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What is Revalidation

Design of Experiments for Chemical, Pharmaceutical, Food, and Industrial Applications
It is the process validation of a device for a second time due to the product specification, the equipment and the parameters of the processor the materials have changed.
Published in Chapter:
Optimization of Injection Molding Process Parameters via Design of Experiments: Medical Devices Environment
Karina Cecilia Arredondo-Soto (Universidad Autonóma de Baja California, Mexico), Arturo Realyvasquez-Vargas (Instituto Tecnológico de Tijuana, Tecnológico Nacional de Mexico, Mexico), and Alejandro Jiménez-Zaragoza (Universidad Autónoma de Baja California, Mexico)
DOI: 10.4018/978-1-7998-1518-1.ch011
The validation of processes is an innovative methodology where a process has been submitted to scrutiny to guarantee the products comply with the specifications of the company and the norms of the country of consumption. In the medical industry, this process is considered as a regulatory requirement, however, this also helps to improve quality, eliminate waste, and reduce costs, among other things. This chapter applied the methodology of process validation in a medical device company; the engineering tests were used in the company's clean room, using an injection molding machine and tests of several parameters were used even without being validated to know which are the best run and the best parameters, for its daily use. This project addresses the validation of the blood filter process by injection molding. The Design of Experiments applied was a 2K factorial design with central points where the replicas consisted of five of 45 in total for the three dimensions. The pieces are shared for those three dimensions that are being evaluated.
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