Abstract: There is provided a method and apparatus for operating a sterilization chamber such that one version of Programmable Logic Controller (PLC) software is compatible with any number of hardware configurations of the sterilization chamber. The PLC software is divided into a core module for operations which are the same across all hardware configurations, and a template module for hardware specific operations. Configuration data, state data, and live data are segregated from each other.

Abstract: The present disclosure provides a microbiological treatment system including a hydration system and microbiological degradation systems. The hydration system may include a gas-liquid mixing chamber, a gas inlet, a gas outlet, a liquid inlet, and a liquid outlet, the latter four being fluidly coupled to the chamber. The gas inlet is configured to introduce an ethylene oxide exhaust gas into the chamber to mix with an aqueous solution to form an ethylene oxide exhaust liquor. The liquid outlet is configured to discharge the ethylene oxide exhaust liquor. Each microbiological degradation system may include a degradation chamber containing degradation bacteria including one of anaerobic bacteria, facultative bacteria, or aerobic bacteria. The degradation chambers of the microbiological degradation systems may be in fluid communication sequentially in a predetermined degradation sequence, with the most upstream in the degradation sequence having a liquid inlet in fluid communication with the liquid outlet.

Abstract: The present disclosure discloses systems and methods for treating ethylene oxide waste gas. The system for treating ethylene oxide waste gas includes a compounding treatment assembly, an adsorption treatment assembly, and a hydration treatment assembly. The compounding treatment assembly includes a compounding tower to contain a compounding substrate, a first gas inlet, and a first gas outlet. The adsorption treatment assembly includes an adsorber to contain an adsorbent, a second gas inlet, and a second gas outlet. A first connecting pipe connects the first gas outlet with the second gas inlet. The hydration treatment assembly includes a hydration tower to contain water, a third gas inlet, and a third gas outlet. A second connecting pipe connects the second gas outlet with the third gas inlet and an exhaust pipe in communication with the third gas outlet exhausts the gas from the hydration tower.

Abstract: The present disclosure discloses systems and methods for treating ethylene oxide waste gas. The system for treating ethylene oxide waste gas includes a compounding treatment assembly, an adsorption treatment assembly, and a hydration treatment assembly. The compounding treatment assembly includes a compounding tower to contain a compounding substrate, a first gas inlet, and a first gas outlet. The adsorption treatment assembly includes an adsorber to contain an adsorbent, a second gas inlet, and a second gas outlet. A first connecting pipe connects the first gas outlet with the second gas inlet. The hydration treatment assembly includes a hydration tower to contain water, a third gas inlet, and a third gas outlet. A second connecting pipe connects the second gas outlet with the third gas inlet and an exhaust pipe in communication with the third gas outlet exhausts the gas from the hydration tower.

Abstract: The invention pertains to analyte sensors designed to include layered compositions that provide these sensors with enhanced functional and/or material properties including, for example, resistance to damage caused by ethylene oxide during sterilization processes. Embodiments of the invention include polyvinyl alcohol N-methyl-4(4?-formylstyryl)pyridinium (SbQ) polymer materials and methods for employing such materials during the ethylene oxide sterilization of glucose sensors.

Abstract: Provided are methods for decontamination of compartments, such as aircraft compartments and other types of compartments, and systems for implementing these methods. In some embodiments, a method involves detecting presence of one or more contaminants in a compartment. This information is used to select various decontamination conditions. In some embodiments, additional information, such as the type of the compartment (e.g., an aircraft compartment), temperature, and humidity, may be also considered while selecting the decontamination conditions. The decontamination conditions include identification of one or more decontaminating agents to be dispensed in the compartment, temperature profile of the air to be flown into the compartment, and timing of the decontaminant dispensing and air flowing operations. These conditions are selected to increase efficacy of the selected decontaminating agents with respect to the one or more detected contaminants and reduce impact on the aircraft compartment.

