Abstract: A vacuum demand valve for delivering a flowable material is disclosed. The valve has a housing having a proximal end, a distal end, an intermediate segment therebetween defining a passageway wherein the flowable substance can flow from the proximal end to the distal end. The housing can be a tubing. A valve member is located along the intermediate segment. The valve member has a closed condition wherein the flow of the flowable material from the proximal end to the distal end is stopped and an open condition wherein the flow of the flowable material from the proximal end to the distal end is unstopped. The valve member is biased in the closed condition and is responsive to a partial vacuum provided by the user through the passageway for placing the valve member in the open condition.

Abstract: A vacuum demand valve for delivering a flowable material is disclosed. The valve has a housing having a proximal end, a distal end, an intermediate segment therebetween defining a passageway wherein the flowable substance can flow from the proximal end to the distal end. The housing can be a tubing. A valve member is located along the intermediate segment. The valve member has a closed condition wherein the flow of the flowable material from the proximal end to the distal end is stopped and an open condition wherein the flow of the flowable material from the proximal end to the distal end is unstopped. The valve member is biased in the closed condition and is responsive to a partial vacuum provided by the user through the passageway for placing the valve member in the open condition.

Abstract: A vacuum demand valve for delivering a flowable material is disclosed. The valve has a housing having a proximal end, a distal end, an intermediate segment therebetween defining a passageway wherein the flowable substance can flow from the proximal end to the distal end. The housing can be a tubing. A valve member is located along the intermediate segment. The valve member has a closed condition wherein the flow of the flowable material from the proximal end to the distal end is stopped and an open condition wherein the flow of the flowable material from the proximal end to the distal end is unstopped. The valve member is biased in the closed condition and is responsive to a partial vacuum provided by the user through the passageway for placing the valve member in the open condition.

Abstract: A vacuum demand valve for delivering a flowable material is disclosed. The valve has a housing having a proximal end, a distal end, an intermediate segment therebetween defining a passageway wherein the flowable substance can flow from the proximal end to the distal end. The housing can be a tubing. A valve member is located along the intermediate segment. The valve member has a closed condition wherein the flow of the flowable material from the proximal end to the distal end is stopped and an open condition wherein the flow of the flowable material from the proximal end to the distal end is unstopped. The valve member is biased in the closed condition and is responsive to a partial vacuum provided by the user through the passageway for placing the valve member in the open condition.

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract: The present invention provides an improved transfer set for use in an automated compounding device. The transfer set comprises a plurality of fluid conduits, each fluid conduit including a first section and a second section, the first and second sections being coupled together in fluid communication by a coupler. A housing is provided for receiving at least a portion of the fluid conduits and the coupler. The housing defines separate channels for receiving a portion of the second section of each fluid conduit. The channels extend for a sufficient distance so that at least substantially an entire length of the second section that is located in the housing is located in a channel thereby securing the fluid conduits in place in the housing. An improved method for making a transfer set is also provided.

Abstract: A container is provided for housing a fluid comprising a pair of flexible plastic walls, one of the plastic walls defining a front face and one of the plastic walls defining a back face. The plastic walls are secured together around a periphery thereof by a peripheral seal thereby defining an interior. An access member is located at an end of the container for allowing one to access a fluid contained within the interior. A fill port is located on a front face for allowing access to the interior of the container so that the interior can receive a fluid. The back and front face are sealed along a seal line located within the interior of the container in juxtaposition to the fill port. In an embodiment, the peripheral seal has a substantially .OMEGA. shape. A method for filling a container with fluid is also provided.

Abstract: A system for metering nutrient media to cell culture containers includes a media flow conduit which defines at one end means for substantially aseptic communication with the source of the media. In a preferred embodiment, sterile connectors may be used for essentially sterile conditions. A branch conduit extends from the flow conduit at a location spaced from the ends. The branch conduit communicates with means for receiving a predetermined-volume aliquot of media through the media flow conduit from said one end. The flow conduit also defines a portion downstream from the branch conduit, which communicates with at least one cell culture container, each container being a flexible bag. At least part of the flexible bag is made of a material capable of providing at least 2 times the oxygen diffusion and at least 2 times the carbon dioxide diffusion between the bag interior and exterior, compared with an identically-sized, sealed bag having polyethylene walls 0.013 inch thick.

Abstract: A cell culture media container is provided. The container comprises a body constructed from flexible film and defining a containment area for containing the cell culture media, the body including a front face and a back face, the front and back face being sealed to each other along at least three sides thereof. The container includes a fill port for filling the containment area with cell culture media, the port being sealed to a face of the body and being so constructed and arranged that it extends from the face normal thereto. The container is constructed from a high barrier, optically clear, radiation sterilizable film.

Abstract: A fluid delivery system has a container with an integrally attached sample cell. A selected fluid can be accumulated in the container. The sample cell can be filled with part of the fluid in the container and then isolated from the container by heat or dielectric sealing. The fluid in the sample cell can be brought into contact with selected test reagents. The test reagents can provide a visual indicia of the presence of selected characteristics in the fluid.

