Validação de procedimentos de remoção de agentes químicos e incrustações em indústria de produtos para a saúde

Abstract

Cross-contamination is a risk that must be identified and mitigated in the medical device industry. In addition to being a process risk, it is a regulatory requirement according to ISO 13485 and RDC 665 regulations. Regarding ISO 13485, the standard specifies that the cleaning procedures must be validated to document their effectiveness, which justifies the proposed case study. However, within Angelus, a company operating in this sector, several challenges were found regarding the cleaning procedures, cleaning agents, and processed products. Additionally, Angelus did not have a validation procedure in place, which led to the development of a workflow that incorporates the rationale for agent selection based on the products and equipment specifications to be cleaned. Study protocols and validation reports were also implemented. Manual cleaning techniques were used, employing cleaning agents at room temperature. The results obtained from implementing this validation procedure with the proposed workflow and cleaning protocols were effective in identifying issues and documenting the effectiveness of the adopted cleaning practices. Among the results, it was determined that the cleaning agents should be changed, cleaning methods should be revised or altered, and equipment maintenance should be performed. As a result, this case study successfully validated four cleaning processes and provided recommendations for improving the other two processes under investigation. It was also possible to identify the effectiveness of agent substitution, with CIP 100 (alkaline), CIP 200 (acidic), CIP 300 (neutral), and 92.8% INPM alcohol being the most suitable detergents for Angelus' processes. The acid detergent proved effective in removing ceramic deposits originating from endodontic cement, while the alkaline detergent outperformed previously suggested solvents for removing epoxy resin residues.