EP3691600A1 - Schutzbehälter für biopharmazeutische flüssigkeitsbeutel - Google Patents

Schutzbehälter für biopharmazeutische flüssigkeitsbeutel

Info

Publication number
EP3691600A1
EP3691600A1 EP18789462.1A EP18789462A EP3691600A1 EP 3691600 A1 EP3691600 A1 EP 3691600A1 EP 18789462 A EP18789462 A EP 18789462A EP 3691600 A1 EP3691600 A1 EP 3691600A1
Authority
EP
European Patent Office
Prior art keywords
shell
lower shell
side wall
protective
upper shell
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP18789462.1A
Other languages
English (en)
French (fr)
Other versions
EP3691600B1 (de
Inventor
Stéphane BAUD
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sartorius Stedim FMT SAS
Original Assignee
Sartorius Stedim FMT SAS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sartorius Stedim FMT SAS filed Critical Sartorius Stedim FMT SAS
Publication of EP3691600A1 publication Critical patent/EP3691600A1/de
Application granted granted Critical
Publication of EP3691600B1 publication Critical patent/EP3691600B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/16Holders for containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/06Liquids or semi-liquids or other materials or articles enclosed in flexible containers disposed within rigid containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers

Definitions

  • the invention relates to the field of biopharmaceutical liquid pocket protection casings, the field of protection assemblies incorporating a protective casing and a pocket of biopharmaceutical liquid, as well as the field of methods of assembling a protective assembly incorporating a protective case and a pocket of biopharmaceutical liquid.
  • a biopharmaceutical liquid bag protection casing comprising on the one hand two upper and lower shells assembled one on the other, as well as two elastic plastic films situated inside these casings. and hulls enclosing two pockets of biopharmaceutical liquid.
  • the pockets of biopharmaceutical liquid are held in place between the films and protected from aggression and shocks external to the protective casing by the spaces respectively held between on the one hand the upper shell and the upper film and on the other hand between the lower shell and the lower film.
  • This protective case ensures a good maintenance of the pockets of biopharmaceutical liquid inside.
  • this protective case has shells of complex and delicate structure, because of the elastic plastic film to be fixed on each of the shells, and has a large size in height because of the two empty spaces stacked one on the other , that between upper film and upper shell and that between lower film and lower shell.
  • Document WO 2015/160348 discloses an implantation solution with an articulated housing enclosing the implantable device.
  • the lower receptacle of the housing alone defines the receiving volume of the implantable device that is pre-filled with a defined volume to coincide exactly with the housing of the lower receptacle, the upper lid being flat.
  • This type of solution is unsuitable for pockets (particularly pockets of volumes greater than 1 liter) which are typically curved in a filled state.
  • the receptacle does not allow any volume adjustment that may be required if filling variations exist from one pocket to another.
  • the present invention improves the situation.
  • a protective case of a pocket of biopharmaceutical liquid comprising:
  • a lower shell comprising a bottom and a side wall
  • the biopharmaceutical liquid bag is held between the walls of the two shells laterally, without excessive stress on the part of the upper shell.
  • the recess of the upper shell also allows to avoid a movement of the pocket when the two shells are assembled one on the other, while protecting the pocket of possible shocks.
  • a two-piece protective housing also provides easy housing mounting and low manufacturing costs.
  • upper part means the part of the wall elements constituting the side wall located either above the mid-height of the side walls or above the mid-height and around the mid-height of the walls. side.
  • the side wall has a frame format, for example rectangular or square, possibly with rounded corners.
  • the side wall extends annularly about a central axis capable of defining the height dimension of the housing.
  • each pair may be parallel, and preferably rectilinear.
  • the lower shell side wall has an inner surface and the upper shell has an upper shell side wall having an outer surface, these inner and outer surfaces being provided with complementary fasteners.
  • complementary fastening elements are designed and arranged to prevent translation (movement / play longitudinal or lateral) relative to each other of the lower shell and the upper shell.
  • the recess has a concave shape facing the bottom of the lower shell.
  • the recess imitates the convex shape of a pocket filled with biopharmaceutical liquid, allowing, on the one hand, to cover a pocket containing a large volume of biopharmaceutical liquid, and on the other hand that the recess is directly in contact with at least one surface of the pocket, so as to wedge the pocket between the two shells.
  • the upper shell sidewall includes or forms insertion and guiding portions which are housed (at least partially) in the interior volume of the lower shell (along the side wall of the lower shell).
  • the insertion and guiding portions comprise two mutually parallel longitudinal wall elements, which extend from one longitudinal end to the other of the upper shell, and each extending between a longitudinal upper edge of the upper shell.
  • the upper shell and a lower face (which may be substantially flat, with the exception of some lugs or local projections that project downwards from the plane of this lower face).
  • the lower shell has no opening in its side wall and has an annular upper edge, which preferably extends in a longitudinal plane, only the upper shell having an access opening which extends under the upper edge in the assembled state between the shells.
  • the insertion and guiding portions are formed in the side wall of the upper shell so as to run continuously along an inner face of the side wall of the lower shell, at least in an interconnection region (between the shells). U-shaped around the pocket housing.
  • the insertion parts consist of an insertion frame optionally provided with pins or similar projections projecting towards the bottom of the lower shell.
