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Choosing the right sterile barrier film or substrate: close collaboration with suppliers is beneficial when selecting the right sterile barrier film or substrate for packaging single-use medical devices. This approach is discussed in the context of ISO EN 11607, Packaging for Terminally Sterilised Products.

Article Excerpt
Important decisions

When selecting materials for packaging medical products various factors are considered. These include the shape, size and consistency of the product to be packaged, the requirement for sterility, and the packaging machine that will be used to manufacture the product. All these factors are addressed in ISO EN 11607. Part I of ISO EN 11607 deals with requirements for materials, sterile barrier systems and packaging systems and replaces Part i of EN 868. (1) Parts 2 to 10 of EN 868, which refer to particular materials such as paper with or without sealing coating, continue to be used. Part 2 of ISO EN 11607 is concerned with validation requirements for the forming, sealing and assembly processes. (2) Complying with ISO EN 11607 shows that the packaged sterilised medical device meets the requirements of the Medical Device Directive (93/42/EEC); thus, this recently introduced standard also serves to harmonise international regulations.

ISO EN 11607-1 makes...

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