Services

We offer a robust Validation Plan for your product packaging system including design V&V, and packaging process qualification in compliance with FDA and global industry standards.

MEDICAL DEVICE PACKAGING DESIGN VERIFICATION & VALIDATION

  • Achieve a robust packaging design, from conceptualization to realization, ensuring all Design Control and validation requirements are met.
  • We partner with certified packaging laboratories and can expedite package transportation testing, package integrity testing and product functionality.

PACKAGING PROCESS OPTIMIZATION & QUALIFICATION

  • We use well-established Process Excellence and Six Sigma techniques to optimize your packaging equipment and ancillary processes to ensure high efficiency, and low scrap, keeping critical sterile barrier defects at bay.

STERILE PACKAGING REMEDIATION

Remediation of packaging design and packaging processes to ensure compliance to current industry standards.

PACKAGING PROCESS SOLUTIONS

We have partnered with the leading manufacturers of packaging equipment in the medical device industry, and can help you with concept development, tooling design, commissioning and validation of the packaging process designed and optimized to meet your business needs.

Packaging Equipment Design and Commissioning

  • Manual Flexible Pouch Sealers
  • Automated Vertical Form Fill and Seal machines
  • Automated Continuous Flow Wrappers
  • Manual Tray Sealers
  • Flexible and rigid Horizontal Form, Fill and Seal Machines
  • Integrated flexographic and digital printing technologies
  • Integrated inspection systems