Abstract: The disclosed technology relates to a sterilization indicator, including a carrier, the carrier having a first surface and a second surface; a support, the support having a first section and a second section, the carrier overlying the first section of the support, the second surface of the carrier being adhered to the first section of the support; and a biological indicator supported by the carrier; the sterilization indicator being formed by applying the biological indicator to the carrier and then adhering the carrier to the support, the carrier being adhered to the support using sonic welding, in which the sonic welding, when applied to the carrier with the biological indicator applied, exhibits no significant difference in viability of the biological indicator following the sonic welding as compared to prior to the sonic welding.

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: 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: The invention relates to a method for characterizing the bioindicators in sterilization processes using an autoclave and the like, in which a bioindicator is kept in the same conditions as the sterilization chamber (2) and extracted after a predetermined time interval. For this purpose the chamber (2) has, passing through it, a tube (5) on the ends of which valves (8-9, 10-11) are mounted, said valves allowing the insertion, from above, of a bioindicator sample and its extraction from below, when required, without a significant loss of sterilizing agent. Alternatively, the duct (5) may also be arranged outside the sterilization chamber (2) and kept in communication therewith by a bypass connection.

Abstract: The invention relates to the use of a cleaning agent that contains surfactants and has a pH value of at least 11 when diluted in an aqueous solution and ready for use. Said cleaning agent is used to destabilize prions during mechanical and manual cleaning and/or disinfection of medical and/or surgical instruments and appliances. It has been recognized that this combination enables a reliable destabilization of prions during the mechanical reconditioning of surgical instruments.

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: The invention concerns test elements, in particular diagnostic test elements, for determining the presence or concentration of biological, medical or biologically or medically effective substances including nucleic acids, proteins, viruses, microorganisms and cells, characterized in that these test elements contain nanofibers.

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 biological indicator for monitoring the effectiveness of a sterilization or disinfection treatment or process. The biological indicator comprises a substrate having a surface layer containing functional groups thereon desirably free of silicon linking groups. The functional groups are added to the surface through the use of a functionalized silane coupling agent, wherein two different functional groups are generally utilized and the functionalized silane is applied in a uniform and consistent manner thereby assuring that the microorganism or etiological agent indicators are attached to the substrate in a uniform and consistent manner through non-covalent bonding to the functional groups. After being subjected to sterilization or other similar disinfecting treatments or processes along with various articles such as instruments, the indicator can be cultivated or cultured to determine the effectiveness of the sterilization or disinfection treatment or process.

Abstract: A device useful in determining the efficacy of a chemical sterilization process includes a dead end cavity closed by an access cap having a port coupled to a challenge tube defining the only path by which a substantial quantity of sterilant can reach the cavity. A biological indicator is located within the cavity and a chemical indicator is also provided. These indicators, and particularly the biological indicator, provide an indication of whether chemical sterilant would reach all interior exposed surfaces of a load in sufficient concentrations to adequately sterilize the load.

Abstract: The invention concerns test elements, in particular diagnostic test elements, for determining the presence or concentration of biological, medical or biologically or medically effective substances including nucleic acids, proteins, viruses, microorganisms and cells, characterized in that these test elements contain nanofibers.

Abstract: The present invention relates to a collection device for a substance, and methods related to collecting thereof.

Abstract: Disclosed herein is test device and method for detection of sample analytes in which after sampling has occurred a closure is provided. Such a test device and method can be usefully employed to detect a variety of analytes including microorganisms.

Abstract: Procedures and means for evaluating effectiveness of bacterial-lethality, following batch-processed containerized food production operations and aseptic-flow food-production operations as containerized in aseptic-containers, in preparing for non-refrigerated marketing are described. The evaluations significantly expedite determining whether thermally-processed containerized food-production is safe for non-refrigerated marketing. The presence or absence of live spore-forming bacteria is determined chemically free of extended storage requirements relying on a mechanical-failure indication of food-spoilage. Also, a biological-indication verification of microbial-biocidal status of the packaged food is made available.

Abstract: A quantitative sampler of pathogens in exhaled air is provided. The quantitative sampler includes an air inputting pipe for a sampled individual to blow exhaled air; a check valve unit for preventing the exhaled air from reversely flowing; an aerosol filtering unit having an aerosol filtering material for collecting aerosol particles in the exhaled air; and an air flow meter for measuring if total accumulated volume of the exhaled air reaches a predetermined sampling volume defined as a concentration denominator of exhaled pathogens. The quantitative sampler can be used to collect the aerosol particles, and then moves the aerosol filtering material out of the aerosol filtering unit followed by separating genetic substances in the aerosol particles from the aerosol filter, so that a real-time qPCR can be reacted by using the genetic substances for obtaining a quantitative concentration of the exhaled pathogens.

