Efficient and flexible cleanroom solution for the highest hygiene standards

Hemovent GmbH is an innovative company in the field of medical technology that develops compact extracorporeal membrane oxygenation (ECMO) systems for mobile use. To enable the production of its highly sensitive medical devices under controlled conditions, the company required a cleanroom solution compliant with ISO 14644-1 Class 7. The challenge: rapid implementation within just five weeks and a design that integrates seamlessly into existing production processes.

Challenge: Rapid implementation and seamless integration

The manufacture of medical devices places the highest demands on cleanliness and particle-free conditions. At the same time, the cleanroom tent had to be designed to fit perfectly into the existing production space and enable smooth work processes. There were special requirements for material logistics: efficient transfer of sensitive components between the cleanroom and adjacent production areas had to be ensured without interrupting the cleanroom conditions.

Cleanroom mit attached material lock and personal lock. The doors are designed with a blue pictogram. On the top right corner of each door is a red door signal.
Cleanroom with personnel lock and material lock

Solution: Semi-circular design with integrated pass-through

Sphairlab developed a customized cleanroom tent with an area of approx. 100 m² in a semicircular design for Hemovent. This special construction makes optimal use of the available space and enables efficient air flow to meet cleanliness requirements.

To ensure safe and efficient access, the cleanroom tent was equipped with a separate personnel airlock and a material airlock. Another key element of the solution is an integrated pass-through, which enables a controlled flow of materials between the cleanroom and adjacent production areas without compromising cleanroom quality.

Result: A standard-compliant and flexible cleanroom solution in record time

The cleanroom tent was fully planned and delivered within just five weeks. Hemovent now has a state-of-the-art cleanroom environment that meets all regulatory requirements and can be flexibly adapted to future changes thanks to its modular design.

The project demonstrates how sphairlab not only ensures the highest standards of cleanliness with customized solutions, but also enables fast delivery times and efficient integration into existing production processes.

„Due to the excellent support from sphairlab we were ready to scale our cleanroom area in no time. 5 weeks production time for a cleanroom ISO 7 is a benchmark. Now ready for a global production from Aachen, Germany“

Dr. Oliver Marseille

CTO

Hemovent GmbH