Abstract: The present invention suppresses the strength reduction or degeneration of a tissue after the tissue is dried and/or sterilized, for the tissue comprising biological components and the like. Specifically, biological tissue is immersed in a trehalose solution and shaken, thereby impregnating the biological tissue with the trehalose solution. The trehalose solution used here is one obtained by dissolving trehalose in a phosphate buffered saline, the concentration of trehalose being preferably in the range of 20 wt % to 35 wt %. Thereafter, the biological tissue is dried to remove moisture in the biological tissue, and sterilized with ethylene oxide gas.

Abstract: Methods and devices for gas sterilization are described, in which products are sterilized using a sterilization gas. Process gases are mixed in a mixer without movable parts before being introduced into the sterilization chamber in order to obtain a homogenous gas mixture. A device for the gas sterilization of products comprises a mixer without movable parts and a sterilization chamber. The sterilization chamber has at least one inlet opening and at least one outlet opening. The mixer is arranged such that it is connected via a first line, which leads into a first opening in the mixer without movable parts, with the at least one outlet opening of the sterilization chamber and is connected via a second line, which leads into a second opening in the mixer without movable parts, with the at least one inlet opening of the sterilization chamber. A third gas supplying line leads into a third opening in the mixer.

Abstract: This invention provides a method for processing produce to reduce microorganisms thereon by treating the produce in a treatment chamber. The method comprises exposing the produce to an atmosphere comprising gaseous chlorine dioxide and a carrier gas in a treatment chamber and can comprise controlling the concentration of chlorine dioxide in the treatment chamber, moving the produce in the treatment chamber during exposure to the gaseous chlorine dioxide, spraying water to remove the gaseous chlorine dioxide, and purging the treatment chamber to remove any residual chlorine dioxide.

Abstract: In one aspect, there is provided assembling an analyte sensor with an analyte sensor insertion device, packaging the assembled analyte sensor and sensor insertion device in a substantially airtight seal, and irradiating the packaged assembled analyte sensor and sensor insertion device at a predetermined dose using one or more electron beam accelerators.

Abstract: A concentrated liquid sanitizing and rinse composition containing peroxycarboxylic acid(s) and compatible rinse aid surfactants is disclosed. The sanitizing and rinsing compositions are formulated in a single liquid concentrate, replacing a traditional dual product of a sanitizer and rinse aid. The sanitizing and rinsing chemistries are particularly effective at neutral pHs against gram negative organisms at elevated temperatures. Methods of using the concentrated liquid sanitizing and rinse composition are also disclosed.

Abstract: Treating absorbable sutures that have been sterilized using ethylene oxide with carbon dioxide at or near its supercritical pressure and temperature conditions to remove any residual ethylene oxide.

Abstract: Syringe assemblies comprising a first cap and a second cap to ensure sterilization of the fluid path without the need for external packaging are described. Also described are methods of sterilizing the fluid path of a syringe assembly.

Abstract: The present invention relates to a method for disinfecting a room and the objects that may be contained therein, or surfaces in general, including the following steps: (a) determining the volume of the room to be disinfected; (b) as a function of the value determined in step a) above, determining a volumetric concentration of an aqueous disinfecting solution delivered into the room in the form of a dry mist required for obtaining a predefined level of disinfection, said disinfecting solution comprising hydrogen peroxide and silver ions (Ag+); (c) delivering into the room said aqueous disinfecting solution in the form of a dry mist until the desired volumetric concentration is achieved; (d) keeping said aqueous disinfecting solution in the form of a dry mist in contact with the room and with the objects that may be contained therein for a predefined time, so as to achieve a desired level of disinfection.

Abstract: An article for sequential dispensing of vapors, notably evaporable fragrances, comprises separated first and second liquids (22, 24). Liquid (22) issues first. Its evaporation may be assisted by a wick (26). The simultaneous evaporation of the second liquid is prevented by an intermediate liquid phase (20). As liquid (22) issues the liquid levels change and there comes a point at which the intermediate phase can no longer prevent the second liquid (24) from flowing past it, to the region from which it can be evaporated. Solids, especially gels, may be employed instead of liquids (22, 24).

