TATYANA SPINOSA BAPTISTA

TATYANA SPINOSA BAPTISTA

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Challenges in iodine-125 sources production for cancer treatment
2023 - FEHER, ANSELMO; BAPTISTA, TATYANA S.; ZEITUNI, CARLOS A.; ROSTELATO, MARIA E.C.M.; MOURA, JOÃO A.
There is a great challenge the implantation on assurance quality system in the brachytherapy sources production. It involves tofulfill the Good Manufacturing Practices (GMPs) requirements, involving the process validation and of all supporting activities such as cleaning and sanitization. The purpose of this work was to execute a process validation in the iodine-125 seeds production on Radiation Technology Center located at IPEN- Brazil. Besides this, the sanitization was to evaluate the effectiveness of different surface cleaning products, determining the best to reduce radiological contamination to acceptable levels during the sources production, according to legislation. The fabrication process was performed three times for evaluation. The parameters evaluated in this study were: the source welding efficiency and the leakage tests results (immersion test). The welding efficiency doesn’t have an established parameter, since is visually evaluated by the operator, and the leakage detection has to be under 5 nCi / 185 Bq, accordingly with the ISO 9978. In the relation of sanitization, it was established a cleaning program for three production lots of iodine 125 seeds using three types of sanitizers: Lot 1 with extran 1/1 (v/v), Lot 2 with hydrogen peroxide 6% and Lot 3 with sodium hydroxide 1M. Each lots contained seven iodine 125 seeds and was immersed in the sanitizer for 1 hour and then two washes with distilled water. An activity detected in each lots does not exceed 0,2 kBq (˭5nCi). The observed values on process validation were: 75% welding efficiency and 32% leakage detection. Although established values for the global efficiency aren’t available in the literature, the results showed high consistency and acceptable percentages, especially when other similar manufacturing processes are used in comparison (average 85-70% found in the literature for other similar metallic structures). According to results of sanitization, the best choice for remove de surface contamination was peroxide hydrogen. Further testing should ensure the sanitizer's choice is based not only on the removal of surface contamination, but also this sanitizer does not leave residues requiring further rinsing with distilled water. Those values will be important data when drafting the validation document and to follow the Good Manufacturing Practices (GMPs).
Implantação e desenvolvimento das Boas Práticas de Fabricação na produção de fontes de iodo-125 para Braquiterapia
2021 - BAPTISTA, TATYANA S.
Garantia da Qualidade (GQ) consiste em um conjunto de atividades planejadas e sistematicamente implementadas no âmbito de Sistema da Qualidade, necessárias para garantir que um processo / produto / sistema estão em condições de satisfazer os requisitos da qualidade. Boas Práticas de Fabricação conhecidas como BPF ou internacionalmente como Good Manufacturing Practices (GMP), são um conjunto de procedimentos que visam garantir que produtos sejam consistentemente produzidos e controlados, de acordo com os padrões necessários de qualidade. Estes procedimentos são baseados em normas, nacionais e internacionais, específicas para cada ramo de atividade industrial. As BPFs abrangem todos os aspectos de produção, desde os insumos e matéria prima, instalações e equipamentos até o treinamento e higiene pessoal dos funcionários. Procedimentos operacionais padrão (POP's) escritos detalhados são essenciais para cada processo que possa afetar a qualidade do produto e deve haver sistemas para fornecer provas documentadas de que os procedimentos corretos são seguidos consistentemente em cada etapa do processo de fabricação. Portanto a Garantia da Qualidade incorpora as Boas Práticas de Fabricação (BPF) e outras ferramentas que visam o desenvolvimento de um produto com qualidade. As BPFs tem seus requisitos descritos em resoluções colegiadas da ANVISA e são muito semelhantes a ABNT ISO IEC 17025:2017 e aos princípios das Boas Práticas de Laboratório. O objetivo deste trabalho foi a implantação e o desenvolvimento das Boas Práticas de Fabricação através de um