  • the upper shell has a bottom or bottom portion, the periphery of which is connected to the insertion and guiding portions to form the recess; in the assembled state of the shells, the recess has a height profile such that the height of the recess increases as one moves away from the two longitudinal wall elements when approaching a central zone bottom or bottom part of the upper shell. It will be understood that this makes it possible to increase the height of the pocket housing of the housing, in a longitudinal median zone equidistant from the two longitudinal wall elements.
  • the support elements are arranged on the periphery of the lower shell.
  • the side walls of the lower shell have recesses forming said support elements, on which rest peripheral stops of the upper shell.
  • At least three of the four side walls of the lower shell have recesses forming said support elements, on which rest the peripheral stops of the upper shell.
  • the three side walls include the two longer side walls, and the rear side wall of the lower shell. These recesses serve in particular to stiffen the structure of the lower shell.
  • an inner surface of a side wall of the lower shell and an outer surface of a side wall of the upper shell are provided with complementary fastening elements preventing translation of the shells with respect to the other. In this way, an inappropriate disconnection of the lower and upper hulls is not possible. This also makes it possible to increase the maintenance of the pocket between the two shells.
  • an inner surface of a side wall of the lower shell and an outer surface of a side wall of the upper shell are provided with complementary fastening elements preventing vertical translation of the shells relative to one another. 'other.
  • the fasteners comprise clips.
  • the fastening elements are located on either side of an opening of the protective housing, and / or at an end opposite the opening of the protective housing.
  • an inner surface of a side wall of the lower shell and an outer surface of a side wall of the upper shell are provided with complementary fastening elements preventing horizontal translation of the shells relative to one another. 'other.
  • the fixing elements comprise a set of lugs and receptacles cooperating with each other.
  • the upper shell is insertable into the lower shell so as not to protrude out of the lower shell height.
  • the upper shell is shorter than the lower shell over at least a portion of its width, making the interior of the housing accessible from the outside, so as to define an opening.
  • a side wall of the lower shell has at least one portion inclined at least at the bottom of the lower shell.
  • the inclined portion is located at a longitudinal end located at the outlet of a pocket tube.
  • the bottom of the lower shell is sealed and has a height sufficient to retain a volume of water at least equal to 5 liters.
  • the bottom of the lower shell is sealed and has a height sufficient to retain a volume of water of at least 10 liters.
  • the bottom of the lower shell is sealed and has a height sufficient to retain a volume of water at least equal to 20 liters.
  • the bottom of the lower shell is sealed and has a height sufficient to retain a volume of water of at least 50 liters.
  • the inclined portion further improves the accessibility of the contents of the housing from the outside.
  • the inclined portion also has the function of maintaining the pocket at its front end, by wedging directly against the inclined portion.
  • it still makes the lower shell waterproof because no opening is necessary on the lower shell.
  • the lower shell can retain the entire biopharmaceutical liquid without overflow.
  • the lower hulls are further dimensioned to retain 20% additional water to the volume of water that can be retained.
  • the lower shell comprises at least one stop at a longitudinal end located at the outlet of a pocket tube, the outer peripheries of the opening of the upper shell coming into contact with said stop.
  • the abutment comprises rounded edges.
  • the stop also ensures contact of the upper shell and the lower shell.
  • the front end of the bag can also come into contact with the stop, and the tubes of the bag, passing over the stop, are not likely to be damaged by this contact, because of the rounded edges of the stop.
  • the upper shell comprises a plurality of recesses adapted to receive and hold connectors at one end of a tube of the pocket.
  • the recesses are disposed on either side of the opening of the upper shell, and / or are disposed at an end opposite the opening.
  • the recesses integrated directly on the upper shell allow a fully functional housing arrangement, to wedge a plurality of connectors without loss of space.
  • the recesses are disposed on either side of the opening of the upper shell, but are not disposed at an end opposite to the opening, the recess comprising an X shape.
  • This embodiment is advantageously used for protective housings that can hold a volume of 5 liters.
  • the X-shape on the upper shell allows to place the tubes of the pocket, which are more difficult to arrange in the case of small protective housings.
  • baffles are arranged around the recess so as to hold in place around the recess at least one tube of the pocket.
  • the tube or the tubes can be stored also in the protective casing while being well held in place. This good holding tubes in place then further improves the maintenance of the pocket relative to the upper shell which protects it.
  • the upper shell comprises at least one arch, preferably at least two or three arches, extending between two side walls of the upper shell, preferably between the two longer side walls.
  • the arch comprises a planar upper portion, adapted to receive an outer surface of the bottom of a lower shell of another housing.
  • the arch bears on the recess of the upper shell.
  • the flat upper part of the arches comprises a protrusion adapted to be inserted into a recess provided on an outer surface of the bottom of a lower shell, always another housing.
  • At least some side walls comprise a gripping zone, preferably at least the inclined portion and the end opposite the opening of the lower shell comprise such a gripping zone, this gripping zone advantageously including several recesses spaced apart from each other.
  • the protective housing is easily manipulated by a controller.
  • the lower shells of different protective housings are able to be stacked on one another, so that the fixing elements of the lower hulls above are based on the fixing elements of the lower hulls most at -Dessous.
