Page 131 - Assurance of Sterility for Sensitive Combination Products and Materials

Seal strength
Visual inspection
Real time aging
Environmental
Transportation
conditioning
simulation
Pkg & seal
integrity
Real time aging
Customer Testing:
-Medical device
-Medical device
performance
cleanliness
Seal strength
Accelerated aging
Packaging testing 114 Test sample build Assurance of sterility for sensitive combination products and materials -Ease of product -Ease of product identification identification Pkg functionality Pkg functionality -Aseptic Pkg challenge -Aseptic Pkg challenge [aseptic presentation [aseptic presentation test [bubble] test
Accelerated aging
Visual inspection
number of cycles]
Sterilization [max.
Environmental
Transportation
conditioning
Pkg & seal
simulation
integrity
Customer Testing:
-Medical device
-Medical device
ISO11607 compliant packaging design validation testing for Base line Environmental conditioning Transportation simulation Customer Testing: Visual inspection -Medical device Pkg & seal performance integrity -Medical device cleanliness -Ease of product identification -Aseptic Pkg challenge presentation tes
performance
cleanliness
Test flow chart Seal strength Pkg functionality [aseptic presentation]