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The Importance of Packaging Operations in Package Development:

A Collaborative Business Model in Medical Device Packaging

 

Medical device manufacturing is a heavily regulated industry.   The regulations differentiate between the design and development of sterile barrier systems and packaging systems, and the development, validation, implementation and maintenance of the packaging process itself.  It is therefore presented that there are discrete responsibilities and skill paths to meet these distinct requirements.  The discrete entities are proposed as Package Design Engineering and Packaging Operations Engineering.  The direct support needed from the packaging professionals who support these entities is a critical component of a successful product development process.

 

This task group considers, discusses and seeks to develop a collaborative business model of the responsibilities of the Packaging Operations Engineering Group.

 

Discussion and presentation topics may include (but need not be limited to) the supporting aspects of process development and manufacturing integration

 

  • Supplier and inventory setup
  • Equipment selection and acquisition
  • Process development
  • Equipment/process validation
    • Process development characterization studies
    • Ranging studies for parameter selection
    • Statistical analysis for proving process capability
  • Regulatory requirements
  • Process documentation creation
  • Statistical Process Control (Monitoring process behavior and capability over time)
  • Design, implementation and validation of controlled environments associated with sterile packaging
  • Operator training
  • Corrective and Preventive Action investigations for packaging non-conformances associated with validated packaging processes
  • Process and machine safety

John Derek Thompson, CPP
DePuy Synthes
(610)-719-1327
thompson.john@synthes.com

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