Abstract:
The biocontainer of the present invention provides a low cost, simple solution of many of the problems encountered during shipping, freezing and thawing of biopharmaceutical materials. The present invention enables a user to monitor the temperature profile of each biopharmaceutical container during the cryogenic process, so as to ensure the integrity of materials within each biocontainer by using a pre-installed and pre-sterilized temperature sensor. In some embodiments, the sensor assembly includes a wireless transmitter and is capable of transmitting information regarding the measured reading. In other embodiments, the sensor assembly includes a processing unit, which determines whether the temperature profile is acceptable. In a further embodiment, an indicator is included, such that the processing unit may indicate whether the biopharmaceutical material has been properly frozen. In other embodiments, the sensor assembly also includes a storage element, which is capable of storing various parameters during the freezing process.
Abstract:
Fluid transfer apparatus including a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger that moves without changing the axial dimensions of the body. A first end of the body contains a face designed to be attached to an upstream component. A second end of the body is connected to a downstream component such as a filter, pipeline, etc. A first end of the plunger, when it is 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 remainder of the interior of the body, the plunger and downstream components. An outer annular collar is rotatable relative to the body and causes the plunger to move axially within the bore from an open to a closed position.
Abstract:
The present invention provides a process for incorporating a wireless device into a plastic container as part of the steps of manufacturing the container. The plastic container can be a flexible plastic bag and are formed of one or more sheets, generally two or more sheets of plastic film or a rigid plastic container such as a tub or tote. The bags are formed by sealing together adjacent edge portions of each film layer. One embodiment of the present invention is to incorporate a wireless device between the edge portions of the film(s) before or during sealing so that the wireless device becomes permanently sealed into the film material but is isolated from both the bag interior and the outside environment. Another embodiment is to incorporate the wireless device onto or into a plastic component that is sealed to the container, such as a nipple or port, so that the wireless device becomes permanently sealed to the container but is isolated from both the container interior and the outside environment.
Abstract:
A method and apparatus for providing more reliable wireless communication and power to sensors in electrically challenging bioprocess environments is disclosed. An unconnected antenna is located within the bioprocess environment, preferably in the same plane as the primary powered antenna. This unconnected antenna, also referred to as reflective antenna, enhances and confines the electromagnetic field created by the powered antenna. This reflective antenna is incorporated in or proximate to the devices containing a sensor or communication device. In one embodiment, the reflective antenna is incorporated into the filter housing. In another embodiment, it is incorporated into the filtering element itself. In another embodiment, it is incorporated into or affixed on the disposable bioprocess components, such as bags and tubes.
Abstract:
The present invention provides a process for incorporating a wireless device into a plastic container as part of the steps of manufacturing the container. The plastic container can be a flexible plastic bag and are formed of one or more sheets, generally two or more sheets of plastic film or a rigid plastic container such as a tub or tote. The bags are formed by sealing together adjacent edge portions of each film layer. One embodiment of the present invention is to incorporate a wireless device between the edge portions of the film(s) before or during sealing so that the wireless device becomes permanently sealed into the film material but is isolated from both the bag interior and the outside environment. Another embodiment is to incorporate the wireless device onto or into a plastic component that is sealed to the container, such as a nipple or port, so that the wireless device becomes permanently sealed to the container but is isolated from both the container interior and the outside environment.
Abstract:
The present invention uses a wireless memory/communication device at least on the one or more sample storage devices, preferably on both the one or more sample storage devices and the sampling holder, optionally the port on the equipment as well. Data such as that relating to the vessel, the location of the port on the vessel, the device, its manufacture date or lot number, the date of the installation, sterilization and/or taking of a sample along with the person who installed the device and/or took the sample can be read and preferably added to the wireless device when a read/write type of device as these events occur through a scanner/reader/writer device (fixed or hand held). The sample storage device in the laboratory can also then be read and recorded to track the sample storage device's life.
Abstract:
A system and method for verifying the occurrence of an environmental condition is disclosed. Rather than store information concerning the occurrence and/or success of the sterilization process, the present invention modifies the wireless transmission characteristics of the device. In some embodiments, the bandwidth of the wireless transceiver is altered as a result of undergoing sterilization. In other embodiments, the resonance frequency of the circuit is affected. In other embodiments, one or more of these parameters are affected based on other environmental conditions, such as shock or vibration.
Abstract:
The present invention uses a wireless memory/communication device at least on the one or more sample storage devices, preferably on both the one or more sample storage devices and the sampling holder, optionally the port on the equipment as well. Data such as that relating to the vessel, the location of the port on the vessel, the device, its manufacture date or lot number, the date of the installation, sterilization and/or taking of a sample along with the person who installed the device and/or took the sample can he read and preferably added to the wireless device when a read/write type of device as these events occur through a scanner/reader/writer device (fixed or hand held). The sample storage device in the laboratory can also then be read and recorded to track the sample storage device's life.
Abstract:
Fluid transfer apparatus including a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger that moves without changing the axial dimensions of the body. A first end of the body contains a face designed to be attached to an upstream component. A second end of the body is connected to a downstream component such as a filter, pipeline, etc. A first end of the plunger, when it is 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 remainder of the interior of the body, the plunger and downstream components. An outer annular collar is rotatable relative to the body and causes the plunger to move axially within the bore from an open to a closed position.
Abstract:
A system and method for interfacing non-sterile sensors to a sterile flow stream is disclosed. Typically, sensors cannot be sterilized in the same manner as other components of the flow stream. This results in complex processes to incorporate a sterilized sensor into a sterilized flow stream. By introducing a separation membrane, the desired sensor can be interfaced to the sterile flow stream. By doing so, the sensor need not be sterile, only sufficiently clean. The membrane separates the sterile environment within the flow stream from the sensor, while still permitting the sensor to function.