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
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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