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.
Keywords
minimum peel strength, seal strength
Rationale
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.
Work Item Status
Date Initiated: 02-02-2017
Technical Contact: Geoffrey Pavey
Item: 001
Ballot: F02.50 (20-03)
Status: Will Reballot Item