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EP-3381430-B1 - HOUSING FOR PROTECTING A BAG OF BIOPHARMACEUTICAL LIQUID, ASSOCIATED PROTECTIVE ASSEMBLY AND ASSEMBLY METHOD

EP3381430B1EP 3381430 B1EP3381430 B1EP 3381430B1EP-3381430-B1

Inventors

  • BAUD, Stéphane
  • BAZIN, Frédéric

Dates

Publication Date
20260506
Application Date
20180329

Claims (14)

  1. Protective casing for a biopharmaceutical liquid pouch (50), comprising: • a lower shell (2) comprising a bottom (20) and lateral walls (21), • an upper shell (3) which comprises a housing (4) intended to receive the pouch (50), and which is insertable into the lower shell (2), so that, when the pouch (50) is placed in the bottom (20) of the lower shell (2), the pouch (50) is covered by the upper shell (3) so as to end up in the housing (4) between the upper shell (3) and the lower shell (2), ∘ the housing (4) comprising a bottom (40), and lateral walls (41 to 43) extending substantially perpendicularly to the bottom (40) of the housing, and the upper shell (3) also presenting external lateral walls (32) surrounding the lateral walls (41 to 43) of the housing (4) and extending substantially parallel to the lateral walls (41 to 43) of the housing (4), so that, between the housing (4) on one hand and the lateral walls (32) of the upper shell (3) on the other hand, there is an annular storage space (38) in which one or more tubes of the pouch (50) can be arranged; the lateral walls of the housing comprising side lateral walls (41), a front lateral wall from which a passage (31) exits and a rear lateral wall (42) forming the rear of the housing; the lateral walls (32) of the upper shell comprising two side lateral walls, a front lateral wall, and a rear lateral wall; each side lateral wall (32) of the upper shell comprising protuberances (35) cooperating with protuberances (36) of a side lateral wall (41) of the housing to form baffles in which the pouch tubes can pass and be maintained in place, • the upper shell being insertable into the lower shell (2), ∘ so that the opening (48) of the housing (4) is in the vicinity of and facing the bottom (20) of the lower shell (2), ∘ and so that the upper shell (3) is maintained in place laterally between the lateral walls (21) of the lower shell (2), • the upper shell comprising a fastener (33) which is located outside the housing (4) and which is arranged so that a handle (54) of the bottom (55) of the pouch (50) can hook onto the fastener (33), the fastener (33) being formed by several notches formed in one of the lateral walls (32) of the upper shell (3).
  2. Protective casing according to claim 1, characterized in that the upper shell (3) is insertable into the lower shell (2) also so that an outer periphery of the upper shell (3) is guided by the lateral walls (21) of the lower shell (2).
  3. Protective casing according to any one of the preceding claims, characterized in that the thickness (e3) of the upper shell (3) is less than the thickness (e2) of the lower shell (2).
  4. Protective casing according to claim 1, characterized in that the upper shell (3) also comprises, at least at the level of one end (42) of the housing (4) intended to receive the bottom (55) of the pouch (50), a rim (45) surrounding the opening (48) of the housing (4), extending preferentially substantially in the plane of the opening (48) of the housing (4), and in that a portion (46) of rim (45) of the upper shell (3), located between the fastener (33) and said end (42) of the housing (4), is arranged so that, when the handle (54) of the bottom (55) of the pouch (50) hooks onto the fastener (33), the connection between the handle (54) and the bottom (55) of the pouch (50) wraps around said portion (46) of rim (45).
  5. Protective casing according to any one of the preceding claims, characterized in that the housing (4) is shorter than the upper shell (3) so as to clear a free space (39) allowing the exit of the tube or tubes (52) of the pouch (50).
  6. Protective casing according to any one of the preceding claims, characterized in that the lateral wall (21) of the lower shell (2) located on the side of the tube or tubes (52) exit of the pouch (50) comprises an exit opening (23) for the tube or tubes (52) to exit laterally out of the lower shell (2), and in that said lateral wall (21) of the lower shell (2) comprises a recess (22) arranged toward the interior of the lower shell (2) and located above or below said exit opening (23).
  7. Protective casing according to any one of the preceding claims, characterized in that it also comprises an external cover (1) covering the upper shell (3) and closing the lower shell (2).
  8. Protective casing according to any one of the preceding claims, characterized in that the upper shell (3) and the lower shell (2) are made of plastic, and preferably in that the plastic is polyethylene terephthalate glycol.
  9. Protective casing according to any one of claims 7 and 8, characterized in that the lateral walls (21) of the lower shell (2) comprise one or more shoulders (25), preferably parallel to the mean plane of the bottom (20) of the lower shell (2), on which the cover (1) rests.
  10. Protective casing according to any one of the preceding claims, characterized in that the lateral walls (21) of the lower shell (2) comprise one or more shoulders (24), preferably parallel to the mean plane of the bottom (20) of the lower shell (2), on which the upper shell (3) rests.
  11. Protective casing according to any one of the preceding claims, characterized in that the lateral walls (21) of the lower shell (2) comprise one or more shoulders (26), preferably orthogonal to the mean plane of the bottom (20) of the lower shell (2), against which the upper shell (3) comes into longitudinal abutment when it is inserted into the lower shell (2).
  12. Protective casing according to claim 1, characterized in that the distance (h) between the opening (48) of the housing (4) and the bottom (20) of the lower shell (2) is greater than or equal to half, preferably three-quarters, of the depth (p) of the housing (4).
  13. Protective assembly for a biopharmaceutical liquid pouch comprising: • a protective casing according to any one of the preceding claims, • a biopharmaceutical liquid pouch (50) placed in said protective casing or an empty pouch (50) intended to receive the biopharmaceutical liquid placed in said protective casing, the biopharmaceutical liquid pouch (50) being flat and elongated and presenting at the level of its pouch bottom (55) a handle (54) connected to said bottom (55) by a flat-shaped connection, and at the level of the opposite side one or more connections for tube (52); the handle (54) of the pouch bottom being hooked to the fastener (33).
  14. Assembly process for a protective assembly for a biopharmaceutical liquid pouch according to claim 13, characterized in that : • an operator hooks, by a first of his hands, the pouch (50) by its handle (54) to the upper shell (3), this upper shell (3) being in a vertical position, • this upper shell (3) remaining in vertical position, this operator positions and maintains, by a second of his hands, the end (51) of the pouch (50) opposite to its handle (54) against the upper shell (3) so that the pouch (50) is in its housing (4) of the upper shell (3), • this operator places the upper shell (3) containing the pouch (50) into the lower shell (2) placed in horizontal position.

