Abstract: Embodiments of method of manufacturing an implantable pump, including providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber, providing a middle deflection layer adjacent the drug chamber, providing a bottom layer comprising electrolysis electrodes, and bonding the upper layer, middle deflection layer, and bottom layer to form the pump.

Abstract: A sterilization system that includes a sensor for determining the concentration of a liquid sterilant in a sterilant fluid. The sterilant fluid is comprised of a blend of sterilant fluids from a plurality of sterilant supplies. The concentration of the liquid sterilant differs in each of the sterilant supplies. The sensor allows a controllable concentration of liquid sterilant to be supplied to a vaporizer.

Abstract: The present invention relates to methods of making a sterilized biosensor, where the biosensor comprises at least one binding reagent, which comprises at least one non-enzyme proteinaceous binding domain. Certain embodiments of the methods described herein comprise partially assembling the components of the biosensor, except for the binding reagent, and separately sterilizing this partial assemblage and the binding reagent. The sterilized binding reagent and the sterilized partial assemblage are then aseptically assembled to produce the sterilized biosensor. Other embodiments of the methods described herein comprise assembling substantially all of the components of the biosensor, including the binding reagent, and sterilizing the assembled biosensor to produce a sterilized biosensor.

Abstract: An apparatus and method for use in sterilizing a surgical instrument is provided. The apparatus includes a surgical instrument that includes a housing having a shaft extending therefrom. The shaft includes one or more grooves defined therein that extends at least partially along the length thereof. The one or more grooves is configured to allow a sterilant passage therethrough. The apparatus also includes a jacket that encloses the shaft and allows the sterilant to travel along the one or more grooves.

Abstract: A method for cleaning and sterilizing a medical device comprises the steps of: placing the device into a container; cleaning the device in the container with a cleaning solution; rinsing the device in the container with a rinse solution; and vaporizing a liquid substance in the container to create a sterilant vapor and contacting the device with the vapor to effect sterilization of the device.

Abstract: A process is provided for sterilizing brachytherapy devices with Ethylene Oxide gas and releasing the devices on a parametric release basis. Devices that can be sterilized with this process include interstitial radiation seed strand implants and the needles used for implantation. In order to be sterilized effectively by EtO gas, the devices are constructed such that surfaces not readily infused with EtO gas are made to be gas permeable, and will not retain the gas after the sterilization process. Performance qualification of the sterilization process is performed through physical and microbiological studies, and set of established physical process parameters. Maintaining the physical process parameters in subsequent sterilization cycles will consistently yield the desired sterility assurance level without having to test the devices for sterility.

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 efficiacy over a broad temperature range (20 to 55° C.) and shows good material compatibility.

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: An antioxidant combined with UHMWPE prior to subjecting the UHMWPE to crosslinking irradiation. In one exemplary embodiment, the antioxidant is tocopherol. After the antioxidant is combined with the UHMWPE, the resulting blend may be formed into slabs, bar stock, and/or incorporated into a substrate, such as a metal, for example. The resulting product may then be subjected to crosslinking irradiation. In one exemplary embodiment, the UHMWPE blend is preheated prior to subjecting the same to crosslinking irradiation. Once irradiated, the UHMWPE blended product may be machined, packaged, and sterilized in accordance with conventional techniques.

Abstract: A hydrogen peroxide vapor generation unit (10) receives hydrogen peroxide and water solution at an interface (20) and interconnects with an air dryer (14) by way of nipples (72, 92). In one embodiment, the dryer includes a clamping assembly (42) which is latched (74, 94) with the nipples and which receives a disposable desiccant cartridge (40). In an alternate embodiment, a reusable desiccant cartridge (40?) is connected directly to the nipples (72, 92). When the desiccant cartridge (40?) is saturated, it is removed and placed in a regenerator unit (120). A regenerated cartridge is installed in its place.

Abstract: A method for disinfecting or sterilizing an article comprising enclosing the article or article part inside a container having a wall of which at least a part is a semipermeable fabric or membrane and introducing an amount of vaporizable biocide, preferably hydrogen peroxide in water, to the interior of said container in solution, vapour, liquid or preferably nebulant form. The semipermeable fabric or membrane is selected to allow the biocide to pass from inside to outside of the container as a vapour at atmospheric pressure and to provide a barrier against entry of micro-organisms. The biocide is allowed to exit the container through said membrane while at or above atmospheric pressure, a fluid eg air is directed to flow adjacent the outside of the membrane to expedite vapour removal from the interior side. The article is exposed to the biocide for a time sufficient to disinfect or sterilize the article.

