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About Sterilization Packaging Manufacturers Council


Flexible packaging for medical devices must withstand a rigorous and complex sterilization process in order to ensure sterility and safety.


SPMC, the Sterilization Packaging Manufacturers Council of the Flexible Packaging Association, develops test methods and guidance documents for the flexible sterilization packaging of medical devices.


SPMC is actively engaged in the development of test methods and guidance documents for the sterilizable flexible packaging of medical devices and pharmaceuticals.


These standard test methods are adopted and published by the Flexible Packaging Association ( FPA ) in the Sterilization Packaging Manufacturers Council Standards. Additionally, some of the standards are referenced by the International Organization for Standards (ISO) and a few have been incorporated into ASTM standards which have been accepted by the Food & Drug Administration (FDA) as Consensus Standards.


SPMC’s standards provide consistency and reproducibility to the design and production of sterilizable flexible packaging and help improve understanding and communication throughout the packaging supply chain. More importantly, they help ensure the quality, performance and safety of flexible sterilization packaging.


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