Industry
Medical Appliance
Why High-Purity needed
- Compliance with International Regulations
Medical devices must adhere to U.S. FDA and EU MDR regulations, ensuring cleanliness in manufacturing to prevent surface contamination and protect patient safety. - Reducing Infection Risk
Residual particles or chemical contaminants on surgical instruments and implants can lead to infections and post-operative complications. High-cleanliness processing significantly mitigates these risks. - Ensuring Biocompatibility
Devices such as catheters must not interfere with blood circulation or provoke rejection reactions. Precision cleaning effectively removes trace contaminants that can impact biocompatibility. - Enhancing Device Quality & Lifespan
Contaminants on metal and plastic components can degrade surfaces, affecting durability and stability. Implementing high-purity cleaning ensures the longevity and reliability of your devices. - Boosting Production Efficiency & Regulatory Compliance
Advanced cleaning technologies enhance production efficiency, ensuring a stable supply while meeting essential market regulatory requirements.
Prioritizing high cleanliness standards in your medical devices is crucial for maintaining quality, safety, and compliance.
Industry Cleanliness Standard
We ensure that our medical devices adhere to international regulatory standards, guaranteeing that all components are free from particle contamination and cytotoxic residues. This commitment to cleanliness is essential for maintaining the safety and reliability of your products.
Our Solutions
Full Vacuum Close System Cleaning Machines
- Designed to meet Tuttlingen, Germany’s rigorous medical manufacturing standards, our machines are trusted by leading global medical device companies.
- Suitable for various medical devices, including surgical tools, implants, and endoscopic components, ensuring the complete elimination of residual particles.
- High-efficiency particle and contaminant removal—effectively eliminating oils, abrasives, and metallic micro-particles for superior cleanliness.
- Eco-friendly solvent cleaning—minimizes material damage while ensuring safety and compliance with regulatory standards.
- Aqueous cleaning—providing high-purity aqueous cleaning solutions for specific medical devices not permitted for solvent cleaning.
Cleanliness & Residue Inspection
- We conduct optical and electron microscopy analysis to assess particle contamination levels.
- Comprehensive inspection reports verify compliance with cleanliness standards.
- Our chemical laboratory testing detects chemical solvent residues on components.
Our cleaning and inspection solutions guarantee the high cleanliness standards essential for the safety and reliability of your medical devices.