Abstract: The present invention pertains to methods utilizing ozone treatment for abating allergens, pathogens, odors, and volatile organic compounds. The methods can be employed to abate pollutants, bacteria, viruses, mold, dander, funguses, dust mites, animal and smoke odors, and the like. The methods employ specific combinations of ozone concentration, hydrogen peroxide concentration, temperature, and humidity delivered over a specified period of time to achieve satisfactory abatement of the allergen, pathogen, odor, or volatile organic compound.

Abstract: The present invention provides an aqueous solution for sterilizing and storing ophthalmic devices, preferably a contact lens, made of a hydrogel material, preferably a poly(oxyalkylene)-containing hydrogel material. The solution comprises one or more organic buffer agents, such as a Good buffer or a bis-aminopolyols; an organic tonicity-adjusting agent with multiple hydroxyl groups in an amount sufficient to provide an osmolarity of from about 200 to about 450 mosm/l, wherein the aqueous solution has a pH of from about 5.5 to about 8.5, provided that the aqueous solution include phosphate buffer at a concentration of about 15 mM or less and about 5000 ppm sodium chloride. The present invention also provides a method for sterilizing and storing an ophthalmic device using an aqueous solution of the invention.

Abstract: A method of decontamination includes generating a decontamination gas by evaporating an aqueous solution in which the decontamination gas with a higher boiling point than water is dissolved. The decontamination gas is charged into a hermetically sealed decontamination chamber, and then condensed therein. A condensed liquid layer is formed in a form of a thin film on an outer surface of a decontamination subject in the hermetically sealed decontamination chamber. The condensed liquid layer is evaporated at least partially by supplying unsaturated gas into the hermetically sealed decontamination chamber. The unsaturated gas does not saturate in the hermetically sealed decontamination chamber. The decontamination gas is re-condensed after the evaporating step to re-form the condensed liquid layer, by closing supply of the unsaturated gas and re-charging the decontamination gas into the hermetically sealed decontamination chamber.

Abstract: An apparatus for sterilizing a sealable enclosure includes a circuit for flow of a sterilizing gas or gasses. The circuit is connected to the enclosure to be sterilized to form a closed circuit and pumps to circulate gas through the circuit and enclosure. The circuit has parallel branches one of which contains apparatus to deactivate a sterilant to be added to the carrier gas flowing through the circuit and apparatus to dehumidify the gas. The other branch contains apparatus to heat the gas and apparatus to supply a sterilant vapor or vapors to the gas. Control apparatus determines which of the parallel branches the gas flows through. The control apparatus maintains flow through one branch passage until the relative humidity falls below a predetermined level. The flow through that branch is then terminated and flow through the other branch initiated.

Abstract: New and in-use fire sprinkler systems can be sterilized by employing antimicrobial gases. The gases include steam, oxygen, and chlorine. Water added to the system after sterilization can be sterilized to prevent the reoccurrence of microbiological contamination.

Abstract: A process is provided for the disinfection of activated carbon. The process comprises contacting contaminated carbon with peroxide-containing materials for a sufficient amount of time using enough peroxide to provide effective disinfection in a process that is relatively non-hazardous, convenient, and carbon-friendly.

Abstract: A sterilization system uses a sterilization process monitoring device which is capable of indicating the efficacy of the sterilization process. To enhance accuracy of the monitoring function, the monitoring device is located in such a fashion that an antimicrobial agent used in the process can only reach the monitor through an area containing the article to be sterilized.

Abstract: A device and method for cleaning and sterilizing tubular structures particularly, long, narrow tubular structures such as lumens of a medical device such as an endoscope by reversing the flow of fluid in interconnected tubular structures. The device comprises a first and second valve in fluid communication with a first and second tubular structure. The valves selectively switch between a first and second position causing a first and second flow path within the tubular structures, at least a part of the second flow path opposite the first flow path.

Abstract: A sterilization system and process is provided which is useful in the chemical sterilization of medical supplies and equipment. The system includes a container having an internal generator of a sterilant such as chlorine dioxide. An internal container activator, such as high humidity or manual manipulation, is provided and stimulates the formation and release of the sterilant. The package includes a first indicator responsive to the release of sterilant and a second indicator which records the passage of a predetermined time interval. The combination of the sterilant indicator and the time interval indicator signals that proper sterilization conditions have been met and that the objects have been suitably sterilized.

Abstract: Adhesive compositions, particularly medical adhesive compositions, often include several components that may react differently to different sterilization processes, particularly when combined with one another. The present invention is directed to methods of sterilizing different components or groups of components of a final adhesive composition. The different components or groups of components may be sterilized in separate containers before packaging the components or groups of components within a kit, and thereafter sterilizing the kit.

