Abstract: Detection of bindable substances such as antibodies and antigens using enzyme linked immunosorbent assays having particular utility in home diagnostic applications. The preferred implementation of the invention is characterized by the steps of admixing a sample suspected of containing the bindable substance to be detected with an antibody-enzyme conjugate, immersing an antibody coated solid support into the mixture and then exposing the coated support to an activated chromogenic solution. The conjugate for use in the home diagnostic assay is preferably contained within a lyophilized mixture. The lyophilized mixture contains components which preserve the antibody-conjugate's reactivity and immunologic binding specificity even if the lyophilized mixture had been subjected to hot, humid environmental conditions. Active components in the lyophilized mixture include polyethylene glycol, sugars, and surfactant.

Abstract: A guide system for improving the orientation of a web of film as it passes around a fill tube structure in a form, fill, seal packaging machine is provided. The guide system comprises at least two members removably coupled to the fill tube structure, and so constructed and arranged that they increase the cross-sectional perimeter of the fill tube structure when they are secured thereto. The members cooperating with the fill tube structure to stretch the web of film as it passes around the fill tube structure. An improved apparatus for attaching fitments to a web of film and method is also provided.

Abstract: An assay employing two antibodies. A microporous carrier supports a plurality of layers, in which conjugates form between test antigens and antibodies. Quantitative results are obtained from an immobilized antibody within an indicating substrate.

Abstract: An apparatus for placing a folded web of film under tension comprising at least one pair of rollers, a first side of the folded web of film being fed between the pair of rollers, the pair of rollers being mounted out of parallel to the first side of the folded web of film and pulling the first side of the folded web of film in a first direction, and a member for preventing a second side of the folded web of film from moving in the first direction. Preferably, the member biases the second side of the folded web of film in a second direction opposite the first direction. A method for placing a folded web of film under tension is also provided.

Abstract: A chromogenic solution for enzyme immunoassay. A stabilizing agent is added to chromogenic solutions containing chromogen of the hydrogen donor type. The stabilizing agent is an alkylhydroxylamine, preferably N,N-diethylhydroxylamine. The N-N diethylhydroxylamine retards degradation of the solution of the chromogen in solvent and is particularly effective in retarding discoloration of a chromogen-solvent solution placed in storage over an extended period of time. The alkylhydroxylamine preferably in the form of N,N-diethylhydroxylamine has the additional property that it does not adversely affect the activity of enzymes employed in enzyme immunoassays. It also does not interfere with binding specificity or reactivity of antibodies.

Abstract: A disposable, ready-to-use container such as a nursing container is provided which includes a protection compartment separating the nipple or other dispensing member from the infant formula or other stored substance until the time of use. The protection compartment is partially defined by and is separated from the storage compartment by a breakable line of securement extending across the interior of the container. When the line of securement is manually broken from the container-exterior, the stored infant formula is allowed to enter the now open protection compartment for open communication through the nipple. An enclosure chamber about the nipple may also be provided in combination with the protection compartment, to separate the nipple from the environment. Alternatively to the enclosure chamber, a nipple cover including two flexible tabs interposed and secured between the container sheet material and the nipple may be provided.

Abstract: A form, fill and seal apparatus for producing flexible containers having fitments located at one end of the container. The invention provides a former for folding into a tubular shape a substantially flat web of film with attached fitments. The former includes a substantially V-shaped member, an elongated member secured to the V-shaped member, and a U-shaped member. The V-shaped member, elongated member, the U-shaped member cooperate to fold the substantially flat web of film to bring opposite longitudinal portions thereof into aligned relationship.

Abstract: A film laminate for flexible containers capable of containing a product to be maintained and accessed under sterile conditions. The laminate having an outside layer of linear low density polyethylene, a core layer of nylon, an inside layer of linear low density polyethylene and two layers of a polyurethane adhesive for bonding the layers.

Abstract: A laminate film for producing a flexible container comprising an outermost layer made of polyethylene terephthalate or biaxially oriented polypropylene, an intermediate layer made of a polyamide optionally layered with a highly transparent resin, and an innermost layer made of a transparent heat-sealable resin.

Abstract: A container such as a nursing container, fabricated from a single web of flexible material, is provided. The container maintains the nursing fluid or other liquid and an attached nipple or other access assembly in a sterile condition until use. The walls of the single web container enclose the nipple during filling, packaging, and shipping, and separate the access assembly from the container contents until accessed for use. Sterility is readily maintained by single point fabrication and filling. A method is provided for fabricating the container from a single web of flexible material. The web is defined, the access assembly, the web folded to enclose the nipple or other access assembly, and folded back to form a liquid compartment. Seals and peelable seals are formed to complete the container and allow access to the nipple for use.

