A biological indicator is provided for measuring the effectiveness of a sterilization procedure. The biological indicator comprises a carrier having a microorganism and at least one of a humectant, anti-agglomerating agent or surfactant disposed thereon, the carrier having a solidity of greater than 5%. Various embodiments of a device, kits and methods are disclosed.

A self contained biological indicator is disclosed having a housing and an ampule disposed within the housing, the ampule having a first dome, a second dome and a sidewall. A cap may be coupled to the housing. The cap may include a projection that may be coupled to the ampule by, e.g., a friction fit. An insert may be disposed within the housing. The insert may include a well within which at least a portion of the bottom dome of the ampule may be disposed. The insert may also include a ramp that is angled relative to the central longitudinal axis of the ampule. The second dome of the ampule may contact the ramp. The insert may also include an arm or finger that extends above the well and has a stress concentrator disposed thereon such that it is also disposed above the second dome of the ampule and adjacent to the sidewall of the ampule. In use, the SCBI generates therein a first reaction force between the second dome of the ampule and the ram having a component directed transverse to a central longitudinal axis of the ampule. The component of the first reaction force causes a second reaction force between the sidewall of the ampule and the stress concentrator. The second reaction force breaks the ampule.

A self-contained biological indicator (“SCBI”) is disclosed. The SCBI may include a first ampule and a second ampule. The first ampule may contain a first volume of a first growth medium, and the second ampule may contain a second volume of a second growth medium. The SCBI is configured such that the first ampule may be broken before the second ampule. The SCBI may be analyzed for changes in fluorescence of the first growth medium. Then, the SCBI may be analyzed for changes in a color of the second growth medium.

A biological sterilization indicator for evaluating the effectiveness of a sterilization process includes a cap containing a culture medium, a container containing a concentration of microorganism, and a breakable barrier attached to the cap to encapsulate the culture medium therein. The breakable barrier is formed from a multilayer structure including an aluminum layer and a sealing layer. The biological indicator is configured such that the breakable barrier may be broken at a selected time by engaging the cap and the container at an activated position to introduce the culture medium into the container.

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.

A biological indicator includes: a BI housing; a germinant container inside the BI housing and housing a germinant composition; a germinant releaser configured to release the germinant composition from the germinant container; a germinant releaser support supporting the germinant releaser and configured to bring the germinant releaser into contact with the germinant container upon application of a force to the germinant releaser support or the germinant container; a first spore carrier inside the BI housing, the first spore carrier having a plurality of spores deposited at a first surface thereof; and an imaging window at a first surface of the BI housing. A BI reader is configured to detect and quantify the presence of live spores in the BI, and includes an excitation source, a camera for capturing images of the spores over time, and a processor for analyzing the images to determine the presence of live spores.

An apparatus to simulate biocide performance in crude oil pipeline conditions is disclosed. The apparatus includes: a reactor to simulate a two-phase crude oil pipeline which includes a crude oil phase above a water phase. The reactor has an agitator to control a flow of the water phase in the reactor in response to a motor that drives an agitation rate of the agitator. A crude oil inlet supplies crude oil to the reactor for the crude oil phase. A water inlet supplies water to the reactor for the water phase. A control circuit is configured by code to control a proportion of the water to the crude oil supplied to the reactor and to control the motor to drive a desired agitation rate of the agitator. A biocide inlet supplies biocide to the reactor. A water sample outlet enables sampling of the water phase of the reactor.

A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.

A plant fat-based scaffold for growing cell-based meat products for consumption. The scaffold comprises primarily plant fats or waxes in addition to cell binding proteins and optional additional components that assist in the growth of cultivated animal cells. The scaffold can exist in both a liquified state during sterilization and a solid state during the formation of the scaffold, the seeding of the cultivated cells, and the cellular growth phase. The scaffold is capable of remaining in the final product for consumption or is partially or completely melted out of the final product and recycled into raw material for forming new scaffolds.

An article for assessing efficacy of a sterilization process is provided. The article includes a housing, a plurality of genetically-modified spore-forming test microorganisms disposed in the housing, a liquid medium disposed in an openable container that is disposed in or attached to the housing, and an enzyme substrate disposed in the housing or in the openable container. The genetically-modified test microorganism comprises a functional fusion gene that encodes a non-naturally occurring chimeric protein, the chimeric protein comprising a first segment and a second segment that is contiguous with the first segment. The first segment comprises at least a portion of a first polypeptide that is normally found in spores and the second segment comprises a second polypeptide having a detectable enzymatic activity. The enzyme substrate is capable of reacting with the detectable enzyme activity to form a detectable product. A method of using the test microorganisms is also provided.