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FP5

TISSUE REACTOR Informe resumido

Project ID: G5RD-CT-2000-00282
Financiado con arreglo a: FP5-GROWTH
País: Netherlands

Sterilisation verification according to ISO TR 13409 of PLGA scaffolds

In this study a sterilization validation was performed on Porous PLGA Scaffolds (UT026-UT045). The study was performed according to the requirements of ISO/TR 13409. This ISO technical report describes a method of substantiating the suitability of 25kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1000 colony forming units (CFU) that are manufactures in small quantities (less than 1000 product units). The method of ISO/TR 13409 is based on method 1 as described in ISO 11137. ISO 11137 requires a relatively large number of product items, drawn from separate production batches, be used to establish the sterilization dose. Since this is not feasible in case of products, which are under development and/or new, ISO/TR 13409 provides guidance on how to allow substantiation of 25kGy as an appropriate sterilization dose.

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Dirk MEIJER
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