  • the upper shells of different protective housings are able to be stacked on top of each other, so that the fastening elements of the upper shells above the upper rest on the fastening elements of the upper shells the more -Dessous.
  • This arrangement helps to better distribute the efforts on all the lower or upper shells, and therefore to avoid damage to the hulls when stacked. In addition, it also limits the height of the stacks.
  • the two longer side walls of the lower shell are inclined towards each other in their lower parts so that, when different protective housings are stacked on each other, a space is formed between two adjacent lower shells along these two adjacent lower shells so as to keep the tubes accessible to the hand of an operator.
  • a controller has easy access to the pocket tubes when multiple protective housings are stacked on top of one another.
  • the space can be large enough to be able to pass a hand between two adjacent lower shells of two stacked protective housings.
  • the present invention also provides a protection assembly for a pouch for receiving a biopharmaceutical liquid comprising:
  • the pocket is held at the longitudinal ends of the housing, so that:
  • the present invention also relates to a method of manufacturing a protective case in which:
  • the lower and upper shells are made by thermoforming
  • the manufacturing method does not include any cutting step, thus greatly reducing the manufacturing cost.
  • the protective housing comprising only two parts, that is to say the upper and lower shells, the manufacturing cost is further reduced.
  • FIG. 1 schematically represents an exploded view of an exemplary pocket-less protective case according to one embodiment of the invention
  • FIG. 2 diagrammatically represents an example of a protective case incorporating a pocket according to one embodiment of the invention
  • FIG. 3 is a diagrammatic plan view of an example of a protective case incorporating a pocket according to one embodiment of the invention
  • FIGS. 4a and 4b schematically represent a detail view in cross-section and in perspective of an example of an abutment of the lower shell in contact with the upper shell
  • FIGS. 5a to 5c show schematically in plan view four successive steps of an exemplary method of assembling a protection assembly of a pocket according to one embodiment of the invention
  • FIG. 6 is a diagrammatic exploded view of an exemplary pocket-less protective case according to a second embodiment of the invention.
  • FIG. 7 is a diagrammatic plan view of an example of a protective case incorporating a pocket according to a second embodiment of the invention.
  • FIG. 8 is a diagrammatic bottom view of an exemplary protective case incorporating a pocket according to a second embodiment of the invention.
  • FIG. 9 schematically represents a side view of a lower shell of a protective case according to a third embodiment of the invention.
  • FIG. 10a schematically represents a view from below of an upper shell of a protective case according to a third embodiment of the invention
  • FIG. 10b schematically represents a view from above of a protective case according to a third embodiment of the invention.
  • FIG. 11 schematically represents an exploded view of an exemplary pocket-less protective case according to a fourth embodiment of the invention.
  • FIG. 12 schematically represents a view from above of a protective case according to a fourth embodiment of the invention
  • FIG. 13 schematically represents a cross section of the rear of a protective case according to a fourth embodiment of the invention
  • FIG. 14 schematically represents a detail view in perspective of a plurality of lower shells nested one on the other
  • FIG. 14a schematically represents a detailed sectional view of a plurality of upper shells nested one on the other
  • FIG. 15 schematically represents a detailed perspective view of a plurality of upper shells nested one inside the other
  • FIG. 15 a schematically represents a detailed sectional view of a plurality of lower shells fitted one over the other
  • FIG. 16 shows schematically in perspective an example of stacking on each other several protective housings incorporating pockets according to one embodiment of the invention.
  • FIG. 1 schematically represents an exploded view of an exemplary pocket-less protective case according to a first embodiment of the invention.
  • the term “front” is used to designate the portion of the protective housing located at the outlet of the tubes of the pocket
  • the term “back” is used to designate the portion of the housing opposite the out of the tubes of the pocket.
  • the protective casing 1 has a direction of longitudinal extension between its rear end and its front end.
  • the protective casing 1 comprises a lower shell 2, and an upper shell 3 comprising a recess 4.
  • the biopharmaceutical liquid bag not shown in FIG. 1, is placed in the bottom 20 of the lower shell 2, covered by the shell upper 3 so as to be covered by the recess 4, the upper shell 3 being inserted into the lower shell 2.
  • the upper shell 3 can be inserted into the lower shell 2 without exceeding the height thereof, or almost without exceeding.
  • the lower shell 2 comprises a bottom 20 and four side walls 21, including the side walls 21 of side, or the longest side walls, and the side walls 21 front and rear.
  • a side wall 21 of the lower shell 2 has at least one inclined portion 22 at least at the bottom 20 of the lower shell 2, in particular by which the tubes of the bag can exit.
  • the inclined portion 22 is located at a longitudinal end located at the outlet of the tubes. More specifically, the front side wall 21 comprises such an inclined portion 22.
  • the side walls 21 have side recesses 23 on which will be able to come to rest the upper shell 3.
  • the recesses 23 have a height h, so that the upper shell 3 is held in the upper part of the side walls 21 of the lower shell 2 when the upper shell 3 rests on the recesses 23 of the lower shell 2.
  • the inner surfaces of the lateral side walls 21 still have fastening elements 24 preventing vertical translation of the shells 2, 3 relative to each other.
  • the fastening elements 24 comprise a hook-out 24a comprising a fixing member 24b.
  • the fasteners are for example clips.