Abstract: A biological indicator for monitoring the effectiveness of a sterilizing, disinfecting treatment or process. A compound or condition is disclosed which comprises a substrate containing functional groups residing on a surface thereof, said functional end groups being desirably free of silicon linking groups. The functional end groups are desirably in the form of a monolayer of a uniform distribution and of a selected quantity. Various types of microorganisms, such as spores, fungi, mycobacteria, vegetative bacteria, protozoa, and/or etiological agents are covalently bonded to the functional end groups through a zero-length crosslinking agent and thus form a uniform number and distribution of microorganisms and/or etiological agent indicators on a surface of the substrate.

Abstract: A process challenge device (PCD) for determining the effectiveness of a microbial deactivation process that uses a vaporous deactivating agent (e.g., vaporized hydrogen peroxide) as a deactivating agent. The PCD includes first and second layers that are joined together to form (1) a chamber dimensioned to receive a biological and/or chemical indicator, and (2) first and second conduits fluidly connecting the chamber with a region outside the PCD. Each conduit has one end in communication with the region outside the PCD and another end in communication with the chamber. A removable seal member seals the biological and/or chemical indicator inside the chamber.

Abstract: Methods of sterilizing dermal fillers and injectable collagen material have been developed which reduce the level of active biological contaminants or pathogens without adversely affecting the material, i.e., wherein the dermal fillers and injectable collagen material retain their same properties before and after its terminal sterilization. In one embodiment the method for sterilizing the dermal filler or injectable collagen material that is sensitive to radiation contains the steps of protecting the filler or material from radiation, and irradiating the filler or material with a suitable dose of radiation for a time and at a rate effective to sterilize the filler or injectable material. In a preferred embodiment the method for sterilizing the dermal filler or injectable collagen material that is sensitive to radiation includes the steps of a) freezing the filler or material at a temperature below its freezing temperature, which is generally below 0° C.

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: 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, 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 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 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 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: 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: This invention refers to a glued or heat-sealed cap for resealing test tubes for clinical analyses which can be easily perforated and permits the application of a second cap.

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: A connection base portion of a stripping solution unit storing a stripping solution is connected to an insertion opening of a channel in an insertion portion of an endoscope. A distal end portion of the insertion portion formed with a distal end opening of the channel is attached, with a sealing film, to an opening in a top cover of a bacteria collection container with a filter inside to be sealed from outside. By suction operation of a syringe at a bottom of the bacteria collection container, the stripping solution is sucked into the insertion opening, flows out from the distal end opening through the channel, and is filtered through the filter. A medium is supplied to the filter for cultivation. A result of the cultivation is observed, and an evaluation result as to cleanliness is obtained from presence or absence of bacteria.

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 enzyme based nondestructive sensor for the qualitative detection of spoilage in seafood is provided wherein the sensor does not alter the physical composition of the seafood specimen. The sensor comprises a sampling matrix, at least three or more enzymes in contact with the sampling matrix, and at least one indicator compound in contact with the sampling matrix. The enzymes are capable of interacting with four target chemicals comprising putrescine, cadaverine, histamine and tyramine, which are located on the surface of the seafood specimen. The indicator compound is capable of changing the color of the sampling matrix thereby indicating a qualitative visually detectable color change. A method for the nondestructive detection of the quality of a seafood specimen at any given time and for determining the remaining usable shelf life of the seafood specimen is disclosed.

Abstract: An actuator for arrangement in contact with a biological solvent includes a housing with a wall which is permeable to the solvent and not permeable to a first solute and which contains micro-organisms for transforming a second solute into the first solute. The actuator further includes a deformable chamber connected to the housing which can increase in volume due to the solvent entering the housing by osmosis. An engine may make use of the actuator.

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: A biological soil detector is provided, the detector including: a solid support member; a specific indicator immobilized on the solid support member; and the solid support member and specific indicator positioned to contact liquid that has been used to contact a surface. The invention also provides a method for detecting biological soil on a surface, the method including the following steps: contacting the surface with a liquid; after the liquid has contacted the surface, contacting the liquid with the solid support member and the specific indicator; and inspecting the solid support member to determine whether the specific indicator has interacted with biological soil.

