METHOD AND APPARATUS FOR CRYOPRESERVATION OF BLOOD CELLS IN A STERILE ENVIRONMENT

摘要

An apparatus and related method for the optimization of the cryopreservation of various types of cells, including but not limited to hematopoietic and mesenchymal stem and progenitor cells, and endothelial progenitor cells found in normal blood, placental/cord blood, bone marrow or the stromal vascular fraction of adipose tissue. The apparatus for cryopreservation of biological materials in a sterile environment comprises a cryopreservation workstation, a rigid disposable cartridge, and a freezing bag assembly. The apparatus and related method provide for the precise, temperature controlled, homogenously distributed introduction of a cryoprotectant containing dimethyl sulfoxide (DMSO) into a solution containing nucleated cells in a manner that provides a safe increase in osmotic pressure and a controlled release of exothermic heat within the cells as the DMSO penetrates the cell membrane and replaces water molecules prior to the freezing of the cells.

主权项

1. An apparatus for cryopreservation of biological materials in a sterile environment comprising:
a cryopreservation workstation comprising:
an upper platform;a freezing bag holder;a mixing module with a mixing chamber compartment comprising a mixing module cap, a cooling plate, a mixing module door, an infrared sensor to record the temperature of fluid contents within any fluid container placed within the mixing chamber compartment and a mechanism for nutating motion;a freezing bag air expresser;a cryoprotectant mixing chamber holder connected to the freezing bag air expresser;a syringe pump module having a syringe holder, an actuator plunger, a pair of retaining pins and a syringe pump module door; anda syringe being placed in the syringe holder and configured to hold a cryoprotectant solution; a rigid disposable cartridge with a harvested cell solution removably positioned on the upper platform; and a freezing bag assembly comprising:
a cryoprotectant mixing chamber having a cryoprotectant filter with a detachable filter cap;at least one input tubing assembly attached to the cryoprotectant mixing chamber; at least one sampling site attached to the at least one input tubing assembly;at least one air filter attached to the at least one input tubing assembly;at least one sampling bulb attached to the at least one input tubing assembly;a Y connector tubing attached to the cryoprotectant mixing chamber;at least one freezing bag attached to the Y connector tubing; andat least one spike port attached to the at least one freezing bag;whereby the cryopreservation workstation, the rigid disposable cartridge and the at least one freezing bag assembly are set up therethrough so that the apparatus provides mixing of contents of harvested cell solution without the formation of standing waves, passage of cryoprotected cell solution under sterile conditions and monitoring, regulating and recording temperature of the cryoprotected cell solution.