Abstract: A nipple assembly is disclosed for attachment to sealed nursing containers which includes accessing means for accessing the container contents by manipulating the nipple assembly. In one embodiment, the accessing means is disposed within a flexible nipple and is movable to pierce the container wall upon lateral compression or squeezing of the nipple. Other embodiments access the container contents by axially compressing or rotating the nipple assembly. Protective covers for the nipple assemblies are disclosed which cooperate to permit the particular manual manipulation needed to access the contents without direct human contact with the nipple surface. Also shown are particular features of a flexible container to which the nipple assemblies may be attached.

Abstract: A improved port and closure assembly is provided. The closure is overmolded to the port. The closure hermetically seals the port and provides a tamper evident closure. The closure cooperates with the port to provide a band that circumscribes the port after the closure is removed.

Abstract: An apparatus and method for creating the transverse seals in a form, fill and seal packaging machine is provided. The apparatus includes a heating member that heats a portion of the web of film to create the transverse seals, and a cooling member that cools the heated portion of the web of film and the heating member. The heating member includes a hot bar, a heater for heating the hot bar, and a biasing member that disengages the hot bar from the heater before the hot bar contacts the web of film.

Abstract: An artifical nipple is disclosed which is interactive with an infant to provide a stimulus/response operation. The nipple portion has a generally cylindrically shaped, but undulated deformable outer wall closed at one end and a resilient elongated member disposed interior of the outer wall, depending from the closed end. The elongated member is spaced from the interior of the outer wall to define an annular chamber such that an infant will meet two levels of resistance to lateral compression of the nipple and a plurality of dispensing apertures provided communicating with said annular chamber, so that fluid flows through certain of said apertures in a manner responsive to infant suckling action.A nursing container utilizes the artificial nipple and a flexible fluid container is sealed to the nipple portion along a tapered shoulder.

Abstract: A reconstitution device for constituting a drug in a standard drug vial with a liquid in a second container such as a parenteral solution container is provided. The reconstitution device 10 includes a housing 52 and a hollow, double-pointed needle 54 mounted within the housing. The housing includes a sheath 70 having a substantially circular base 72 and a skirt 74 depending from the base. The skirt 72 includes a free end 76, a substantially cylindrical inner surface 78 and an outer surface 80. A plurality of inwardly projecting bumps 82 are intermittently spaced about the inner surface 78. The bumps are disposed a substantially equal distance from the base 72, the distance being substantially equal to the width of the malleable band.

Abstract: An apparatus for shaping a web of film with attached fitments into a tubular shape. The apparatus including a plate member including a cut-out portion and an oblong member. The plate member and oblong member defining a channel and cooperating to fold a web of film with attached fitments into a substantially tubular shape.

Abstract: A sealing closure for a male Luer fitment includes a rigid hollow cap and flange means for a pressure lock with the fitment. The sealing closure includes a compressively retained elastomeric insert which deforms over time to compensate for creep between the fitment and the hollow cap. The sealing closure provides a liquid-tight seal over time against a pressurized liquid supply in open communication with the fitment.

Abstract: A cannula assembly especially for medical use is disclosed which virtually eliminates coring during the piercing of a barrier. The cannula assembly includes a hollow cylindrical shank and a piercing tip removably mounted in and closing one end of the shank. Pressurized introduction of fluid through the shank forces the piercing tip out of engagement with the shank, placing opposite sides of the barrier in fluid communication.

Abstract: A sterile, closed drug delivery system (10) is provided comprising a flexible container (12), a capsule (22) coupled to the flexible container and a standard glass drug vial (36) positioned within the capsule. The flexible container has a liquid diluent therein. The capsule has supporting legs (32-35) which extend inwardly from the capsule to support the vial and also a highly flexible, pleated cap (28) which enables the drug vial to be manually moved relative to the supporting legs. The capsule is coupled to the flexible container by means of a hollow spike (54) located within the capsule and a frangible member (58) located within the flexible container, which frangible member allows fluid passage only when it is broken. Manual pressing of the pleated cap moves the drug vial downwardly onto the spike, piercing the stopper of the drug vial. Once the frangible member is broken, there is sterile communication between the drug vial and the liquid diluent contents of the flexible container.