Fluid plug for sterile processes and methods of using the same
Inventors
Assignees
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Publication Number
US-11530772-B2
Publication Date
2022-12-20
Expiration Date
Abstract
A fluid plug for use with sterile processes such as the manufacture or production of pharmaceuticals and biologics is disclosed. The fluid plug is made of a material or materials that will tolerate sterilizing processes such as gamma irradiation. The fluid plug is used to selectively plug the ends of flexible polymer conduits that may be connected to fluids, reagents, or products used or generated as part of the manufacturing process. Also disclosed is the use of the plugs in combination with a series of valves in a block-and-bleed arrangement to enable the sterile transfer and connection of fluids, reagents, or products within a process flow.
Core Innovation
The invention relates to a sterile fluid system for pharmaceutical and biological applications that includes a flexible polymer conduit and removable plugs for sealing ends of the flexible polymer conduit. The removable plugs are configured to be inserted into a main conduit and a branch conduit of a valve body so that fluid passage through the second end or the first end or second end of the flexible polymer conduit is prevented.
Each removable plug includes a cap, a shank portion extending from the cap, and a flexible ring disposed along a portion of the shank. The removable plug further includes a lever mounted on the cap and configured to shorten the shank upon actuation. Actuation of the lever in a first direction causes radial expansion of the flexible ring to form a fluidic seal with an interior surface of the flexible polymer conduit to prevent passage of fluid.
Actuation of the lever in a second direction causes contraction of the flexible ring to allow removal of the removable plug from the second end of the flexible polymer conduit. The removable plug is formed from a polymer material that tolerates gamma radiation, and the flexible ring is movable between a contracted configuration away from the inner surface and an expanded configuration contacting the interior surface, with lever actuation enabling fluidic sealing and reversibly allowing removal.
Claims Coverage
The document provides three independent claims that share a common inventive concept: a sterile fluid system using removable plugs with lever-actuated flexible rings that radially expand to form fluidic seals and contract to permit plug removal, with additional structural variations and gamma-radiation tolerance limitations.
Gamma-radiation-tolerant lever-actuated flexible ring plug for main and branch sealing
A sterile fluid system with a container holding fluid, a flexible polymer conduit having first and second ends, a valve body coupled to the second end and including first and second valves configured for a main conduit and a branch conduit, and first and second removable plugs inserted into the main conduit and branch conduit; each plug includes a cap, a shank portion, a flexible ring, and a lever that shortens the shank upon actuation, wherein lever actuation in a first direction causes radial expansion of the flexible ring to form a fluidic seal with an interior surface to prevent passage of fluid through the second end, and lever actuation in a second direction causes contraction of the flexible ring to allow removal; the removable plug is formed from a polymer material that tolerates gamma radiation.
Lever-actuated contraction and expansion ring for preventing passage through one of conduit ends
A sterile fluid system for pharmaceutical and biological applications with a flexible polymer conduit having first and second ends, a valve body coupled to the second end and including first and second valves configured for a main conduit and a branch conduit, and first and second removable plugs inserted into the main conduit and branch conduit; each removable plug includes a cap, a flexible ring sized to be movable between a contracted configuration away from the inner surface and an expanded configuration contacting the interior surface, and a lever, wherein lever actuation in a first direction causes radial expansion of the flexible ring to form a fluidic seal to prevent passage of fluid through one of the first end or second end, and lever actuation in a second direction causes inward contraction away from the inner surface to allow removal.
Lever-driven abutment compression with ring expansion to seal conduit interior
A sterile fluid system for pharmaceutical and biological applications with a flexible polymer conduit having first and second ends, a valve body coupled to the second end and including first and second valves configured for a main conduit and a branch conduit, and first and second removable plugs inserted into the main conduit and branch conduit; each removable plug includes a flexible ring disposed between a first abutment and a second abutment and a lever, wherein actuation of the lever moves the second abutment closer to the first abutment to compress the flexible ring and cause radial expansion of the flexible ring to contact an inner surface of the flexible polymer conduit to prevent passage of fluid through one of the first end or the second end.
Across the independent claims, the removable plugs provide a lever-actuated flexible ring mechanism that prevents fluid passage by forming a fluidic seal through radial expansion into contact with an interior surface, and allows reversibly removing the plugs by contracting the flexible ring away from the inner surface. The claims also cover a system-level arrangement with a valve body having main and branch conduits controlled by first and second valves, and include gamma-radiation tolerance in the first independent claim.
Stated Advantages
Forms a fluidic seal with an interior surface of the flexible polymer conduit to prevent passage of fluid.
Allows removal of the removable plug by contracting the flexible ring.
Tolerates gamma radiation through polymer material forming the removable plug.
Documented Applications
Pharmaceutical and biological applications using a flexible polymer conduit and sterile fluid system with removable plugs and a valve body.
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