Medical-Grade Material Selection
USP Class VI and ISO 10993 compliant materials
Expertise in engineering thermoplastics for specific mechanical and chemical resistance requirements
Precision Mold Design & Construction
Certified mold steels (1.2344, S136, NAK80)
Scientific molding processes with full validation (IQ/OQ/PQ)
Mold flow analysis to prevent defects and optimize performance
Controlled Manufacturing Environment
Dedicated cleanroom production cells
Strict particulate and microbial control
Full material and process traceability
Validation & Documentation
Comprehensive DMR/DHF support
Complete lot traceability
Material certifications and COC for every shipment





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