Abstract: Sterilization methods for implantable prostheses are described, where a polymeric stent may be sterilized, e.g., via ETO sterilization, at a temperature below a glass transition temperature of the stent. A separate delivery catheter may be sterilized separately and the stent and delivery catheter may then be combined in an aseptic, or semi-aseptic environment and sterilized as an assembled system such that the requirements for sterilizing the system are relatively lower. Additionally and/or alternatively, valve and filter assemblies may be used with an optional mandrel assembly for maintaining sterility of the internal components of a catheter system.

Abstract: The present invention relates to a process for sterilizing implantable biomaterials. In particular, the invention relates to a process for sterilizing collagen-containing implantable biomaterials and storage thereafter.

Abstract: This invention concerns a hydrogen peroxide sterilization device, with injection of hydrogen peroxide vapor, provided with a vaporizer that feeds a sterilization chamber, with a dose that varies in function of the control performed by a computer or control unit. The vaporizer works with a pressure inferior to the atmospheric one and is heated by an electrical resistance heater, or by micro-waves. All the vaporization process is made in vacuum, by heat or ultra-sounds. The filling of the sterilant agent is made drop-by-drop by a capillary tube which transforms the liquid into a pulverized gas. The computer controls the electrical valve following the dosing pump from the pressure and/or temperature information that comes from various pressure and/or temperature sensors, whereby the pressure inside the chamber is maintained during the sterilization process in a constant predefined value, appropriate to use simple cellulose-base paper or paper composed to the packaging of the devices.

Abstract: The invention relates to a method for providing an aseptic chromatography column, said method comprising the steps of: pre-sterilize an empty chromatography column; pre-sterilize a chromatography medium; introducing the pre-sterilized chromatography medium into the pre-sterilized chromatography column using aseptic equipment, thereby providing an aseptic chromatography column comprising chromatography medium.

Abstract: A method for manufacturing of ultrahigh molecular weight polyethylene (UHMWPE) for implants, where the implants have been machined out of UHMWPE blocks or extruded rods, has anthocyanin dispersely imbedded in the polyethylene. The implant is then exposed to ? ray or electron beam irradiation in an amount of at least 2.5 Mrad followed by a heat treatment to prevent the implant from becoming brittle in the long term as well as to improve strength and wear. The method includes mixing a powder or granulate resin of UHMWPE with an aqueous liquid that contains anthocyanin in a predetermined amount. The water is then evaporated to deposit the anthocyanin in a predetermined concentration on the polyethylene particles. The doped UHMWPE particles are compressed into blocks at temperatures in a range of approximately 135° C.-250° C. and pressures in a range of approximately 2-70 MPa. Medical implants are made from the blocks.

Abstract: An implant is set forth having at least one first element and a second element, wherein the first element is provided in a pre-determined relative location to the second element, in particular at least partly in a recess of the second element. The first element has a pre-positioning location having play with respect to the second element and allowing a fully area gas sterilization of both elements and can be displaced from this pre-positioning location into an end positioning location corresponding to a fixed connection of both elements.

Abstract: Methods of sterilizing medical devices, particularly stents, that include a polymer with ethylene oxide. The polymer may be in the device body or a coating on the device. The method entails exposure such that the temperature of the device does not exceed the glass transition temperature of the polymer in the wet stage, that is as plasticized by the sterilant. The sterilant may include water vapor.

Abstract: A method of sterilizing a closed environment is provided in which a disinfection apparatus is placed into the closed environment; it then generates ozone to a predetermined ozone concentration, following which the humidity of the closed environment is rapidly increased. A catalytic converter then reduces the ozone concentration to safe levels. When the ozone concentration is reduced to a predetermined safe level, the disinfection apparatus signals.

Abstract: A pre-assembled orthopaedic implant adapted for improved gas sterilization. The implant includes a first component adapted for assembly with a second component such that a mating surface of the first component is in close proximity with a mating surface of the second component. At least one gas conduit associated with the mating surface of the first component facilitates a sterilizing gas to penetrate into and dissipate from the interface defined by the mating surfaces.

