< previous | next >

&A: Ask your supplier and other departments for help, and be sure to conduct the appropriate tests. Specifically:

• Establish and document the package requirements early in the project and get buy-in from other departments (QA, operations, marketing, etc.)
• Leverage supplier data and resources wherever possible to confirm:
  • Stability (aging) data
  • Biocompatibility
  • Seal curves
  • Compatibility with sterilization process
  • Microbial barrier properties
  • O2, WVTR and UV barrier properties (when applicable)
  Ask your supplier for assistance with package design, project management, validation documentation, specification documentation, and technical input.
• Conduct screening studies using smaller sample sizes to identify and resolve potential issues early in the project
• Ensure that new materials are compatible with in-line printing processes (Ink should adhere to the new substrate and not scuff during distribution).
• Choose test methods that are validated, repeatable and appropriate for the package/product.
• Conduct a thorough review of the process and resolve any potential issues up front.
  • Ensure all equipment calibrations are current and acceptable
  • Ensure preventative maintenance procedures and calibrations have been conducted
  • Ensure all sealing equipment, gaskets, tooling are in good repair
  Consider running a control group with the validation samples using existing materials to verify new materials are equivalent or better (Example: If a similar seal defect is evident in both sample groups, it is likely caused by an equipment issue vs. a material issue).
• Understand your distribution channels and design the simulated distribution test to correlate to reality
  • Temperature, humidity, shock, vibration, pressure differentials used in simulation should relate to the actual distribution environment