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: In a container defining a flexible wall, means for sealingly receiving a puncture member through the wall which comprises an insert member positioned within the container. The insert member defines an aperture for sealingly receiving the puncture member after penetration through the wall. The aperture provides flow communication between the container interior and a puncture member received in the aperture. Thus, access may be provided to a container which has no conventional tubular port carried on its exterior. Optionally, tape means may be removably adhered to the flexible wall so that removal of the tape means exposes a clean surface through which the puncture member can penetrate.

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: An apparatus and method for attaching a fitment to a web of film in a form, fill, and seal packaging machine is provided. The apparatus includes a press for orienting the fitments on one side of a web of film, and a film piercer and sealer. The film piercer and sealer includes a heated face and tip and is designed to contemporaneously pierce and seal of web of film to the fitment.

Abstract: A film laminate for flexible containers capable of containing a product to be maintained and removed under sterile conditions. The film laminate having an outside layer of linear low density polyethylene, a gas barrier layer, a core layer of polyamide, and an inside layer of linear low density polyethylene. The layers being bonded together by a polyurethane adhesive.

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 container is disclosed having a semirigid or rigid outer shell and a co-extensive flexible inner liner which is weakly or temporarily adhered to the shell to permit more convenient manufacturing of the container, and yet is collapsible to permit dispensing of the contents without displacement air. The liner may be weakly adhered to the shell by a low tensile strength adhesive although natural adherence or static electric attraction may also be used. Alternatively, a degradable adhesive may be used which holds the liner and shell together during assembly, but weakens to a point below the threshold of release between the shell and liner prior to the time of use. The container is particularly useful as a nursing container for feeding infants.

Abstract: A fitment for attachment to a container having an integral body constructed from a thermoplastic foam and having an integral skin outer surface and a cellular core. The body has a top and bottom surface and includes at least one resealable port.

Abstract: A container (10) having a line of weakness (18) at which the container is opened includes an inner closure (20) mounted within the container cover (16) above the line of weakness (18), and an annular sidewall (22) depending below the frangible line of weakness (18). The inner closure (22) protects the line of weakness (18) from the liquid contents, thereby preventing spillage of liquid contents onto outer non-sterile surfaces upon opening of the container. The container prevents the commercially undesireable retention of moisture in the volume (40) defined by the cover (16) and the inner closure (20). The container may be integrity tested using standard testing procedures.

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: An improved disposable liquid container adapted for infant nursing is provided for maintaining nursing liquid in a sterile or aseptic condition until dispensed therefrom. Rigid penetrating means carried by a semirigid support member penetrate a compartment closing diaphragm to allow nursing liquid to flow from the compartment to a communicating, attached nipple. The semirigid support member is integral with the liquid compartment and substantially preserves its shape as the fluid is dispensed therefrom. Flexible walls of the container are allowed to collapse together as the fluid is dispensed to prevent excessive ingestion of air by a nursing infant. The attached nipple is maintained in a clean, uncontaminated, sterile, or aseptic condition until use by means of separable sealing tabs or a discardable cover.

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.