Patent ID: 8517998

Claim:
A process for the sterile transfer of a fluid, comprising: a) providing a sterile fluid transfer device, the device comprising: a body having a bore formed through at least a portion of its interior, the body including a first end connectable to an upstream component; a port positioned downstream from the first end of the body, the port being connectable to a downstream component; a fluid pathway through the device between the first end of the body and the port; a movable plunger contained within the bore, the plunger having a first end and being movable within the bore between a closed position and an open position, the first end of the plunger and at least the first end of the body forming a steamable surface when the plunger is in the closed position, and the plunger enabling a transfer of fluid through the fluid pathway when the plunger is in the open position; a handle to facilitate movement of the plunger within the bore; and a sterile barrier between the environment and at least a portion of the plunger and between the environment and at least a portion of the interior of the body to enable the transfer of fluid through the fluid pathway while maintaining the sterile condition of the fluid being transferred through at least one actuation of the device; b) connecting the transfer device to the downstream component and sterilizing the downstream component and the transfer device when the plunger is in the closed position; c) connecting the first end of the body to an upstream component when the plunger is in the closed position; d) steam sterilizing the upstream component and the steamable face when the plunger is in the closed position; e) moving the plunger to the open position to allow for fluid communication between the upstream component, the fluid pathway and the downstream component; and f) moving the plunger to the closed position to seal the fluid pathway and the downstream component from the upstream component, thereby maintaining the sterile condition of the fluid being transferred through at least one actuation of the device.