Abstract: A testing method that includes the steps of evacuating air from a container to a negative atmospheric pressure, the container being a collapsible, flexible container, and comprising at least two opposing flexible walls, wherein a surface of at least one of the walls internal to the container comprises a plurality of channels or recessed features on said at least one wall and monitoring a mass flow or a state of vacuum so as to determine the integrity of the container. The container can be of any size or conformation, with or without attached fittings.

Abstract: A device for storing, transporting and/or handling a liquid or liquids and methods for using the device are described. The device is suitable for use with sterile or aseptic liquids, particularly with large liquid volumes such as 10-1000 liters or more, and avoids the need for bags, bins and carriers commonly used for storing and transporting large volumes of liquids. The device comprises a coiled tubing. The coiled tubing can be loaded onto a spool to support the coiled tubing. The tubing can be filled, sealed, stored and transported in a more robust manner than previously achieved with bags, bins and carriers.

Abstract: A testing method that includes the steps of evacuating air from a container to a negative atmospheric pressure, the container being a collapsible, flexible container, and comprising at least two opposing flexible walls, wherein a surface of at least one of the walls internal to the container comprises a plurality of channels or recessed features on said at least one wall and monitoring a mass flow or a state of vacuum so as to determine the integrity of the container. The container can be of any size or conformation, with or without attached fittings.

Abstract: A device for storing, transporting and/or handling a liquid or liquids and methods for using the device are described. The device is suitable for use with sterile or aseptic liquids, particularly with large liquid volumes such as 10-1000 liters or more, and avoids the need for bags, bins and carriers commonly used for storing and transporting large volumes of liquids. The device comprises a coiled tubing. The coiled tubing can be loaded onto a spool to support the coiled tubing. The tubing can be filled, sealed, stored and transported in a more robust manner than previously achieved with bags, bins and carriers.

Abstract: A system and method for measuring integrity of flexible containers is disclosed. The system uses a low mass flow transducer to monitor the flow of fluid into the flexible container. Based on this flow rate, the existence of an orifice in the flexible container may be detected. The system also includes a second flow path to the flexible container to allow for faster fill times. Greater flow rates are achieve through the use of a second high mass flow transducer or a calibrated bypass path. These alternate paths allow greater flow rates until the flexible container is determined to be nearly full, at which point all flow passes with the low mass flow transducer.

Abstract: The present invention relates to a process for the sterile transfer of fluids, be they liquids or gases. It uses a presterilized device comprised of a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components. The device is attached to an upstream component and the face and the first end of the plunger are steam sterilized in place.

Abstract: The present invention is a disposable, presterilized bioreactor formed of molded plastic, having a top and body attached to each other. One or more ports are formed in the top, side and bottom of the housing. The one or more ports that are below the liquid/air interface level may be used as sampling ports, access ports for probes or drains or supply ports for liquids or gases. The bioreactor provides a direct retrofit for the existing glass or steel assembly that utilizes the existing support structures and controls. The molded design overcomes issues of discontinuity, dead spots and the like due to its fixed dimensions that are built in by the molding process. Reproducible probe and other equipment locations are guaranteed through the use of the molded port features.

Abstract: The present invention is a disposable bioreactor formed of molded plastic. The bioreactor is presterilized and has a top and body sealed to each other. One or more ports are formed in the top and side of the housing. Preferably at least one port is below the liquid/air level for the housing. The one or more ports that are below the liquid/air interface level may be used as sampling ports or access ports for probes or drains or supply ports for liquids or gases. The bioreactor provides a direct retrofit for the existing glass or steel assembly that utilizes the existing support structures and controls. The molded design overcomes issues of discontinuity, dead spots and the like due to its fixed dimensions that are built in by the molding process. Reproducible probe and other equipment location is also guaranteed through the use of the molded port features. The molded plastic allows for greater flexibility in material selection to reduce or eliminate lipid or cholesterol binding.

Abstract: The present invention relates to a process for the sterile transfer of fluids, be they liquids or gases. It uses a presterilized device comprised of a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components. The device is attached to an upstream component and the face and the first end of the plunger are steam sterilized in place.

