Disposable storage, transport and resuspension system
AssigneeMerck & Co., Inc.
InventorsAnand Ekambaram, Wendy L. Radcliff, Mark S. Rienstra, Brett L. Allred, Doyle W. Stewart
Life of this patent
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Abstract
The present invention relates to a package for storing, mixing, resuspending and dispensing sterile or non-sterile solutions or suspensions and comprises a sterilizable bag having fittings which provide for the introduction and exit of fluids and solids, as well as means for resuspending and stirring the fluids. Additionally, structural support means are provided for shipment, filling and dispensing. Unlike conventional stainless steel equipment, the system is disposable, does not require cleaning, provides for safe, rapid and accurate resuspension of suspended solids and can accommodate a wide range of liquid volumes.
Claims10
A collapsible container and a support device for use in the manufacture of sterile and non-sterile liquids and suspensions, the collapsible container having means for ingress and egress of fluids and solids into the container, and means for mixing and resuspending the contents of the container;
- the egress, mixing and resuspending means comprising a closed loop mixing manifold which is external to the container and a mixing block located inside the collapsible container.
A system for use in the manufacture of vaccines comprising:
- a collapsible container and a support device,
- the collapsible container being flexible and having a top, bottom and sides which enclose a volume of space, the bottom of the container having a mixing block being weldably affixed inside the container, the mixing block having a top, bottom and sides, the mixing block further having a plurality of recirculation outlets;
- the mixing block also having a plurality of openings which communicate the inside of the mixing block to the inside of the container;
- the sides of the mixing block having a plurality of spray arms, the spray arms being directed from the bottom of the container to the sides and top of the container, the spray arms being hollow and attached to the mixing block, the top end of the spray arms being sealed, the spray arms having a plurality of holes which communicate the inside of the container with the inside of the spray arms;
- the top of the container having an inlet tube which provides for ingress of fluids and solids into the container,
- the top of the container further having a long dip tube which extends from outside the top of the container through the top of the container and inside the container where it terminates in the mixing block, the long dip tube being hollow and communicating the inside of the container, at the bottom of the mixing block, with the outside of the container, the portion of the long dip tube which extends outside the top of the container being fitted with a pinch clamp and terminating on one arm of a "Y" fitting;
- the top of the container further having a short dip tube which extends from outside the top of the container, through the top of the container and inside the container to a distance from about 1% to about 80% of the length of the container, the portion of the short dip which extends outside the top of the container being fitted with a pinch clamp and terminating on one arm of a "Y" fitting;
- the top of the container further having a recirculating dip tube which extends from outside the top of the container to the mixing block, the portion of the recirculation dip tube which extends outside the top of the container terminating in a valve, such that when the valve is open, the recirculation dip tube communicates the outside of the container with the inside of the inside of the mixing block;
- an external recirculation loop being attached to the leg of the "Y" fitting connected to the long dip tube and to the short dip tube, the recirculation loop having means for pumping the liquid from the short dip tube or the long dip tube, depending upon the position of the snapper clamps attached to the long and short dip tubes, to the recirculation dip tube, the liquid then moving out the mixing block and through the spray arms;
- the top of the container further having a pump out tube which extends from outside the top of the container to the mixing block, the portion of the pump out dip tube which extends outside the top of the container terminating in a valve, such that when the valve is open, the pump out dip tube communicates the outside of the container with the inside of the mixing block;
- the outside of the container having tabs which allow the container to be fastened to the support device;
- the support device being a rigid frame capable of holding the container in position when in use;
- wherein, a solution or suspension is introduced into the container through the inlet tube and mixed or resuspended by pumping the contents from the container through the short or long dip tube, through the recirculating loop and back into the container through the recirculating dip tube;
- the solution or suspension may be pumped out of the container using the pump out tube.
A system for use in the manufacture of sterile and non-sterile liquids and suspensions comprising a collapsible container and a support device, the collapsible container having means for ingress and egress of fluids and solids into the container, and means for mixing and resuspending the contents of the container, said container comprising a flexible plastic container having a top, bottom and sides which enclose a volume of space, the bottom of said container having a mixing block being weldably affixed inside said container.
Dependencies are inferred from the claim text.