Abstract: A sterilization challenge specimen holder is used with a test indicator to challenge sterilization on a consistent basis. The holder includes a body having an internal chamber region and a sleeve positionable within the internal chamber. A cap is sealable on the holder and a plug is positioned in the body. The plug has a wall having a spiral formed groove therein in communication with the internal chamber region. An opening in the holder provides for a flow path for communication between the environs and the internal chamber, and another opening(s) provides for a second flow path for communication between the internal chamber and the inner chamber of the sleeve. An indicator tube carries a biological indicator and has openings therein.

Abstract: A sterilization challenge specimen holder is used with a test indicator to challenge sterilization on a consistent basis. The holder includes a body having an internal chamber region. A cap is sealable on the holder. A plug is positioned in the body. The plug has a wall having a spiral formed groove therein in communication with the internal chamber region. An opening provides for a single flow path for communication between the environs and the internal chamber via the groove.

Abstract: A biological indicator for monitoring the effectiveness of a sterilizing or disinfecting treatment or process. A compound or condition is disclosed which comprises a substrate having a surface layer containing functional groups thereon desirably free of silicon linking groups. The functional groups are desirably in the form of a monolayer of a uniformed distribution and of a selected quantity. Various types of microorganism indicators, such as spores, and/or etiological agent indicators are covalently bonded to the surface layer functional groups through a crosslinking reagent and thus form a uniform number and distribution of the microorganism and/or etiological agent indicators. After being subjected to sterilization or other similar disinfecting treatments or processes, along with various articles such as instruments, the indicator can be cultivated to determine the effectiveness of the sterilization, disinfection, etc. treatment or process.

Abstract: A method for rapidly detecting infectious conjunctivitis in a host is provided. The method includes contacting an ocular test sample with a chromogen (e.g., Reichardt's dye) that exhibits a color change in the presence of a microbe. The present inventors have discovered that the extent of the color change may vary depending on whether the microbe is a bacteria or virus. Without intending to be limited by theory, the present inventors believe that the chromogen interacts with the peptidoglycan-based cell wall structure of bacteria to induce a color change that is even more apparent at infectious levels. It is believed that this interaction occurs to a much greater extent in bacteria than in viruses. Accordingly, although the chromogen may still undergo a color change in the presence of the viruses, it is typically to a much lesser extent.

Abstract: A sterilization challenge specimen holder is used with a test indicator to challenge sterilization on a consistent basis. The holder includes a body having an internal chamber region. A cap is sealable on the holder. A plug is positioned in the body. The plug has a wall having a spiral formed groove therein in communication with the internal chamber region. An opening provides for a single flow path for communication between the environs and the internal chamber via the groove.

Abstract: A method for monitoring cleaning of a surface includes applying an amount of transparent indicator material to an area of a surface and measuring the amount of transparent indicator material remaining on the surface. The transparent indicator material may be fixed on the surface by drying and, when a fluorescent material, may be measured through exposure to ultraviolet radiation.

Abstract: The disclosed invention provides a self-contained sterilization indicator for evaluating the effectiveness of a sterilization process. The sterilization indicator includes a cap configured for housing a growth medium, the cap being mountable on a container that contains a concentration of microorganisms. The cap comprises an inner chamber for housing the growth media. The inner chamber has an opening and a breakable barrier overlying the opening for encapsulating the growth media within the inner chamber of the cap. The biological indicator is adapted for breaking the breakable barrier at a selected time to introduce the growth medium into the container such that the growth medium contacts the microorganisms.

Abstract: Suitable dyes are used herein to indicate the presence of microbial contamination by spraying them onto surfaces in the form of an aqueous solution. The dye solution may also be allowed to dry, thus producing the dried residue of an aqueous solution. It's believed that these dyes change color in response to a change in polarity of the environment. Since water is a polar solvent and most bacteria are made from non-polar substances, the presence of bacteria changes the polarity of the environment, triggering a change visible by the unaided eye.

Abstract: This invention is directed to a method and kit for detecting microorganisms on a surface. The invention involves contacting a household surface with a cleaning composition comprising hydrogen peroxide and then placing an acoustic device in close proximity to the household surface to determine if the microorganisms are still present.