Abstract: The present invention relates to a process for the sterile transfer of fluids, be they liquids or gases. It uses a presterilized device comprised of a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components. The device is attached to an upstream component and the face and the first end of the plunger are steam sterilized in place.

Abstract: The present invention relates to a sterile sample collection device for fluids and a method of using the same. It is comprised of a transfer device having a body with a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to tube which is then connected to a collection bag. The plunger has corresponding first and second ends. The first end of the plunger when in the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components.

Abstract: The present invention relates to a process for the sterile transfer of fluids, be they liquids or gases. It uses a presterilized device comprised of a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components. The device is attached to an upstream component and the face and the first end of the plunger are steam sterilized in place.

Abstract: The present invention relates to a process for the sterile transfer of fluids, be they liquids or gases. It uses a presterilized device comprised of a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components. The device is attached to an upstream component and the face and the first end of the plunger are steam sterilized in place.

Abstract: The present invention relates to a sterile transfer device for fluids, be they liquids or gases. It is comprised of a body having a bore formed through at least a portion of its interior. Preferably, it is a central bore formed through the entire length of the body. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components.

Abstract: The present invention is a disposable bioreactor formed of molded plastic. The bioreactor is presterilized and has a top and body sealed to each other. One or more ports are formed in the top and side of the housing. Preferably at least one port is below the liquid/air level for the housing. The one or more ports that are below the liquid/air interface level may be used as sampling ports or access ports for probes or drains or supply ports for liquids or gases. The bioreactor provides a direct retrofit for the existing glass or steel assembly that utilizes the existing support structures and controls. The molded design overcomes issues of discontinuity, dead spots and the like due to its fixed dimensions that are built in by the molding process. Reproducible probe and other equipment location is also guaranteed through the use of the molded port features. The molded plastic allows for greater flexibility in material selection to reduce or eliminate lipid or cholesterol binding.

Abstract: A light emitting diode (LED) array with beam directors outputting a high-intensity collimated beam. The LED array is constructed from a substrate component on which the LEDs and necessary electronics are disposed and a director attachment having a plurality of beam directors. The beam directors have a unique structure that is designed to shape the light beam into a collimated form. The LEDs are arranged in a pattern on the substrate, and the beam directors are arranged within the director attachment to coincide with the LEDs. The substrate and the director attachment may be manufactured and processed as separate components; they are then affixed together for operation.

Abstract: A bioreactor formed of a flexible material is provided having a constant aspect ratio and an adjustable length. The bioreactor is rendered self standing by a support means secured to the bioreactor.

Abstract: The present invention provides a fluid sampling device comprising a port insert, a plurality of flexible conduits, and a plurality of sample containers. The port insert comprises a body having a plurality of shafts therethrough and a rotatably displaceable member for individually opening and closing any of said shafts to enable the flow of fluid therethrough. Flexible conduits (e.g., flexible tubing) are equal in number to the shafts, with each flexible conduit connected to or otherwise in fluid communication with an individual shaft. Similarly, sample containers (e.g., flexible bags) are equal in number to the conduits, with each sample container connected to an individual conduit opposite the connection to the shaft. A specific configuration for the port insert, as well as kit containing sterilized components of the fluid sampling device, are also described.

Abstract: A light emitting diode (LED) array with beam directors outputting a high-intensity collimated beam. The LED array is constructed from a substrate component on which the LEDs and necessary electronics are disposed and a director attachment having a plurality of beam directors. The beam directors have a unique structure that is designed to shape the light beam into a collimated form. The LEDs are arranged in a pattern on the substrate, and the beam directors are arranged within the director attachment to coincide with the LEDs. The substrate and the director attachment may be manufactured and processed as separate components; they are then affixed together for operation.

Abstract: A depth filter design is disclosed which has little if any open void area upstream of the media. Preferably, it also has little if any open void area downstream of the media as well. A preferred embodiment uses layers of stacked, fibrous media with several of the layers being separated from the others by spacers which serve to compress the media and to prevent the bypass of fluid around the media adjacent the inner wall of the housing. Several designs for attaching the end caps which allow for the compression of the media are also disclosed.