Margherita Guerra
Validation of the injection molding process to produce the primary packaging of tissue heart valves.
Rel. Silvia Spriano, Arnaldo Giannetti, Carlo Guala. Politecnico di Torino, Master of science program in Biomedical Engineering, 2020
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Abstract
Nowadays, companies which aim to high degree of fulfillment of the specified requirements, i.e. high quality, of product/service, must properly manage the company’s processes underling the implementation of the products/services themselves. Particularly, the focus is to analyze beforehand the conditions of every productive process in order to establish the features that guarantee the desired level of quality of the output of the process. For this reason, the company must validate all of the productive processes when their final results can not be verified by further activities of monitoring or measurement and subsequently the shortcomings may appear when the products are in use.
Through validation, the objective evidence is given that guarantees that a specific process is capable to provide a product compliant to specified requirements in a repeatable way
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