Abstract: A lyophilization container includes a first section having a first layer, a second layer aligned with the first layer, and a cavity defined by the alignment of the first and second layers, where at least one of the first and second layers is preformed to have a three-dimensional shape. A lyophilization fixture includes a base member and a lid member. The lid member is movable between a first position and a second position relative to the base member. The base member and lid member together define a housing that receives at least a portion of a lyophilization container.

Abstract: A lyophilization container includes a first section having a first layer, a second layer aligned with the first layer, and a cavity defined by the alignment of the first and second layers, where at least one of the first and second layers is preformed to have a three-dimensional shape. A lyophilization fixture includes a base member and a lid member. The lid member is movable between a first position and a second position relative to the base member. The base member and lid member together define a housing that receives at least a portion of a lyophilization container.

Abstract: A premounted fluid conveyance assembly for use with a cell expansion machine comprises a tubing-organizer and a fluid conveyance system. The fluid conveyance system is at least partially attached to the tubing-organizer, and the fluid conveyance system comprises an oxygenator or gas transfer module, a length of tubing and a bioreactor all fluidly interconnected. The premounted fluid conveyance assembly is adapted to be detachably-attached to the cell expansion machine. Accordingly, after a premounted fluid conveyance assembly is used, it is removed from the cell expansion machine by disengaging it from the cell expansion machine. Thereafter, another premounted fluid conveyance assembly can be attached in place of the previously used premounted fluid conveyance assembly.

Abstract: The present invention provides thermoplastic tubes, thermoplastic melting plates, thermoplastic tube connecting apparatus, and methods for using the same.

Abstract: A system and method are used in connection with processing of blood components. The processing of blood components may involve centrifugal separation and/or filtering of the blood components. In some examples, at least some blood components are centrifugally separated in a chamber and then filtered via a filter rotating along with a centrifuge rotor, wherein the filter is located closer than the chamber to an axis of rotation of the rotor. The filter may include a porous filtration medium configured to filter leukocytes, platelets, and/or red blood cells. Some examples include a pressure sensor sensing pressure of pumped blood components. The sensed pressure may be used in connection with controlling the pumping of the blood products and/or in connection with determining the location of an interface associated with the blood products. Other uses of the sensed pressure are also possible.

Abstract: A centrifugal fluid separation system is disclosed for centrifugally separating a composite fluid into components thereof. This centrifugal separation system includes at least a centrifugal rotor which has a composite fluid containment area, a fluid flow channel/tubing and at least one separated component collection area defined therein. A composite fluid to be separated is delivered to the fluid containment area where under centrifugal forces the composite fluid is separated into components and then from which a component travels through an outlet channel to a respective separated component fluids flowing therethrough. A centrally disposed pump is also provided to move the separated component(s) to the collection area(s). Optical sensing of the interface of the separated fluid components may be used with a clamp to stop flow. A disposable bag and tubing system is also disclosed for use with reusable rotor devices.

Abstract: A blood component collection system with manipulation and optimization capabilities. Process parameters are derived from an input/configured predetermined blood component yield and which is based upon the maximization of at least one process parameter. Thereafter, the blood component collection procedure is performed with these derived process control parameters. Also, process parameters are derived from an input total procedure time from a maximized value for at least one of the other process control parameters so as to maximize blood component yield in this fixed time. Thereafter, the blood component collection procedure is performed with these derived parameters.

Abstract: A method is disclosed for collecting and processing whole blood. Whole blood is collected at several remote donor sites and transported to a central blood-processing center, where information regarding demand for blood products is used to direct processing of whole blood into blood products. Whole blood is initially collected in collection bags unattached to satellite bags instead of commonly used multiple bag sets. When the determination is made at the blood processing center as to which blood products are to be made, the appropriate satellite bags and/or other system components are sterile docked to the blood-collection bag and the whole blood is processed. The use of blood-collection bags initially unattached to satellite bags eliminates waste and simplifies the transportation and processing of whole blood. Also disclosed are blood collection systems that remove leukocytes and collect whole blood into blood-collection bags unattached to satellite bags.

Abstract: A system and method are used in connection with processing of blood components. The processing of blood components may involve centrifugal separation and/or filtering of the blood components. In some examples, at least some blood components are centrifugally separated in a chamber and then filtered via a filter rotating along with a centrifuge rotor, wherein the filter is located closer than the chamber to an axis of rotation of the rotor. The filter may include a porous filtration medium configured to filter leukocytes, platelets, and/or red blood cells. Some examples include a pressure sensor sensing pressure of pumped blood components. The sensed pressure may be used in connection with controlling the pumping of the blood products and/or in connection with determining the location of an interface associated with the blood products. Other uses of the sensed pressure are also possible.

Abstract: A centrifugal fluid separation system is disclosed for centrifugally separating a composite fluid into components thereof. This centrifugal separation system includes at least a centrifugal rotor which has a composite fluid containment area, a fluid flow channel/tubing and at least one separated component collection area defined therein. A composite fluid to be separated is delivered to the fluid containment area where under centrifugal forces the composite fluid is separated into components and then from which a component travels through an outlet channel to a respective separated component fluids flowing therethrough. A centrally disposed pump is also provided to move the separated component(s) to the collection area(s). Optical sensing of the interface of the separated fluid components may be used with a clamp to stop flow. A disposable bag and tubing system is also disclosed for use with reusable rotor devices.

