Efficiancy of hydrogen peroxide for cleaning production areas and equipments in the Laboratory for Brachyterapy Sources Production
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2017
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Medical Physics
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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.
Como referenciar
BAPTISTA, T.; ROSTELATO, M.C.M.; ZEITUNI, C.; PERINI, E.A.; SOUZA, C.D. de; MARQUES, J. de O.; NOGUEIRA, B.R.; ANGELOCCI, L.V. Efficiancy of hydrogen peroxide for cleaning production areas and equipments in the Laboratory for Brachyterapy Sources Production. Medical Physics, v. 44, n. 6, p. 2828-2828, 2017. DOI: 10.1002/mp.12304. Disponível em: http://repositorio.ipen.br/handle/123456789/31132. Acesso em: 13 Mar 2025.
Esta referência é gerada automaticamente de acordo com as normas do estilo IPEN/SP (ABNT NBR 6023) e recomenda-se uma verificação final e ajustes caso necessário.