Abstract: The present invention provides a method and apparatus for sterilizing a pharmaceutical composition, the method comprising providing a sterilization system including a heat exchanger for elevating and then lowering the temperature of the fluid in a time period; measuring temperature at an input of the heat exchanger, measuring temperature at an output of the heat exchanger and measuring temperature at least one point in the heat exchanger intermediate to the input and output; calculating a coefficient of heat transfer for the sterilization system using the temperature measurements; calculating a degree of sterilization (F.sub.o) using the coefficient; and adjusting the temperature of the heat exchanger to minimize degradation of the pharmaceutical composition while maintaining an acceptable degree of sterilization.

Abstract: A method of prefilling and terminally sterilizing a syringe including providing a syringe barrel having first and second opposite ends where the first end includes a port therethrough with a connector member formed about an exterior of the port and the second end being open. Particulate matter is removed from the interior of the syringe barrel and a cap and stopper are sterilized, the stopper including first and second opposite longitudinal ends. The first end of the stopper is inserted into the second open end of the syringe barrel until the first end of the stopper reaches the first end of the syringe barrel. The syringe barrel then is filled with a desired liquid, such as a medicament or imaging agent, through the port of the first end of the syringe barrel so that substantially no air enters the syringe barrel and where the stopper moves within the syringe barrel from the first to the second ends thereof upon filling.

Abstract: An apparatus is disclosed which has utility for assembling a flexible tubular segment telescopically upon an end portion of a length of tubing when the tubing has an outer diameter which is substantially the same or greater than the inner diameter of the tubular segment. The apparatus has the capacity to controllably stretch the flexible tubular segment sufficiently to facilitate passage therethrough of an end portion of a length of the tubing. The end portion of the length of tubing is then positioned inside the stretched flexible tubular segment such that the stretched tubular segment is located a pre-selected distance from the free end of the end portion of the length of tubing. The tubular segment is then allowed to contract around the the end portion. The assembled tubular segment and end portion of the length of tubing are then ejected from the apparatus while maintaining the pre-selected distance of the tubular segment from the free end of the end portion of the length of tubing.

Abstract: A disposable pumping cassette having an integral auxiliary flow control and pressure monitoring member is used for delivering a medicinal fluid to a patient. The pumping cassette includes an elastomeric member mounted in a rigid body having an inlet and an outlet. An inlet valve and an outlet valve on the cassette are opened, and the flow control is positioned to allow the medicinal fluid to flow freely through the cassette, priming it before the outlet is connected to the patient. The cassette is then coupled to an associated pump driver, closing the flow control to disable free fluid flow through the cassette, and the outlet of the cassette is coupled in fluid communication with the patient's body. The medicinal fluid is drawn into a pumping chamber formed in the rigid body as a plunger of the associated pump driver is drawn up from the elastomeric membrane at a recess formed in the rigid body.

Abstract: The present invention provides an apparatus and method for testing seal strength and integrity of packages and for testing container and lid integrity, during an on-line production processing environment. Air pressure is introduced in a unique way to test the container and/or container seal in an additional step of an otherwise typical processing environment. A computer may be in communication with the testing sensors to control the processing in the event a failure is detected. The present invention provides a way to meet the continuously increasing line speed in form, fill and seal production processes with a unique ability of having complete package integrity testing for any odd shapes and package combinations.

Abstract: A drug reconstitution and administration system includes a container for a concentrated drug or other medicament, a syringe assembly which can be pre-filled with a liquid diluent, and a mixing adapter assembly which facilitates mixing of the medicament with the liquid diluent. The adapter assembly includes inner and outer concentrically arranged, relatively movable sleeves, which together define an expandable mixing chamber within the adapter assembly. The container and pre-filled syringe are respectively fitted to the adapter assembly, with the contents of the container and the contents of the syringe transferred into the internal mixing chamber. A diluted drug mixture is formed in the mixing chamber, and the mixture is transferred into the syringe assembly for subsequent patient administration.

Abstract: The hand grip device of the present invention is designed for use with an associated syringe having a plunger stem with a push and pull flange at a terminal end of the plunger stem. The hand grip device includes a grip portion extending generally the width of a hand and having opposite ends. A C-shaped bracket portion includes two arms and a push bar. Each arm is connected to the opposite ends of the grip portion and the push bar connects the two arms so as to be generally parallel to the grip portion. A pull bar is spaced from and parallel to the push bar. The pull bar is cantilevered from conveniently the lower bracket arm and has a V-shaped slot extending away from the cantilevered arm for slidably engaging the push-pull flange of the associated syringe.