Abstract: A device and a method for rapidly determining the effectiveness of sterilization or disinfection processes are provided. The method involves contacting a biological indicator containing a known number of live spores to a sterilization or disinfection process. When the spores are killed, the minerals in the spores are released. Water is contacted with the dead spores to form an aqueous solution. A parameter related to the concentration of a mineral in the aqueous solution is measured. The effectiveness of the germicidal process is determined from the parameter and the initial number of spores in the biological indicator. Measuring the parameter by measuring the conductivity of the aqueous solution is particularly effective and sensitive.

Abstract: Methods and apparatus for testing the sterility of a product to be administered to a patient. The sterility of the product is tested by monitoring the pH change of a culture medium in contact with any culturable organisms (e.g., bacteria) that are collected by filtration of the product to be tested.

Abstract: The present invention provides a device for activating a self-contained biological indicator. The biological indicator includes a casing, an ampule having a growth-promoting medium disposed therein and microorganisms. The ampule and microorganisms are disposed within the casing. The device is comprised of a first lever arm having a cavity formed therein. The cavity is dimensioned to receive a biological indicator. A second lever arm has a protrusion extending from a surface thereof and is moveable relative to the first lever arm to deform a casing of the biological indicator thereby fracturing an ampule in the casing and exposing microorganisms in the casing to a growth-promoting medium in the ampule of the biological indicator.

Abstract: A method and an apparatus for detecting and quantifying bacterial spores on a surface. In accordance with the method: bacterial spores are transferred from a place of origin to a test surface, the test surface comprises lanthanide ions. Aromatic molecules are released from the bacterial spores; a complex of the lanthanide ions and aromatic molecules is formed on the test surface, the complex is excited to generate a characteristic luminescence on the test surface; the luminescence on the test surface is detected and quantified.

Abstract: A method and an apparatus for detecting and quantifying bacterial spores on a surface. In accordance with the method: a matrix including lanthanide ions is provided on the surface containing the bacterial spores; functionalized aromatic molecules are released from the bacterial spores on the surface; a complex of the lanthanide ion and the aromatic molecule is formed on the surface; the complex of the lanthanide ion and the aromatic molecule is excited to generate a characteristic luminescence of the complex on the surface; and the bacterial spores exhibiting the luminescence of the complex on the surface are detected and quantified.

Abstract: An indicator device for determining the efficacy of an antimicrobial treatment process. The indicator device includes an active agent encapsulated in an encapsulation component. The encapsulation components preferably takes the form of an electrospun nanofiber including a polymer.

Abstract: Multiple-component integral-structure dual-test sterility indicator, method of assembling physical components, selected spores, and chemical constituents in solution, within the indicator and arranged to enable dual-evaluations of bacterial-lethality of a dry-goods load, resulting from exposure to a selected saturated-steam sterilizing cycle. The chemical constituents are formulated to chemically produce reaction-product, which is quantitatively responsive to the combined effect of cycle steam temperature and time of exposure at that temperature, for providing a promptly-available spectroscopic evaluation of bacterial-lethality. Absorption of narrow-band selected visible-light wavelength by reaction-product, if any, of chemical-constituent solution, is used to quantitatively measure that combined-effect exposure.

Abstract: An apparatus for testing the efficacy of a sterilizing environment on a test indicator, comprising a test chamber, a loading chamber adjacent to the test chamber and an opening connecting the test chamber to the loading chamber. A movable gate mechanism has a first position closing the opening and isolating the test chamber from the loading chamber, and a second position wherein the opening connects the test chamber to the loading chamber. A system is connected to the inlet port and the outlet port of the test chamber for supplying a sterilant vapor to the test chamber to establish a sterilizing environment in the test chamber. An indicator holder is operable to move a test indicator from the loading chamber into and out of the test chamber when the gate mechanism is in the second position.

Abstract: An apparatus for on-site microbial diagnosis and disinfection comprising a mobile unit for being brought to an infected site in the event of an emergency. The mobile unit comprises at least a first compartment and a second compartment. The first compartment comprises a laboratory for on-site microbial diagnosis of samples of the site. The second compartment comprises a water supply for washing the site and a disinfectant supply for disinfecting the site. A method comprising on-site evaluation of the biological security of a microbiologically contaminated site and of the washing requirements of the site followed by sampling and on-site diagnosis the sample. A disinfection protocol is provided on-site and then applied, the efficacy of the protocol is later evaluated. Bacterium which are competitors to the identified microbiological agent or agents responsible for contamination or infection are then applied to the site.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.

