow conditions in the cleanroom. The multi-stage airlock chain was seamlessly integrated into the overall system so that all regulatory requirements can be reliably met.

The mobile structure of the cleanroom system offers particular added value: if space requirements change, the tent can be dismantled, reassembled at a new location, or adapted to new requirements - a clear advantage over conventional cleanroom constructions.

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Result: GMP-compliant cleanroom system with future prospects

After a short planning and implementation phase, the cleanroom tent for pharmaceutical production was successfully put into operation. The BioTex chair now has a high-performance, GMP-compliant cleanroom solution that not only meets current research and production standards but can also be used flexibly in the long term. The project underscores sphairlab's innovative capabilities and service expertise in the field of modular cleanroom systems.

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“The sphairlab impressed me with its high flexibility and textile, transparent design. Especially in the academic world, where there is no continuous production, the sphairlab is ideally suited for periodic, project-based use thanks to its simple installation and removal. This allows for significant savings in operating costs and enables flexible use of space.”

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Univ.-Prof. Dr. med. Stefan Jockenhövel

NRW focus professorship BioTex – Biohybrid & Medical Textiles

RWTH Aachen, Institute of Applied Medical Engineering