Abstract: The invention provides methods and apparatus for treating hazardous biological wastes. According to one exemplary method, a biological waste material is placed into a chamber and a vacuum is applied to the chamber. After the pressure within the chamber is sufficiently reduced, water vapor is introduced into the chamber and electromagnetic radiation energy is applied to produce a plasma. In one particularly preferable aspect, the chamber is allowed to reach a static condition before the water vapor is introduced. In this way, the water vapor is able to equally distribute itself throughout the volume of the chamber so that an equally distributed plasma can be produced upon application of the electromagnetic radiation energy.

Abstract: A method is provided for sterilizing materials, particularly polymers, for drug delivery and implantation, wherein the material is treated with supercritical fluid carbon dioxide at pressures in the range of 2000 to 3000 psi (140 to 210 bar) and temperatures preferably between 30 and 45.degree. C. for periods between 20 minutes and six hours, more preferably between 0.5 and 2 hours. Agitation, pressure cycling, and the presence of water were found to enhance the sterilization method, which promotes diffusion of the supercritical fluid carbon dioxide into the cells of the microorganism to thereby alter the pH within the cells, killing them. The magnitude and frequency of the pressure cycling, as well as the process time and temperature, may vary according to the type and form of the material to be sterilized and the type of organisms to be killed.

Abstract: The invention relates to toilet seat, body support, non food surface, disinfecting, cleaning and sanitizing by using a liquid cleaning or sanitizing solution, in general, and to provide a liquid for manual application, and alternatively for spray application; using a brush or disposable dispensing spray apparatus that permits an individual to quickly sanitize, or disinfect the surface, such as a toilet seat, which solution will rapidly dry or evaporate to allow almost immediate body part to body support non food surface contact use.

Abstract: Apparatus for manufacturing articles including isolation structure isolating the first end of an article producing machine from the second end of the machine to permit a higher level of cleanliness to be established at the first machine end where the articles are actually manufactured than at the second machine end.

Abstract: A method for sterilizing an article in a diffusion restricted container includes placing the article in a diffusion restricted container with at least one communication port, placing the container in a vacuum chamber, introducing a vaporizable germicide into the container, and reducing the pressure in the vacuum chamber, generating germicide vapor and sterilizing the article. The article to be sterilized can be a diffusion restricted device, such as a hinge, a mated surface, or a lumen. The germicide may be peroxide or peracetic acid.

Abstract: A method for aerating an ethylene oxide-sterilized article, said method comprising exposing said article to at least one co-adsorbate under conditions such that said co-adsorbate remains vaporized, said co-adsorbate having a partial pressure under said conditions sufficient to displace at least a portion of ethylene oxide adsorbed by said article.

Abstract: The present invention provides a system for the decontamination of agricultural products by reacting the toxins and microorganisms, contaminating the product, with ozone. The ozone is generated on site and upon demand, thus eliminating ozone waste associated with long periods of ozone storage. The systems of the invention provide efficient, safe, and environmentally friendly use of ozone for product decontamination by optimizing the delivery of ozone to the contaminated product, monitoring and controlling the pressure in the treatment systems, monitoring and controlling the heat generated during the treatment of contaminated product with ozone, and controlling ozone release into the atmosphere.

Abstract: For sterilizing surfaces with hydrogen peroxide, a stream of hot air is fed through a tube which includes a porous section, and vaporized hydrogen peroxide is diffused from the porous section into the hot air stream to obtain a combined hot air and vaporized stream mixture for supplying the vaporized hydrogen peroxide to a surface for sterilizing the surface. Further for carrying out the process, liquid hydrogen peroxide is fed to the porous section for forming a film on the porous section, and the porous section is heated to a temperature to vaporize the hydrogen peroxide for diffusion via the porous section into the hot air stream.

Abstract: Microbial contaminated materials, such as medical instruments and waste from medical laboratories or hospitals, are disinfected and sterilized by using a combination of peracetic acid and ozone in a sterilization chamber. The peracetic acid is formed within the sterilization chamber by introducing liquid hydrogen peroxide and liquid acetic acid into the chamber.

Abstract: A system for providing fluid to a device comprises an interface separating a first space from a second space. The interface has at least one opening for receiving the device. The opening has a contact surface which contacts the device forming a contact area. Means for enhancing penetration of the fluid to the contact area is coupled to the opening. This system significantly reduces or total eliminates the occlusion area on the surface of the device.

