Stand-alone set of biological indicators

Abstract

The present invention is entitled "Self-Contained Biological Indicators". Disclosed herein is a biological sterilization indicator that, in some embodiments, includes a housing having a first housing and a second housing, an ampoule containing a liquid growth medium, and at least partially An insert disposed in the first housing. A portion of the ampoule may be disposed within the interior of the first housing. The insert may have a platform comprising a top surface, a docking surface and side surfaces, a first void disposed in the platform and a second void configured to allow a first volume of liquid growth medium to enter the second void. In the housing, a second void is disposed through at least a portion of the side surface and is configured to allow a second volume of liquid growth medium to enter the second housing. The second void of the insert may be an angled cut through the abutment surface and the side surface, the angled cut may be disposed completely below 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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