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Material and Sterile Barrier Systems

"Establishing Minimum Seal Strength"

How do we establish the minimum seal strength for a given product? Is there a standard that explicitly states the minimum seal strength for a given type of product?

Last Updated On May 15, 2008

There is no current US regulatory standard that states the minimum seal strength for a given type of product. This is because the type of product is not the only determining factor in assessing seal strength requirements. The mass and shape of the product may be the same but there can be dramatic differences based on the sterilization protocol, protective packaging, distribution environment and other factors that would render a guideline difficult if not impossible to create.

The seal strength requirements can be determined through the design process for the packaging system. The first step in the design process is to determine the design inputs- these are the requirements and constraints that will guide the development process. Design inputs include the product design itself as well as, package development, manufacturing, regulatory, marketing, sales, and the customer or end user.

In this process, you should be using the nine drivers that are listed in Annex D of AAMI TIR 22:2007: As always – the earlier you involve your packaging supplier in discussions, the greater your likelihood for success and the more efficient the material and package selection process will be.  With the right inputs your supplier should be able to guide you towards the right seal strength requirements for your product.