Container for the aseptic transfer of a biopharmaceutical product

Patent metadata

Field	Value
Publication number	US-2016354772-A1
Application number	US-201615242415-A
Country	US
Kind code	A1
Filing date	Aug 19, 2016
Priority date	Jul 29, 2011
Publication date	Dec 8, 2016
Grant date	—

Abstract

A container for ensuring the transport and the aseptic transfer of a biopharmaceutical product from or to a closed chamber provided with a leaktight joining device, includes: an annular flange delimiting an opening, a removable cover, built-in elements for locking/unlocking the removable cover and a peripheral envelope. The built-in locking/unlocking elements include a built-in functional locking/unlocking arrangement formed by a through-housing formed in the annular flange and a blind housing formed in the removable cover, and by a pin at an inner radial position and a pin at an outer radial position. The container is capable of being in an initial locking position, in an intermediate unlocking position and in a final locking position owing to the displacements of the pin at an inner radial position and the pin at an outer radial position in the blind hole of the removable cover and in the through-housing of the annular flange.

First claim

1 . A container ( 20 ) specially intended for the transport and the aseptic transfer of a biopharmaceutical product to or from a closed chamber ( 10 ) equipped with a leaktight joining device ( 40 ), comprising:
an annular flange ( 30 ) delimiting an opening ( 26 ); a removable cover ( 28 ) adapted for sealing the opening ( 26 ) of the annular flange ( 30 ); built-in means for locking/unlocking ( 110 ) the removable cover ( 28 ) on the annular flange ( 30 ); and a peripheral envelope ( 22 ) integral with the annular flange ( 30 ) and delimiting an enclosed inside space ( 24 ) adapted for receiving products belonging to the biopharmaceutical field; wherein the built-in locking/unlocking means ( 110 ) comprise at least one built-in functional locking/unlocking arrangement ( 112 ) formed, on the one hand, by a through-housing ( 114 ) formed in the annular flange ( 30 ) and a blind housing ( 116 ) formed in the removable cover ( 28 ) and in an extension of the through-housing ( 114 ) when the removable cover ( 28 ) seals the opening of the annular flange ( 30 ), and, on the other hand, by a pin at an inner radial position ( 118 ) and a pin at an outer radial position ( 120 ) which can be introduced and moved within the blind housing ( 116 ) of the removable cover ( 28 ) and the through-housing ( 114 ) of the annular flange ( 30 ); the container ( 20 ) being able to be in an initial locking position where, on the one hand, the pin at the inner radial position ( 118 ) has an internal functional portion for initial locking ( 118 INT ) arranged in the blind housing ( 116 ) of the removable cover ( 28 ) and an external functional portion for initial locking ( 118 EXT ) arranged in the through-housing ( 114 ) of the annular flange ( 30 ) so as to prevent the relative movement of the removable cover ( 28 ) with respect to the annular flange ( 30 ), and, on the other hand, the pin at the outer radial position ( 120 ) is at least partially arranged in the through-housing ( 114 ) of the annular flange ( 30 ); the container ( 20 ) being able to be in an intermediate unlocking position in which, on the one hand, the pin at the inner radial position ( 118 ) is at least partially arranged in the blind housing ( 116 ) of the removable cover ( 28 ) and is completely outside the through-housing ( 114 ) of the annular flange ( 30 ) and, on the other hand, the pin at the outer radial position ( 120 ) is at least partially arranged in the through-housing ( 114 ) of the annular flange ( 30 ) and is completely outside the blind housing ( 116 ) of the removable cover ( 28 ) so as to allow the relative movement of the removable cover ( 28 ) with respect to the annular flange ( 30 ); wherein the container ( 20 ) is able to be in a final locking position where, on the one hand, the pin at the inner radial position ( 118 ) is arranged in the blind housing ( 116 ) of the removable cover ( 28 ), and, on the other hand, the pin at the outer radial position ( 120 ) has an internal functional portion for final locking ( 120 INT ) arranged in the blind housing ( 116 ) of the removable cover ( 28 ) and an external functional portion for final locking ( 120 EXT ) arranged in the through-housing ( 114 ) of the annular flange ( 30 ) so as to prevent the relative movement of the removable cover ( 28 ) with respect to the annular flange ( 30 ), wherein the through-housing ( 114 ) and the pin at the outer radial position ( 120 ) have lengths such that, when the container is in the final locking position, said pin at the outer radial position ( 120 ) has a functional end portion at the outer radial position ( 122 ) which is either completely outside the through-housing ( 114 ) or is flush with the outer end opening of the through-housing ( 114 ).

