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

Jan 1981
PDA Item Number
PDF Single user
Member Price
Nonmember Price
Government Price

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.

Clearance Sale 30% Off!
Original Price US$35 PDA Member, US$50 Nonmember, US$15 Government
Sale prices are already displayed and will be reflected during checkout

Available to download
Format: PDF (1 file - 1.40 MB)

Table of Contents

Table of Contents:

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