Characteristics of Medical Injection Molding
Medical injection molding is one of the core processes in medical device manufacturing. Its products are widely used in medical scenarios such as syringes, infusion sets, in vitro diagnostic equipment. Due to the unique nature of medical products, this type of processing must adhere to strict standards in terms of materials, processes, environment, and quality management, exhibiting distinct industry characteristics.
1. Stringent Material Selection with a Focus on Biocompatibility
Medical injection-molded products come into direct or indirect contact with the human body, necessitating materials that meet requirements for biocompatibility, chemical stability, and non-toxicity. For example:
Medical-grade plastics: Must pass biosafety certifications such as ISO 10993. Common materials include medical-grade PP, PC, PE, and PEEK.
Sterilization adaptability: Materials must withstand high-temperature and high-pressure conditions, ethylene oxide (EO), or radiation sterilization without deformation or performance degradation.
Transparency and strength: For instance, infusion sets require highly transparent materials (e.g., COP), while orthopedic devices demand high-strength materials (e.g., PEEK).
2. High Precision and Stability Requirements
Medical injection-molded parts are often used in precision instruments, requiring micron-level tolerance compliance.
3. Controlled Cleanroom Production Environment
Medical injection molding workshops must comply with GMP (Good Manufacturing Practice) requirements:
Cleanrooms: Typically need to achieve ISO Class 7-8 cleanliness to prevent particulate contamination.
Cross-contamination prevention: Equipment and molds require dedicated cleaning procedures, with some products needing to be produced in isolated environments.
Environmental monitoring: Regular testing for microorganisms, temperature, humidity, and pressure differentials to ensure compliance with production conditions.
4. Strict Regulatory and Certification Systems
Medical injection molding companies must obtain multiple international certifications and maintain full traceability:
Quality management systems: ISO 13485 (Medical Device Quality Management System) and FDA 21 CFR Part 820.
Product registration certifications: Such as CE marking (EU) and NMPA (China) registration.
5. Complex and Miniaturized Mold Design
Medical injection molds must adapt to the special requirements of products:
Miniaturized structures: For example, insulin pen needle caps and minimally invasive surgical instrument components require high-precision micro-injection molding technology.
Medical injection molding integrates multidisciplinary technologies from materials science, precision manufacturing, and quality management. Its core characteristics are reflected in the pursuit of ultimate biosafety, stringent precision control, and comprehensive regulatory compliance.
