RSS icon

Medical and Pharmaceutical Packaging, Primary Films and Flexible Packaging Materials Q&A

  •   What are the latest regulatory trends in medical packaging?

    Answered June 9th, 2009 by Expert: Chris Heezen

    All medical packaging comes under the scope of ISO 11607:2006 parts 1 and 2 and European norm EN 868 parts 2 to 10. In addition, many device manufacturers refer to technical report TIR22. This document was published in March 2007 by the Association for Advancement of Medical Instrumentation and is designed to help medical device manufacturers comply with the standards within the regulatory framework of US FDA.

    One segment that is not addressed in TIR22 involves healthcare facilities, i.e. hospitals, clinics and other locations where devices may be packaged, particularly for resterilisation in central sterile supply departments. That gap is now being closed with the creation of an Annex J for these facilities and the inclusion of hospital users in the task force that is writing the document. An interesting twist here is that hospital professionals from both North America and Europe are being included to make sure both regions are covered, as working practices and definitions seem to be very different.

    The next review of ISO 11607 will start in 2010 and should be completed in 2011; the revised TIR22 will be published soon after. Potential changes or additions to the standard could include tougher environmental challenges to packaging or new measures involving resin interchangeability within a flexible film structure.

    .