  • the inner surfaces of the lateral side walls 21 also comprise horizontal shoulders 25 on which a rim 35 of the upper shell can bear when the shells 2, 3 are assembled.
  • the lower shell 2 further comprises at least one stop 26 at a longitudinal end located at the outlet of a pocket tube, that is to say at the front side wall 21 of the hull lower 2.
  • the upper shell 3 is adapted to come into contact with the stop 26.
  • the upper shell 3 comprises a recess 4.
  • the recess 4 has a concave shape, facing the bottom 20 of the lower shell 2.
  • the upper shell 3 also has an annular side wall 32 typically consisting of a plurality of side wall elements, here four side wall element, with in particular two longitudinal wall elements 32a, 32b of the side wall 32, which are for example the two elements the longer ones of the side wall 32, and a rear side wall member 32c.
  • the annular lateral wall 32 may have a frame format, for example rectangular or square, possibly with rounded corners. It is the same for the side wall 21 of the lower shell 2. Typically each side wall 21, 32 extends annularly about a central axis able to define the height dimension of the protective housing 1.
  • the longitudinal edges of each pair may be parallel, and preferably rectilinear.
  • the upper edges B2 in the lower shell 2 can, in the assembled state of the shells 2, 3, be located above the upper edges B3 of the upper shell 3 with a difference in level of the order of 1 cm for example or more.
  • the lateral wall 32 of the upper shell 3 includes or forms insertion and guiding parts which are housed (at least partially) in the interior volume V2 of the lower shell 2, the along the side wall 21.
  • the insertion and guiding portions comprise two mutually parallel longitudinal wall members 321, 322 which extend from one longitudinal end to the other longitudinal end of the hull. upper 3, and each extending between the corresponding upper longitudinal edge B3 of the upper shell 3 and a respective lower face F31, F32 of the upper shell 3 (lower face F31,
  • F32 which may be substantially flat, with the exception of some lugs 62a or local projections which project downwards from the plane of this lower face, as shown in Figure 10a).
  • the insertion and guiding portions may form the side wall 32, in the form of an insertion frame optionally provided with lugs 62a or similar projections projecting towards the bottom of the lower shell 2.
  • the upper shell 3 is for example shorter than the lower shell 2 over at least part of its width, so as to define an opening 30, making the inside of the housing 1 accessible from the outside.
  • the opening 30 is for example located at the front end (longitudinal end opposite the rear wall element 32c) of the upper shell 3.
  • the opening remains framed by at least one or even two front end portions 38 of the upper shell 3.
  • the opening 30 is in particular located at least partially facing the inclined portion 22 of the lower shell 2, to create a passage 31 through which the tubes of the bag can exit the recess 4 to open out of the protective housing.
  • the opening 30 includes outer peripheries 30a intended to bear against the abutments 26 of the lower shell 2.
  • the side walls 32 of the upper shell side also comprise peripheral stops 33, able to bear on the recesses 23 of the lower shell 2.
  • the lateral walls 32 of the upper shell 3 also comprise complementary fastening elements 34 of the fastening elements 24 of the lower shell 2.
  • the fastening elements 34 likewise comprise a hook-and-key hook 34a capable of coming into contact with the hook-off 24a of the elements.
  • complementary fixation 24 of the lower shell 2 and a fastener 34b cooperating with the complementary fastener 24b.
  • the peripheral abutments 33 of the side walls cooperate with protuberances 36 of side walls 41 on the side of the recess 4 to form baffles 45 in which the pocket tubes can pass and be held in place.
  • Between the recess 4 and the side walls 32 of the upper shell 3 is an annular space 37 in which one or more pocket tubes may be arranged.
  • This annular space 37 is therefore a storage space for all or part of the tubes of the pocket.
  • the recess 4 intended to cover the pocket 50, has a bottom 40, here in the ceiling position, the side walls 41 of a side, a side wall 43 before which the passage 31 leaves, a rear side wall 42 forming the rear of the recess 4 against which comes the back of the pocket.
  • FIG. 2 schematically represents an assembled perspective view of an example of a protective casing 1 incorporating a pocket 50 according to one embodiment of the invention.
  • the upper shell 3 has been fully inserted into the lower shell 2.
  • the side walls 32 of the upper shell 3 have slid along the side walls 21 of the lower shell 2, and are practically against them, once the upper shell 3 resting on the recesses 23 of the lower shell 2.
  • the recess 4 has a height profile such that the height of the recess 4 increases as one moves away of the two longitudinal wall elements 321, 322 of the upper shell 3 and approaching a central zone of the bottom 40.
  • the height of the pocket housing of the housing is then increased by this profile, selectively in a central zone longitudinally equidistant from the edges B2 and the two longitudinal wall members 321, 322.
  • the height differential in the profile of the recess 4 may correspond to the difference in height between the upper edge B2 and the upper edge B3 placed here entirely in the volume V2 interior of the lower hull.
  • the pocket 50 not visible in Figure 2 is covered by the recess 4 and is located between the upper shell 3 and the lower shell 2.
  • a connector 52 at the end of tube 51 is fixed in recesses 39 of the upper shell 3.
