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PDA Technical Methods Bulletin 2, Elastomeric Closures: Evaluation of Significant Performance and Identity Characteristics (single user digital version)

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Gov. Price: $10.50Member Price: $24.50Nonmember Price: $35.00
  • Description
  • Table of Contents

This Technical Methods Bulletin was prepared by the Task Group 14, under the chairmanship of Mr. Frank Keim, has provided a lucid, pragmatic approach to this subject, which should be of lasting and significant value to those involved with elastomeric closures. The aim of this effort is to provide a guide, specifically detailing methods and procedures for elastomer evaluation. It provides a basis to compare the physico-mechanical properties of elastomeric formulation as they are used as closures for parenteral products.

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Format: PDF (1 file - 1.40 MB)

Table of Contents:

Introduction
Part I: Physico-Mechanical Properties of Elastomeric Closure Formulations

Part II
: Functional Characteristics of Closure Formulations/Designs

  • Coring
  • Frictional Testing of Syringes
  • Device Penetration and Retention
  • Vacuum Retention
  • Needle Penetration/Resealability
  • Volume Swell
  • Relative Abrasion Test
  • Moisture Vapor Transmission

    Part III: Generic Tests for Identification of Elastomeric Closure Formulations

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