Biocontainer with integrated temperature sensor

摘要

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.

主权项

1. A biocontainer adapted to receive a biopharmaceutical material therein, wherein the biocontainer comprises:
an indicator to indicate whether the biopharmaceutical material was properly frozen; a sensor attachment mechanism affixed to opposite edges of said biocontainer, disposed within said biocontainer and passing through the geometric center of said biocontainer, said sensor attachment mechanism comprising a sealed enclosure holding:
at least one wireless temperature sensor positioned near said geometric center of said biocontainer;at least one processing unit in communication with said indicator and configured to:
compare data obtained by said wireless temperature sensor to predetermined values to determine whether the biopharmaceutical material, once frozen, was properly frozen, andactuate said indicator to indicate the result of said determination of whether the biopharmaceutical material was properly frozen; anda storage element, in communication with said processing unit, to store data obtained by said temperature sensor.