Bag containing a biopharmaceutical product and probe holder port for such a product

Patent metadata

Field	Value
Publication number	US-11633328-B2
Application number	US-201816652846-A
Country	US
Kind code	B2
Filing date	Sep 26, 2018
Priority date	Oct 2, 2017
Publication date	Apr 25, 2023
Grant date	Apr 25, 2023

Abstract

A bag for containing a biopharmaceutical product includes at least one fluid input/output port and a measurement opening remote from the fluid port. A probe holder port has a body with an axial through-bore and a peripheral collar with a second fastening zone and defining a fastening plane. A contact probe, extending in the axial through-bore, is assembled on the probe holder port, has an active measurement end portion in contact with the product, and has an end portion opposite the end portion. The probe holder port includes a transition portion between the body and the collar, which extends between a radially central end portion of the collar and a first axial end portion of the body. The first axial end portion is the axial end portion closest to the radially central end portion of the collar. The first axial end portion is disposed on the outer side relative to the fastening plane, and the active measurement end portion is axially disposed on the outer side relative to the fastening plane.

First claim

The invention claimed is:

1. A bag adapted to contain a biopharmaceutical product, said bag comprising:
a flexible plastic sheath provided with at least one biopharmaceutical fluid input/output port and a measurement opening remote from the biopharmaceutical fluid input/output port, a first fastening zone surrounding said at least one measurement opening;
a probe holder port produced in the form of a thin part, the probe holder port comprising a body provided with an axial through-bore and a peripheral flange comprising a second fastening zone and defining a fastening plane, the body extending from a side outside the flexible plastic sheath relative to the fastening plane, the first and second fastening zones being sealably assembled together by bonding or welding;
a contact probe extending in the axial through-bore, being sealably assembled on the probe holder port, the contact probe comprising an active measurement end portion disposed in contact with the biopharmaceutical product when the bag is filled therewith, and an end portion opposite the active measurement end portion, the probe holder port comprising a transition portion between the body and the peripheral flange, the transition portion extending between a radially central end portion of the peripheral flange and a first axial end portion of the body said transition portion having a circumferentially continuous conical inner surface defining a cavity facing the at least one measurement opening and being axially disposed on an outer side relative to the fastening plane, the first axial end portion of the body being the axial end portion of the body that is closest to the radially central end portion of the peripheral flange, the first axial end portion of the body being disposed on the outer side relative to the fastening plane, the active measurement end portion being axially disposed on the outer side relative to the fastening plane.

2. The bag according to claim 1 , wherein, the height of the transition portion lies in the range 5 mm to 20 mm.

3. The bag according to claim 1 , wherein the contact probe comprises an intermediate part between the active measurement end portion and the end portion opposite the active measurement end portion, the intermediate portion comprising at least one O-ring being in sealing contact with the axial through-bore of the body.

4. The bag according to claim 1 , wherein the contact probe is assembled with the body of the probe holder port in a permanent manner.

5. The bag according to claim 4 , wherein the body comprises a second axial end portion, the second axial end portion of the body being opposite the first axial end portion of the body, and wherein the end portion opposite the active measurement end portion of the contact probe has an external diameter that is equal to the external diameter of the second axial end portion of the body.

6. The bag according to claim 5 , wherein the external diameter of the intermediate part of the contact probe is less than the diameter of the end portion opposite the active measurement end portion of the contact probe.

7. The bag according to claim 1 , wherein the diameter of the axial through-bore of the body of the probe holder port decreases from the second axial end portion of the body towards the first end portion of the body.

8. The bag according to claim 1 , wherein a locking element is disposed externally around the body and the end portion opposite the active measurement end portion of the contact probe.

9. The bag according to claim 8 , wherein the body comprises, on an external surface thereof, a circular abutment for retaining the locking element, capable of engaging with the locking element.

10. The bag according to claim 9 , wherein the locking element is cylindrical in shape and hollow and comprises a second axial through-bore, on the axis of said second axial through-bore aligned with the axis of the axial through-bore of the body.

11. An assembly intended to contain a biopharmaceutical product, the assembly comprising a bag and a probe holder port, said bag comprising a flexible plastic sheath provided with at least one biopharmaceutical fluid input/output port and a measurement opening remote from the biopharmaceutical fluid input/output port, a first fastening zone surrounding said at least one measurement opening, the probe holder port being produced in the form of a thin part, the probe holder port comprising a body provided with an axial through-bore and a peripheral flange comprising a second fastening zone and defining a fastening plane, the body extending from a side outside the flexible plastic sheath relative to the fastening plane, the first and second fastening zones being sealably assembled together by bonding or welding, the probe holder port comprising a transition portion between the body and the peripheral flange, the transition portion extending between a radially central end portion of the peripheral flange and a first axial end portion of the body said transition portion having a circumferentially continuous conical inner surface defining a cavity and facing the at least one measurement opening and being axially disposed on an outer side relative to the fastening plane, the first axial end portion of the body being the axial end portion of the body that is closest to the radially central end portion of the peripheral flange, the first axial end portion of the body being disposed on the outer side relative to the fastening plane, the active measurement end portion being axially disposed on the outer side relative to the fastening plane.

Assignees

• Sartorius Stedim Fmt Sas

Inventors

• Pallares Alain
• Yi Shuai
• Salaun Mathilde
• Prediger Andreas
• Lueders Julia
• Regen Thomas

Classifications

• A61J1/2058

  having multiple connecting ports · CPC title

• A61J1/1475

  Inlet or outlet ports · CPC title

• A61J2200/70

  Device provided with specific sensor or indicating means · CPC title

• A61J2200/72

  for temperature · CPC title

• A61J1/18

  Arrangements for indicating condition of container contents, e.g. sterile condition · CPC title