Abstract: A process wherein outgassing rates of volatile organic compounds (VOCs) in an object, particularly habitable vehicles, are accelerated by placing the subject object in a vacuum chamber and placing heat sources either inside the object being treated, outside the object, or both. The process includes measuring and monitoring the temperature of selected surfaces inside the object being treated. The heat sources are adjusted to maintain a temperature which is safe for the materials and which will promote maximum outgassing rates. During the treatment process, while a vacuum and heat are being applied to the subject object, the gasses in the chamber are monitored for both their composition and quantity. When the outgassing rates of the VOCs reach acceptable levels, the process cycle is terminated. The vacuum in the chamber is broken to restore atmospheric pressure, and the object being treated is removed from the chamber.

Abstract: The present invention relates to the use of a composition comprising (a) at least three different amino acids, (b) at least two different amino acids and a saponin or (c) at least one dipeptide or tripeptide for stabilizing biomolecules immobilized on a solid carrier. The invention furthermore relates to a method for producing stabilized biomolecules, comprising embedding the biomolecules in the composition according to the invention and a method of producing a solid carrier having biomolecules attached thereto. The invention furthermore relates to a solid carrier producible or produced by the method of the invention and a method of diagnosing a disease using the carrier of the invention.

Abstract: The present invention, inter alia, relates to a closed sterilized container comprising at least one carrier which is a stabilizer; and at least one biomolecule reversibly attached to the carrier, wherein said carrier partially or completely covers the attached biomolecules and wherein said at least one carrier is selected from the group consisting of (poly)peptides such as dipeptides or tripeptides, amino acids, polyalcohols, polyethyleneglycols, ionic liquids, compatible solutes, saponins and a mixture thereof. The invention also relates to methods for producing sterilized containers according to the invention and uses thereof.

Abstract: The invention relates to a new process for treatment of residual nucleic acids present on the surface of laboratory consumables. This process combines two treatment phases: i) Treating with ethylene oxide in gaseous phase; then ii) Treating said surface with hydrogen peroxide in liquid phase or in gaseous phase; The effect of this treatment is to avoid the amplification of said residual nucleic acids, in particular during PCR or TMA reactions.

Abstract: Skin antiseptic composition dispensers and methods of use are disclosed. The skin antiseptic composition dispenser may include a container with one or more walls that are substantially impermeable to ethylene oxide gas during normal ethylene oxide sterilization processes. In some embodiments, the container may include flexible walls free of metallic foil barrier layers. The containers may also include one or more vents in addition to one or more openings used to dispense the skin antiseptic composition within the container. The dispenser may include an applicator with a hydrophilic foam.

Abstract: A method which enhances a disinfection process by using a catalyst which increases in effective surface area during the process. Also disclosed are contact lens disinfecting systems which are designed to maintain a high concentration of hydrogen peroxide solution for a longer period of time before increasing the overall surface area of catalyst exposed to the hydrogen peroxide solution. The devices utilize pressure from expanding oxygen generated within the system through use of a small catalyst, or through exposure of only a small portion of a large catalyst, to control deployment of the large catalyst for completing disproportionation of the hydrogen peroxide.

Abstract: A method which enhances a disinfection process by using a catalyst which increases in effective surface area during the process. Also disclosed are contact lens disinfecting systems which are designed to maintain a high concentration of hydrogen peroxide solution for a longer period of time before increasing the overall surface area of catalyst exposed to the hydrogen peroxide solution. The devices utilize pressure from expanding oxygen generated within the system through use of a small catalyst, or through exposure of only a small portion of a large catalyst, to control deployment of the large catalyst for completing disproportionation of the hydrogen peroxide.

Abstract: A pre-assembled orthopaedic implant adapted for improved gas sterilization. The implant includes a first component adapted for assembly with a second component such that a mating surface of the first component is in close proximity with a mating surface of the second component. At least one gas conduit associated with the mating surface of the first component facilitates a sterilizing gas to penetrate into and dissipate from the interface defined by the mating surfaces.

Abstract: A highly stabilized hydrogen peroxide useful for chemical sterilization of packaging materials in high-speed aseptic packaging plants.

