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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In recent decades the consumption of medical devices has generated one of the fastest growing industries worldwide. This has resulted in organizations developing strategic manufacturing operations in different regions of the world in order to compete in a globalized market. So companies seek to generate high quality products, as well as low cost and timely deliveries. The main market for the consumption of medical devices is located in the United States of America. In this area, Mexico is considered a strategic point for the installation of manufacturing plants for medical products that are capable of supplying the main market. That is why, in recent years, Mexico registers the largest growth in the installation of medical device manufacturing plants in Latin America.
The Baja California region is characterized by concentrating 50% of the national total of the medical industry, consisting of 66 manufacturing plants that generate 42,000 jobs (Cervantes, 2013). Among the strengths that investors have identified to locate the manufacturing plants in this area are the following: geographic location, the availability of qualified human resources, the cost of competitive operation, logistics infrastructure, technological development and innovation. The last one is identified as a key element to ensure the manufacture of quality products that meet the specifications established by the company and country standards (Acevedo, Saldarriaga, & Garcia, 2015). The validation of processes is considered as an innovative methodology in the manufacturing processes of medical devices; by means of this methodology it is established that a process has been submitted to scrutiny in order to guarantee that 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.
The present study 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. Validation is part of the procedure to introduce a new injection molding process where the qualified specifications have to be validated so that it is controlled and can be constantly reproduced. The operational qualification was applied, which is where the parameters were defined to obtain the blood filter as a result.
It is important to optimize the processes of medical devices, but for that you need qualified personnel to carry out a stable process and have a point of reference to where the process was improved and something very important to reduce costs using advanced statistics and reduction the scrap indexes. With the methodology of design of experiments will give the solution to define the parameters of injection molding and know what parameters are those that are going to work to have the desired result of the blood filter. The Quality Policy, indicate to provide medical products and devices that meet all requirements, in order to obtain customer satisfaction through a process of continuous improvement, aiming zero rejections of the customer and deliveries on time. That is why advanced statistics is the important part to achieve the improvement of the process through the design of experiments, addressing issues of factorial designs with central points.
In recent years, the Design of Experiments (DoE) has been increasingly recognized as an essential tool for the validation of medical manufacturing processes (Mark, 1999), but in the experience of the authors, the adoption of these methods by the medical device sector has been limited. Research on British companies in a wide range of industries reported that only about 30% apply DoE techniques. This is due in part to the inadequate teaching of statistical methods such as DoE in university engineering courses (Alexander, 2000). The widespread teaching of statistical techniques as part of the Six Sigma training can improve the situation.