A sealed pharmaceutical container including: a shoulder; a neck extending from the shoulder; a flange extending from the neck, the flange including: an underside surface extending from the neck; an outer surface extending from the underside surface, the outer surface defining an outer diameter of the flange; and an upper sealing surface extending between the outer surface and an inner surface defining an opening in the sealed pharmaceutical container, and a sealing assembly including: a stopper including a sealing portion extending over the upper sealing surface of the flange and covering the opening, and an insertion portion extending into the opening and in contact with the inner surface of the flange, the stopper having a first CTE; and a filler member encased within the stopper and having a second CTE, the second CTE being lower than the first CTE.

A sealed pharmaceutical container includes a shoulder, a neck extending from the shoulder, and a flange extending from the neck. The flange includes an inclined sealing surface defining an opening in the sealed pharmaceutical container. The sealed pharmaceutical container also includes a sealing assembly including a stopper extending over the sealing surface of the flange and a cap securing the stopper to the flange. The stopper has a glass transition temperature (T.sub.g) that is greater than or equal to −70° C. and less than or equal to −45° C. The sealing assembly maintains a helium leakage rate of the sealed pharmaceutical container of less than or equal to 1.4×10.sup.−6 cm.sup.3/s as the sealed pharmaceutical container is cooled to a temperature of less than or equal to −45° C.

Disclosed are systems and methods for aseptically filling pharmaceutical containers with a pharmaceutical substance and then lyophilizing it. In one general aspect, the system and method can employ a lyophilizer loader subsystem having an interior chamber in communication with an interior chamber of a lyophilizer subsystem via a portal with a sealable door, with the collective interior being aseptically sealable. An articulated robotic arm can be employed to batch transfer to the lyophilizer subsystem container nests bearing the pharmaceutical containers. In one embodiment, the nests may be transferred serially to the loader subsystem, with the articulated robotic arm being configured to transfer the nests of containers in batches to the lyophilizer subsystem. The articulated robotic arm can also be configured to be used to move batches of nests within the lyophilizer subsystem. One implementation includes two articulated arms and a joint rotary wrist driven by two rotary shoulders.

Disclosed embodiments include portable devices for cold chain storage and methods of fabricating portable devices for cold chain storage. In an illustrative embodiment, a portable device for cold chain storage includes a container defining therein a storage region. The container includes an inner cylinder, and the storage region is defined coaxially inwardly of the inner cylinder. The inner cylinder includes phase change material disposed therein, and the phase change material is in thermal communication with the storage region. The inner cylinder also includes evaporative coils disposed therein. The evaporative coils are embedded in the phase change material. The container also includes a thermally insulated outer cylinder. An outer wall of the outer cylinder is disposed radially outwardly of an outer wall of the inner cylinder.

A device and method for enterally hydrating a patient with cooled fluids. The patient may be a paralyzed or limited upper body mobility patient with a functional gastrointestinal system who is nonetheless incapable or not fully capable of drinking unassisted. Here fluids are provided by a suspended container which also has a pouch to admit cooling material such as ice, but to keep the cooling material separate from the fluid. The container may also have optional graduation markings to allow for convenient estimation of fluid use, and an upper open and closeable cap to allow the container to be refilled. The container has a lower fluid conducting tube that terminates in a mouthpiece. The mouthpiece contains a fluid valve formed from at least one slit in an elastic material. Patient mouth force on the valve causes the slit to enlarge, thus enabling cooled fluid to flow into the patient.

This invention relates to an apparatus and method for applying writings and other markings to a frozen vial or ampoule, which is filled with biological material, and which is held at temperatures between about −70° C. and about −196° C. More particularly, the invention relates to a laser marking method that allows frozen vials to be labeled, while maintaining the integrity of the biological material contained therein.

A teething device for exercising gums and deciduous teeth. Two hollow receptacles sealingly mate to form a body of the teething device. A plurality of hollow knobs extend outwardly from the receptacles. The hollow interior of each knob is in a fluid communication with the interior space of the teething device. The teething device may be filled with a cold liquid to cool the exterior surfaces of the knobs. The liquid may be periodically discarded, and the hollow interior of the teething device may be refilled with a liquid of a predetermined temperature.

A teething glove is provided for cold relief associated with the discomfort that generally accompanies infant teething. The teething glove may include a temporary and/or permanent cold pack. The cold pack may provide a child relief while chewing and/or sucking on the portion of the teething glove containing the cold pack.

A drug delivery system includes a storage container defining one or more storage compartments and having at least one container sensor coupled thereto, a container condition change mechanism coupled to the storage container for imparting a change on one or more conditions of the one or more storage compartments, at least one drug delivery device adapted to deliver a drug to a user and adapted to be at least partially disposed within one or more of the one or more storage compartments, at least one delivery device sensor, a delivery device condition change mechanism coupled to the drug delivery device, and a controller coupled to the storage container. The storage container may be adapted to hold a number of drug delivery devices within a number of sealable storage compartments. The container sensor is adapted to sense a condition of the storage container, and the delivery device sensor is adapted to sense a condition of the at least one drug delivery device. The controller is adapted to instruct the container condition change mechanism and/or the delivery device change mechanism to impart a change on at least one condition of the storage container and/or the drug delivery device.

A container may include a storage volume configured to store a payload. A thermal insulation layer may surround the storage volume. A thermoregulation layer may surround the thermal insulation layer. There may be activation of a chemical reaction in the thermoregulation layer. The thermal insulation layer may have R-value per inch configured to expose the payload to a desired temperature to ensure viability of the payload and dampen a temperature spike of the chemical reaction. A system of containers may include a system storage volume with N containers in the system storage volume, wherein N is a whole number of 2 or more. A method of making an insulated container may include preparing an outer skin barrier layer, stacking a thermoregulation layer on the outer skin barrier layer, stacking a thermal insulation layer on the thermoregulation layer, and stacking an inner skin barrier layer on the thermal insulation layer.