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What is validation by design? |
Answer:
In designing the new Asep-Tec generation of aseptic fillers, Stork started from a concept approach based on certifiable processes. This means that all the factors that could potentially affect the operational reliability and sterility are analysed beforehand.
On the basis of these analyses the machine is then designed so as to preclude the occurrence of factors that could negatively affect the machine’s operating reliability and sterility – and this is shown demonstrably by well-documented batch records. In other words first demonstrate that the concept is good, without a shadow of a doubt, and then build it. Stork calls this “Design for validation”. This approach, which is unique for aseptic lines, has given Stork a clear lead.
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