SPMC's FAQs provide guidance for your technical challenges.
Validation of Sealing Process
We are in need of guidance as to how to validate our pouch sealer. Are there any published documents available?
Last Updated On October 3, 2025
The Sterilization Packaging Manufacturers Council (SPMC) of the Flexible Packaging Association (FPA) has taken a lead role in developing process validation guidance and has been incorporated into ISO 16775. ISO 16775 provides guidance in validating sealing conditions. ISO 11607-3 will be released in 2026 and provides guidance in developing sealing conditions.