Self-contained biological indicator

Abstract

The invention provides a self-contained biological indicator. A biological sterilization indicator is disclosed that in some embodiments comprises a housing having a first enclosure and a second enclosure, an ampule containing a liquid growth medium, and an insert disposed at least partially in the first enclosure. A portion of the ampule may be disposed inside the first enclosure. The insert may have a platform including a top surface, an abutment surface, and a side surface, as well as a first void disposed in the platform and configured to allow passage of a first volume of the liquid growth medium into the second enclosure and a second void disposed through at least a portion of the side surface and configured to allow passage of a second volume of the liquid growth medium into the second enclosure. The second void of the insert may be an angled cut through the abutment surface and the side surface, which may be disposed entirely beneath the top surface. In some embodiments, stress concentrators and other features are included to reduce the force required to activate the biological sterilization indicator.

Description

technical field [0001] The subject matter disclosed herein relates to self-contained kits of biological sterilization indicators. Background technique [0002] Medical devices are often sterilized prior to use in order to minimize the possibility of applying a contaminated device to a subject, which could result in the subject becoming infected. Various sterilization techniques can be employed, such as steam, hydrogen peroxide, and gas phase sterilization with or without gas plasma and ethylene oxide (EtO). Each of these methods depends to some extent on the rate of diffusion of a sterilizing fluid, usually a gas, over the medical device to be sterilized. [0003] Prior to sterilization, medical devices are typically packaged within containers or pouches with semi-permeable barriers that allow the passage of sterile fluids (sometimes called sterilants) but prevent the ingress of contaminating organisms (especially in after sterilization and before opening the package by me...

AI Technical Summary

Problems solved by technology

The accuracy of such assays can be compromised by the presence of debris formed after the breakage of the fragile container containing the growth medium, as these debris may obstruct or partially block the optical path between the SCBI and the sensor, or they may alter the wavelength of light or the amount of fluorescence from SCBI that the sensor can detect

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