O pacote de teste Bowie-Dick TP01 é um indicador de Tipo 2, projetado especificamente para o monitoramento diário de autoclaves a vapor que utilizam bomba de vácuo e ciclos de pré-vácuo. É uma ferramenta crítica para detectar vazamentos, penetração inadequada de vapor, bolhas de ar e/ou falhas na bomba de vácuo.
Funcionamento e Diagnóstico:
Avaliação de Precisão: Seu design gera uma resistência controlada ao vapor para simular uma carga real, avaliando se o sistema de remoção de ar funciona corretamente.
Interpretação de Resultados: Uma mudança de cor uniforme e completa confirma que o ar foi evacuado e o vapor penetrou com eficácia. Se surgirem zonas sem viragem ou descolorações parciais, indica presença de ar residual ou falhas no sistema.
Rastreabilidade: A folha impressa com tinta sensível oferece uma mudança de cor permanente, permitindo seu arquivamento como registro físico da validação do ciclo.
Especificações Técnicas:
Condições de Exposição:
$134°C$ por 3,5 minutos ($±30$ seg).
$121°C$ por 15 minutos.
Normas e Qualidade: Desenvolvido sob a norma ISO 11140-1, 4. Processos certificados por ISO 13485 e Boas Práticas de Fabricação (GMP).
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