Abstract: The present invention provides a mixture and method for remediating air dispersed biological particles. The mixture contains a carrier, an active biocidal ingredient, and a deliquescent which are mixed, heated and then grinded into biocidal particles approximately 1-50 microns in size. The biocidal particles are then dispersed into the air infected with biological particles using an aerosol generator and similar device. The biocidal particles may be charged to attract the biological particles and the carrier assists in attaching to the biological particles. Upon exposure to ambient humidity the deliquescent dissolves and allows the active biocidal ingredient to react creating a chemical byproduct which attacks and remediates the biological particles. The present invention may utilize two mixtures with two separate active biocidal ingredients which react with one another to create the desired chemical byproduct such as chlorine dioxide. The chemical byproduct may be hydrogen peroxide.

Abstract: A method for cleaning and sterilizing a medical device comprises the steps of: placing the device into a container; cleaning the device in the container with a cleaning solution; rinsing the device in the container with a rinse solution; and vaporizing a liquid substance in the container to create a sterilant vapor and contacting the device with the vapor to effect sterilization of the device.

Abstract: Methods are provided for quenching undesired side reactions of pathogen inactivating compounds in biological materials. In a particular embodiment, methods are provided for quenching undesired side reactions of a pathogen inactivating compound that includes a functional group which is, or which is capable of forming, an electrophilic group. In this embodiment, the material is treated with the pathogen inactivating compound and a quencher, wherein the quencher comprises a nucleophilic functional group that is capable of covalently reacting with the electrophilic group. The electrophilic group on the pathogen inactivating compound is preferably a non-radical cationic group. In one embodiment, the pathogen inactivating compound includes a nucleic acid binding ligand and a mustard group, wherein the mustard group is capable of reacting in situ to form the electrophilic group. Preferred quenchers are thiols, such as glutathione.

Abstract: The present invention is directed to new and improved solutions for packaging contact lenses and to methods for treating contact lenses with such solutions to improve the comfort of the lenses during wear. In particular, the present invention is directed to packing solutions comprising certain non-ionic surfactants containing a poly(oxyalkylene) copolymer and having a molecular weight of 4000 to 30,000. Such surfactants are retained on the surface of an unused lens for extended periods of time, resulting in surface modification that persists in the eye, thereby providing significant improvement in the wetting properties of fresh contact lenses used for the first time and, moreover, even several hours after lens insertion, preventing dryness and improving lubricity.

Abstract: The present invention relates generally to the sterilization and disinfection of agricultural and botanical products such as botanical powders. More particularly, the present invention is directed towards the use of HBS technology whereby contaminated agricultural products are contacted, at ambient pressure, with an oxidant such as nascent oxygen or hydroxyl radicals thus resulting in the oxidization and destruction of the contaminating microorganisms.

Abstract: A chemical vapor sterilization process is enhanced by flowing a portion of the sterilant vapor through an instrument container using a normal portion of the exhaust process. Preferably, an exhaust conduit which draws a vacuum on a sterilization chamber is oriented so that the container is adjacent an inlet to the conduit.

Abstract: A system and method for sterilizing to a desired level a food packaging area or room including the associated atmosphere that can be automated is provided. The method includes introducing the sterilizing agent as an aerosol suspension into the atmosphere of the food packaging area and exposed surfaces in the area, and then distributing the sterilizing agent to contact the surfaces therein that are to be sterilized with the sterilizing agent. The method may also include condensing the aerosol suspension to form a thin liquid film containing the sterilizing agent on exposed and nonexposed surfaces in the area or room to thereby effect sterilization of those surfaces.

Abstract: A unit for sterilizing strip packaging material for a pourable food product packaging machine, and having a sterilizing chamber for containing a liquid sterilizing agent and along which the packaging material is fed; a control circuit for controlling the sterilizing agent, and in turn having a collecting tank, input means for feeding the sterilizing agent from the tank to the chamber, and a drain assembly for draining the sterilizing agent from the chamber into the tank; a control system for controlling the temperature in the chamber; and preheating system for preheating the sterilizing agent in the tank, and which may be activated prior to feeding the sterilizing agent from the tank into the chamber; the preheating system for preheating the sterilizing agent may be activated independently of the control system for controlling the temperature in the chamber to bring the sterilizing agent to a temperature at least equal to that of the chamber before the sterilizing agent is fed into the chamber.

