Validation Engineering

Millstone Medical remains highly active in the standards and regulatory committees that drive the ever-changing requirements for package validation. We act as a key resource to our customer’s internal teams throughout the product life cycle.

validation engineering

Validation Engineering

Process and medical packaging design validation from equipment selection and aging studies through final packaging design verification.

  • Comprehensive package integrity testing including Installation Qualification (IQ), Operational Qualification (OQ) and Process Qualification (PQ):
    • Sealing Validations
    • Distribution Testing
    • Accelerated Aging
    • Cleaning Validation
    • Sterilization Validation (Ethylene oxide (EtO) and Gamma)
  • Label Design and Production
  • Process Failure Mode Effects Analysis (PFMEA) Development