Abstract: The disclosure below relates to apparatus and methods for producing medicament using sub-optimal water sources. One embodiment of the disclosure is directed to an apparatus comprising a preliminary purification component, a disinfection component, a pharmaceutical grade water preparation (PGW) component, and a drug pack. Another disclosed embodiment relates to a method for producing a peritoneal dialysis solution, comprising, passing diluent through a preliminary purification component, passing diluent through a disinfection component, passing diluent through a PGW preparation component, passing diluent through a drug pack, and collecting solute produced by the drug pack.

Abstract: A method for sterilizing medical devices and similar instruments in diffusion-restricted containers is provided. The sterilization method includes placing a liquid solution containing vaporizable germicide such as hydrogen peroxide into the diffusion-restricted container and vaporizing the germicide. The containers can be attachable and detachable to a sterilization system, and used as a vacuum chamber. An attachable/detachable container containing an article to be sterilized can be nested with a second container, and the article and inside and outside of the inner container are sterilized. The sterile article inside the nested containers can be transported and the sterile inner container with the sterilized article can removed from the outer container and placed in a sterile environment without contaminating the sterile environment. The sterile article can then be removed from the sterile container and utilized.

Abstract: The disclosure below relates to apparatus and methods for producing medicament using sub-optimal water sources. One embodiment of the disclosure is directed to an apparatus comprising a preliminary purification component, a disinfection component, a pharmaceutical grade water preparation (PGW) component, and a drug pack. Another disclosed embodiment relates to a method for producing a peritoneal dialysis solution, comprising, passing diluent through a preliminary purification component, passing diluent through a disinfection component, passing diluent through a PGW preparation component, passing diluent through a drug pack, and collecting solute produced by the drug pack.

Abstract: A method for sterilizing medical devices and similar instruments in diffusion-restricted containers is provided. The sterilization method includes placing a liquid solution containing vaporizable germicide such as hydrogen peroxide into the diffusion-restricted container and vaporizing the germicide. The containers can be attachable and detachable to a sterilization system, and used as a vacuum chamber. An attachable/detachable container containing an article to be sterilized can be nested with a second container, and the article and inside and outside of the inner container are sterilized. The sterile article inside the nested containers can be transported and the sterile inner container with the sterilized article can removed from the outer container and placed in a sterile environment without contaminating the sterile environment. The sterile article can then be removed from the sterile container and utilized.

Abstract: A method for sterilizing medical devices and similar instruments in diffusion-restricted containers is provided. The sterilization method includes placing a liquid solution containing vaporizable germicide such as hydrogen peroxide into the diffusion-restricted container and vaporizing the germicide. The containers can be attachable and detachable to a sterilization system, and used as a vacuum chamber. An attachable/detachable container containing an article to be sterilized can be nested with a second container, and the article and inside and outside of the inner container are sterilized. The sterile article inside the nested containers can be transported and the sterile inner container with the sterilized article can removed from the outer container and placed in a sterile environment without contaminating the sterile environment. The sterile article can then be removed from the sterile container and utilized.

Abstract: A sterilized article is within the interior of a diffusion-restricted container. The container substantially prevents entry of microorganisms into the interior thereof. The container has at least one entry/exit port which permits entry/exit of gas and/or vapor into/out of the interior, but prevents entry of microorganisms into the interior.

Abstract: A sterilized article is within the interior of a diffusion-restricted container. The container substantially prevents entry of microorganisms into the interior thereof. The container has at least one communication port which permits entry of gas and/or vapor into the interior, but prevents entry of microorganisms into the interior.

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 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: 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 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: 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: 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: 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 nonreinforced microfiber fabric is disclosed. The fabric has minimum grab tensile strength to weight ratio greater than 0.8 N per gram per square meter and a minimum Elmendorf tear strength to weight ratio greater than 0.04 N per gram per square meter. The fibers in the fabric have an average length greater than 10 centimeters and at least 80% of the fibers have a diameter of 7 microns or less. The fabric is made by thermally embossing a microfiber web which is made with a minimum of degradation to the polymer and employing high velocity secondary air to maintain air flow uniformity and fiber length.

Abstract: A nonreinforced microfiber fabric is disclosed. The fabric has minimum grab tensile strength to weight ratio greater than 0.8N per gram per square meter and a minimum Elmendorf tear strength to weight ratio greater than 0.04N per gram per square meter. The fibers in the fabric have an average length greater than 10 centimeters and at least 80% of the fibers have a diameter of 7 microns or less. The fabric is made by thermally embossing a microfiber web which is made with a minimum of degradation to the polymer and employing high velocity secondary air to maintain air flow uniformity and fiber length.

Abstract: A method for minimizing the accumulation of static charges on fibers resulting from the dry-fiberization of pulp lap sheets includes the steps of: (1) directing a plurality of the pulp lap sheets into a stacked condition; (2) directing the stack of sheets in a downstream direction to a fiberizing device for separating the fibers from the stack; and (3) applying an antistatic chemical to less than all of the sheets in the stack upstream of the fiberizing device.