A New Microbial Barrier Test for Porous Medical Packaging Materials – Progress Report

Paul Fielding 

DuPont Medical Packaging

3 Druid Road, Stoke Bishop, Bristol BS9 1LJ, United Kingdom

Tel: +44 +44 117 962 6940

Email: Paul.Fielding@lux.dupont.com

Biography 

Paul Fielding is a packaging consultant for DuPont Medical Packaging. He has worked on technical aspects of medical packaging for over 25 years. For the last 12 years he has concentrated on regulatory affairs, with the emphasis on legislation, particularly European, which impacts on medical packaging.

He currently holds the following committee positions:

Senior UK delegate on CEN/TC102/WG4 and ISO/TC198/WG7. These are the working groups responsible for preparing the EN 868 and ISO 11607 standards concerned with packaging for terminally sterilized medical devices.

Chairman of the Technical & Environmental committee of the SBA (Sterile Barrier Association previously known as ESPA).

A member of the Environmental committees of EUCOMED and the ABHI.

Abstract

The harmonization the CEN and ISO standards for packaging materials for terminally sterilized medical devices highlighted the need for a universally recognised microbial barrier test for porous materials.

A group of companies therefore formed The Barrier Test Consortium to fund work by Air Dispersions Ltd (Manchester, UK). This successfully demonstrated that a correlation existed between a physical test using a modified version of commercially available equipment that measures the efficiency of filter media and ADL’s own microbiological test.

Development of a commercial test unit designed specifically for this application has now been completed and ASTM standard test method F 2638 was published in 2007. It is intended to reference this standard in future editions of the new global medical packaging standard ISO 11607 Part 1.

Further work is now underway to compare the results obtained using the new method with those using existing methods, in particular, ASTM F 1608.