Abstract: The liquid composition is based on surfactants and enzymes, and is particularly useful for manual cleaning of instruments. In manual and ultrasonic application the composition in use concentration shows low foaming and gives a cleaning solution which is not cloudy at least at a temperature in the range from 16° C. to 40° C. In addition, the composition has good cleaning efficacy over a broad temperature range (20 to 55° C.) and shows good material compatibility.

Abstract: The invention relates to an injection device (1), which comprises a support housing (2), an activating sleeve (9), a cartridge (3) containing a medicine (14), a first drive unit (4), a safety device (5), a needle arrangement (6), a needle protection element (7) and a second triggerable drive unit (8), whereby the latter moves the needle protection element (7) from the non-effective position into the position covering one needle end (21) of a cannula (20). The support housing (2) is surrounded over most of its longitudinal extension between its distal and proximal end (11, 12) by the activating sleeve (9), whereby the needle protection element (7) with the second drive unit (8) cooperating therewith is arranged radially between the support housing (2) and the activating sleeve (9), as viewed in axial cross section.

Abstract: A pre-assembled orthopaedic implant adapted for improved gas sterilization. The implant includes a first component adapted for assembly with a second component such that a mating surface of the first component is in close proximity with a mating surface of the second component. At least one gas conduit associated with the mating surface of the first component facilitates a sterilizing gas to penetrate into and dissipate from the interface defined by the mating surfaces.

Abstract: The present invention relates to methods for making oxidation resistant medical devices that comprise polymeric materials, for example, ultra-high molecular weight polyethylene (UHMWPE). The invention also provides methods of making antioxidant-doped medical implants, for example, doping of medical devices containing cross-linked UHMWPE with vitamin E by diffusion and materials used therein.

Abstract: Disclosed are apparatus for delivery of a gas, e.g., carbon dioxide and/or chlorine dioxide, and methods of its use and manufacture. The apparatus includes a sachet constructed in part with a hydrophobic material. The sachet contains one or more reactants that generate a gas in the presence of an initiating agent, e.g., water. The apparatus can also include a barrier layer and/or a rigid frame. In another embodiment, the apparatus is combined with a reservoir that can be used to deliver a gas to the reservoir and, optionally, a conduit. In another embodiment, the apparatus is incorporated into a fluid dispersion system that includes a dispersion apparatus, e.g., a humidifier.

Abstract: The liquid composition is based on surfactants and enzymes, and is particularly useful for manual cleaning of instruments. In manual and ultrasonic application the composition in use concentration shows low foaming and gives a cleaning solution which is not cloudy at least at a temperature in the range from 16° C. to 40° C. In addition, the composition has good cleaning efficacy over a broad temperature range (20 to 55° C.) and shows good material compatibility.

Abstract: Disinfection of waste can be carried out by first cutting the waste into small pieces to expose surfaces in the waste and then simultaneously spraying the waste pieces with disinfectant and agitating them. The waste pieces are agitated by applying sufficient vacuum to suck the waste pieces through a processing system, the vacuum creating a wind inside the system that sweeps up the waste pieces, suspends them in air, and keeps them separate from one another, thereby exposing substantially all surfaces of the waste pieces to the sprayed disinfectant.

Abstract: A chemical vapor sterilization process is enhanced by concentrating a germicide via condensation and re-vaporization thereof, exploiting the difference between the vapor pressures of the germicide and its solvent to extract some of the solvent during the condensation process.

Abstract: A surface which carries a material which is infected with prions is cleaned with an alkaline cleaning solution to remove as much proteinaceous material as possible from the surface. The solution contains an alkaline cleaning agent which attacks prions remaining on the surface and which attacks prions removed from the surface during the cleaning step. After the cleaning step, the surface is exposed to a strong gaseous oxidant, preferably hydrogen peroxide vapor. The hydrogen peroxide or other strong oxidant attacks the prions, particularly the unclumped prion strands, deactivating the prions.

