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Exceptional Quality


The Harmac Quality Management System is bi-lingual between English and Mexican Spanish while also being fully digital and validated to meet 21 CFRPart 11, the U.S. Food and Drug Administration requirements for electronic document control. This allows us to electronically access all internal procedures and quality related information at all Harmac facilities at the touch of a button, ensuring efficiency and consistency.

Harmac uses many quality tools within our Quality Management System to ensure the highest standards of compliance and efficiency. Among the tools we use are:

  • Statistical Process Control
  • Six Sigma Methodology
  • DMAIC Process to define goals, measure, analyze, improve where necessary and control the process


We help our customers define the ideal sterilization method for their product based on materials, process and intended use. We can manage the sterilization validation process as well as routine sterilization with the contract sterilizer for your product(s). We have experience with the following sterilization processes:

  • Ethylene Oxide
  • Gamma Irradiation
  • E-beam