Abstract:
A self-contained sterilization process biological indicator is provided. The indicator includes a housing. Test microorganisms disposed in the housing are enveloped by a wax composition. The wax composition comprises a long-chain (greater than C22) linear or branched alkyl or alkenyl alcohol, wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a short chain alkyl or aryl (C1-C6) group, wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a long chain (C8-C36) alkyl or alkenyl group, wherein the alkyl or alkenyl alcohol is not linked through an amide bond to a linear or branched long chain (C8-C36) alkyl or alkenyl amine or acid. The wax composition has a melting point between 78°C and 120°C. Also contained in the housing are a nutrient composition and an openable container containing a liquid medium.
Abstract:
A microbial indicator device for liquid disinfection comprises a first cavity, a source of biological activity fluidically coupled to the first cavity via a portion of a first fluidic path, a filter membrane positioned in a second fluidic path for a disinfectant, and a first coupling portion fluidically coupled to the source of biologically activity via the second fluidic path. The filter membrane has a first side and a second side, wherein the first side is in fluid communication with the first fluidic path. The filter membrane has a pore size sufficient to retain at least a portion of the source of biological activity on the first side. The device further comprises a frangible container contained in the first cavity, wherein a liquid in the container is in fluid communication with the first cavity when the container is fractured.
Abstract:
A biological sterilization indicator (BI) is provided. The BI can include a housing, and a container positioned in the housing. The BI can further include a first chamber, and a second chamber with a source of biological activity disposed therein. The BI can further include a substrate positioned in the housing between the first chamber and the second chamber. The substrate can be positioned in fluid communication with the first chamber and the second chamber, and the substrate can be further positioned such that the substrate is not in direct contact with the source of biological activity. The substrate can comprise a hydrophobic nonporous film having an aperture. The substrate and the aperture are dimensioned to control fluid flow between the first compartment and the second compartment. The substrate can extend around substantially the entire inner perimeter of the housing between the first compartment and the second compartment.
Abstract:
A system for assessing efficacy of a sterilization process is disclosed. The system includes a biological indicator, a receptacle configured to receive the biological indicator, an actuator mechanism, and a sensing system operatively coupled to the actuator mechanism. A method of using the system for assessing efficacy of a sterilization process is also disclosed.