Abstract: A device, system, and method are provided for separating blood components. The device includes a separation vessel for placement in a retainer of a rotatable centrifuge rotor. The separation vessel includes an inlet end portion, an outlet end portion, and a flow path extending from the inlet end portion to the outlet end portion. Blood components to be separated are supplied to the vessel via an inlet port at the inlet end portion, and separated blood components are removed via one or more outlet ports at the outlet end portion. The device also includes a leukocyte reduction filter including a porous filtration medium configured to filter leukocytes from at least some of the separated blood components removed from the vessel.

Abstract: A blood component collection system with data manipulation and/or optimization capabilities. In one embodiment, process parameters are derived from an input and/or configured predetermined blood component yield and which is based upon the maximization of at least one process parameter. Thereafter, the blood component separation and collection procedure is performed with these derived process control parameters. In another embodiment, process parameters are derived from an input total procedure time from a maximized value for at least one of the other process control parameters so as to maximize blood component yield in this fixed time. Thereafter, the blood component separation and collection procedure is performed with these derived parameters.

Abstract: A method is disclosed for collecting and processing whole blood. Whole blood is collected at several remote donor sites and transported to a central blood-processing center, where information regarding demand for blood products is used to direct processing of whole blood into blood products. Whole blood is initially collected in collection bags unattached to satellite bags instead of commonly used multiple bag sets. When the determination is made at the blood processing center as to which blood products are to be made, the appropriate satellite bags and/or other system components are sterile docked to the blood-collection bag and the whole blood is processed. The use of blood-collection bags initially unattached to satellite bags eliminates waste and simplifies the transportation and processing of whole blood. Also disclosed are blood collection systems that remove leukocytes and collect whole blood into blood-collection bags unattached to satellite bags.

Abstract: Methods for decontaminating fluids such as blood products, particularly platelets or red blood cells, are provided. The methods include mixing substantially non-toxic amounts of an endogenous photosensitizer such as riboflavin, or an endogenously-based derivative photosensitizer, with the fluid, increasing the dissolved oxygen content of the fluid to an amount sufficient to enhance a reaction of the photosensitizer in which singlet oxygen is formed and reduce competing reactions; and exposing the fluid to visible light photoradiation to activate the photosensitizer and substantially inactivate the pathogens. Blood products produced by the method, and systems for carrying out the method are also provided.

Abstract: Containers, methods and systems for treating blood or blood component products; whereby the containers are adapted to contain blood products and the containers have connected thereto respective information/identification chips for use in maintaining information about the blood products which may be contained within the containers and whereby the information/identification chips are adapted for having information written to and read from the information/identification chips including the writing of information to an information/identification chip that the respective blood product was subjected to a pathogen inactivation process.

Abstract: A method and apparatus for use in inactivating pathogens in fluids such as blood or blood components. The apparatus includes a container having a main body portion, a plurality of openings into the main body portion of the container, and at least one weld which partially surrounds at least one opening into the main body portion of the container. The method includes flowing fluid into the container via at least one of the plurality of openings and sealing at least one opening closed by extending the partially surrounding weld so that it completely surrounds the opening.

Abstract: A cell storage maintenance and monitoring system includes a blood product storage container, such as a flexible bag, and a microporous membrane which may be attached to an inner wall of the blood storage container to form a contained space between the inner wall and the membrane. The membrane includes a plurality of pores, preferably filled with an erodible substance responsive to a characteristic of the blood product. When the pH value drops to a predetermined level, the substance begins to erode, causing the pores to enlarge, and allowing a portion of the blood product to pass through the pores into the contained space, where it can be visibly detected. The contained space may contain a chemical indicator or buffers and nutrients, which are released into the blood product when the pores begin to open. In another embodiment, the microporous membrane may be in the form of a pod or capsule which may be attached to the wall or allowed to free-float within the contents of the storage container.

Abstract: A blood component collection system with manipulation and optimization capabilities. In one embodiment, process parameters are derived from an input/configured predetermined blood component yield and which is based upon the maximization of at least one process parameter. Thereafter, the blood component collection procedure is performed with these derived process control parameters. In another embodiment, process parameters are derived from an input total procedure time from a maximized value for at least one of the other process control parameters so as to maximize blood component yield in this fixed time. Thereafter, the blood component collection procedure is performed with these derived parameters.

Abstract: An apparatus and method are disclosed for filtering or separating particles. The apparatus has a centrifuge rotor rotatable about an axis of rotation. A fluid chamber rotates with the rotor. A substance is supplied to the inlet of the chamber. A saturated fluidized bed of first particles forms within the fluid chamber and obstructs flow of second particles through the chamber. Additive substances alter sedimentation velocity of the first particles to modify the filtration characteristics of the saturated fluidized bed.

Abstract: An apparatus and method are disclosed for filtering or separating particles. The apparatus has a centrifuge rotor rotatable about an axis of rotation. A fluid chamber rotates with the rotor. A substance is supplied to the inlet of the chamber. A saturated fluidized bed of first particles forms within the fluid chamber and obstructs flow of second particles through the chamber. Additive substances alter sedimentation velocity of the first particles to modify the filtration characteristics of the saturated fluidized bed.