Abstract: Apparatus is provided for the sterilization of Prion infected surgical tools and the method for such sterilization includes disposing Prion infected surgical tools in the chamber, evacuating the chamber and introducing ozone into the chamber for a period of time sufficient to oxidize Prion amino acids. During this exposure the tools are agitated in order to insure all surface areas are exposed to the ozone. Following sterilization the ozone and sterilized tools are removed from the chamber.

Abstract: The present invention provides a hydrogen peroxide indicator and a peracetic acid indicator that include a substrate on which is disposed an indicator composition that includes at least one of a select group of colorants and a transition metal salt. As a result of exposure to hydrogen peroxide and/or peracetic acid, the colorants change color, and even become colorless, thereby providing an indication of the presence of hydrogen peroxide and/or peracetic acid.

Abstract: The present invention relates generally to the sterilization and disinfection of agricultural and botanical products such as botanical powders. More particularly, the present invention is directed towards the use of HBS technology whereby contaminated agricultural products are contacted, at ambient pressure, with an oxidant such as nascent oxygen or hydroxyl radicals thus resulting in the oxidization and destruction of the contaminating microorganisms.

Abstract: The present invention relates to a two-part or multi-part concentrate system for preparing an activated solution which can be diluted with water to a use-dilution solution having improved anti-corrosive properties at room temperature. The concentrate system contains a first component containing at least one oxidizing agent, preferably hydrogen peroxide and a second component containing at least formic acid in a concentration of about 25 wt %. At least one corrosion inhibitor and at least one surfactant are also included in the concentrate system. When mixed and diluted, the resulting solution is excellent in its sterilization and anti-corrosive properties.

Abstract: An anticorrosive, penetration enhancing composition for cleaning decontaminating and rinsing includes electrochemically activated (ECA) water as the decontamination agent. The anticorrosive decontamination composition has, as the anticorrosive agent, a compound or mixture of compounds capable of inhibiting corrosion of various metals used in sterilization decontamination and rinsing systems and objects such as medical instruments. Preferred anticorrosive compounds include phosphates, azoles, and sulfates. Other additives, including wetting agents, are added to reduce the surface energy of the ECA water. This reduced surface energy permits the ECA water to penetrate into objects of complex design thus permitting complete decontamination of the treated object.

Abstract: Balloons and balloon catheters with a superior overall combination of distensibility, elastic stress response and strength. The improved properties of the balloons result from the method or process used to form the balloons, as well as the polymeric materials used in said balloon forming process. Additionally, the enhanced combination of properties of the balloons will not be adversely affected by the novel sterilization process contemplated by this invention.

Abstract: The invention relates to a shelf stable liquid disinfectant concentrate composition containing at least 1% by weight of a quat biocide (biocidally active quaternary ammonium compounds) and capable of dilution with 20 parts of water to 1 part of concentrate to produce a diluted solution, the diluted solution exhibiting a MIC after 24 hours in the presence of up to 2% tryptone (or the protein equivalent thereof) which is less than the MIC of a simple solution of the same concentration of the same quat biocide in water in the presence of the same concentration of the protein. The biocidal efficacy of the quat biocide may be protected by an “activity protector” selected from the group consisting of “enzyme stabilisers”, “enzyme stabilising systems”, micelle formation modifiers and inhibitors, and combinations thereof. The invention also relates to a disinfectant working solution prepared from the concentrate, and to a method of protecting a quat biocide from deactivation.

Abstract: The presently disclosed disinfection process for use in the processing of foodstuffs is designed as an intervention step in poultry processing to allow for continuous on-line processing of poultry carcasses that may have accidentally become contaminated during the evisceration process. Such on-line processing is designed to replace the need for off-line manual washing and cleaning of the contaminated carcasses. By eliminating such off-line manual washing, food safety will be enhanced due to the elimination of the physical handling of carcasses and the cross-contamination that may result from such physical handling. An additional benefit is that the production process will also be able to run with a reduced number of interruptions, which will result in a more efficient production process.

Abstract: This invention relates to a method and apparatus for using ozone to disinfect and decontaminate infectious microbial agents including mold in a building or container. This invention contemplates treating biological and viral agents with ozone containing gases.

Abstract: This invention provides oil soluble sulfhydryl compound scavengers which are salt compositions of the formula: Mn+(R—CO2−)x(OH)n−x wherein M is a metal ion whose sulfide salt is less than 0.1% soluble in water, n is 2 or 3, x is an integer from 1 to n, and R a hydrocarbyl radical containing from about 4 to about 19 carbon atoms, or mixture of these compositions. A method is also provided to control odors produced by sulfhydryl compounds wherein the he said sulfhydryl compounds are contacted with the metal salts described above.

