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 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:
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:
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 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:
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.
Abstract:
An autonomous filter device and a method for improving the filter life and performance is disclosed. The filter element is equipped with one or more sensors, adapted to measure one or more characteristics. In response to the measured characteristic, the control logic within the filter element is able to determine an appropriate response. For example, the control logic may determine that a sudden, but temporary, blockage has occurred in the filter membrane. In response, the control logic may initiate a specific response designed to alleviate the blockage. The control logic will then determine the success of the response, based monitoring any change in the fluid characteristics. Based thereon, the control logic may alert the operator that the filter element must be replaced. Alternatively, if the response was successful in correcting the blockage, the control logic need not notify the operator, as the filter element is back to normal operating operation.
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.