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PDA Technical Information Bulletin 4, Aspects of Container/Closure Integrity (single user digital version)

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Gov. Price: $15.00Member Price: $24.50Nonmember Price: $35.00
  • Description
  • Table of Contents

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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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

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