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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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