As a production base for special medical consumables in the Yangtze River Delta, Jinhua City currently has more than 200 medical device companies with an annual output value of over 8.5 billion yuan. However, after the implementation of the new "Medical Device Supervision and Management Regulations", traditional welding processes have exposed three core pain points:
Biocompatibility risk: Laser welding of stainless steel catheters produces a 0.1-0.3 mm heat-affected zone, which is prone to microcracks and bacterial growth.
Hidden danger of sealing failure: The airtightness qualification rate of the infusion bag interface welded by manual hot plate welding is only 91.7%
Insufficient cleanliness: Ethylene oxide residue exceeds ISO 10993 standard limit by 2.3 times
Ultrasonic welding technology for medical grade solutions
In the production line upgrades of Jinhua Innofa, Kangenbei and other companies, ultrasonic welding machines have shown unique advantages:
Hemodialyzer: 0.05 seconds to complete the non-destructive welding of polysulfone hollow fiber membrane and ABS end cap, bursting pressure > 0.45MPa
Disposable infusion set: 100% sealing of three-layer TPE hose welding passed the negative pressure test (-80kPa)
Surgical instrument packaging: low-temperature welding of PETG blister cover and filter paper, total colony count <5 CFU/cm² (GMP certification data)
AP Sonic's technological breakthrough
Compared with general-purpose equipment, the medical adaptability innovation of AP Sonic ultrasonic welding machine is reflected in:
Medical-grade servo system: welding pressure control accuracy 0.01N, achieving 0.005mm repeatability accuracy (third-party test report)
Clean welding module: built-in HEPA filtration system, the cleanliness of the working area reaches ISO Class 5 standard
Material database: 126 medical polymer material parameters are preset, including special material solutions such as PEEK and PTFE
Double guarantee of compliance services
AP Sonic provides three types of professional support at the Technical Service Center:
Process verification service: Free YY/T 0287 standard welding sample test report
Customized development: Develop micro welding heads (minimum diameter 0.8mm) for precision devices such as heart stent delivery systems
System certification support: assist enterprises to pass FDA 21 CFR Part 11 electronic data compliance certification
Against the backdrop of stricter global regulation of medical devices, ultrasonic welding technology is becoming a core link in quality control. With traceable process parameters (data storage for 10 years) and verifiable clean production efficiency (energy consumption reduced by 38%), AP Sonic ultrasonic welding machines provide technical support for Jinhua companies to break through the barriers of the new EU MDR regulations. It is recommended to systematically evaluate the feasibility of technology upgrades through welding sample analysis, process verification consultation and other means.
