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About Our Organization.

Flexible packaging for medical devices must withstand a rigorous and complex sterilization process in order to ensure sterility and safety. SPMC, in conjunction with standards setting organizations, is actively engaged in the development of test methods and guidance documents for the sterilizable flexible packaging of medical devices and pharmaceuticals. Some of our 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. Overall, these 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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