Efficiancy of hydrogen peroxide for cleaning production areas and equipments in the Laboratory for Brachyterapy Sources Production

Abstract

Purpose: A great challenge in the brachytherapy sources production is to fulfill the Good Manufacturing Practices (GMPs) requirements, involving the process validation and of all supporting activities such as cleaning and sanitization. The increasingly strict requirements for quality assurance system, with several norms, normative resolutions and rules that must follow both medical products and radiochemical requirements, has led to a constant validation concerns. The main goal of GMP is to reduce inherent risks such as product contamination with microorganisms and cross-contamination. Methods: In the Laboratory for Brachytherapy Sources Production it was established a cleaning program for cleanrooms and hot cells using a hydrogen peroxide solution (6%). This work aims to assess the effectiveness of this cleaning agent in reducing and/or eliminating microbial load into the cleanrooms and equipments to acceptable levels in accordance with the current legislation. Results: The analysis was conducted using the results of the environmental monitoring program with settling contact plates in cleanrooms after the cleaning procedures. Furthermore, it was possible to evaluate the action of the sanitizing agent on the microbial population at the equipment and cleanrooms’ surfaces. It was also evaluated the best way to accomplish the cleaning program considering the dosimetry factor in each production process, hence the importance of radiological contamination. All the following environmental monitoring procedures presented satisfactory results, showing that the cleaning procedures was able to reduce and maintain the acceptable levels of viable and non-viable particles for the cleanroom classification (ISO 5 and ISO 7). The cleaning process with this sanitizer (hydrogen peroxide) can be performed quickly right before the production; allowing the production of brachytherapy sources without after use residues. Conclusion: This data will help the production of a clean and reliable product.