Sterile system and methods for collecting, transporting, storing and cyropreserving body fluids

A method for forming an expandable closed, sterile bag system to be used for collecting, transporting and storing a biological fluid and the cells contained therein, the method comprising:

• providing a sterile, closed bag system, constructed for long-term exposure to biological fluid, the system having at least one inlet element and at least one outlet element;
• a plurality of sterile communicable components or compartments, separably connected to one another for holding, receiving, mixing, transporting, cryopreserving or storing biological fluid/cells in sterile form;
• one or more regions for containing or mixing liquid(s) and biological fluid(s) and for storing same;
• at least one closable air vent for removing air from one compartment to another within the system without opening the closed system;
• and shut-off elements and connecting lines communicably connecting parts of the bag system to maintain a closed, sterile system, and wherein the regions for storing contents of the bag system are hermetically sealable and separable from one another;
• providing at least one sterile expansion connection assembly for fluids, the assembly comprising a sterile filter for sterile filtration of fluids added to the system, and blind-sealed, sterile tube extending therefrom;
• and
• operably and connectably attaching the tube of the at least one expansion connection assembly to the closed, sterile bag system by sterile connection without opening the closed bag system, thereby sealing the at least one expansion connecting assembly to and extending from the closed, sterile bag system.