Sartorius Stedim North America Inc.

Gilson Sas

Marc Sanchez

Jonathan E Cutting

Michael Allen Zumbrum

Kevin M Perdue

Jan Neuhaus

Disclosed is a system for freezing, storing, transporting, and thawing biopharmaceutical product, comprising a stationary equipment and one or more movable pallets, each pallet configured to carry one or more container units, each containing biopharmaceutical product, the stationary equipment comprising a gas circulating unit configured to cause a circulation of cold gas and/or warm gas, from a pull inlet toward a blow outlet, wherein there is provided at least a first side plenum having one or more gas conveying channel therein, configured to be fluidly coupled to the blow outlet of the gas circulating unit, the first side plenum having a plurality of outlet ports directed toward an interior volume of the pallet, wherein the gas circulates substantially in a horizontal direction in the interior volume of the pallet, and wherein a shaking arrangement is provided.

Rapid freezing, storage, transport, and thawing system for containers of biopharmaceutical products

A flexible pouch is placed in a stack provided with two plates forming a protecting body to sandwich and constrain the flexible pouch. At opposite margin portions, the protecting body has slots cooperating with positioning members of an outer shell device belonging to the stack. Between the shell parts, the plates can move during filling of the pouch and the margin portions shrink inwardly in a protecting body plane. Some of the positioning members act as stoppers, in order to have lower clearance range for shrink strokes of the protecting body in a middle part thereof, as compared to a higher clearance range at respective longitudinal end parts of the two opposite margin portions. A higher constraining effect can be obtained in a center of the pouch, to limit maximum thickness of its content, which is of interest for managing freeze/thaw operations of biopharmaceutical materials contained in the pouch.

Storage/containement unit for flexible pouch filled with biopharmaceutical fluid, and method of assembling a freeze/thaw containment system, using a protecting body of controlled deformation

A freeze/thaw containment system is provided, having a protecting body and a flexible pouch, of a first capacity, protected by two plates of the protecting body. The two plates are attached together at a peripheral margin and form a rectangular protecting body. The peripheral margin is mounted in a stationary frame and allowed to be displaced inwardly during filling of the pouch, while the protecting body extends generally planar to sandwich and constrain the pouch. One amongst the stationary frame and the protecting body includes fastening members for attachment of a casing configured for storing the bag, in order to have the bag fastened parallel to the protecting body. Two fasteners for cooperating with the fastening members are distributed around a bag containing part of a second capacity at least ten times inferior to the first capacity. Same biopharmaceutical composition is contained in the pouch and in the bag.

Freeze/thaw containment system for flexible pouch filled with biopharmaceutical fluid, and method of assembling a freeze/thaw containment system, using a protecting body

A protecting device is provided, having two plates forming a rectangular protecting body for sandwiching, constraining and protecting a flexible pouch. The two plates are attached together at a peripheral margin. Each plate has an outer surface with ribs provided in a peripheral annular region of a covering part receiving the pouch, along the peripheral margin. The peripheral margin is mounted in supporting parts of a frame and sliding positioning members may be secured to the peripheral margin, so that the peripheral margin is guided and allowed to be displaced inwardly during filling of the pouch, while the protecting body extends generally planar, at least at panel parts surrounded by the ribs. This allows for progressive conformational change of the protecting body when filling the pouch with biopharmaceutical product, while facilitating reverse displacement of the peripheral margin during draining operations.

Storage/containment unit for flexible pouch filled with biopharmaceutical fluid, and method of assembling a freeze/thaw containment system, using a protecting body

A freeze/thaw containment system is provided, having a protecting body and a flexible pouch protected by two plates of the protecting body. The two plates are attached together at a peripheral margin and form a rectangular protecting body. The peripheral margin is mounted in supporting parts of a stationary frame and sliding positioning members are secured to the peripheral margin, so that the peripheral margin is guided and allowed to be displaced inwardly during filling of the pouch, while the protecting body extends generally planar to sandwich and constrain the pouch in empty state of the pouch. This way of holding and retaining the protecting body allows for progressive conformational change of the protecting body due to the change in volume of the pouch when filled with a biopharmaceutical product, while facilitating reverse displacement of the peripheral margin during draining operations.

A fluid transfer assembly is described that includes a fitting comprising a lumen having an opening, and at least one barb, the at least one barb extending circumferentially around the lumen proximate to the opening. The assembly also includes a flexible conduit, a deformable sleeve, and an elastomeric liner disposed between the sleeve and the conduit. The fitting extends at least partially into the conduit such that the conduit extends over the at least one barb. The elastomeric liner applies substantially 360 degree radial pressure to the conduit such that the conduit is sealingly compressed around the at least one barb of the fitting. The assembly is fluid tight up to a burst pressure of the conduit.

Fluid transfer assembly

The protecting package for a flexible pouch specially designed to contain a biopharmaceutical fluid, includes two frames which respectively form a lower frame and an upper frame and which have a peripheral area, respectively to a main plane of the frames, each frame has an opening on a central area, the two frames are fixed to each other such that they are able to respectively surround two plates which sandwich the flexible pouch.

Protecting body for a flexible pouch, system for containing a biopharmaceutical fluid and methods for using such a system

A system for freezing, storing, transporting, and thawing biopharmaceutical product, the system including a stationary equipment and one or more movable pallet, each pallet being configured to carry one or more container units, each containing biopharmaceutical product, the stationary equipment including a gas circulating unit configured to cause a circulation of cold gas and/or warm gas, from a pull inlet toward a blow outlet, wherein there is provided at least a first side plenum having one or more gas conveying channel therein, configured to be fluidly coupled to the blow outlet of the gas circulating unit, the first side plenum having a plurality of outlet ports directed toward an interior volume of the pallet, wherein the gas circulates substantially in a horizontal direction in the interior volume of the pallet.

A protecting system for containing a biopharmaceutical fluid includes: a flexible pouch designed to contain a biopharmaceutical fluid; a protecting package including: two frames which respectively form a lower frame and an upper frame and which have a peripheral area; a fastening system able to clamp the two frames of the protecting package to each other, the frames sandwiching the flexible pouch. The fastening system includes at least an assembly only including: a snap including a backing part; and a cap including a washer. The lower and the upper frames of the protecting package are directly clamped between the washer of the cap and the backing part of the snap in a clamping position.

Protecting system for containing a biopharmaceutical fluid

The protecting body for a flexible pouch is specially designed to contain a biopharmaceutical fluid. It includes two substantially planar plates which respectively form a lower surface and an upper surface and which are fixed to each other. The two plates are able to sandwich the flexible pouch for constraining the flexible pouch such that the protecting body is substantially planar, and includes, on a peripheral side, at least one opening able to receive at least one port of the flexible pouch.

The leak test for a flexible pouch specifically designed to contain a biopharmaceutical fluid includes the following steps:

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Patchogue, NY, United States of America

Marc Sanchez