2 . Container ( 20 ) according to claim 1 , wherein the through-housing ( 114 ) and the pin at the outer radial position ( 120 ) have lengths such that, when the container is in the initial locking position, said pin at the outer radial position ( 120 ) has a functional end portion at the outer radial position ( 122 ) which is either completely outside the through-housing ( 114 ), or is housed inside the through-housing ( 114 ), or is flush with the outer end opening of the through-housing ( 114 ).

3 . Container ( 20 ) according to claim 1 , wherein the through-housing ( 114 ) and the pin at the outer radial position ( 120 ) have lengths such that, when the container is in the intermediate unlocking position, said pin at the outer radial position ( 120 ) has a functional end portion at the outer radial position ( 122 ) which is either completely outside the through-housing ( 114 ), or is housed inside the through-housing ( 114 ), or is flush with the outer end opening of the through-housing ( 114 ).

4 . Container ( 20 ) according to claim 1 , wherein the pin at the inner radial position ( 118 ) and pin at the outer radial position ( 120 ) have substantially identical lengths.

5 . Container ( 20 ) according to claim 1 , wherein the through-housing ( 114 ), the blind housing ( 116 ), the pin at the inner radial position ( 118 ), and the pin at the outer radial position ( 120 ) are coaxial and oriented in a radial direction relative to the annular flange ( 30 ).

6 . Container ( 20 ) according to any one of claim 1 , wherein the through-housing ( 114 ), the blind housing ( 116 ), the pin at the inner radial position, and the pin at the outer radial position ( 120 ) are coaxial and oriented in a direction forming an angle α with respect to a radial direction relative to the annular flange ( 30 ).

7 . Container ( 20 ) according to claim 1 , comprising built-in isolation and protection means ( 124 ) arranged on an outer peripheral edge of the annular flange ( 30 ) so as to obstruct an inadvertent manipulation of the built-in locking/unlocking means ( 110 ).

8 . Container ( 20 ) according to claim 7 , wherein the built-in isolation and protection means ( 124 ) comprise at least one built-in functional arrangement for isolation and protection ( 126 ), provided around the through-housing ( 114 ) so as to obstruct an advertent manipulation of the pin at the outer radial position ( 120 ).

9 . Container ( 20 ) according to claim 8 , wherein the built-in functional arrangement for isolation and protection ( 126 ) has radial dimensions such that, in a temporary locking position, the pin at the outer radial position ( 120 ) does not extend beyond said isolation and protection means ( 124 ).

10 . Container ( 20 ) according to claim 8 , wherein the built-in arrangement for functional isolation and protection ( 126 ) comprises at least one lug ( 128 ) arranged around the through-housing ( 114 ) of the annular flange ( 30 ).

11 . Container ( 20 ) according to claim 8 , wherein the isolation and protection arrangement ( 126 ) comprises a bore formed in the annular flange ( 30 ) and having a diameter greater than the diameter of the through-housing ( 114 ).

12 . Container ( 20 ) according to claim 1 , comprising built-in temporary clamping means ( 100 ) arranged on an outer peripheral edge of the annular flange ( 30 ) so as to allow temporarily clamping the container ( 20 ) by preventing axial movement on the closed chamber ( 10 ) via actuation of the leaktight joining device ( 40 ).

13 . Container ( 20 ) according to claim 12 , wherein the built-in temporary clamping means ( 100 ) comprise at least one built-in functional arrangement for temporary clamping ( 102 ) formed by at least one lug ( 104 ) having a built-in functional surface for axial clamping ( 106 ) adapted to abut against a stationary functional surface for axial clamping ( 56 ), of the leaktight joining device

Assignees

• Sartorius Stedim Fmt Sas

Inventors

• Nodin Gaëlle

Classifications

• B65B7/16

  Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons · CPC title

• B01L1/02 Primary

  Air-pressure chambers; Air-locks therefor · CPC title

• B01L2300/0832

  cylindrical, tube shaped · CPC title

• B01L2200/141

  Preventing contamination, tampering · CPC title

• C12M37/04

  Seals · CPC title