Work Item
ASTM WK57656

New Guide for determining minimum seal strength for Medical Device Packaging

1. Scope

The scope of the Committee shall include the development of standards for physical, chemical, and barrier properties of primary barrier packaging materials and the promotion of research in this field. The committee’s focus includes the component materials, their properties, and primary package design, development, and production.

A primary barrier packaging is defined as a package constructed from porous or nonporous barrier materials and designed to control or eliminate the passage of gas vapor, humidity, liquid, microbes, and light into or out from the package and is in direct contact with the contents.

Typical primary barrier packaging materials are papers, nonwovens, plastic films, rigid plastics, glass, and metal foils, used alone, treated, or in various combinations

Typical primary barrier packages include but are not limited to bottles, vials, pouches, blisters, and trays.

Recognition shall be made of related national and international standards with the encouragement of full participation in those activities. Standards under the jurisdiction of other committees shall be used when applicable.

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.

Details

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: Negative Votes Need Resolution