PDA Technical Report No. 87 (TR 87) Current Best Practices for Pharmaceutical Glass Vial Handling and Processing (single user digital version)

Jul 2021
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This technical report focuses on a technical understanding of glass, its strength, and its limitations, and provides guidance in best handling practices for glass vials throughout the pharmaceutical process — receipt, storage, preparation, filling, stoppering, freeze-drying, and capping. This document focuses on where surface damage may occur and where excess stresses may be applied during processing and handling.

This report also reviews typical pharmaceutical glass handling processes and identifies areas of concern. Points to consider are presented for line, material, and equipment enhancements as well as guidance and practical approaches for using procedural controls to better employ existing equipment.

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Format: PDF (1 file 5.51 MB)

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary and Abbreviations
  3. Best Practices for Handling Glass Vials
  4. Risk Assessments
  5. Glass Vial Handling Process
  6. Considerations for Preventing Additional Damage
  7. References
  8. Appendix I: Fundamentals of Glass Science
  9. Appendix II: Investigations
  10. Appendix III: Glass Breakage Investigation Worksheet and Checklist

Figures and Tables Index