Device for conveying a bag comprising a biopharmaceutical fluid and systems and a method using same

A device for storing and transporting a biopharmaceutical fluid, comprising:

• an inner bag made of plastic, flexible and fluidtight, the inner bag forming an inner chamber adapted and intended for receiving a biopharmaceutical fluid, the inner bag being provided with a wall and one orifice for at least one of fill and discharge of biopharmaceutical fluid and at least one of a fill tube and a discharge tube associated in a fluidtight manner with the at least one of fill and discharge orifice,
• an outer container comprising an outer receptacle, the outer receptacle comprising a wall forming an outer chamber, the entire inner bag being placed in the outer chamber of the outer container,
• an expandable protective element arranged at least partially between the outer receptacle and the inner bag and adapted to receive the inner bag, the expandable protective element being adapted to expand in volume to an expanded state so as to be interposed between the outer receptacle and the inner bag,
• wherein the expandable protective element in the expanded state surrounds the inner bag and fills the space between the wall of the outer receptacle and the inner bag,
• wherein the expandable protective element is inflatable, the expandable protective element being provided with an injection orifice providing a passage for injection of inflation gas, the injection orifice being in fluid communication with the protective element, the injection orifice associated by a fluidtight connection with a first end of an injection tube, the injection tube having at an opposite second end an inlet for the injection of inflation gas into the expandable protective element,
• wherein the expandable protective element comprises a wall joined in a fluidtight manner to a common edge with the wall of the outer receptacle.

A system for receiving and transferring under controlled pressure a biopharmaceutical fluid, comprising:

• a device for storing and transporting a biopharmaceutical fluid, comprising:
• an inner bag made of plastic, flexible and fluidtight, the inner bag forming an inner chamber adapted and intended for receiving a biopharmaceutical fluid, the inner bag being provided with a wall and one orifice for at least one of fill and discharge of biopharmaceutical fluid and a fill tube and a discharge tube associated in a fluidtight manner with the at least one of fill and discharge orifice, an outer container comprising an outer receptacle, the outer receptacle comprising a wall forming an outer chamber, the entire inner bag being placed in the outer chamber of the outer container, an expandable protective element arranged at least partially between the outer receptacle and the inner bag and adapted to receive the inner bag, the expandable protective element being adapted to expand in volume to an expanded state so as to be interposed between the outer receptacle and the inner bag, wherein the expandable protective element in the expanded state surrounds the inner bag and fills the space between the wall of the outer receptacle and the inner bag, wherein the expandable protective element is inflatable, the expandable protective element being provided with an injection orifice providing a passage for injection of inflation gas, the injection orifice being in fluid communication with the protective element, the injection orifice associated by a fluidtight connection with a first end of an injection tube, the injection tube having at an opposite second end an inlet for the injection of inflation gas into the expandable protective element,
• the inner bag being provided with a fill orifice for filling with biopharmaceutical fluid and a discharge orifice for discharging biopharmaceutical fluid, and, in fluidtight association with the fill orifice and the discharge orifice, the fill tube having a fill inlet for filling the chamber with biopharmaceutical fluid, adapted to be associated with a line for filling with biopharmaceutical fluid, and the discharge tube having a discharge outlet for draining biopharmaceutical fluid from the chamber, adapted to be associated with a fluid discharge line,
• a system for inflating the expandable protective element, comprising a member adapted and intended for supplying a pressurized inflation gas having a line for the injection of pressurized inflation gas, able to be associated in fluid communication or being associated in fluid communication with the injection orifice for the injection of pressurized inflation gas of the expandable protective element of the device, the system also comprising a member for controlling and managing the pressure of the pressurized inflation gas in the line for the injection of pressurized inflation gas,
• a fill line and a discharge line which are adapted to be associated in fluid communication or are associated in fluid communication at the outlet respectively of the fill orifice and the discharge orifice of the device.