Abstract: There is provided a method for infecting a target cell with a TSE agent, comprising: i) contacting said target cell with a membrane preparation, wherein the membrane preparation comprises the TSE agent and a donor membrane; and ii) infecting said target cell with the TSE agent. There is also provided a contiguous membrane, comprising a donor membrane and a membrane containing a TSE agent, wherein the TSE agent is selected from the group consisting of CJD, vCJD, familial CJD (e.g. FFI or CSS), iatrogenic CJD, BSE, ovine BSE, and CWD.

Abstract: An object of the present invention is to provide a method capable of detecting and quantifying endotoxin in a sample in which endotoxin derived from gram-negative bacteria cannot be accurately detected or quantified by the method described in Commentary of the Japanese Pharmacopoeia Fourteenth Edition, Hirokawa Publishing Co. 2001 B-63. It has been found that the above object can be achieved by performing an endotoxin test using a lysate reagent in which the lysate reagent is added into a sample in the presence of albumin and/or globulin.

Abstract: A sterilization challenge specimen holder is used with a test indicator to challenge sterilization on a consistent basis. The holder includes a body having an internal chamber region. A cap is sealable on the holder. An opening is defined in the body or cap that forms a single tortuous ingress and egress path communicating the interior chamber with the environs. An insulating layer is disposed over the body and cap to fully insulate the body and cap other than over the opening so as to not interfere with the ingress and egress path. The insulating layer reduces the heat transference from the environs to the interior chamber region.

Abstract: The present invention provides a hydrogen peroxide indicator that includes a substrate on which is disposed an indicator composition that includes at least one of a select group of colorants. As a result of contact with hydrogen peroxide, the colorants change color, and even become colorless, thereby providing an indication of the presence of hydrogen peroxide.

Abstract: A biological soil detector is provided, having: a solid support member; a specific indicator immobilized on the solid support member; and a retaining member which holds the solid support, the retaining member and solid support are configured so that the solid support will readily contact a surface being tested for the presence of biological soil. A method for the use of the detector is also provided, the method including the following steps: contacting the biological soil detector with a surface; withdrawing the biological soil detector from the surface; and inspecting the solid support member of the detector to determine whether the specific indicator immobilized has interacted with biological soil. In still another aspect, the invention provides biological soil detector and a method for using the detector in which the detector includes: a solid support member that has been treated with at least one amine or quaternary functional coating; and a specific indicator immobilized on the coating.

Abstract: The present invention provides for a method for recovering microorganisms from a sample that is rapid and provides microorganisms substantially free of adsorbents and other particles. The method includes mixing a sample comprising a medium, an adsorbent and microorganisms with a first solution in a first vessel; separating the adsorbent from the medium and the microorganisms and removing the microorganisms and a portion of the medium from the first vessel; mixing the microorganisms and the portion of the medium with a second solution in a second vessel to resuspend the microorganisms; and separating the microorganisms from the resulting mixture.

Abstract: A biological indicator for monitoring the effectiveness of a sterilizing, disinfecting, etc., compound or condition is disclosed which comprises a substrate having a surface layer containing functional groups thereon desirably free of silicone linking groups. The functional groups are desirably in the form of a monolayer of a uniformed distribution and of a selected quantity. Various types of microorganisms such as spores and/or etiological agents are covalently bonded to the surface layer functional groups through a crosslinking reagent and thus form a uniform number and distribution of the microorganisms and/or etiological agents. After being subjected to sterilization or other similar treatment, etc., along with various articles such as instruments, the indicator can be cultivated to determine the effectiveness of the sterilization, disinfection, etc. process.

Abstract: This invention relates to a device for testing the efficacy of any disinfectant treatment, such as water disinfectants or equipment disinfectants. The device includes a culture of live unsporulated free-living protozoan parasites. If the disinfectant treatment successfully kills all or a substantial number of parasites, then the treatment is effective. One can determine whether the parasites have been killed or not by exposing them to sporulation conditions, and if they sporulate after exposure to the disinfectant treatment, then they were not killed by the disinfectant treatment.

Abstract: Aspects of the present invention provide novel apparatus and methods for sampling microbial organisms present on surfaces.

Abstract: A process for trapping and confining microorganisms in air using water-soluble polymers is disclosed. The water-soluble polymers are readily soluble in water or a physiological diluent, have reasonable mechanical strength so that they can be transported without rupture, retain water and adhere to microorganisms. A process for the rapid and sensitive detection of microorganisms in air under aseptic conditions is also disclosed.

