PDA Technical Information Bulletin 4, Aspects of Container/Closure Integrity (single user digital version)
- Published
- Jan 1983
- Pages
- 7
- PDA Item Number
- 43204
- Format
- PDF Single user
- Member Price
- $24.50
- Nonmember Price
- $35.00
- Government Price
- $15.00
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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)
Table of Contents
Table of
Contents:
Introduction
Physicomechanical
Parameters
Physical Determination of Integrity
Microbiological Determination of Integrity
Conclusions
Glossary
Bibliography