Online Program

Thursday, February 20
PS1 Poster Session I & Opening Mixer Thu, Feb 20, 5:15 PM - 6:45 PM
Bayshore II-IV

Equivalence Acceptance Critieria for Container Closure System Moisture Permeation Rates Using the Two One-Sided Test Approach (302794)

*Katherine Giacoletti, McNeil Consumer Healthcare 
Jeanne Kretschman, McNeil Consumer Healthcare 
Scott Schneider, Synthes, Inc. (J&J) 
Scott Shorts, McNeil Consumer Healthcare 

Keywords: equivalence, noninferiority

Container water vapor permeation testing is performed as part of the pharmaceutical package development process to characterize the amount of moisture that can permeate through a container/closure system, potentially affecting product quality. In addition, these data serve as a baseline such that should changes be needed in the future (e.g., changes to materials or suppliers), the package performance of the proposed configuration can be compared to the currently approved configuration. The objective of this historical data analysis was to estimate water vapor transmission rate (WVTR) variability to determine prospective noninferiority margins for future WVTR comparisons.