Abstract: A process challenge device tailored to mimic the resistance of a particular product to a particular biological inactivation, disinfection, or sterilization process, and used to challenge the process, thus providing a means to validate the efficacy of the process. The process challenge device is used by subjecting the device containing indicator organisms to an inactivation or sterilization process, and culturing any surviving indicator organisms as a means to assess the efficacy of procedures for the inactivation of microorganisms. The device uses a self-containing biological indicator (SCBI) with a biological indicator and media ampule located within a plastic vial. By altering the materials and/or configuration of the SCBI a wide range of resistances to sterilant gas processes may be achieved.

Abstract: A process challenge device tailored to mimic the resistance of a particular product-package combination to a particular biological inactivation, disinfection, or sterilization process. The device is used to challenge the process, thus providing a means to validate the efficacy of the process. In one embodiment, the process indicator includes a biological indicator organism stored on a carrier enclosed within a chamber formed by a barrier film material. The specific indicator organism and carrier substrate are chosen for their appropriateness for a given process. The materials comprising the barrier film material of the process challenge device are chosen for the materials' specific resistance to the given process. The process challenge device may also comprise a separate second chamber filled with an appropriate culture medium or enzyme substrate that is separated from the chamber containing the process indicator by a separation means, such as a valve, a clip, or a frangible separation.

Abstract: A process challenge device tailored to mimic the resistance of a particular product to a particular biological inactivation, disinfection, or sterilization process, and used to challenge the process, thus providing a means to validate the efficacy of the process. The process challenge device is used by subjecting the device containing indicator organisms to an inactivation or sterilization process, and culturing any surviving indicator organisms as a means to assess the efficacy of procedures for the inactivation of microorganisms. The device includes a biological indicator organism stored on a carrier substrate enclosed within a chamber formed by a barrier film material. The specific indicator organism and carrier substrate are chosen for their appropriateness for a given process. The materials comprising the barrier film material of the process challenge device are chosen for the materials' specific resistance to the given process.

Abstract: A biological culture growth and observation system provides for the growth of a biological sample in a growth medium, and the observation of the grown sample (organism) through a microscope objective once growth is sufficient as to permit discrimination of the biological sample. Observation and growth is achieved in a single device. The system includes a tray with a top, and a sealable section on the top. Included within the tray is a depression, or well, that receives the growth medium to grow the biological organism in the well. A lid is sealable and resealable around the sealable section on the top of the tray. An interior side of the lid, that faces the growth medium, does not fog up in the presence of the growth medium. Optionally included is a barrier layer that is positioned over the well. The barrier layer minimizes evaporation from the growth medium and permits the biological culture growth and observation system to have a long shelf life.

Abstract: A wedge-shaped access port for a flexible container is described. The flexible container is formed of at least one or more sheets of material which are sealed together about the edges to form a cavity. The wedge-shaped port is sealed to the container so that a base of the wedge is exterior to the cavity and a thin edge of the wedge is located inside the cavity. An orifice in the port provides a passageway from the base of the wedge to the cavity. The wedge shape of the port allows sealing of the port to container with minimal stress or thinning of material at the seal between the port and the container.

Abstract: Novel films are disclosed which contain blends of ethylene-based copolymers or other elastomers with polypropylene and polyethylene. Typical films have two-five layers wherein at least one layer is a blend of high density polyethylene with an ethylene-based copolymer or another elastomer and has additional layers of polypropylene blended with an ethylene-based copolymer or another elastomer.

Abstract: This invention pertains to the use of polymer blends in making multiple layer films. In some layers, the elastomer or ethylene-based copolymer is blended with polypropylene, and in some layers, with polyethylene. Typical films have two to five layers. In multilayer films, at least one layer of a blend of polyethylene, preferably high density polyethylene, with elastomer and/or ethylene-based copolymers. Another layer is polypropylene blended with elastomers and/or ethylene-based copolymers. The films may have as few as two layers, one each having polypropylene and polyethylene, preferably high density polyethylene. Additional layers may be added to the two or three layer films taught herein, for variety of purposes.

Abstract: A clear, flexible, sealed container may be made of first and second plastic sheets sealed together at their peripheries. The first plastic sheet defines a bulge to increase the inside volume of the container, and comprises a laminate of a layer of polyolefin and a blended layer of polyolefin and a block copolymer of polyolefin and polystyrene. The second plastic sheet is a bonded laminate of a layer of biaxially oriented polypropylene and nonoriented polypropylene, peripherally bonded to the layer of polyolefin of the first plastic sheet.

Abstract: A multiple-layered, autoclavable, flexible plastic sheet comprises (a) at least one first layer consisting essentially of 30 to 90 percent by weight of a block copolymer having thermoplastic rubbery characteristics and having rubbery olefin blocks and blocks of a polystyrene; and from 10 to 70 percent by weight of a polyolefin derived principally from at least one of propylene, ethylene and 4-methylpentene-1, said polyolefin having a Vicat Softening Temperature of about 120.degree. C.; and (b) at least one second layer consisting essentially of a polyolefin derived principally by from at least one of propylene, ethylene, and 4-methylpentene-1 and being of semi-crystalline characteristics to exhibit low permeability to water vapor, the first and second layers being bonded together in alternating arrangement.