Description

DOMAINE DE L'INVENTION L'invention concerne le domaine des boîtiers de protection de poche de liquide biopharmaceutique, le domaine des ensembles de protection intégrant un boîtier de protection et une poche de liquide biopharmaceutique, ainsi que le domaine des procédés d'assemblage d'un ensemble de protection intégrant un boîtier de protection et une poche de liquide biopharmaceutique. CONTEXTE DE L'INVENTION Selon un premier art antérieur, il est connu un boîtier de protection de poches de liquide biopharmaceutique comprenant d'une part deux coques supérieure et inférieure assemblées l'une sur l'autre, ainsi que deux films plastiques élastiques situés à l'intérieur de ces coques et venant enserrer deux poches de liquide biopharmaceutique. Les poches de liquide biopharmaceutique sont maintenues en place entre les films et protégées des agressions et chocs extérieurs au boîtier de protection par les espaces respectivement maintenus entre d'une part la coque supérieure et le film supérieur et d'autre part entre la coque inférieure et le film inférieur. Ce boîtier de protection assure un bon maintien des poches de liquide biopharmaceutique à l'intérieur. En revanche, ce boîtier de protection présente des coques de structure complexe et délicate, à cause du film plastique élastique à fixer sur chacune des coques, et présente un encombrement important en hauteur à cause des deux espaces vides empilés l'un sur l'autre, celui entre film supérieur et coque supérieure et celui entre film inférieur et coque inférieure. Selon un deuxième art antérieur, par exemple présenté dans la demande de brevet EP1993921, il est connu un boîtier de protection de poches de liquide biopharmaceutique comprenant d'une part deux coques supérieure et inférieure assemblées l'une sur l'autre, et venant enserrer une poche de liquide biopharmaceutique. Ce boîtier de protection présente d'une part l'inconvénient soit d'une insuffisance de maintien latéral de la poche de liquide biopharmaceutique (cas où la poche est plus petite que l'espace disponible inter-coques) soit d'une pression trop importante exercée par les coques directement sur la poche de liquide biopharmaceutique (cas où la poche est juste dimensionnée pour l'espace disponible inter-coques), à cause de la constitution du logement de la poche par la coopération des deux coques entre elles (chaque coque ne définissant qu'une partie du logement), et d'autre part l'inconvénient d'un montage délicat nécessitant la superposition exacte et précise des deux coques par la coopération d'un jeu de pions et d'alésage. US 2010/140124 divulgue un boitier de protection d'une poche de liquide biopharmaceutique, comprenant une coque inférieure, une coque supérieure qui est insérable dans la coque inférieure et qui comprend un logement et des parois latérales, de sorte qu' entre le logement et les parois latérales se trouve un espace annulaire de rangement. RESUME DE L'INVENTION Le but de la présente invention est de fournir un boîtier de protection de poche de liquide biopharmaceutique, et/ou un ensemble de protection d'une poche de liquide biopharmaceutique, et/ou un procédé d'assemblage d'un ensemble de protection d'une poche de liquide biopharmaceutique, palliant au moins partiellement les inconvénients précités. Plus particulièrement, l'invention vise à fournir un boîtier de protection de poche de liquide biopharmaceutique qui améliore le maintien latéral de la poche, cette poche étant maintenue dans un logement d'une coque supérieure elle-même maintenue entre les parois d'une coque inférieure dans laquelle elle est insérée, sans exercer de contrainte excessive sur la poche de liquide biopharmaceutique, et tout en facilitant l'assemblage du boîtier de protection, la simple insertion d'une coque supérieure dans une coque inférieure, la coque supérieure définissant la quasi-totalité du logement à elle seule (le débattement latéral dans le logement étant entièrement limité par la seule coque supérieure), aboutissant ainsi à un bon compromis entre d'une part l'efficacité de maintien de la poche (sans risquer d'abîmer cette poche) et d'autre part la facilité d'assemblage du boîtier de protection. Selon l'invention, il est prévu un boitier de protection d'une poche de liquide biopharmaceutique, selon la revendication 1, comprenant : une coque inférieure comprenant un fond et des parois latérales, une coque supérieure : qui comprend un logement destiné à recevoir la poche, et qui est insérable dans la coque inférieure, de sorte que l'ouverture du logement soit au voisinage et en regard du fond de la coque inférieure, et de sorte que la coque supérieure soit maintenue en place latéralement entre les parois latérales de la coque inférieure. Selon ce premier objet de l'invention, une poche pleine de liquide biopharmaceutique étant placé dans le boîtier de protection, il est aussi prévu un ensemble de protection d'une poche de liquide biopharmaceutique comprenant : un boitier de protection selon l'in