PDA Technical Report No. 16, (TR 16) Effect of Gamma Irradiation on Elastomeric Closures (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.
This Technical Report was prepared by A Parenteral Drug Association Task Force.
The report examines the effects of gamma irradiation emitted by the cobalt-60 isotope on elastomeric closures used in parenteral vial packaging.
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Format: PDF (1 file - 1.77 MB)
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Table of Contents
Table of Contents:
Mission
Introduction
Experimental Design
Phase 1 - Elastomer Screening Study
Phase II -
Elastomer Performance
Evaluation
Tables/Figures
Conclusions
Appendices
References