Maintenance and Life Cycle Analysis of Biomedical Devices in the Pharmaceutical Industry

The global population growth, as well as the increasing longevity of people's lives allied with the mobility between Countries, is necessarily linked to an increasing number of pathologies and other associated comorbidities.In this way, health sciences, and particularly the pharmaceutical industry, play a fundamental role in responding to these challenges caused by the high number of illnesses affecting the human condition, in place and expected.Within the pharmaceutical industry, chromatography is an analytical technique with a very importance in terms of quality, safety and compliance with the most demanding international standards of pharmaceutical products and compounds, in addition to being able to be a determining factor in terms of economical differentiation from other companies inside the market.Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process.Failure mode (FM) refers to the way in which something might break down.It includes potential errors that might occur, especially errors that could affect the customer.Effective analysis (EA) involves deciphering the consequences of those breakdowns.It does this by ensuring all failures can be detected, by determining how frequently a failure might occur and by identifying which potential failures should be prioritized.Business analysts typically use FMEA templates to assist them in the completion of analyses.The case study in the present paper applies the chromatography knowledge and the FMEA technique to the pharmaceutical industry.This paper was carried out at the pharmaceutical company Hovione, more specifically in the Engineering and Maintenance department, and aims to analyze the life cycle of biomedical devices in the pharmaceutical industry, particularly those involving the chromatography technique.It was possible to identify the importance of this study in this type of industries.