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3 Pillars of Packaging Validation

Your Guide to Understanding ISO 11607

ISO 11607 can be difficult to read and comprehend.  We designed this guide to summarize the key points and highlight often missed key details.  This serves as a supplement to begin dipping your toes into ISO 11607:2006.

Get to the Point:

  • Understanding supplier requrements, material requirements, and design & performance requirements.
  • The keys to process validation (IQ/OQ/PQ) to verifiy that eqiupment operates as intended.
  • The purpose and method to proper transit testing (ASTM D4169) to challenge a packaging systems ability to maintain a sterile barrier through sterilization, handling, and distribution.  
  • The importance of accelerated aging (ASTM F1980) and real-time aging testing to demonstrate maintained sterile integrity over time. 

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