Page 132 - Assurance of Sterility for Sensitive Combination Products and Materials
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114 Assurance of sterility for sensitive combination products and materials
Seal strength Pkg functionality [aseptic presentation]
Environmental conditioning Transportation simulation Real time aging Visual inspection Pkg & seal integrity Pkg challenge test [bubble] Seal integrity test [liquid dye]
Real time aging
Customer Testing: -Medical device performance -Medical device cleanliness -Ease of product identification -Aseptic presentation product -Ease of product removal
Seal strength Pkg functionality [aseptic presentation]
Packaging testing Test sample build Sterilization [max. number of cycles] Accelerated aging Environmental conditioning Transportation simulation Accelerated aging Customer Testing: Visual inspection -Medical device Pkg & seal performance integrity -Medical device cleanliness -Ease of product identification -Asept
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
Test flow chart Seal strength Pkg functionality [aseptic presentation]
