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.
Clearance Sale 30% Off!
Original Price US$35 PDA
Member, US$50 Nonmember, US$15 Government
Sale prices are already
displayed and will be reflected during checkout
Available to download
Format: PDF (1 file - 343 KB)
*This document supersedes by
PDA Technical Report 27, Pharmaceutical Package Integrity
Table of
Contents:
Introduction
Physicomechanical
Parameters
Components
Closure Formulation
Capping Equipment
Physical Determination of Integrity
Vacuum Retention
Vacuum Chamber
Internal Pressure
Dye Immersion
Seal Force Testing
Microbiological Determination of Integrity
Conclusions
Glossary
Bibliography