Sistema de Garantia da Qualidade na produção de fontes para Braquiterapia, no Centro de Tecnologia das Radiações - IPEN. Primeiramente todas as etapas de produção foram definidas e descritas em procedimentos, relacionando aos equipamentos, utilidades e instalações necessárias para sua execução. Consequentemente foi avaliado a efetividade da higienização da área produtiva através da determinação do melhor produto de limpeza aplicado (sanitizante) para reduzir a contaminação radiológica superficial a níveis aceitáveis, durante a produção das fontes de iodo-125. Neste caso foi estabelecido um programa de limpeza, onde três diferentes sanitizantes foram testados durante a produção de três lotes de iodo-125, respectivamente: (1) detergente neutro (Extran®); (2) peróxido de hidrogênio (6%) e (3) hidróxido de sódio (1M). Em outra análise, realizou-se um estudo de validação de processo, utilizando dois parâmetros: eficiência na soldagem e detecção de vazamento (estanqueidade) das sementes. A eficiência da soldagem não possui parâmetro estabelecido em normativa, sendo então avaliada visualmente pelo operador, já a detecção de vazamento, deve estar de acordo com o estabelecido na norma ISO 9.978, ou seja, ser inferior a 5nCi. Os resultados de eficiência produtiva foram de 79 a 87% e no estudo de validação para o vazamento em todas as sementes foram abaixo de 5nCi, este último em conformidade com a normativa. De acordo com os resultados relacionados aos métodos de higienização, o melhor sanitizante para remoção da contaminação superficial das sementes de iodo-125, durante a sua produção, foi o peróxido de hidrogênio. Em geral, todos estes dados, indiretamente, foram de suma importância porque avaliaram a implantação do Sistema de Garantia de Qualidade como um todo, além dos POPs elaborados, estando de acordo com os preceitos de "Boas Práticas de Fabricação".
A proposal of process validation in the implementation of Good Manufacturing Practices in brachytherapy sources production
2021 - BAPTISTA, TATYANA S.; FEHER, ANSELMO; RODRIGUES, BRUNA T.; ZEITUNI, CARLOS A.; MOURA, JOÃO A.; ROSTELATO, MARIA E.C.M.
New laboratories for brachytherapy sources production are being implemented in our facility at IPEN, in São Paulo. A great challenge implementing a production laboratory is to comply with the Good Manufacturing Practices (GMPs), which involves process validation and all supporting activities such as cleaning and sanitization. Much more than compliance with regulatory guidelines, required for certification and inspections, a validation builds large process knowledge, provides possibilities for optimization and improvement, increasing the degree of maturity of all people involved and the quality system. The process validation results in a document that certifies that any procedure, process, equipment, material, operation, or system leads to the expected results. This work focused on the new laboratory, been assembled to produce small iodine-125 seeds. The process validation was performed three times for evaluation. The parameters evaluated in this study were: the source welding efficiency and the leakage tests results (immersion test). The welding efficiency does not have an established parameter, since is visually evaluated by the operator, and the leakage detection must be under 5 nCi / 185 Bq, accordingly with the ISO 9978. We observed values were average 79-87% production efficiency and leakage tests were under 5 nCi/seed. Although established values for the global efficiency aren’t available in the literature, the results showed high consistency and acceptable percentages, especially when other similar manufacturing processes are used in comparison (average 85-70% found in the literature for other similar metallic structures). Those values will be important data when drafting the validation document and to follow the Good Manufacturing Practices (GMPs).
Efficiancy of hydrogen peroxide for cleaning production areas and equipments in the Laboratory for Brachyterapy Sources Production
2017 - 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.
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.
Gold nanoparticle applied to brachytherapy
2019 - GONZALEZ, ANDREZA A.D.C.C.; SOUZA, CARLA D.; ARCOS, WILMER A.; RODRIGUES, BRUNA T.; DOMINGUES, PAULO R.; SPINOSA, TATYANA B.; ROSTELATO, MARIA E.C.M.