Abstract: The present invention relates to a method and apparatus for the encapsulation of biologically-active substances in red blood cell, characterized by an optionally automated, continuous-flow, self-contained electroporation system which allows withdrawal of blood from a patient, separation of red blood cells, encapsulation of a biologically-active substances in the cells, and optional recombination of blood plasma and the modified red blood cells thereby producing blood with modified biological characteristics. The present invention is particularly suited for use to encapsulate allosteric effectors of hemoglobin, thereby reducing the affinity of erythrocytes for oxygen and improving the release of oxygen from erythrocytes in tissues.

Abstract: The present invention relates to a process for degerminating drugs in a vacuum drying system comprising a multi-blade stirrer under the conditions of reduced pressure, keeping the active ingredients intact and largely destroying toxic mould fungi.

Abstract: A method for sterilizing an interior of an article with a diffusion-restricted area therein includes the steps of contacting the interior of the diffusion-restricted area with a source of peroxide, and exposing the device to negative pressure for a time period sufficient to effect complete sterilization of the diffusion-restricted area.

Abstract: An apparatus for the sterilization of a medical device includes a multi-chambered compartment having at least a first and a second rigid chamber therein. Each of the first and second chambers is adapted to independently serve as a sterilization chamber and can be operated independently. The apparatus also has a removable interface between the first and second chamber. The interface can have an opening for receiving a lumen device in such a way that the first and second chamber is put in fluid communication through the lumen. A source of sterilant is also included in the apparatus. This source is adapted to provide the sterilant in the first and/or second chamber. Containers sealed with gas-permeable, but microorganism-impermeable membrane can be used in the apparatus so that the sterility of the devices in the container is kept after the completion of a sterilization cycle.

Abstract: A plasma-enhanced vacuum drying method is disclosed. It is advantageously applied in plasma sterilization processes in particular, and represents a significant improvement for general evacuation drying methods. Articles to be sterilized are placed in a sealed chamber and the chamber is evacuated. A plasma of residual gas species is generated in the chamber during an initial evacuation step. This promotes drying of the articles and advantageously allows a desired pressure to be attained more quickly than without the plasma. Sterilizing gas is injected into the chamber, and a second plasma is generated to activate the sterilizing gas plasma, thereby sterilizing the articles in the chamber.

Abstract: A method and apparatus for treating an object with ozone by: introducing the object to be treated and ozone into a sealed treatment chamber; and applying a negative pressure to said treatment chamber to prevent ozone leaking from said treatment chamber into the atmosphere and to provide an indication of the condition of the seal. The object may be treated according to a Static mode, or a Flow mode.

Abstract: This invention relates to a method and apparatus for using ozone to disinfect, decontaminate and deodorize animal manure. The invention contemplates injecting ozone gas into manure, while the manure is rotated on an auger in a sealed chamber. As a result of the invention, the manure is disinfected, decontaminated, and deodorized, while nutrients in the manure and a neutral pH are maintained.

Abstract: An autoclave is disclosed which includes direct heating and improved access. The autoclave includes a heating system which is placed directly into the pressurized chamber such that materials which are placed directly into the autoclave are directly heated. The autoclave includes doors which are disposed inside of the pressure vessel which seal against the inside surface of the pressure vessel upon pressurization. In one embodiment a pivot system is used to hold the door in place when the autoclave is not sufficiently pressurized so as to hold the door against the inside wall of the autoclave. In an alternate embodiment a robotic system is used to hold the door in place when the autoclave is not sufficiently pressurized so as to hold the door against the inside wall of the autoclave. The robotic system is also used to move the door out of the way after depressurization.

Abstract: A method for sterilizing fresh produce (e.g. onions) comprising contacting the produce with an aqueous solution of an oxidizing agent (e.g. hydrogen peroxide) under a pressure of at least 25 psig for sufficient time to significantly reduce the microbiological count.

Abstract: A sterilizing machine facilitates the introduction of a bath liquid into empty crevasses in the article to be sterilized by evacuating a chamber holding the article to be sterilized prior to covering the article with a bath of liquid. The sterilizer equipment also applies a high pressure to the article to enhance killing of organisms contained therein.

