Biological indicator for sterilization processes with double...

C - Chemistry – Metallurgy – 12 – Q

Patent

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C12Q 1/22 (2006.01) A61L 2/26 (2006.01) A61L 2/28 (2006.01) C12M 1/00 (2006.01) C12M 1/34 (2006.01) G01N 31/22 (2006.01)

Patent

CA 2359715

A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.

Divulgation d'une méthode et d'un appareil pour prévenir le retour de la couleur d'un colorant indicateur dans un indicateur biologique. Le colorant indicateur change de couleur en présence de microorganismes viables après stérilisation, car des sous-produits acides sont formés quand les microorganismes métabolisent le milieu de culture. On a trouvé que le colorant peut retourner à sa couleur initiale après la fin de la stérilisation en raison de la lixiviation ou de la diffusion d'impuretés basiques dans le milieu de culture. La méthode et l'appareil sont basés sur un système de tampon double, un tampon agissant à pH élevé pour modérer les fluctuations de pH au commencement de la stérilisation et le deuxième tampon agissant à pH faible pour réduire au minimum les fluctuations de pH quand la stérilisation est finie. On utilise moins de tampon de pH élevé que de tampon de bas pH afin de maximiser la vitesse et la sensibilité de l'indicateur biologique.

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