Abstract: A valve including a substantially rigid cannula and a valve member connected for operable communication with the cannula. The valve member is formed from a substantially resilient material and is movable with respect to the cannula between a first closed position and a second open position. The cannula cooperates to extend through the valve member during movement from the first closed position to the second open position to establish a fluid flow path through the cannula and the valve member. A sealing member is also provided which operates independent from a flow of fluid within the fluid flow path and independent from any component utilized with the valve to automatically provide positive sealing of an opening within the valve member when the valve member is positioned in the first closed position, the cannula extending through the opening during movement of the valve member.

Abstract: A method for dye marking a liquid enteral nutritional product during delivery thereof from a supply container to a feeding tube delivering the nutritional product to the gastrointestinal tract of a patient includes the steps of: (1) providing apparatus such as a formulation chamber, e.g., a drip chamber, connectable to the supply container, with at least one sustained release reservoir containing a physiologically acceptable and dispersible marker dye positioned within the formulation chamber, and, liquid communication means connecting the formulation chamber to the feeding tube of a patient; (2) providing a supply container containing the nutritional product; (3) connecting the formulation chamber to the supply container and the liquid commmunication means to the feeding tube; and (4) flowing the dye-marked nutritional product through the apparatus and into the feeding tube.

Abstract: An apparatus and method are disclosed for modifying a liquid enteral nutritional product during delivery thereof from a supply to a feeding tube delivering the modified liquid enteral nutritional product to the gastrointestinal tract of a patient. At least one beneficial agent not in controlled release dosage form in a useful, dose unit, amount, is disposed within a formulation chamber so as to be taken up in a liquid enteral nutritional product traversing the formulation chamber while feeding the modified nutritional product into the gastrointestinal tract of a patient. The beneficial additive(s) are selected from nutrients, medicaments, probiotics, or diagnostic agents, or mixtures thereof, each in a dosage form that is dispersible in the medium of the liquid enteral nutritional product in less than two hours.

Abstract: A spring-loaded reciprocable stylet holder assembly includes a cap; a hollow body element partially nested within and reciprocable a major part of its length into the cap; a spring urging the body element outwardly of the cap; and a stylet supported at one end by the cap and extending through and beyond the body element. The remote end of the body element has a small borehole through which the stylet extends. The remote end is also provided with attachment means for a hypodermic needle with slotted tip for T-fastener emplacement, the needle telescopically surrounding the full length of the stylet. In a useful modification of the device an insufflation adapter having a side port for attachment of a hypodermic syringe is placed in line between the body element and the hypodermic needle. The stylet holder assembly with a slotted hypodermic needle attached thereto may be used for emplacing a T-fastener in a hollow organ of a person, such as the stomach.

Abstract: A method is disclosed for modifying a liquid enteral nutritional product during delivery thereof from a supply container to a feeding tube delivering the nutritional product to the gastrointestinal tract of a patient. During enteral tube feeding the nutritional product passes through a formulation chamber, e.g., a drip chamber, having located therein at least one controlled release dosage form unit containing at least one beneficial agent. The beneficial agent may be selected from nutrients, medicaments, probiotics, or diagnostic agents or mixtures thereof, and any such together with a physiologically acceptable marker dye in controlled release dosage form and/or the same or different additional beneficial agent not in controlled release dosage form. Controlled release dosage forms may be of a conventional sustained release type or an osmotically driven delivery device.

Abstract: An apparatus is disclosed for modifying a liquid enteral nutritional product during delivery thereof from a supply thereof, such as a hangable container, to a feeding tube delivering the liquid enteral nutritional product to the gastrointestinal tract of a patient. The apparatus has at least one formulation chamber, such as a drip chamber, with at least one controlled release dosage form unit in the form of a coated tablet, osmotically driven device, coated capsule, microencapsulated microspheres, agglomerated molecular sieving type material, or a quantity of fine hollow permeable fibers located therein. The controlled release dosage form unit or units contain at least one beneficial agent selected from nutrients, medicaments, probiotics, or diagnostic agents or mixtures thereof, to any of which a physiologically acceptable marker dye in controlled release dosage form and/or the same or different beneficial agent not in controlled release dosage form may be added.

Abstract: An apparatus is useful for dye marking a liquid enteral nutritional product during delivery thereof from a supply container to a feeding tube delivering the nutritional product to the gastrointestinal tract of a patient. A formulation chamber, such as a drip chamber, is connectable to the supply container. At least one sustained release reservoir containing a physiologically acceptable marker dye is positioned within the formulation chamber, or if not, is included as part of a kit. The sustained release reservoir may be in the form of a coated tablet, osmotically driven device, coated capsule, microencapsulated microspheres, agglomerated molecular sieving material, or chopped hollow fibers having permeable walls. A liquid communication means connects the formulation chamber to the feeding tube of a patient. The marker dye may be a colorant dye or a fluorescing dye or a mixture thereof.