Abstract: The present invention discloses the use of peracid vapor as a sterilant. A process is disclosed for sterilizing a load by exposure to peracid vapor, the load being disposed in a sterilization chamber adapted to contain the peracid vapor, including the steps of exposing the load to the peracid vapor in the sterilization chamber at reduced pressure, i.e., below atmospheric pressure and introducing a quantity of another gas, the gas being of a type which does not interfere with the sterilization procedure, to increase the pressure in the chamber to a value above that at which the chamber was when the peracid vapor alone was present but below atmospheric pressure, whereby the penetration of any vapor penetrable portions of the load to be sterilized by the peracid vapor is enhanced.

Abstract: Method for substantially decreasing the viability of microorganism and deactivating enzymes in a contaminated substance by exerting a high pressure the substance. The substance is conducted in a steady flow through and open narrow tube while the pressure difference between the entrance and the exit of the tube is maintained at 100 Mpa or more. The temperature rise of the product while passing through the tube can be confined to less than 5.degree. C. The method provides a continuous ultra high pressure preservation process suitable for processing foods.

Abstract: A method for hydrogen peroxide vapor sterilization of medical devices and similar instruments having long narrow lumens or diffusion restricted areas includes the step of pretreating the article to be sterilized with a dilute solution of hydrogen peroxide prior to exposure to a vacuum or a vacuum followed by plasma. The method is such that, upon vaporization of the solution caused by the vacuum, the hydrogen peroxide remains in contact with the article for a time sufficient to achieve sterilization.

Abstract: Sterilization device intended to sterilize objects, such as bottles, comprising feed and discharge means for objects, a rotatable treatment unit, which in the region of its circumference comprises treatment cavities, each treatment cavity comprising an opening for feeding and discharging the objects, which opening can be closed and opened with the aid of closure means in the form of an endless belt which bears against the treatment unit over at least a part of its circumference, and it being possible to connect the treatment cavities to a feed for process media. A description is also given of a method for sterilizing objects using the device.

Abstract: An improved method for processing an industrial sterilization agent utilized to sterilize medical instruments includes the use of a regenerative thermal oxidizer. The sterilization agent is removed from the sterilization chamber and directed into the combustion chamber with little chance for the sterilization agent to mix with air or any other source of oxygen. In this way, the present invention reduces the possibility of explosion of the sterilization agent prior to its being directed into the combustion chamber.

Abstract: A method for cleaning/sterilizing a medical device with a lumen comprises the steps of: a) providing a container having one enclosure and one openable and closeable interface separating the container and the enclosure, b) placing the device on a tray, c) placing the tray into the container and enclosure so that one end of the device and a portion of the tray are located in the container and the other end of the device and another portion of the tray are located in the enclosure, d) creating a pressure difference between the two ends, e) cleaning the device with a cleaning solution, f) rinsing the device with rinse solution, g) treating the device with a chemical germicide. An apparatus for cleaning/sterilizing a device with a lumen comprises a container having at least two separated close compartments. An openable and closeable interface separates the container into the compartments.

Abstract: A method for cleaning/sterilizing a device having a lumen with at least two open ends comprises the steps of: a) providing a container having at least one enclosure and at least one interface separating the enclosure from the container, the interface having at least one opening thereon, b) placing the device across the opening with one open end in the container and another open end in the enclosure, c) generating a flow of a cleaning solution through the lumen to clean the inner surface of the lumen, d) generating a flow of rinse solution through the lumen to rinse the inner surface of the lumen, e) treating the device with a chemical germicide, and f) adjusting the opening in any of steps c) to e) to reduce the areas on surface of the device occluded by contacting with the opening. An apparatus for cleaning/sterilizing a lumen device comprises a container having a fluid port for flowing and draining a fluid in and out the container.

Abstract: A method sterilizes a device having a diffusion restricted area and a non-diffusion restricted area. The method includes the steps of vaporizing a first solution of hydrogen peroxide within the diffusion restricted area and vaporizing a second solution of hydrogen peroxide outside of the diffusion restricted area, with the first solution having a lower concentration of hydrogen peroxide than the second solution.