  • the recesses 39 are for example disposed on either side of the opening 30 of the upper shell 3. More specifically, the portions 38 of the upper shell flanking the opening include such recesses 39, so as to form a chute. More depressions 39 may be disposed at a rear end of the upper shell 3.
  • the bottom 40 of the recess 4 comprises such recesses 39, for example two.
  • Figure 3 schematically shows a top view of an example of a protective case incorporating a pocket according to one embodiment of the invention.
  • the upper shell 3 is inserted into the lower shell 2, the side walls 32 of the upper shell 3 being substantially against the side walls 21 of the lower shell 2.
  • the tube 51 attached to the pocket 50 covered by the recess 4, out through passage 31, pass over the stop 26 and the portion 38 flanking the opening, is at least partly around the recess 4 in the annular space 37 located between the walls 41 to 43 of the housing or recess 4 and the side walls 32 of the upper shell 3, passing through the baffles 45 and the protuberances 36, to come to lock by its connector 52 in one of the recesses 39 provided for this purpose.
  • FIGS. 4a and 4b more precisely illustrate the passage 31, the abutment 26 of the lower shell 2 and one of the portions 38 flanking the opening 30 of the upper shell 3.
  • the portion 38 of the upper shell 3 rests between the lateral edge 32 and the abutment 26, so that the outer peripheries of the opening 30 are directly in contact with the abutment 26.
  • the abutment 26 has rounded edges, in order to avoid weakening the tubes 51 of the bag 50 when they are wound around the recess 4 in the annular space 37.
  • the stop 26 also makes it possible to keep the pocket 50 in the space delimited by the recess 4 and the bottom 20 of the lower shell 2, which in fact allows the front of the pocket 50 to bear against the abutment 26.
  • inclined portion 22 of the lower shell 2 also plays this role of holding the pocket 50, since the front portion of the pocket 50 bears directly against the inclined portion 22.
  • FIGS. 5a to 5c schematically show in top view four successive steps of an exemplary method of assembling a protection assembly of a pocket according to one embodiment of the invention.
  • the pocket 50 is disposed in the bottom 20 of the lower shell 2. From an upper opening 53 of the pocket 50 start tubes 51 terminated by connectors 52, these tubes 51 exiting at the inclined portion 22 of the lower shell 2. The rear of the pocket 50 is on the side of the rear side wall 21 of the lower shell 2.
  • the upper shell 3 covers the pocket 50 which is no longer visible. Only the tubes 51 coming out of the upper shell 3 through the passage 31 are still visible.
  • the annular space 37 is around the recess 4. This annular space with the baffles 45 is empty because it does not yet contain the tubes 51.
  • the rear portion of the pocket 50 is actually folded and pinched between the bottom 20 of the lower shell 2 and the rear side wall 32 of the upper pocket 3, thereby maintaining the pocket 50 at its rear portion.
  • the tubes 51 issued from the passage 31 through the opening 30, go around the housing 4 inside the lateral walls 32 of the upper shell 3, passing through the baffles 45 and the protuberances 36, before that the connector 52 of one of these tubes 51 is locked in one of the recesses 39 provided for this purpose.
  • Several other tubes 51 or connectors 52 can also be wedged in the annular space 38 or in the recesses 39.
  • the protective housing 1 is then completely closed.
  • the bag 50 can be filled with biopharmaceutical product after closing the protective case
  • the bag 50 can be filled before being placed in the bottom 20 of the lower shell 2, or before placing the upper shell 3.
  • the inclined portion 22 of the lower shell 2 further ensures the retention of the biopharmaceutical product in the protective housing 1 in case of release of the biopharmaceutical product in said housing 1, for example if the pocket 50 is pierced.
  • the retention volume may be at least equal to 5 liters, or even 10 liters, or even 20 liters or even 50 liters.
  • the lower shell 2 is dimensioned such that it is able to retain a volume equivalent to 20% of the retention volume in addition to the retention volume.
  • FIGS. 6 to 8 an example of a protective case 1 according to a second embodiment of the invention is described.
  • the side walls 21 of the lower shell 2 have recesses 54 on which the upper shell 3.
  • the recesses 54 have a height E, so that the upper shell 3 is held in the upper part of the side walls 21 of the lower shell 2 when the upper shell 3 rests on the recesses 54 of the lower shell 2.
  • the height E of the recesses 54 is greater than the height h of the recesses 23 described in connection with the first embodiment.
  • the height E of the recesses 54 on the one hand makes it possible to stiffen the structure of the lower shell 2.
  • the height E of the recesses remains lower than the height of the side walls 21. For example, there always remains a distance at least equal to 1 centimeter between the upper end of the recesses 54 and the upper end of the side walls 21.
  • This distance is chosen in particular to allow optimum stacking of several housings on each other.
  • the arches 44 of the upper shell 3 must not or slightly exceed in height of the upper ends of the side walls 21 of the lower shell.
  • the protuberances 44b protrude from the protective housing 1 to allow the interlocking of several protective housings 1.
  • the recesses 54 may be located on at least three of the four side walls 21 of the lower shell 2.
  • the recesses 54 are located on the lateral side and rear side walls 21, as can be seen in FIG.
  • the recesses 54 may further comprise a positioning orifice 54a at their upper end. This positioning orifice 54a is able to receive a complementary pion 54b, provided on the outer surface of the lower shell 2. This improves the positioning and maintenance of the lower shells together when stacked on top of each other.
