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Validações De Limpeza Em Equipamentos Utilizados Na Produção De Medicamentos E Dermocosméticos No Setor De Formas Líquidas e Pastosas
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Resumo(s)
O principal foco da indústria farmacêutica é garantir a qualidade dos produtos assegurando a
segurança do consumidor. Desta forma, é preciso assegurar a limpeza dos equipamentos entre produções
de diferentes produtos, de modo a evitar contaminação cruzada que ponha em causa a composição dos
produtos ou a saúde do consumidor através da validação da limpeza do equipamento.
A recente aquisição da marca Barral e de novos equipamentos para produção dos dermocosméti-
cos da marca levou à necessidade de realização de novas validações de limpeza no setor de Formas
Líquidas e Pastosas dos Laboratórios Atral tanto dos equipamentos utilizados para a produção de medi-
camentos como de dermocosméticos.
De modo a definir a quantidade de substância ativa do primeiro produto que pode ser encontrada
no segundo recorre-se ao cálculo do PDE. Nesta dissertação foram revistos e calculados os valores de
PDE de diversas substâncias ativas utilizadas nos medicamentos produzidos nos diversos setores.
Por forma a garantir que a limpeza dos equipamentos é adequada foram determinados os locais
críticos para amostragem, os diferentes testes a efetuar aos equipamentos para a validação de limpeza e
a posterior amostragem dos mesmos. As análises efetuadas aos equipamentos são TOC, condutividade,
análise em HPLC e análise microbiológica recolhidas em Agitadores, Máquinas de Enchimento de Lí-
quidos, Homogeneizadores, Reservatórios, Reatores e Bombas de Trasfega de Líquidos do setor FLP.
Adicionalmente, foi também validado o método analítico de determinação de Cloridrato de Oxi-
metazolina por TOC.
Em suma, os resultados obtidos apresentam grande valor para a empresa na medida em que os
valores dos PDE calculados permitem a melhor avaliação dos produtos-pior caso em cada equipamento,
as amostragens efetuadas proporcionaram o ajustamento das instruções de limpeza tornando a higieni-
zação dos equipamentos mais robusta e a validação do método analítico de deteção de substância ativa
por TOC permitiu a sua utilização como método de análise para prevenir contaminações cruzadas.
The focus of the pharmaceutical industry is to guarantee the quality of products while ensuring consumer safety. Therefore, it is necessary to ensure the cleanliness of equipment between productions of different products by validating the cleanliness of the equipment, in order to avoid cross-contamina- tion that could jeopardize the composition of the products or the health of the consumer. The recent acquisition of the Barral brand and new equipment to produce the brand's dermo- cosmetics led to the need to carry out new cleaning validations in the Liquid and Pasty Forms sector of Atral Laboratories for both the equipment used for the production of medicines as well as dermocosmet- ics. To define the amount of active pharmaceutical ingredient from the first product that can be found in the second, the PDE is calculated. In this dissertation, the PDE values of several active pharmaceutical ingredients used in medicines produced in different sectors were reviewed and calculated. In order to ensure that the equipment is adequately cleaned, the critical locations for sampling were determined, as well as the different tests to be carried out on the equipment for cleaning validation and subsequent sampling. The analyzes carried out on the equipment are TOC, conductivity, HPLC analysis and microbiological analysis collected from Agitators, Liquid Filling Machines, Homogenizers, Reservoirs, Reactors and Liquid Transfer Pumps in the FLP sector. Additionally, the analytical method for determining Oxymetazoline Hydrochloride by TOC was also validated. In short, the results obtained are of great value to the company as the calculated PDE values allow for a better assessment of the worst-case products in each equipment, the sampling carried out allowed for the adjustment of cleaning instructions, making the hygiene of equipment the more robust and the validation of the analytical method for detecting the active pharmaceutical ingredient by TOC allowed its use as an analysis method to assess cross-contamination.
The focus of the pharmaceutical industry is to guarantee the quality of products while ensuring consumer safety. Therefore, it is necessary to ensure the cleanliness of equipment between productions of different products by validating the cleanliness of the equipment, in order to avoid cross-contamina- tion that could jeopardize the composition of the products or the health of the consumer. The recent acquisition of the Barral brand and new equipment to produce the brand's dermo- cosmetics led to the need to carry out new cleaning validations in the Liquid and Pasty Forms sector of Atral Laboratories for both the equipment used for the production of medicines as well as dermocosmet- ics. To define the amount of active pharmaceutical ingredient from the first product that can be found in the second, the PDE is calculated. In this dissertation, the PDE values of several active pharmaceutical ingredients used in medicines produced in different sectors were reviewed and calculated. In order to ensure that the equipment is adequately cleaned, the critical locations for sampling were determined, as well as the different tests to be carried out on the equipment for cleaning validation and subsequent sampling. The analyzes carried out on the equipment are TOC, conductivity, HPLC analysis and microbiological analysis collected from Agitators, Liquid Filling Machines, Homogenizers, Reservoirs, Reactors and Liquid Transfer Pumps in the FLP sector. Additionally, the analytical method for determining Oxymetazoline Hydrochloride by TOC was also validated. In short, the results obtained are of great value to the company as the calculated PDE values allow for a better assessment of the worst-case products in each equipment, the sampling carried out allowed for the adjustment of cleaning instructions, making the hygiene of equipment the more robust and the validation of the analytical method for detecting the active pharmaceutical ingredient by TOC allowed its use as an analysis method to assess cross-contamination.
Descrição
Palavras-chave
validação de limpeza medicamentos dermocosméticos TOC SA PDE