Abstract: Process for maintaining the cleanliness of the inner cavity of a medical operating instrument (I), particularly a surgical instrument used in minimally invasive medicine, having an outer casing (M) and operating or actuating elements (SS, SH) arranged therein, said instrument being used to enter the body of a living person or animal, wherein during its use the instrument is acted upon essentially from its proximal end through a fluid connection (A) with a medically clean fluid (G) in such a way that essentially all the crevices and cavities in the inner space, in fluid contact with the inside of the body, between the operating or actuating elements (SS, SH) or between the latter and the casing (M) are filled with the fluid.

Abstract: A method for hydrogen peroxide vapor sterilization of medical devices and similar instruments having long narrow lumens or diffusion restricted areas includes the step of pretreating the article to be sterilized with a dilute solution of hydrogen peroxide prior to exposure to a vacuum or a vacuum followed by plasma. The method is such that, upon vaporization of the solution caused by the vacuum, the hydrogen peroxide remains in contact with the article for a time sufficient to achieve sterilization.

Abstract: The present invention is directed to a process for cleaning large bone grafts using a pressure mediated flow of solutions, and to the bone grafts produced thereby where the bone grafts are suitable for transplantation into a human. The present method includes inducing a positive and/or negative pressure-mediated flow of solvent through an opening in the bone shaft of the large bone graft thereby removing bone marrow elements, as well as any bacteria particles and/or virus particles present. The bone grafts produced are suitable for transplantation into a human and are essentially free from viral and bacterial contamination, for example, free from HIV infectious particles.

Abstract: Methods for peroxide vapor sterilization of medical devices and similar instruments having long narrow lumens or diffusion restricted areas includes the step of contacting the article to be sterilized or a diffusion-restricted environment containing said article with a source of peroxide prior to exposure to a vacuum or a vacuum followed by plasma. The methods are such that, upon vaporization of the source of peroxide caused by the vacuum, the peroxide remains in contact with the article for a time sufficient to achieve sterilization.

Abstract: During a vacuum evacuation of a chamber, the presence of water in the chamber can be detected by monitoring the pressure level in the chamber. In the absence of water, the pressure will decrease continuously and smoothly. If water is present, the pressure will rise slightly one or more times, especially as the pressure falls below 5 torr. This rise in pressure can be detected to signal the unwanted presence of water in the chamber. The method has particular application to ensuring the chamber is free of water during the evacuation of a chamber employed in vapor or vapor/plasma sterilization.

Abstract: Apparatus for the decontamination, disinfection, or sterilization of materials such as medical waste by exposure to ozonized air comprises a generator of ozonized air, an enclosure for the accumulation of ozonized air, a processing enclosure in which the materials to be processed are placed, and a destroyer of residual ozone leaving the processing enclosure. The ozonized air reaches the processing enclosure via the accumulation enclosure. A vacuum pump operating in air is situated downstream from the ozone destroyer for creating a partial vacuum in the processing enclosure. The generator of ozonized air is connected in open circuit with the accumulation enclosure. The apparatus further comprises an injection valve interposed between the accumulation enclosure and the processing enclosure. The injection valve is controlled in such a way as to periodically to trigger the sudden and forceful injection of ozonized air into the processing enclosure as soon as the pressure drops below a certain limit.

Abstract: An improved cleaning and sterilizing apparatus adapted for cleaning and sterilizing medical instruments in which a wash cycle and rinse cycle are repeated if proper cleaning of the instrument has not been obtained. Using a turbidity monitor or comparable instrument, an indicia representative of the particles in the rinse water is obtained. If the indicia does not meet some pre-defined standard, such as those set by the Food and Drug Administration, then the wash/rinse cycles are repeated. This is done either until the standards are met or for a certain number of times. If the standards are met, then the medical instrument is sterilized for later use. In the preferred embodiment, proper sterilization is monitored by the turbidity monitor.

Abstract: A cleaning system for an endoscope is disclosed wherein the inlets of respective channels of the endoscope are connected to a suction pump through a connecting device enabling the endoscope to be cleaned by aspirating fluid through the channels under operation of the pump. The connecting device includes as passage arrangement having a plurality of first connecting ports and at least one second connecting port. The device further includes control means to control fluid flow through the passage arrangement enabling individual channels in the endoscope to be isolated from the suction.