Cancer is a global public health problem, that consists in a disease is characterized by the uncontrolled growth of anomalous cells that impair the functioning of the body. One of the treatments for cancer is the brachytherapy. This technique a non-invasive treatment in which the radiation is placed close or in contact with the region to be treated, brachytherapy may save the healthy tissues and consequently reduces the amount of side effects. An unexplored strand is nanobrachytherapy, that unites the advantages of brachytherapy with the small size in the nanoparticle (NP), resulting in an even less invasive treatment. Nanotechnology is the science that studies the properties of nanometric materials with the aim of creating new materials with different properties of interest. In view of the synthesis of the NP and their applicabilities, there is a fundamental role that is made to coatings, which have the function of avoiding the aggregation of particles, stabilize and also control their functional properties. Besides being able to add molecules of interest, such as antibiotics and anti-inflammatories. Among the range of coatings, the most outstanding are polyethylene glycol (PEG). PEG improves the surface properties of NP and presents high stability under biomedical conditions. The NP have their size controlled, which facilitates their penetration into the vasculature, in addition to being a non-toxic coating. After the synthesis of gold nanoparticles (Au-NP) was developed, PEG were successfully incorporated into the surface. Incorporation was confirmed by DLS, FT-IR and HRTEM.
A proposal of process validation in the implementation of good manufacturing practices in brachytherapy sources production
2019 - BAPTISTA, TATYANA S.; FEHER, ANSELMO; RODRIGUES, BRUNA T.; ZEITUNI, CARLOS A.; MOURA, JOÃO A.; ROSTELATO, MARIA E.C.M.
New laboratories for brachytherapy sources production are being implemented in our facility at IPEN, in São Paulo. A great challenge implementing a production laboratory is to comply with the Good Manufacturing Practices (GMPs), which involves process validation and all supporting activities such as cleaning and sanitization. Much more than compliance with regulatory guidelines, required for certification and inspections, a validation builds large process knowledge, provides possibilities for optimization and improvement, increasing the degree of maturity of all people involved and also the quality system as a whole. The process validation results in a document that certifies that any procedure, process, equipment, material, operation or system actually leads to the expected results. This work focused on the new laboratory, been assembled to produce small iodine-125 seeds. The process validation was performed three times for evaluation. The parameters evaluated in this study were: the source welding efficiency and the leakage tests results (immersion test). The welding efficiency doesn’t have an established parameter, since is visually evaluated by the operator, and the leakage detection has to e under 5 nCi / 185 Bq, accordingly with the ISO 9978. We observed values were: average 79-87% production efficiency and leakage tests were under 5 nCi/seed. Although established values for the global efficiency aren’t available in the literature, the results showed high consistency and acceptable percentages, especially when other similar manufacturing processes are used in comparison (average 85-70% found in the literature for other similar metallic structures). Those values will be important data when drafting the validation document and to follow the Good Manufacturing Practices (GMPs).
Efficiency test on three types of sanitizers for cleaning sealed radioactive sources for brachyterapy
2019 - BAPTISTA, T.S.; ZEITUNI, C.A.; RODRIGUES, B.; MOURA, J.; ROSTELATO, M.E.
Blood evaluation of Cl and Na concentration in crioulo breed horses using NAA: comparison with humans levels
2009 - BAPTISTA, TATYANA S.; ZAMBONI, CIBELE B.; MEDEIROS, JOSE A.G. de; MARCELINO, JOSE R.; HIGASHI, HISAKO G.; FREITAS, MONICA G.
Blood evaluation of Cl and Na concentration in crioulo breed horses using NAA: compararison with humans levels
2008 - BAPTISTA, TATYANA S.; ZAMBONI, CIBELE B.; MEDEIROS, JOSE A.G. de; MARCELINO, JOSE R.; HIGASHI, HISAKO G.; FREITAS, MONICA G.
Quality control of hyperimmune sera by neutron activation analysis: parametric and Ksub(o)-standardization methods
2009 - BAPTISTA, T.S.; ZAMBONI, C.B.; MENEZES, M.A.B.C.; MARCELINO, J.R.; HIGASHI, H.