Abstract: A testing unit and a method of testing a sterilization packaging unit for microbial contamination of sterilized objects after they have been sterilized are disclosed. The testing unit includes a dry matrix for accommodating a nutrient medium and a receptacle containing a liquid. By applying the liquid onto the matrix, the matrix is provided with a nutrient medium. In the method, the testing unit is inserted into the sterilization packaging unit which is sterilized and stored. At a desired point in time, the receptacle is opened in order to produce the nutrient medium in the matrix. After a possible multiplication of microbes on the matrix, an observation of microbes takes place. The invention also relates to a sterilization packaging unit which has a rigid outer casing and is suitable for the application of the method.

Abstract: A Biological Indicator Evaluator Resistometer (BIER vessel) provides enhancements in controlling the start and end points of exposure to a sterilant gas. The end point control employs a large volume relative to the test chamber volume upon which is drawn a deep vacuum and then exposed to the test chamber to quickly exhaust the sterilant gas from the test chamber.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.

Abstract: A novel biological indicator system to detect the effectiveness of a sterilization treatment for assessing the viability of and/or changes in bacterial spores exposed to sterilization or disinfection by multi-angle light scattering thereby detecting a change in the spores as indicators of spore viability and the efficacy of the sterilization or disinfection.

Abstract: An elastomeric article that contains a chromogen that undergoes a detectable change in color in the presence of one or more microbes is provided. For example, in one embodiment, the chromogen is a solvatochromic dye (e.g., Reichardt's dye) that undergoes a color change in the presence of bacteria or other microbes. More specifically, such dyes may respond to differences in polarity between microbe components (e.g., cell membrane, cytoplasm, etc.) and the environment outside the cell. Alternatively, other mechanisms may be wholly or partially responsible for the interaction between the dye and the microbe, such as acid-base reactions, redox reactions, and so forth.

Abstract: A device for use in monitoring a swab method, the device includes a first substrate substantially adjacent a second substrate, the first substrate and the second substrate having disposed therebetween a test material.

Abstract: An object of the present invention is to provide a process challenge device for a high-pressure steam sterilizer capable of reuse with little trouble. A process challenge device 1 for a high-pressure steam sterilizer, includes a plurality of stacked steam permeable bodies 7, 8, and 9 formed by a material capable of permeating of steam 11 and an indicator 10. The steam permeable bodies 8 (except the steam permeable bodies 7 and 9 arranged at both sides among the stacked steam permeable bodies 7, 8, and 9) each have an opening 8a for accommodating the indicator 10. The steam permeable bodies 7, 8, and 9 are stacked, so that the indicator 10 is surrounded by the inner wall of a cavity 24 formed by the openings 8a of the intermediate steam permeable bodies communicated with one another and the steam permeable bodies 7 and 9 arranged at both sides.

Abstract: Solvatochromic dyes are used herein to indicate the presence of bacteria by incorporating them into various substrates such as films, woven and nonwoven fabrics, paper towels, coform and airlaid materials and bonded carded webs. These dyes change color in response to a change in polarity of the environment. Since water is a polar solvent and most bacteria are made from non-polar substances, the presence of bacteria changes the polarity of the environment, triggering a change visible by the unaided eye. A lateral flow device incorporating solvatochromic dyes and a method of detecting bacteria are also included.

Abstract: A sterilization process challenge device has a sterilization indicator contained within a container; and a variable diffusion restriction into said container.

Abstract: A test method and test device for hygiene monitoring of a test sample from a biological material or a surface with a biological material to detect the presence of phosphate and glucose as a measure of hygiene by employing a swab-type, puncturable-membrane test apparatus or a lateral-flow or capillary-flow test apparatus.

Abstract: The invention relates to methods and kits and methods for assessing the effectiveness of a sterilization process by determining the release of dipicolinic acid (DPA) from bacterial or other spores that contain DPA. A biological indicator containing a spore may be included together with articles being sterilized, and an assay of DPA released from the spore can be performed moments after the sterilization process is completed, or during the process. The kits and methods thus provide a rapid and reliable method of assessing the effectiveness of a sterilization process and, consequently, assure the sterility of article subjected to the same process.