Abstract: Biological fluids, e.g. bodily fluids such as plasma/serum, semen, milk or blood, can be treated efficiently with ozone to inactivate certain viruses, bacteria, fungi etc. To effect and enhance the contact of such fluids with ozone, or another disinfecting or deactivating gas, the fluids are thoroughly nebulized, or atomized, i.e. dispersed into minute droplets. Nebulization has been found to afford a faster O.sub.3 -fluid reaction rate than other known methods. It is proposed to create a fine "rain" of droplets to fall through a controlled atmosphere of O.sub.3 /O.sub.2 and/or O.sub.3 /inert gas mixture. Electric and magnetic fields are superimposed over the space through which the droplets are passed.Three types of nebulizers/atomizers are described: compressed gas (O.sub.3 /O.sub.2 mixture) atomizer, ultrasonic nebulizer, and rotary nebulizer.The invention was tested on coliphage MS2 which is safe, easy to handle, and more resistant to chemical disinfections than viruses such as HIV. More than 7 log.sub.

Abstract: A device for cleaning, disinfecting, and/or drying an endoscope consists of a basin supported on a base. The basin forms a channel that defines a teardrop shape. The device includes a lid that sealingly engages the basin. During operation, the endoscope to be cleaned is completely immersed in cleaning solution in the basin. The basin includes injectors arranged so as to create a rotating flow of cleaning liquid and sterile rinsing water or recycled drying air within the channel. The vessel also includes injection nozzles that attach to various inlets of the endoscope to inject products at specified pressures and to continuously test the tightness of the seal.

Abstract: An apparatus and process for hydrogen peroxide vapor sterilization of medical instruments and similar devices make use of hydrogen peroxide vapor released from a substantially non-aqueous organic hydrogen peroxide complex, such as a urea-peroxide complex. Optionally, a plasma can be used in conjunction with the vapor. A method for preparing substantially non-aqueous hydrogen peroxide complexes is also provided. These complexes are useful as a source of peroxide vapor in hydrogen peroxide vapor sterilizers and as a component of self-sterilizing packaging materials.

Abstract: An arrangement for sterilizing objects in which a quantity of liquid and one or more objects to be sterilized are introduced into a pouch formed of flexible sheet material at least partially transparent to microwave radiation whereupon the pouch is sealed to form a gas-tight assembly. The gas-tight assembly is situated in an inner rigid cavity of an enclosure which is at least partially formed of material that is substantially transparent to microwave radiation. The enclosure is irradiated with microwave radiation which passes into the cavity and then into the gas-tight pouch assembly situated therein to vaporize the liquid to produce an atmosphere of hot vapor under pressure in the pouch. The pouch expands under pressure until the sheet material of which it is formed presses against the rigid inner surfaces of the enclosure cavity.

Abstract: An apparatus and method for vapor sterilization of articles such as medical devices and instruments with lumens. The lumens are connected in a sterilization chamber to a conduit which leads to an exhaust flow restrictor, which exhausts to a vacuum pump. The exhaust flow restrictor has a bypass also which exhausts to the vacuum pump. The majority of the gas from the sterilization chamber flows through the bypass on the exhaust flow restrictor while only a portion of the gas flows through the lumen. Because most of the gas flows through the bypass rather than through the lumens, the sterilization chamber can be pumped down rapidly. The attached lumens are sterilized effectively in spite of the rapid pumpdown rate.

Abstract: An ozone sterilizer includes a generator capable of generating a gas containing at least about 10% by weight ozone, a holding tank, a humidification chamber for receiving the ozonated gas and humidifying it to form a sterilant including at least about 8% by weight ozone at a humidity of at least about 60%, a vent for bleeding sterilant from the humidification chamber over a first catalyst, a sterilization chamber for receiving a controlled flow of sterilant which is in fluid communication with a pump for evacuating the sterilization chamber over a second catalyst, a vent for bleeding the sterilant from the sterilization chamber and a heater for providing warm air drawn into the sterilization chamber by the pump.

Abstract: A method for sterilizing process fermentation vessels with a concentrated alcohol and water mixture integrated in a fuel alcohol or other alcohol production facility. Hot, concentrated alcohol is drawn from a distillation or other purification stage and sprayed into the empty fermentation vessels. This sterilizing alcohol/water mixture should be of a sufficient concentration, preferably higher than 12% alcohol by volume, to be toxic to undesirable microorganisms. Following sterilization, this sterilizing alcohol/water mixture can be recovered back into the same distillation or other purification stage from which it was withdrawn. The process of this invention has its best application in, but is not limited to, batch fermentation processes, wherein the fermentation vessels must be emptied, cleaned, and sterilized following completion of each batch fermentation process.

