A carregar...
Publicação
Impacto da limpeza e desinfeção na garantia de esterilidade num ambiente cGMP
| Nome: | Descrição: | Tamanho: | Formato: | |
|---|---|---|---|---|
| 4.05 MB | Adobe PDF |
Orientador(es)
Resumo(s)
Os produtos farmacêuticos injetáveis são preparações para a injeção através da pele
ou de outro tecido de contorno externo, e não através das vias entéricas. Os produtos
farmacêuticos injetáveis são preparados por métodos que têm em conta os requisitos
farmacopeicos de esterilidade. A esterilidade é definida como a ausência de
microrganismos viáveis.
Os produtos estéreis podem compreender diferentes formas de preparação, podendo
apresentar-se como preparações sólidas ou líquidas. No caso das preparações sólidas,
que não são esterilizadas no final, o seu enchimento tem que ser assético. No caso das
preparações líquidas o enchimento pode ser ou não assético, dependendo se o produto
tem ou não esterilização final. A escolha entre proceder ou não ao enchimento assético
terá uma influência significativa na construção e design das instalações.
As cGMPs exigem que o produto esteja sempre protegido, através da existência de
salas limpas e do uso de tecnologias de barreira. A área limpa apresenta salas/zonas com
diferentes classificações, que devem ser rigorosamente controladas para atingir certos
graus de qualidade de ar. Essas zonas são desenhadas de modo a que zonas com níveis
de limpeza superior fiquem sempre protegidas do exterior por zonas com um nível de
limpeza inferior. O pessoal envolvido no fabrico de produtos injetáveis deve ser
qualificado e treinado para tal, de forma a garantir a conformidade com as cGMP
aplicáveis a estas formas farmacêuticas.
Estas áreas devem ser limpas e completamente desinfetadas de acordo com um
programa escrito. De modo a reduzir a possibilidade de resistência microbiana deve ser
usado mais do que um tipo de desinfetante, bem como o uso periódico de um agente
esporicida, uma vez que muitos desinfetantes comuns são ineficazes contra esporos.
Deve existir um programa de monitorização ambiental, capaz de fornecer
informações significativas sobre o ambiente no local de enchimento assético e, desta
forma, determinar se as condições asséticas são ou não mantidas.
Os dados microbiológicos demostraram algumas tendências para o número de
alertas, ações e microrganismos patogénicos, entre 2019 e 2020, em algumas linhas de
produção da Hikma Farmacêutica, Portugal. Foi realizada uma análise do risco e foram
propostas estratégias, de forma a contrariar as tendências já verificadas e algumas
possíveis tendências que possam vir a surgir. Concluiu-se que, perante as medidas
sugeridas, a probabilidade de contrariar os resultados observados é alta e que a limpeza
e desinfeção têm um papel extremamente importante na garantia de esterilidade.
Injectable pharmaceutical products are preparations for injection through the skin or other external contoured tissue, not through the enteral routes. Injectable pharmaceutical products are prepared by methods that take into account the pharmacopoeia sterility requirements. Sterility is defined as the non-existence of viable microorganisms. Sterile products can comprise different forms of preparation and can thus be presented as solid or liquid preparations. In the case of solid preparations, that cannot be sterilized at the end, their filling must be aseptic. In the case of liquid preparations, the filling may or may not be aseptic, depending on whether the product has final sterilization or not. The choice between to proceed or not with aseptic filling will have a significant influence on the construction and design of the facilities. According to cGMPs the product should be always protected, through the existence of clean rooms and the use of barrier technologies. The clean area has rooms/zones with different classifications, which must be strictly controlled to achieve certain degrees of air quality. These zones are designed so that zones with higher cleaning levels are always protected from the outside by zones with a lower cleaning level. Personnel involved in the manufacture of injectables products must be qualified and trained in order to ensure compliance with cGMP applicable to these dosage forms. These areas must be cleaned and thoroughly disinfected according to a written program. More than one type of disinfectant should be used, in order to reduce the possibility of microbial resistance, as well as the periodic use of a sporicidal agent, since many common disinfectants are ineffective against spores. There must be an environmental monitoring program, capable of providing significant information about the environment at aseptic filling place, and in this way determining whether or not aseptic conditions are maintained. The microbiological data showed some trends for the number of alerts, actions and pathogenic microorganisms, between 2019 and 2020, in some production lines of Hikma Farmacêutica, Portugal. A risk analysis was carried out and strategies were proposed in order to counter the trends already verified and some possible trends that may appear. It is concluded that, in view of the suggested measures, the probability of contradicting the observed results is high and cleaning and disinfection play an extremely important role in quality assurance.
Injectable pharmaceutical products are preparations for injection through the skin or other external contoured tissue, not through the enteral routes. Injectable pharmaceutical products are prepared by methods that take into account the pharmacopoeia sterility requirements. Sterility is defined as the non-existence of viable microorganisms. Sterile products can comprise different forms of preparation and can thus be presented as solid or liquid preparations. In the case of solid preparations, that cannot be sterilized at the end, their filling must be aseptic. In the case of liquid preparations, the filling may or may not be aseptic, depending on whether the product has final sterilization or not. The choice between to proceed or not with aseptic filling will have a significant influence on the construction and design of the facilities. According to cGMPs the product should be always protected, through the existence of clean rooms and the use of barrier technologies. The clean area has rooms/zones with different classifications, which must be strictly controlled to achieve certain degrees of air quality. These zones are designed so that zones with higher cleaning levels are always protected from the outside by zones with a lower cleaning level. Personnel involved in the manufacture of injectables products must be qualified and trained in order to ensure compliance with cGMP applicable to these dosage forms. These areas must be cleaned and thoroughly disinfected according to a written program. More than one type of disinfectant should be used, in order to reduce the possibility of microbial resistance, as well as the periodic use of a sporicidal agent, since many common disinfectants are ineffective against spores. There must be an environmental monitoring program, capable of providing significant information about the environment at aseptic filling place, and in this way determining whether or not aseptic conditions are maintained. The microbiological data showed some trends for the number of alerts, actions and pathogenic microorganisms, between 2019 and 2020, in some production lines of Hikma Farmacêutica, Portugal. A risk analysis was carried out and strategies were proposed in order to counter the trends already verified and some possible trends that may appear. It is concluded that, in view of the suggested measures, the probability of contradicting the observed results is high and cleaning and disinfection play an extremely important role in quality assurance.
Descrição
Tese de mestrado, Engenharia Farmacêutica, 2021, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
cGMP Desinfeção Esterilidade Injetável Limpeza Teses de mestrado -2021