Medical injection molding requires the highest level of process control, quality assurance, and environmental cleanliness in the industry. Medical devices must meet stringent regulatory requirements including FDA QSR (21 CFR 820), ISO 13485, and EU MDR.
Medical molding typically requires ISO Class 7 (Class 10,000) or ISO Class 8 (Class 100,000) clean rooms. Class 7 clean rooms limit particles to 352,000/m³ at 0.5μm. Requirements include HEPA filtration, positive pressure, gowning protocols, and regular particle monitoring. Automated handling and packaging systems minimize human contact with molded parts.
USP Class VI and ISO 10993 certified materials are required for medical devices contacting tissue or fluids. Common materials: medical-grade PC, PP, PE, PA, PEEK, TPU, and silicone. Material lot traceability from supplier through finished device is mandatory. Material certifications must be maintained for each production lot.
Statistical process control (SPC) for all critical dimensions. In-process inspection with automated vision systems. First article inspection (FAI) per AS9102 for initial approval. Process validation per IQ/OQ/PQ protocols. Device history records (DHR) maintained per FDA requirements. CAPA system for corrective and preventive actions.