Abstract: A decontamination apparatus for medical devices includes a decontamination basin (14a, 14b) with a selectively opened and closed cover member (16a, 16b) to provide selective access to the basin (14a, 14b). A mixing chamber assembly (80) selectively dispenses detergent concentrate and decontaminant concentrate into a liquid to form a liquid cleaning solution or a liquid decontaminant solution, respectively. A source of decontaminated rinse liquid, such as a microbe removal filter (54), is in selective fluid communication with the basin (14a, 14b). A source of anti-microbial liquid is in selective fluid communication with the microbe removal filter (54) and rinse liquid flow paths (58) between the microbe removal filter and the basin for decontaminating the filter (54) and the rinse lines (58). Each channel of a medical device (E) being decontaminated is connected to a channel flush line (30) and a channel pump (32) for flushing the channels of the device (E).

Abstract: A method for sterilizing a device, includes the following steps: contacting the device with liquid sterilant outside or inside a sterilization chamber at a first pressure, placing the device in the chamber before or after the contacting step, and decreasing the pressure of the chamber to a second pressure below the vapor pressure of the liquid sterilant. At least the decrease in pressure below about the vapor pressure of the liquid sterilant occurs at a pumpdown rate of less than 0.8 liters per second, calculated based on the time required to evacuate the chamber from atmospheric pressure to 20 torr when the chamber is empty and dry.

Abstract: A pressure flow system and method for its use are provided for contacting the interior of a fluid permeable, e.g., porous, workpiece. The system includes a fluid pressure chamber having an inlet port and an opening formed in one of the chamber walls. An adjustable seal capable of providing a fluid-tight seal about the exterior of a workpiece having a non-uniform surface is positioned within the opening. Fluid under pressure is supplied to the pressure chamber to force fluid to flow through the internal matrix of the workpiece. In a preferred embodiment, the workpiece is a bone or a section thereof, and the fluid is forced to flow from the endosteal portion of bone to the periosteal portion of bone through the vasculature and porous structure of the bone to remove blood, bone marrow and/or other non-bone constituent(s) from the bone.

Abstract: A method of decontaminating or sterilizing freeze dryers at low temperature and pressure levels by utilizing sterilant vapor is disclosed.

Abstract: Hot, saturated water vapor in the form of low-temperature subatmospheric steam is employed to shorten the aeration period after sterilization with a condensable, heat-labile chemical sterilant. The application of steam accelerates the rate of outgassing of sterilant residuals that are absorbed into, or adsorbed or condensed onto chamber or load materials. The method is particularly suitable for removing residuals from polymeric materials and/or materials that are poor heat conductors. Apparatus is provided to supply steam in situations where a utility steam supply is not available.

Abstract: A method sterilizes a device having a diffusion restricted area and a non-diffusion restricted area. The method includes the steps of contacting the device with liquid sterilant outside or inside a sterilization chamber fluidly connected to at least one pump, placing the device in the chamber (before or after the contacting step), bringing the pressure of the chamber to a first pressure range at which liquid sterilant is vaporized from the non-diffusion restricted area to sterilize the non-diffusion restricted area, and bringing the pressure of the chamber to a second pressure range at which the liquid sterilant is vaporized from the diffusion restricted area to sterilize the diffusion restricted area. The minimum pressure in the second pressure range is lower than the maximum pressure in the first pressure range.

Abstract: Method and apparatus for cleaning the internal channels of a medical endoscope wherein the water bottle is replaced with a cleaning bottle adapted to pass fluids stored in the bottle into both the air and the water channels of the instrument. An end cap having a fluid reservoir is placed over the distal end of the instrument. The air/water pump and the suction pump are then cycled to pass a cleaning solution stored in the replacement bottle through the air and water channels into the end cap. The solution in the end cap is drawn through the suction line and collected in a container for disposal. The procedure is repeated using a rinse solution. The pumps are allowed to run after the rinse solution is exhausted, thus air drying the channels.