**100,000-Class Cleanroom: Medical Manufacturing Benchmark**
In 2017, a 600㎡ Class 100,000 cleanroom was constructed to meet the precision demands of medical devices, achieving ISO13485:2016 certification for full lifecycle quality control. Core technologies include:
Positive pressure air purification system** (≥20 air exchanges/hour)
UV and ozone combined disinfection system** (settling bacteria ≤1 CFU/m³) Fully enclosed material conveying system**.
Intelligent production matrix deployed:
8 Japanese SUMITOMO electric injection molding machines (200-500KN clamping force) 6-axis robotic arms (±0.01mm precision)
Real-time SPC process monitoring.
The facility integrates advanced equipment, stringent contamination control, and digital management (MES system for 10+ years of batch traceability), establishing a medical-grade precision manufacturing system .
The workshop is a 100000 level dust-free workshop
Passed ISO13485:2016
Medical Device Quality Management System Certification
The workshop covers an area of approximately 600 square meters
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