  • a flange 35 of the upper shell can bear on the upper ends of the recesses 54 when the shells 2, 3 are assembled.
  • the inner surfaces of the side walls 21 also have fasteners 55 preventing horizontal translation of the shells 2, 3 relative to each other.
  • the fixing elements 55 comprise a receptacle 55a, able to receive a fastening element complementary to the upper shell 3.
  • Receptacles 57 are also provided on either side of the abutments 26, and at the rear ends of the side walls 21 as seen in Figure 8.
  • the receptacles 57 cooperate with lugs 60 provided on the upper shell.
  • the receptacles 57 and the lugs 60 cooperate in such a way as to prevent the vertical translation of the lower and upper shells 3.
  • the receptacles 57 and the lugs 60 comprise, for example, clips. Alternatively, a larger number of receptacles 57 and lugs 60 may be provided.
  • receptacles 57 and lugs 60 may be provided respectively along the lateral side walls 21 of the lower shell 2 and along the lateral side walls 32 of the upper shell 3, in addition to the receptacles 57 provided from and other abutments 26, and the rear ends of side walls 21 side.
  • This alternative embodiment is illustrated in FIGS. 11 and 12.
  • the clips may be irreversible. More specifically, the lugs 60 and the receptacles 57 prevent the lower and upper shells from being disengaged from one another. In another embodiment, the clips may be reversible. More specifically, the lower and upper shells can be disengaged from each other after assembly.
  • the lower shell 2 further comprises at least one gripping zone 56 preferably located at the inclined portion 22.
  • the gripping zone 56 advantageously includes several recesses spaced from each other, as shown in FIG. 8.
  • Another gripping zone 56 may also be located at the outer surface of the bottom 20, in particular at the rear of the lower shell 2.
  • the gripping zone 56 may also include depressions spaced from each other. The gripping zones allow an operator to be able to easily grasp and handle a protective casing 1.
  • the side walls 32 of the upper shell 3 comprise peripheral stops 58, able to bear on the recesses 54 of the lower shell 2.
  • the rear side wall 32 of the upper shell 3 may also comprise peripheral stops 58, cooperating with the recesses 54 situated on the rear side wall 21 of the lower shell 2.
  • Peripheral stops 58 may include locating holes 58a at their upper end. These positioning holes 58a is adapted to receive complementary pins (not shown) provided on the upper shell 3. This improves the positioning and maintenance of the upper shells together when stacked on top of each other.
  • the side walls 32 of the upper shell 3 also comprise complementary fixing elements 59 of the fastening elements 55 of the lower shell 2.
  • the fastening elements 59 comprise lugs 59a that can be inserted into the receptacles 55a of the fasteners 55. of the lower hull 2.
  • Lugs 60 are also provided on the two front end portions 38 of the upper shell 3, and at the rear ends of the side walls 32 of side.
  • the lugs 60 are able to be inserted into the receptacles 57 of the lower shell 2 so as to prevent vertical translation of the shells 2 and 3 relative to each other.
  • the side walls 32 of the upper shell 3 have a greater height than the side walls 32 of the first embodiment.
  • the rim 35 of the side walls 32 of the upper shell 3 can bear on the recesses 54 of the lower shell 2, so that the protuberances 44b of the arches 44 protrude from the protective housing 1.
  • Figure 9 is a side view of a lower shell 2 of a protective housing according to a third embodiment of the invention.
  • the lower shell 2 is particularly intended to contain a pocket of smaller volume, typically 5 liters.
  • the side walls 21 of the lower shell 2 comprise fastening elements 61 cooperating with fastening elements 62 provided on the upper shell 3.
  • the fastening elements 61 are for example provided on the side walls 21 of the side of the lower shell.
  • the fixing elements 61 make it possible to maintain the upper and lower shells when they are assembled, and prevent the horizontal translation of the lower and upper shells relative to one another.
  • the fastening elements 61 comprise a receptacle 61a, adapted to receive a lug complementary to the upper shell 3.
  • the receptacles 61a cooperate with lugs 62a provided on the upper shell.
  • the receptacles 61a and the lugs 62a cooperate in such a way as to prevent the vertical translation of the lower and upper shells 3.
  • the receptacles 61a and the lugs 62a comprise for example clips.
  • the upper shell 3 is shown in bottom view in Figure 10a.
  • the side walls 32 of the upper shell 3 comprise fastening elements 62 cooperating with the fastening elements 61 provided on the lower shell 2.
  • the fastening elements 62 are for example provided on the side walls 32 on the side of the upper shell.
  • the fastening elements 62 of the upper shell 3 comprise in particular lugs 62a cooperating with the receptacles 61a of the lower shell 2.
  • a protective case is shown in plan view in Figure 10b.
  • FIGS. 11 to 13 an example of a protective case 1 according to a fourth embodiment of the invention is described.
  • the protective case 1 according to this fourth embodiment is for example particularly intended to contain a smaller volume bag of 50 liters.
  • the side walls 21 of the lower shell 2 have recesses 73, and recesses 54 described with reference to the previous embodiments.
  • the lateral side walls 21 may comprise at least one recess 73, for example located at the middle of the length of the lateral side walls 21.
