At Austofix, our commitment to manufacturing excellence is underpinned by our state-of-the-art ISO Class 8 cleanroom facility. Certified to ISO 14644-3, our cleanroom meets stringent international standards for airborne particulate cleanliness and environmental control.
This controlled environment is purpose-built to support the assembly and packaging of Class I, IIa and IIb medical devices, ensuring high-quality standards in line with regulatory requirements. The ISO 14644-3 certification reflects our focus on maintaining a validated cleanroom that undergoes regular testing, monitoring, and verification to ensure ongoing compliance.
Our cleanroom is a critical part of our production process, enabling us to maintain contamination control while supporting the manufacture of safe, reliable, and effective medical technologies.