Abstract: A diagnostic microbiological testing system and method for microorganism identification (ID) and antimicrobial susceptibility determinations (AST). The system includes multiple-well test panels capable of performing ID and AST testing on the same test panel. Each test panel is inoculated with reagents, broth-suspended organisms, and placed into the instrument system. The instrument system includes a rotating carousel for incubation and indexing, multiple light sources each emitting different wavelength light, precision calorimetric and fluorometric detection, barcode test panel tracking and a control processor for making determinations based on measured test data. One light source includes a plurality of LEDs arranged in a linear array. Each of the LEDs' junction currents are controllable to produce a predetermined illumination profile.

Abstract: Sterilization indicator test packs for testing the effectiveness of a sterilization procedure are provided. Both non-challenge and challenge-type test packs are disclosed. The non-challenge test packs include generally comprise a tray for holding a sterilization indicator the tray containing an elevated rim surface defining the perimeter of the tray and a recessed trough for receiving a sterilization indicator. The rim surface includes a plurality of spaced-apart grooves along its length extending through the rim to the recessed trough; a sterilization indicator within the recessed trough of the tray; and a lid that forms a plurality of channels with the grooves in the tray such that sterilant can enter the tray through the channels and contact the sterilization indicator.

Abstract: A method for detecting oxygen in a test sample is provided, the method involving exposing a test sample and a control sample to sensor compositions having a luminescent compound capable of generating a signal indicative of oxygen depletion. The method further involves determining the strengths of such signals for the test sample versus the control sample, and using the difference to determine whether oxygen in the test sample is being consumed.

Abstract: The present invention is directed to a sensor system for monitoring metabolic activity of an anaerobic or aerobic microorganism. The present invention further relates to a sensor system that can individually and simultaneously monitor oxygen and carbon dioxide levels of a gas composition. Also provided is a sensor formulation for use with the sensor system of the present invention and a method of making the same.

Abstract: A method for the evaluation of a material to determine whether the material is susceptible to bacterial contamination or colonization comprising providing bacteria which are modified to produce a first detectable signal, exposing the material being evaluated to the bacteria and determining whether the first signal is present determining whether the first signal is present on the material or within the material.

Abstract: A novel biological indicator system to detect the effectiveness of a sterilization treatment and methods for assessing the viability of and/or changes in bacterial spores exposed to a sterilization or disinfection method by multiangle light scattering thereby detecting a change in the spores as indicators of spore viability and the efficacy of the sterilization or disinfection method.

Abstract: A BIER vessel evaluates biological indicators for sterilization processes. By flowing gaseous sterilant, such as vaporized hydrogen peroxide, through a chamber (12) before, during, and after introducing the indicators, the indicators are instantaneously exposed to preselected steady state conditions, allowing accurate and reproducible evaluation of the indicator response. A door (32) to an opening (30) in the chamber opens for introducing the indicators to the chamber without appreciably disturbing the steady state conditions therein. After a preselected time, the biological indicators are removed and evaluated for remaining biological activity.

Abstract: A rapid method for detecting spoilage of a food sample, particularly a fish sample, by detecting and enumerating sulfide-producing bacteria (SPB). A growth medium containing iron and sulfur is combined with the food sample forming an incubation mixture which is incubated for a period of time. In one embodiment, a plurality of fluorescence measurements are taken during an incubation period of about 3 hours to 17 hours at 30° C. SPB are determined to be present in the sample if the fluorescence measurement initially increases and then decreases to form a fluorescence maximum (peak). The time to detection of the fluorescence peak can be used with a correlation schedule to enumerate the SPB in the food sample. In another embodiment, a visual test can also be used to identify color changes in the incubation mixture to provide a semi-quantitative enumeration of SPB effective after about 3 hours to 17 hours of incubation.

Abstract: A sterilization indicator for testing the effectiveness of a sterilization procedure comprises a source of an enzyme, a sterilant-resistant chemical associated with the enzyme, and a substrate that reacts with the enzyme to form a detectable enzyme-modified product that provides an indication of the failure of the sterilization procedure. The sterilant-resistant chemical may be a polyglycerol alkyl ester, polyglycerol alkyl ether, an ethoxylated polyhydric alcohol ester, or a polyhydric alcohol ether. The indicator may be used to test the effectiveness of a hydrogen peroxide plasma sterilization procedure and may be provided with a non-challenge test pack or a lumen-challenge test pack.

Abstract: A Biological Indicator Evaluator Resistometer (BIER vessel) provides enhancements in controlling the start and end points of exposure to a sterilant gas. The end point control employs a large volume relative to the test chamber volume upon which is drawn a deep vacuum and then exposed to the test chamber to quickly exhaust the sterilant gas from the test chamber.