  • the recesses 73 include an outgrowth 73a.
  • the height of the protuberances 73a is greater than the height of the recesses 54, so that the upper end of the protuberances 73a extends beyond the horizontal shoulder 25.
  • the height of the protuberances 73a is smaller than the height of the side walls 21 of the lower hull 2.
  • the recesses 73 cooperate with peripheral stops 63 of the side walls 32 of the upper shell 3.
  • the peripheral stops 63 comprise a protrusion 63A complementary to the protuberance 73a of the recesses 73 of the lower shell.
  • the cooperation of the protuberances 63A, 73a of the recesses 63, 73 makes it possible to avoid a horizontal translation of the upper and lower shells 3, 2 with respect to each other.
  • the protuberances 63a and 73a form complementary fixing elements preventing translation of the shells 2, 3 relative to each other.
  • the side walls 21 of the lower shell 2 may further comprise stiffening elements 74 cooperating with stiffening elements 64 included on the side walls 32 of the upper shell 3.
  • the stiffening elements 64 form peripheral stops.
  • the stiffening elements 74 form recesses, forming support elements.
  • the stiffening elements 64, 74 are for example located on the rear side walls 21, 32 of the shells 2, 3.
  • at least one stiffening element 64, 74 is provided at the rear side wall of the shells 2, 3, and preferably at least two stiffening elements 64, 74 are provided.
  • the stiffening elements 74 of the lower shell 2 comprise a height less than the height of the horizontal shoulder 25, so that the stiffening elements 64 of the upper shell 3 have a height less than the height of the flange 35 of the side walls. 32.
  • the rear side wall 21 of the lower shell does not comprise a horizontal shoulder 25.
  • the stiffening elements 74 of the lower shell 2 comprise a bearing portion 74a on which abuts a bearing portion 64a of the stiffening element 64 of the upper shell 3, as illustrated more particularly in FIG. 13.
  • the stiffening elements 74 of the lower shell 2 further comprise an insertion portion 74b projecting from the bearing portion 74a, on which a complementary insertion portion 64b of the stiffening elements 64 is adapted to be inserted.
  • the insertion portions 64b, 74b are of complementary shape, so that after the insertion of the upper shell 3 into the lower shell 2, the insertion portions 64b, 74b prevent a horizontal translation of the two shells 2, 3 one compared to the other.
  • the insertion portions 64b, 74b form complementary fastening elements preventing the translation of the shells relative to each other.
  • stiffening elements 64, 74 make it possible to stiffen the structure of the casing 1, and make it possible to distribute the resistance forces when several casings 1 are stacked on one another.
  • the insertion portions 74b of the lower shell 2 further improve the maintenance of the pocket in the rear portion of the protective housing.
  • a pocket handle can advantageously be passed around the insertion portion 74b protruding, so as to maintain it pinched between the two shells 2, 3.
  • a space 67 resides between the bearing portion 74a of the lower shell 2 and the rim 35 of the upper shell 3. An end of the pocket can then be contained in this space 67, without exceeding out of the housing 1.
  • the lower shell 2 further comprises a channel 66, provided on at least one of the abutments 26, or on the two abutments 26.
  • the channel 66 extends for example from the inclined portion 22 of the hull bottom to the point of contact of the abutment 26 with the upper shell 3.
  • one end of the channel 66 is in contact with the outer peripheries 30a of the opening 30 of the upper shell 3.
  • the channel 66 is for example intended to receive a tube connector type, for example, "needle less" (or
  • the upper shell 3 may comprise at least one reinforcement 65, located for example at a front end of the recess 4.
  • the upper shell 3 comprises at least two reinforcements 65.
  • reinforcements 65 are for example attached to the arch 44 adjacent the opening 30.
  • the reinforcements 65 extend for example transversely to the arch 44. In the case of the stacking of several housings 1 on each other, the weight of the housings 1 supported by the arches 44 is then evenly distributed over the reinforcements 65.
  • the reinforcements 65 also increase the rigidity of the protective casing 1.
  • the reinforcements 65 are not attached to the arches 44.
  • Other reinforcements 65 may also be provided, especially at the rear end of the recess 4, or between the arches 44.
  • Figures 14 and 14a show schematically in perspective an example of stacking of several lower shells 2, according to the first embodiment, one on the other.
  • the lower shells 2 are stacked on top of each other.
  • the lower shells 2 do not contain a pocket.
  • the fastening elements 24 of the side walls 21 of the side of the lower shells 2 of the top rest on the fastening elements 24 of the side walls 21 of the side of the lower shells 2 of the top.
  • the fixing members 24b of the fixing elements of the lower hulls of the top rest on the hooks 24a of the fixing elements of the lower hulls 2 of the underside.
  • the side walls 21 of the lower shells 2 from above touch the side walls 21 of the lower lower shells. This particular arrangement allows to nest several lower shells 2 without loss of space.
  • Figures 15 and 15a show schematically in perspective an example of stack of several upper shells 3, according to the first embodiment, on top of each other.
  • Five upper shells 3 are stacked on top of each other.
  • the fastening elements 34 of the lateral walls 32 of the upper shells 3 of the top rest on the fastening elements 34 of the side walls 32 of the upper shells 3 of the top side.
