Work Item
ASTM WK57656

New Guide for determining minimum seal strength for Medical Device Packaging

1. Scope

to provide guidance on determining minimum seal strength for terminally sterilized peel-able medical device packaging.


minimum peel strength, seal strength


For many years in Medical Device Packaging there has been an arbitrary seal strength minimum value of 1.0 lbs./in. width. It is often perceived as a regulator requirement and it is not. No one knows where the value came from and it is inappropriate for many types of packaging. It is too low for large and/or heavy devices and too high for some small and/or light weight devices. Because of these reasons it is inappropriate to apply a single arbitrary minimum value to all packaging applications. Many Packaging Engineers have been faced with challenges stemming from the perception and a guidance document would help clarify and define a more appropriate way.

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: F02.50

Committee: F02

Staff Manager: W Scott Orthey

Work Item Status

Date Initiated: 02-02-2017

Technical Contact: Geoffrey Pavey

Item: 001

Ballot: F02.50 (20-03)

Status: Will Reballot Item