Validation of the injection molding process to produce the primary packaging of tissue heart valves

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. In this work, we re-validate the injection molding process used to produce the components of the tissue heart valve sterile barrier, which provides the aseptic presentation and of the tissue heart valves until the point of use, because the equipment of the process have been changed. Firstly, we develop the validation technical protocol, which is a document that establishes how the validation will be conducted and that is subdivided in three operative phases: Installation, Operational and Performance Qualification. We also define, through an improved visual inspection procedure, the requirements that the components must exhibit in term of aesthetic prestation, which will be used during validation. We perform and collect the results of the operative phases of validation and we analyze them to assess if the process is still capable to produce an output that meet specifications even though the modification of the equipment.