PDA Technical Report No. 5, (TR 5) Sterile Pharmaceutical Packaging: Compatibility and Stability (single user digital version)

Jan 1984
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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 Dr. Y. John Wang and Dr. Yie W. Chien under the auspices of the PDA Research Committee.
It provides a comprehensive review of sterile packaging systems, product-packaging interactions, stability and compatibility. It is arranged by the type of interaction between formulation and packaging components and is important to manufacturing chemists involved in the development and production of sterile pharmaceutical products. The document is also recommended as a reference tool for hospital pharmacists, since admixture programs have grown in popularity and complexity, and hospital pharmacists must be able to identify and solve the problems of sterile packaging.

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Table of Contents

Table of Contents:

Preface and Acknowledgement

I. Introduction
II. Primary Packaging Systems
III. Potential Physicochemical Interactions
IV. References