PASSIVE AUTOMATIC ANTIFOAM DELIVERY SYSTEM FOR USE WITH SINGLE-USE BIOREACTORS

Abstract

The aspects of the disclosed embodiments generally relate to an apparatus which allows for the controlled addition of antifoam to the foam present in the headspace of a disposable single-use bioreactor in a reliable manner. The aspects of the disclosed embodiments also generally relate to a method of using such apparatus which allows for the controlled addition of antifoam to the foam present in the headspace of a disposable single-use bioreactor in a reliable manner. The aspects of the disclosed embodiments generally relate to antifoam systems, methods and apparatus, and more particularly, to an antifoam device operably connected to a single use biobag.

Claims

1. A passive automatic antifoam delivery system for use with a single-use bioreactor comprising: a medical grade porous non-reactive object secured proximally to the exhaust port of the bioreactor; wherein said porous object absorbs an antifoam substance from a bioreactor reservoir connected to the bioreactor and the porous object, and wherein said porous object retains said antifoam substance therein until foam from the bioreactor rises to the level wherein it makes contact with the antifoam absorbed porous object which releases small quantities of an antifoam substance sufficient to neutralize the foam and clear the exhaust port.

2. A passive automatic antifoam delivery system according to claim 1 wherein said medical grade porous non-reactive object is in the shape of a cylindrical wick or a ring.

3. A passive automatic antifoam delivery system according to claim 1 wherein said medical grade porous non-reactive object is in direct contact with a small reservoir attached to the bag or tubing and the antifoam is introduced into the reservoir by a user via a sterile syringe fitting or by tube welding of a small container of antifoam.

4. A passive automatic antifoam delivery system according to claim 1 wherein said antifoam is selected from polydimethylsiloxane, block copolymer of polyethylene glycol and polypropylene glycol, polypropylene based polyether dispersions, fatty acid esters, insoluble oils, polydimethylsiloxanes, mineral oil, vegetable oil, and EO/PO based defoamers contain polyethylene glycol and polypropylene glycol copolymers.

5. A passive automatic antifoam delivery system according to claim 1 wherein said medical grade porous non-reactive object comprises open cell porous foams, fibrous mesh or pads or sintered bead foams.

6. A passive automatic antifoam delivery system according to claim 5 wherein said medical grade porous non-reactive object comprises polymeric plastic materials, metals or metal alloys or ceramics.

7. A passive automatic antifoam delivery system according to claim 6 wherein said medical grade porous non-reactive object comprises polymeric plastic materials selected from polyethylene, polypropylene, polyester, polyolefins, polyamides, polyurethane, acrylics, and styrenics.

8. A passive automatic antifoam delivery system according to claim 6 wherein said medical grade porous non-reactive object comprises metals or metal alloys selected from titanium and stainless steel.

9. A passive automatic antifoam delivery system according to claim 6 wherein said medical grade porous non-reactive object comprises ceramics selected from silicon nitride and zirconium dioxide.

10. A medical grade porous object in the shape of a cylindrical wick or ring; wherein said porous object is absorbed/wicked with antifoam and retains said antifoam therein until exposed to a mass of foam which causes the release of small quantities of antifoam sufficient to neutralize the foam from the mass.

11. A method of controlling foam formation in a single use bioreactor bag comprising: securing a medical grade porous object around or adjacent to the exhaust port in the top of a single-use bioreactor bag; absorbing/wicking antifoam onto the porous object; retaining antifoam absorbed/wicked porous object therein until exposed to a mass of foam, and neutralizing foam in a bioreactor reservoir by the release of small quantities of antifoam.

12. The use of a medical grade porous object in the shape of a cylindrical wick or ring to neutralize foam in a bioreactor reservoir comprising: securing a medical grade porous object around or adjacent to the exhaust port in the top of a single-use bioreactor bag; absorbing/wicking antifoam onto the porous object; retaining antifoam absorbed/wicked porous object therein until exposed to a mass of foam, and neutralizing foam in a bioreactor reservoir by the release of small quantities of antifoam.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The accompanying drawings illustrate presently preferred embodiments of the present disclosure, and together with the general description given above and the detailed description given below, serve to explain the principles of the present disclosure. As shown throughout the drawings, like reference numerals designate like or corresponding parts.

[0035] FIG. 1 refers to one embodiment in which the exhaust gas exit tube is connected to a section of the bioreactor bag wall.

[0036] FIG. 2 refers to another embodiment in which the exhaust gas exit tube is connected to a section of the bioreactor bag wall.

[0037] FIG. 3 refers to another embodiment in which the exhaust gas exit tube is connected to a section of the bioreactor bag wall.

[0038] FIG. 4 refers to another embodiment in which the exhaust gas exit tube is connected to a section of the bioreactor bag wall.

[0039] FIG. 5 refers to another embodiment in which the exhaust gas exit tube is connected to a section of the bioreactor bag wall.

[0040] FIG. 6 refers to another embodiment in which the exhaust gas exit tube is connected to a section of the bioreactor bag wall.