Abstract: An endoscope sterilization evaluation device is provided with an elongated hollow body having a hollow portion opened at opposite ends, the elongated hollow body simulating an endoscope having a tubular passage, an exterior member having a first housing portion in which a biological indicator for performing sterilization evaluation on the hollow body is housed, and a second housing portion in which a culture solution for cultivating germs attached to the biological indicator is housed, the exterior member also having at a predetermined position a communication passage for communication between the first housing portion and the outside, and a mount device for holding the communication passage in a state of communicating with the hollow portion, and mounting the exterior member to the hollow body.

Abstract: A biological indicator including a carrier and an indicator material, said indicator material adhering on the surface of the carrier, and having a contact portion being contact with the surface of the carrier and a non-contact portion being not in contact with the surface of the carrier, and wherein the carrier includes an adhering area having a adhering portion to which the indicator material adheres and a non-adhering area having an non-adhering portion to which the indicator material does not adhere.

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 soil detector and a method for detecting bio soil are provided. The biological soil detector has a solid support member; a specific indicator immobilized on the solid support member, the specific indicator having a material sensitive to the presence of blood; and the solid support and specific indicator positioned within or on a retaining member to readily contact a liquid that has been used to contact a surface. In the method for detecting bio soil, the method includes the following steps: contacting the surface with a liquid; after the liquid has contacted the surface, contacting the liquid with the solid support member and the specific indicator of the detector described herein; and inspecting the solid support member for a detectable response to determine whether the specific indicator has interacted with biological soil.

Abstract: A process challenge device (PCD) for determining the effectiveness of a microbial deactivation process that uses a vaporous deactivating agent (e.g., vaporized hydrogen peroxide) as a deactivating agent. The PCD includes first and second layers that are joined together to form (1) a chamber dimensioned to receive a biological and/or chemical indicator, and (2) first and second conduits fluidly connecting the chamber with a region outside the PCD. Each conduit has one end in communication with the region outside the PCD and another end in communication with the chamber. A removable seal member seals the biological and/or chemical indicator inside the chamber.

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: An enzyme based nondestructive sensor for the qualitative detection of spoilage in seafood is provided wherein the sensor does not alter the physical composition of the seafood specimen. The sensor comprises a sampling matrix, at least three or more enzymes in contact with the sampling matrix, and at least one indicator compound in contact with the sampling matrix. The enzymes are capable of interacting with four target chemicals comprising putrescine, cadaverine, histamine and tyramine, which are located on the surface of the seafood specimen. The indicator compound is capable of changing the color of the sampling matrix thereby indicating a qualitative visually detectable color change. A method for the nondestructive detection of the quality of a seafood specimen at any given time and for determining the remaining usable shelf life of the seafood specimen is 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: Device and method for sterility testing, in particular of pharmaceutical products, includes a closed sterility test system having at least two test containers, in each case having an integrated test filter, an outlet connecting branch arranged below the test filter and an inlet connecting branch which is arranged above the test filter and can be connected with a tube connection via a sampling device to a sample container. The tube connection of the test container in each case has a distributing component via which a fixed tube connection to an associated nutrient medium container is formed and can be used to feed an associated nutrient medium to the test container.

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: A device and method for detecting anthrax or other pathogens are disclosed. Individual self-contained monitoring devices of a monitoring system can be portable or stationary (e.g. installed in air ducts or plumbing of buildings) and can be part of a network of devices. Monitoring devices may be used for the detection of a variety of airborne or surface pathogens, including but not limited to anthrax, smallpox, and Salmonella. Bioamplification-coupled proteomics assays provide rapid and reliable detection of pathogens, with self-checking capabilities reducing or eliminating false positives and false negatives. Sample preservation capability allows pathogen samples to be preserved after detection for further testing. The device of the invention can be remotely operated by minimally trained technicians or security personnel.

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 apparatus for culture is provided, which apparatus enables to increase the ratio of a culture medium solution to the number of cells while keeping the density of the cells at a high level and diminishing the absolute number of the cells. The apparatus comprises a container having at least one concave part and at least one member (x) selected from the group consisting of a gelatinous material, a sponge material, and a mesh material, wherein the member (x) is placed within the concave part of the container, has at least one hollow by which a part or parts of a surface of the container in the concave part is bared, and holds a solution containing culture medium components. Further, processes for preparing the apparatus, culturing methods that use the apparatus, a method for studying or observing an influence of a substance to be examined on cells or a piece of a tissue, a kit for making the apparatus, and a flat substrate for culture are provided.