Abstract: The present invention overcomes the difficulties in the sterilization and delivery of viscous, multi-component compositions that require pre-mixing prior to usage by disclosing a sterile, multi-component, ready-to-use product wherein each component is sterilized independently and then assembled into a sterilized delivery kit. In certain preferred embodiments of the present invention, a sterile, polymerizable system is provided that comprises a plurality of sterile polymerizable monomers, said monomers having been sterilized by passing them through a filter; at least one sterile filler which has been exposed to conditions effective to render said filler sterile, and the sterile monomers and the sterile filler being blended together to form at least one substantially homogeneous blend contained within a sterile delivery vessel.

Abstract: Embodiments of passive vent valve devices are disclosed. One of the novel aspects of the invention is its ability to transform from a packaging configuration to a use configuration. The packaging configuration allows sterilization gases to penetrate into the device through standard valve openings as well as through vented mesh openings. Passage of gas into the device, in turn, provides a means of sterilizing all surface areas in the device. Alternatively, when the valve is placed in a use configuration, the passage of gas through the vented mesh is inhibited providing a sealed environment that functions as a valve. The invention is useful in manufacturing sterile medical devices by allowing all surfaces to communicate with the sterilizing agent when the valve is in a packaging configuration or when it is in a use configuration.

Abstract: Embodiments of luer-type needle-free valve devices are disclosed. One of the novel aspects of the invention is its ability to transform from an open state to a closed state. The open position eliminates the potential for a differential pressure to exist between the volume connected to the inlet and outlet of the valve fitting. The closed position enables the device to maintain a differential pressure between the volume connected to the inlet and outlet of the valve fitting. The invention is useful in manufacturing sterile medical devices by allowing all surfaces to communicate with the sterilizing agent when the valve is in an open configuration when it is in a closed position.

Abstract: Sterilization methods for implantable prostheses are described where a polymeric stent may be sterilized, e.g., via ETO sterilization, at a temperature below a glass transition temperature of the stent. A separate delivery catheter may be sterilized separately and the stent and delivery catheter may then be combined in an aseptic or semi-aseptic environment and sterilized as an assembled system such that the requirements for sterilizing the system are relatively lower. Additionally and/or alternatively, valve and filter assemblies may be used with an optional mandrel assembly for maintaining sterility of the internal components of a catheter system.

Abstract: A single-use sterilization container for use in the sterilization of medical instruments is provided. The sterilization container includes a lid having central portion defined by a frangible region. Upon activation of the frangible region, the central portion may be removed rendering the sterilization container inoperable for future use.

Abstract: As shown in FIG. 1 there is one embodiment of a fumigation apparatus in the form of a module (8) including a panel (10) which can be positioned in or at an opening of an enclosed space in use to define a fumigation chamber. Fumigant inlet means in the form of an orifice (12) are arranged in the panel (10) to allow a flow of a fumigant directly into the fumigation chamber. A nominal number of mixing fans, in this case two fans (16) and (18), thoroughly circulate gases within the fumigation chamber when operating. The module (8) includes a system control box (14) linked to the fumigant delivery orifice (12) and valve system which functions to control the flow of toxic gas into the fumigation chamber. The panel (10), when positioned in use, is secure against the passage of fumigant and gases by means of an inflatable rubber seal (22) which is located around a lip edge perimeter of the panel (10).

Abstract: The liquid composition is based on surfactants and enzymes, and is particularly useful for manual cleaning of instruments. In manual and ultrasonic application the composition in use concentration shows low foaming and gives a cleaning solution which is not cloudy at least at a temperature in the range from 16° C. to 40° C. In addition, the composition has good cleaning efficacy over a broad temperature range (20 to 55° C.) and shows good material compatibility.

Abstract: The invention relates to a method for priming a blood tubing set comprising a venous and an arterial line whose connections at the patient side are in communication with two separate inlets of a chamber of in particular a bag and whose connections at the machine side are in communication with a dialyzer comprising the steps: parallel filling of both the venous and the arterial line via a feed line so that priming liquid flows through both inlets into the chamber; and circulation of the priming liquid in the circuit of the lines, the dialyzer and the chamber via a pump so that one of the inlets of the chamber acts as an inlet and the other as an outlet. The invention likewise comprises a corresponding blood tubing set and a bag as well as methods for providing them.