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BS PD ISO/TS 4452:2025
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  • BS PD ISO/TS 4452:2025

BS PD ISO/TS 4452:2025

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Specification and demonstration of system reliability of single-use drug delivery systems

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Full Description

This document addresses the specification and demonstration of capability and system reliability to successfully deliver a medicinal product as part of design verification and manufacture, utilizing empirical methods as well as modelling. This includes risk-based techniques to establish and demonstrate the required reliability level for all disposable single use drug delivery systems (DDSs) for which there is a single opportunity to deliver a single dose of a medicinal product. See more

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