We are in need of guidance as to how to validate our pouch sealer. Are there any published documents available?
The Association for the Advancement of Medical Instrumentation (AAMI) has developed a revised Technical Information Report (TIR22) for Packaging of Terminally Sterilized Medical Devices, ISO Standard 11607– 1 & 2. The Sterilization Packaging Manufacturers Council (SPMC) of the Flexible Packaging Association (FPA) has taken a lead role in the development of this document. It was published in April 2007. We also suggest visiting the Global Harmonization Task Force web site for guidance documents that are relevant to the question. Additionally, FDA has developed guidelines for process validation, which are posted on its web site.