Biomaterial freezing

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 method for monitoring the thawing of a frozen biopharmaceutical material contained in a biocontainer, the method comprising of:
providing said frozen biopharmaceutical material in a sterilized biocontainer of a predetermined volumetric capacity comprising an indicator to indicate whether the biopharmaceutical material was properly thawed, a storage element, and 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 a wireless temperature sensor, said wireless temperature sensor positioned at or about the geometric center of said biocontainer; removing said biocontainer from a freezer such that said biopharmaceutical material thaws; taking a plurality of measurements of the temperature of said frozen biopharmaceutical material within said biocontainer at or about the geometric center as said frozen biopharmaceutical material thaws; storing said plurality of measurements on said storage element; allowing said frozen biopharmaceutical material to completely thaw; comparing said plurality of measurements to a reference temperature profile; determining whether the difference between said plurality of measurements and said reference temperature profile indicates that the frozen biopharmaceutical material, once thawed, has been properly thawed; and actuating said indicator to indicate the result of said determination of whether said biopharmaceutical material was properly thawed.