Cleanrooms for medical devices and hospitals
Cleanroom for the production of medical devices
Medical devices, from diagnostic devices to life-sustaining implants, require a production process that is completely sterile and controlled. A clean room for medical devices is essential to exclude risks such as germ formation and contamination. Highcare cleanrooms comply with ISO 13485:2016 and provide a safe, hygienic space that meets the highest standards.
Hospital cleanrooms: Hygiene & safety
Inside hospitals, such as in operating rooms and treatment rooms, a hospital clean room is of vital importance. These spaces provide a fully controlled environment that ensures the safety of patients and medical staff. Maximum hygiene prevents infections and reduces the risk of contamination. Our cleanrooms are designed to meet the highest standards and provide peace of mind in every situation.
Air quality standards
The air quality in cleanrooms for hospitals is strictly monitored according to three key standards:
- Colony Forming Units (CFU): The number of microorganisms per m³ of air is measured to ensure sterile conditions.
- Bacterial sedimentation rate: Microorganisms on surfaces are measured according to ISO 14698-1 (CFU/m²/h).
- Particle count: The amount of particles per m³, with or without bacterial load, is checked and classified by size.
With these strict controls, our medical clean room systems guarantee the highest air quality, essential for sterile production and patient safety.
Why the medical industry chooses Highcare
Since 1994, Highcare has been supplying cleanrooms that perfectly meet the requirements of the medical sector. Our modular cleanrooms feature IFD technology, allowing for easy adjustment of walls and ceilings even years after installation. This makes our cleanrooms ideal for dynamic environments, such as hospitals and production facilities that require medical device cleanrooms.
What makes Highcare cleanrooms unique?
- Flexible design: Easily adapt your cleanroom without interruptions.
- Advanced technology: HEPA filters and air flush systems ensure fewer than 100 particles per m³ and minimal bacteria formation.
- Hygienic and reliable: Fully certified to ISO 13485:2012 and cGMP validation.
- Long-lasting quality: Our cleanrooms continue to deliver top performance even after years of operation.
Discover how Highcare cleanrooms can support your medical device production and hospital processes. Contact us today and receive a free quote.