DETAILED DESCRIPTION

[0041] The present disclosure is generally directed towards the use of antifoam devices and methods so as to improve the use of bioreactor bags. As will be understood, the various diagrams, flow charts and scenarios described herein are only examples, and there are many other scenarios to which the present disclosure will apply.

[0042] Referring to FIG. 1 and FIG. 2, two embodiments of the passive antifoam system are illustrated. In these Figures the exhaust gas exit tube (1) is shown connected to a section of the bioreactor bag wall (4) via a port fitment (6) which is heat welded to the bag film (4). The tube can be made of one of many materials commonly used in the pharmaceutical industry such as platinum cured silicone or C-Flex. The tube can be flexible, semi-rigid or rigid. There can be one or more exhaust gas exit tubes attached to a bioreactor bag. The other end of each exhaust tube can be connected to a condenser (not shown), an exhaust filter (not shown) or to another bag (not shown). Inside the bioreactor bag headspace located in proximity to the exhaust gas port fitment is shown the porous or fibrous material pad or wick (3) which retains the antifoam. The porous or fibrous material pad or wick (3) can be formed into many different shapes such as the shape of a disc or ring. The antifoam reservoir in these Figures is depicted as a tubular or cylindrical shaped container (2) which is connected to a section of the bioreactor bag wall (4) via a port fitment (6) heat welded to the bag film (4). An aseptic connector (5) is shown at the top of the antifoam reservoir through which the user can fill the reservoir with antifoam. This aseptic connector (5) could be replaced by a simple plug (not shown) if tube welding a sterile bag of antifoam is to be the method of adding antifoam to the reservoir.

[0043] FIG. 3 and FIG. 4 illustrate other embodiments of the passive antifoam system. In these Figures, the exhaust gas exit tube (1) is shown connected to a section of the bioreactor bag wall (4) via a port fitment (6) which is heat welded to the bag film (4). The tube can be made of one of many materials commonly used in the pharmaceutical industry such as platinum cured silicone or C-Flex. The tube can be flexible, semi-rigid or rigid. There can be one or more exhaust gas exit tubes attached to a bioreactor bag. The other end of the exhaust tube can be connected to a condenser (not shown), an exhaust filter (not shown) or to another bag (not shown). Inside the bioreactor bag headspace located in proximity to the exhaust gas port fitment are one or more porous or fibrous material pads or wicks (3) which retain the antifoam. The porous or fibrous material pads or wicks (3) can be formed into many different shapes such as the shape of a cylinder or tube. The antifoam reservoirs in these Figures are depicted as a tubular or cylindrical shaped container (2) which is connected to a section of the bioreactor bag wall (4) via a port fitment (6) heat welded to the bag film (4). An aseptic connector (5) is shown at the top of one of the antifoam reservoirs through which the user can fill the reservoir with antifoam. The aseptic connector (5) could be replaced by a simple tube plug (8) if tube welding a sterile bag of antifoam is to be the method of adding antifoam to the reservoir.

[0044] FIG. 5 and FIG. 6 illustrate other embodiments of the passive antifoam system. In these Figures, the exhaust gas exit tube (1) is shown connected to a section of the bioreactor bag wall (4) via a port fitment (6) which is heat welded to the bag film (4). The tube can be made of one of many materials commonly used in the pharmaceutical industry such as platinum cured silicone or C-Flex. The tube can be flexible, semi-rigid or rigid. There can be one or more exhaust gas exit tubes attached to a bioreactor bag. The other end of each exhaust tube can be connected to a condenser (not shown), an exhaust filter (not shown) or to another bag (not shown). Inside the bioreactor bag headspace located in proximity to the exhaust gas port fitment are one or more porous or fibrous material pads or wicks (3) which retain the antifoam. The porous or fibrous material pads or wicks (3) can be formed into many different shapes such as the shape of a disc or ring. The antifoam reservoir in this figure shown to be of a bag shaped container (2) which is connected through a section of tubing (7) to a section of the bioreactor bag wall (4) via a port fitment (6) heat welded to the bag film (4). An aseptic connector (5) is shown at the top of a section of tubing (7) through which the user can fill the reservoir with antifoam. The aseptic connector (5) could be replaced by a simple tube plug (not shown) if tube welding a sterile bag of antifoam is to be the method of adding antifoam to the reservoir.

[0045] Thus, while there have been shown, described and pointed out, fundamental novel features of the invention as applied to the exemplary embodiments thereof, it will be understood that various omissions and substitutions and changes in the form and details of devices and methods illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit or scope of the invention. Moreover, it is expressly intended that all combinations of those elements and/or method steps, which perform substantially the same function in substantially the same way to achieve the same results, are within the scope of the invention. Moreover, it should be recognized that structures and/or elements and/or method steps shown and/or described in connection with any disclosed form or embodiment of the invention may be incorporated in any other disclosed or described or suggested form or embodiment as a general matter of design choice. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto.