ISO 11607:2006 Part 2: A Roadmap for Validating Packaging Equipment and Processes

In this blog we look at compliance with ISO 11607:2006, part 2, packaging equipment and processes. As with any engineering compliance activity, one must develop a validation plan and associated packaging protocols suitable for fulfilling requirements of ISO 11607:2006, part 2 for terminally sterilized medical device packaging.

Packaging equipment

Karen K. Greene
Start with:

  • Equipment Installation Qualification (EIQ)
  • Equipment Operational Qualification (EOQ)

Keep the packaging process development and packaging qualifications activities separate from the equipment operational qualification. The equipment operational qualification should focus on the performance of the packaging equipment for your intended use, relatively independent of a specific package type.

EOQ parameters: Be as broad as practical
The EOQ should very broadly bracket the equipment performance. The EOQ must only be performed upon successful completion of the equipment EIQ or installation qualification. Remember, the EOQ is not just about sealing the packaging material.
The EOQ should include:

  • The utilization of the full range of any fixtures or guides on the packaging equipment with the packaging materials identified
  • Select a representative worst-case or multiple worst-case packaging materials for this exercise
  • Multiple startups and shutdowns of the equipment by different operators over the course of multiple days
  • All operators of the equipment must have documented training for the equipment and packaging process
  • Operation of the equipment at process extremes, such as minimum and maximum sealing parameters
  • The evaluation of process challenge outputs -- for example, seal integrity (visual quality evaluation) and seal strength

Packaging production process

  • Packaging Process Operational Qualification (OQ)
  • Worst-case operation conditions established
  • Validated worst-case conditions acceptable
  • Packaging Process Qualification (PQ)
  • Actual or simulated devices are imperative in order to evaluate the effect of assembly and packaging of your medical device on the sterile barrier integrity of the package
  • Minimum of three production lot runs must be run
  • Process repeatability and reproducibility is under evaluation
  • This approach verifies product/package requirements are met


  • Develop a comprehensive outline for packaging process validation
  • Utilize your equipment supplier for technical support and knowledge base
  • Enlist your manufacturing and quality teams for support and execution of the packaging process validations
  • Allow separation of various processes and steps for easier evaluation
  • Allow time for the processes to be completed
  • A thorough packaging process validation program is a competitive advantage

Stay relevant as a medical device packaging engineer

Karen K. Greene, CPP, Vice President, Life Packaging Technology

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