This Information Bulletin was prepared by the Container Sealability Task Force.
This bulletin presents information on the various aspects of container/closure integrity and offers generic physical and microbiological tests that may be used as alternatives to the USP Sterility Test in determining container/closure integrity. The methods described in this bulletin are intended for investigational use in determining integrity during product development phases.
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Format: PDF (1 file - 343 KB)
*This document supersedes by PDA Technical Report 27, Pharmaceutical Package Integrity
Physical Determination of Integrity
Seal Force Testing
Microbiological Determination of Integrity