System and Method for Aseptically Transferring Fluid

A method of manufacturing a system for aseptically transferring a liquid substance comprising the steps of:

• sterilizing a vial and a septum;
• aseptically filling the sterilized vial with the liquid substance and sealing the sterilized vial with the sterilized septum;
• providing a fluidic assembly that includes:
• a piercing member including therein first and second channels and having a tip end that operably punctures the sterilized septum, the first and second channels having first and second tip openings at the tip end of the piercing member;
• and
• an outlet line fluidically connected to the second channel of the piercing member at one end and sealed at the other end;
• sterilizing the fluidic assembly;
• and
• assembling the vial and the fluidic assembly and enclosing the vial and the piercing member with a sterilized pouch in an aseptic environment,
• wherein the sterilized pouch allows the piercing member to puncture the sterilized septum without breaching the sterilized pouch when one of the sterilized vial and the piercing member is manually pushed against the other one of the sterilized vial and the piercing member from an exterior of the sterilized pouch.

A method for aseptically transferring a liquid substance comprising the steps of:

• providing a transfer system including:
• a sterilized vial filled with the liquid substance and sealed with a sterilized septum;
• a sterilized fluidic assembly comprising:
• a piercing member including therein first and second channels and having a tip end that operably punctures the sterilized septum, the first and second channels having first and second tip openings at the tip end of the piercing member;
• and
• an outlet line fluidically connected to the second channel of the piercing member at one end and sealed at the other end;
• and
• a sterilized pouch enclosing the sterilized vial and the piercing member;
• aseptically connecting the outlet line to an external line for receiving the liquid substance;
• puncturing the sterilized septum with the piercing member by manually pushing one of the sterilized vial and the piercing member against the other one of the sterilized vial and the piercing member from an exterior of the sterilized pouch without breaching the sterilized pouch, thereby aseptically establishing fluidic communication between the sterilized vial and the outlet line;
• and
• pumping the liquid substance from the sterilized vial disposed in an inverted orientation to the external line using a pump.