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Do any types of devices or implants require double barrier packaging?

Last Updated On May 15, 2008

The use of a double barrier system is influenced by the situation in which the product will be presented for use. Thus, the decision to utilize a double barrier system is highly dependent on input from other areas such as marketing and product development.

For example, there are double barriers that are required because the outside of the package needs to remain sterile – as the whole package is introduced into the sterile field, not the contents of the package.  An example of this may be an absorbable suture pouch which would be used in an operating room.  The whole package may be required to be packaged in a second barrier – such as a Tyvek®/film pouch that would allow the outside of the inner pouch to be sterile as it is introduced into the sterile field.