Abstract: A fluid delivery system has a container with an integrally attached sample cell. A selected fluid can be accumulated in the container. The sample cell can be filled with part of the fluid in the container and then isolated from the container by heat or dielectric sealing. The fluid in the sample cell can be brought into contact with selected test reagents. The test reagents can provide a visual indicia of the presence of selected characteristics in the fluid.

Abstract: A system for metering nutrient media to cell culture containers includes a media flow conduit which defines at one end means for substantially aseptic communication with the source of the media. In a preferred embodiment, sterile connectors may be used for essentially sterile conditions. A branch conduit extends from the flow conduit at a location spaced from the ends. The branch conduit communicates with means for receiving a predetermined-volume aliquot of media through the media flow conduit from said one end. The flow conduit also defines a portion downstream from the branch conduit, which communicates with at least one cell culture container, each container being a flexible bag. At least part of the flexible bag is made of a material capable of providing at least 2 times the oxygen diffusion and at least 2 times the carbon dioxide diffusion between the bag interior and exterior, compared with an identically-sized, sealed bag having polyethylene walls 0.013 inch thick.

Abstract: A fluid delivery system has a container with an integrally attached sample cell. A selected fluid can be accumulated in the container. The sample cell can be filled with part of the fluid in the container and then isolated from the container by heat or dielectric sealing. The fluid in the sample cell can be brought into contact with selected test reagents. The test reagents can provide a visual indicia of the presence of selected characteristics in the fluid.

Abstract: A storage system (10) includes an interior envelope (12) and an exterior envelope (14). Tissue or other material to be stored may be placed in interior envelope (12), sealed and placed in exterior envelope (14). Exterior envelope (14) is sealable in a first sealed position that allows gas sterilization of the interior of exterior envelope (14) and the contents contained therein. After sterilization, exterior envelope (14) is sealed in a gas impermeable position. Each of interior and exterior envelopes (12, 14) have one side which is transparent. A grid (22) may be provided on the transparent side of interior envelope (12) for sizing tissue contained therein.

Abstract: A wide-mouthed flexible, collapsible, sterile bag made of sheeting of poly (ethylene-vinyl acetate) containing from 5 to 35 weight percent of vinyl acetate units. The bag is made to be used for storing solid, living tissue portions at cryogenic temperatures. The wide mouth of such a container may be heat sealed prior to storage. Such containers, while flexible and collapsible, exhibit effective strength and durability at such cryogenic temperatures.

Abstract: A fluid processing system includes an integral flow control and distribution manifold for establishing fluid communication between conduit segments of the system. In use, the fluid manifold is received in an actuator head of an associated processor apparatus, wherein valving elements selectively crimp valving passageways in the manifold to perform the procedure. The fluid circuit of the system accommodates multiple procedures, obviating the need to stock multiple systems and enabling manufacturing economics to be realized from higher production volumes.

Abstract: A single needle batch-type blood fractionation system for separating plasma from whole blood includes a disposable flow system having a single-lumen phlebotomy needle and associated donor conduit, a flow-through plasma separation filter, and an in-process fluid reservoir. During an initial draw cycle whole blood is pumped through the filter to the in-process reservoir by a peristaltic-type inlet pump operating at a predetermined draw rate. When a predetermined volume of filtered plasma-deficient blood has been collected in the reservoir, as sensed by the weight of the reservoir, the system reverts to a return cycle wherein a portion of the plasma-deficient blood in the reservoir is pumped back to the donor conduit by a peristaltic-type return pump operating at a predetermined return rate higher than the draw rate of the inlet pump.

Abstract: An apparatus for separating and collecting plasma from whole blood includes a ratio control system which enables replacement fluid to be added by a replacement fluid pump within the apparatus to processed plasma-deficient blood at a predetermined ratio to the volume of plasma collected in a collection container. A transducer within the system develops an electrical signal frequency-dependent on the weight of the collected plasma. This signal is applied through a first rate multiplier circuit to the up-count input of a bidirectional counter. A second signal derived from a tachometer on the replacement fluid pump is supplied through a second rate multiplier circuit to the down-count input of the counter. A digital-to-analog converter converts the count in the counter to an analog control signal which controls the operation of the replacement pump motor. The multiplication factors of the rate multipliers are set by a user-operated switch to obtain a desired replacement ratio.

Abstract: An apparatus for the continuous flow fractionation of whole blood incorporates motor driven whole blood, anti-coagulant and replacement pumps, negative and positive pressure monitors, and a dual bubble detector which function in conjunction with a disposable single-use flow system and a hollow fiber filter to separate and collect plasma from whole blood. Operation of the pump motors, pressure monitors and bubble detector is controlled by a control circuit within the apparatus to provide one of several operator-selected operating modes, including run, prime and reinfuse modes. The control circuit provides an alarm which can be cancelled by the operator when certain system parameters fall outside of normal operating limits, and interrupts operation of the pumps when the parameters exceed maximum limits. A failsafe circuit independent of the control circuits interrupts power to the pump motors in the event the motors do not stop upon detection of a bubble or fluid absence in the flow system.