Abstract: A sterilization system employs an attachable/detachable container to which is connected a source of sterilant for sterilizing items within the container. When disconnected from the source of sterilant the container is sealed from microbial ingress.

Abstract: A unitary container housing having a plurality of sealed compartments each containing a dry composition which will gradually release an antimicrobially active gas upon exposure to moist air, and each compartment being separately openable to expose its contents to the environment, and a method of using the same.

Abstract: The present invention relates to the use of a cleaning composition concentrate in particular for the mechanical cleaning of medical and/or surgical instruments and/or apparatuses and to a process for carrying out this cleaning.

Abstract: Apparatus and methods are disclosed for decontaminating mail. The preferred embodiment includes a sealable container of sufficient size to hold one or more pieces of mail. A chamber, in gaseous communication with the container, holds a quantity of oxidizer material, and a heater is used to raise the temperature of the oxidizer to form a disinfecting gas that permeates the mail. The oxidizer material is preferably a liquid such as chlorine dioxide or hydrogen peroxide. The apparatus may further include a timer so that the oxidizer is heated for a desired period of time, a pressure relief valve, and/or an indicator responsive to the pressure within the container when sealed.

Abstract: Solid sanitizing compositions have advantages over corresponding liquids and powders. A solid sanitizing product can be contained within a plastic bottle with a label indicating that the contents have antimicrobial or deodorizing properties containing a non-flowable solid composition having greater than about 0.02 percent by weight antimicrobial compounds. The preferred solid sanitizing compositions consist essentially of an antimicrobial compound selected from the group consisting of quaternary ammonium salts, fatty amines and diamines, chlorhexidine gluconate, phenol, derivatives of phenol, parachloro metaxylenol and mixtures thereof, and between 0 and 99.98 percent by weight of a cleaning composition. The solid sanitizing compositions can be effectively used with solid dispensers. The solid dispensers have a bowl with a drain at the bottom and an upward pointing spray nozzle.

Abstract: Disclosed is a method of producing a shaped article suitable for use as the load bearing component of a prosthetic device formed from ultrahigh molecular weight polyethylene. polyethylene.

Abstract: The present invention relates to a disinfecting composition comprising a first component as peracetic ion precursor, and a second component as source of peroxide. The invention also relates to a method for disinfecting and/or sterilising the water line of a dental unit. The method comprises the steps of: preparing an aqueous solution comprising peracetic ions as active agent; introducing in the water line of the dental unit a portion of the aqueous solution comprising the peracetic ions; allowing the portion of aqueous solution comprising the peracetic ions to act; and flushing the water line with an aqueous rinsing solution.

Abstract: A washing vessel capable of housing an endoscope is formed in an apparatus body. A washing solution containing a detergent is spurted against the endoscope arranged within the washing vessel for washing the endoscope. Also, an oxide-based disinfecting-sterilizing solution is supplied into the washing vessel for disinfecting-sterilizing the endoscope after the washing step together with the washing vessel.

Abstract: A sterilization system (14) includes a sensor (10) for detection of a component, such as hydrogen peroxide vapor, in a multi-component vapor, such as a mixture of vapor hydrogen peroxide and water supplied to a chamber (12) of the system. The sensor preferably uses a wavelength range in which hydrogen peroxide strongly absorbs but other components of the vapor, such as water, do not. A suitable wavelength for detection of hydrogen peroxide is from about 7500 to about 8400 nm, since there is little absorption by water in this range. This avoids the need to use complex subtraction procedures normally used to remove the contribution of water from detected absorbance measurements. A control system (16, 30) controls operating conditions of the sterilization system, such as a heater (82), pressure release valves (74), vaporization rate of hydrogen peroxide by a vaporizer (22), and the like to maintain optimum sterilization conditions within the chamber.

Abstract: A method of sterilizing absorbable sutures using a sterilant gas such as ethylene oxide gas. The method utilizes a first degassing step, and a second degassing step at elevated temperatures to remove residual sterilant gas, diluent gas, by-products and moisture.

Abstract: The present invention is directed to new and improved solutions for packaging contact lenses and to methods for treating contact lenses with such solutions to improve the comfort of the lenses during wear. In particular, the present invention is directed to packing solutions comprising certain non-ionic surfactants containing a poly(oxyalkylene) copolymer and having a molecular weight of 4000 to 30,000. Such surfactants are retained on the surface of an unused lens for extended periods of time, resulting in surface modification that persists in the eye, thereby providing significant improvement in the wetting properties of fresh contact lenses used for the first time and, moreover, even several hours after lens insertion, preventing dryness and improving lubricity.