Healthcare Masterbatch Solutions

Medical and pharmaceutical plastics demand the highest levels of safety, purity, and consistency in the industry. A colored device or container must be biocompatible, free of contamination, and traceable to the exact production batch for regulatory compliance. A single quality failure in this sector is not an inconvenience — it is a patient-safety risk with serious regulatory consequences.

• USP Class VI and ISO 10993 biocompatibility for body-contact and implantable devices
• Clean-room production environments that prevent particle and microbial contamination
• Precise color coding that enables reliable drug and device identification
• Full traceability and regulatory documentation including DMF support data
• Batch-to-batch consistency required for process validation
• Migration-free pigments that stay locked in the polymer matrix
• Gamma and EtO sterilization compatibility without color shift
• Strict change-control to prevent unapproved formulation drift

MHK Color delivers medical-grade masterbatches with rigorous quality controls and complete documentation, from raw pigment to finished pellet.

• USP Class VI compliant pigments selected for biocompatibility
• Clean-room production environments with strict contamination control
• Spectrophotometric color verification on every production batch
• Complete traceability including DMF and CoA documentation
• Dedicated QC protocol engineered for zero color-related rejections
• Low-migration formulations for long-term contact applications
• Sterilization-stable colors that hold their shade after gamma or EtO exposure
• Change-control documentation that keeps every formulation locked and auditable

From pill bottles to diagnostic devices, our medical masterbatches help you meet regulatory requirements and deliver safe, consistent, color-coded products that clinicians and patients can trust.