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Implementação de melhorias nas áreas de preparação de injetáveis de acordo com o Anexo 1 das Boas Práticas de Fabrico
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Resumo(s)
O fabrico de fármacos com via de administração parenteral deve seguir rigorosamente a legislação
em vigor, de forma a garantir que não se introduz contaminação particular ou microbiológica direta-
mente no sistema do paciente, potencialmente prejudicando a sua saúde. Desta forma, com a atualização
do Anexo 1 das Boas Práticas de Fabrico do Eudralex, é necessário identificar as diretrizes aplicadas ao
processo de preparação de injetáveis dos Laboratórios Atral e garantir o respetivo cumprimento das
mesmas.
Posto isto, elaboraram-se instruções de montagem das máquinas de enchimento asséptico, atualiza-
ram-se instruções de limpeza e desinfeção de zonas limpas, criou-se uma instrução de limpeza para a
sala de preparação de matérias-primas e desenvolveu-se um protocolo para a entrada de materiais pelas
antecâmaras das áreas assépticas, a partir do qual se procedeu à validação do processo de desinfeção
para a entrada de materiais pelas antecâmaras no INJ3, encontrando-se a conclusão pendente dos resul-
tados de investigações em aberto.
Validou-se o método de estanquicidade para a verificação da integridade do sistema de fecho de
frascos de injetáveis, em relação a defeitos na rolha, no vidro e no processo de capsulagem e realizou-
se a qualificação de instalação e de operação de microdifusores para desinfeção aérea da Linha 1 do
INJ2 e da Microbiologia. Iniciou-se a qualificação de desempenho dos equipamentos da Linha 1, tendo
o 1ºciclo de desinfeção resultado em não conformidades cuja origem foi determinada através de uma
árvore de análise de falhas. Os protocolos de desinfeção foram alterados para garantir a eficácia dos
próximos ciclos de desinfeção. Definiu-se ainda uma estratégia de monitorização microbiológica em
anaerobiose e, através da análise de resultados, decidiu-se realizar esta monitorização anualmente du-
rante a simulação do processo asséptico.
A implementação destas diretrizes permite a melhoria contínua nos setores de preparação de injetá-
veis da unidade fabril, reduzindo o risco de contaminação microbiológica e reforçando a segurança e
qualidade do produto.
The manufacture of drugs for parenteral administration must follow current legislation, in order to ensure that no particular or microbiological contamination is introduced directly into the patient’s sys- tem potentially harming their health. Therefore, with the update of Annex 1 of Eudralex, it is necessary to identify the guidelines applied to the injectable preparation process at Laboratórios Atral and ensure compliance with them. With that being said, assembly instructions for aseptic filling machines were developed, cleaning and disinfection instructions for clean areas were updated, a cleaning instruction was created for the raw materials preparation room and a protocol was developed for the entry of materials through the ante- chambers of the aseptic areas, from which the validation of the disinfection process for the entry of materials through the antechambers in INJ3 was initiated, with conclusion pending of the results of open investigations. The blue dye method was validated to verify the integrity of the injection vial closure system, in relation to defects in the stopper, glass and capping process, and installation and operation qualification was carried out of microdiffusers for air disinfection of Line 1 of INJ2 and Microbiology. The perfor- mance qualification of Line 1 equipment began, with the 1st disinfection cycle resulting in non-con- formities whose origin was determined through a failure analysis tree. Disinfection protocols have been changed to ensure the effectiveness of future disinfection cycles. A microbiological monitoring strategy in anaerobiosis was also defined and, through analysis of results, it was decided to carry out this moni- toring annually during the simulation of the aseptic process. The implementation of these guidelines allows for continuous improvement in the injectable prep- aration sectors of the manufacturing unit, reducing the risk of microbiological contamination and rein- forcing product safety and quality.
The manufacture of drugs for parenteral administration must follow current legislation, in order to ensure that no particular or microbiological contamination is introduced directly into the patient’s sys- tem potentially harming their health. Therefore, with the update of Annex 1 of Eudralex, it is necessary to identify the guidelines applied to the injectable preparation process at Laboratórios Atral and ensure compliance with them. With that being said, assembly instructions for aseptic filling machines were developed, cleaning and disinfection instructions for clean areas were updated, a cleaning instruction was created for the raw materials preparation room and a protocol was developed for the entry of materials through the ante- chambers of the aseptic areas, from which the validation of the disinfection process for the entry of materials through the antechambers in INJ3 was initiated, with conclusion pending of the results of open investigations. The blue dye method was validated to verify the integrity of the injection vial closure system, in relation to defects in the stopper, glass and capping process, and installation and operation qualification was carried out of microdiffusers for air disinfection of Line 1 of INJ2 and Microbiology. The perfor- mance qualification of Line 1 equipment began, with the 1st disinfection cycle resulting in non-con- formities whose origin was determined through a failure analysis tree. Disinfection protocols have been changed to ensure the effectiveness of future disinfection cycles. A microbiological monitoring strategy in anaerobiosis was also defined and, through analysis of results, it was decided to carry out this moni- toring annually during the simulation of the aseptic process. The implementation of these guidelines allows for continuous improvement in the injectable prep- aration sectors of the manufacturing unit, reducing the risk of microbiological contamination and rein- forcing product safety and quality.
Descrição
Palavras-chave
Anexo 1 do EudraLex Asséptico Injetáveis Desinfeção Validação