Cleanroom Production at Entrhal Medical – Quality That Sets Standards

From Renovation to First Production

With the start of renovation work in June 2021, Entrhal Medical laid the foundation for a significant milestone in the company’s development: its own cleanroom. By February 2022, the first machine was delivered, marking another decisive step toward in-house cleanroom production.

After an intensive planning, renovation, and setup phase, the moment finally arrived: in September 2023, the first production began in our own cleanroom. Since then, Entrhal Medical has been manufacturing selected products under strictly controlled cleanroom conditions and according to the highest hygiene and quality standards.

Our Cleanroom

A Project with Strong Team Spirit and Reliable Partners

A special feature of this cleanroom project was the extraordinary commitment of our employees. The renovation was not only carried out externally but also actively supported by our own team. Many colleagues contributed hands-on during the renovation, setup, and preparation phases.

In addition, Entrhal Medical works closely with Caritas. Trained personnel from Caritas support us in and around the cleanroom, reliably ensuring adherence to high hygiene, quality, and process standards. This collaboration combines professional expertise with social engagement and is an integral part of our cleanroom concept.

Production on our machine

Highest Quality Standards for Medical Devices

Today, our own cleanroom is a central component of our professional production structure. Assembly, quality inspection, packaging, and shipping all take place under controlled conditions and in full compliance with legal requirements.

Our high-quality standards are documented through our certified cleanroom management system according to DIN ISO 14644-1, ensuring that our products consistently meet the needs of medical practices and hospitals.

Made in Germany – Controlled, Safe, Reliable

With cleanroom production at our own site, Entrhal Medical emphasizes the “Made in Germany” promise. Short distances, qualified personnel, trained cleanroom support staff, and clearly defined processes ensure consistently high product quality—from the first step of production to the finished packaged product.

Quality Control

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