  • the fixing members 34b of the fastening elements 34 of the upper upper shells rest on the unhooked portions 34a of the fixing elements 34 of the upper shells of the underside.
  • the side walls 32 of the upper shells 3 from above touch the side walls 32 of the upper shells 3 from below. This particular arrangement allows to nest several upper shells 3 without loss of space.
  • Figure 16 schematically shows in perspective an example of stacking on each other. others of several protective housings incorporating pockets according to the first embodiment of the invention.
  • the upper shell 3 further comprises at least one arch 44, preferably at least two or three arches 44.
  • the arches 44 extend between two side walls 32 of the upper shell 3, for example between the two side walls 32 on the side .
  • the arches 44 in fact bear on the recess 4.
  • the arches 44 comprise a flat upper portion 44a, adapted to receive the outer surface of the bottom 20 of the lower shell 2 of one to the protective housing, as shown in FIG. 44a of the arches 44 includes a protuberance 44b adapted to be inserted into a complementary recess 27 provided on the outer surface of the bottom 20 of the lower shell 2 still another housing.
  • the two longer side walls of the lower shell are inclined towards each other in their lower parts so that, when different protective boxes are stacked on top of each other, a space is formed between two adjacent lower shells. along these two adjacent lower hulls so as to keep the tubes accessible to the hand of an operator.
  • a controller has easy access to the pocket tubes when multiple protective housings are stacked on top of one another.
  • the space can be large enough to be able to pass a hand between two adjacent lower shells of two stacked protective housings.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP18789462.1A 2017-10-06 2018-09-26 Schutzbehälter für biopharmazeutische flüssigkeitsbeutel Active EP3691600B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1771062A FR3072021B1 (fr) 2017-10-06 2017-10-06 Boitiers de protection de poche de liquide biopharmaceutique
PCT/FR2018/000225 WO2019068965A1 (fr) 2017-10-06 2018-09-26 Boitiers de protection de poche de liquide biopharmaceutique

Publications (2)

Publication Number Publication Date
EP3691600A1 true EP3691600A1 (de) 2020-08-12
EP3691600B1 EP3691600B1 (de) 2023-07-05

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EP18789462.1A Active EP3691600B1 (de) 2017-10-06 2018-09-26 Schutzbehälter für biopharmazeutische flüssigkeitsbeutel

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US (1) US11992457B2 (de)
EP (1) EP3691600B1 (de)
JP (1) JP7224358B2 (de)
CN (1) CN111182878B (de)
FR (1) FR3072021B1 (de)
WO (1) WO2019068965A1 (de)

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Publication number Priority date Publication date Assignee Title
CN118202033A (zh) * 2021-10-29 2024-06-14 环球生命科技咨询美国有限责任公司 用于包装生物处理袋的装置和系统

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5163587A (en) * 1989-12-11 1992-11-17 Rehrig-Pacific Co. Syrup delivery system
FR2717782B1 (fr) * 1994-03-22 1996-06-21 Stephane Ibled Emballage de protection pour poche de transfert contenant un liquide, du type produit sanguin.
GB9702921D0 (en) * 1997-02-13 1997-04-02 Isserstedt Robert K A storage device
GB9724713D0 (en) * 1997-11-21 1998-01-21 Procter & Gamble Delivery systems
JP3547674B2 (ja) * 1999-12-22 2004-07-28 有限会社スグロ鉄工 成型品の外周用バリ取り装置
US8146762B2 (en) 2006-03-09 2012-04-03 Nalge Nunc International Corporation Flexible container handling system
US9301520B2 (en) * 2007-12-21 2016-04-05 Sartorius Stedim North America Inc. Systems and methods for freezing, storing and thawing biopharmaceutical materials
US20120033902A1 (en) * 2010-02-05 2012-02-09 Pro-Mart Industries, Inc. Household storage container
US8490811B2 (en) * 2011-05-16 2013-07-23 Water Tech Llc Foldable pool accessory storage and organizing container
WO2013053011A1 (en) * 2011-10-12 2013-04-18 Bluechiip Limited Storage cassette
KR101655726B1 (ko) * 2012-05-03 2016-09-07 쇼오트 아게 의료, 제약 또는 화장품 어플리케이션들을 위한 물질들을 저장하기 위한 컨테이너들을 처리하기 위한 방법 및 장치
FR3017122B1 (fr) * 2014-02-06 2016-02-26 Sartorius Stedim Fmt Sas Procede de chargement d'une poche souple 3d a emplir, un systeme de chargement et stockage de cette poche souple et dispositif de support associe.
EP4289467A3 (de) * 2014-04-16 2024-02-21 ViaCyte, Inc. Instrumente zur verwendung mit implantierbaren verkapselungsvorrichtungen

Also Published As

Publication number Publication date
FR3072021B1 (fr) 2023-06-30
FR3072021A1 (fr) 2019-04-12
US11992457B2 (en) 2024-05-28
CN111182878A (zh) 2020-05-19
WO2019068965A1 (fr) 2019-04-11
CN111182878B (zh) 2023-04-28
US20200237620A1 (en) 2020-07-30
JP7224358B2 (ja) 2023-02-17
EP3691600B1 (de) 2023-07-05
JP2020535946A (ja) 2020-12-10

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