1. Scope

Keywords

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 ultimately 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 ways.