Patent Grant
10532870
The invention relates to the field of receiving, storing, and transporting biopharmaceutical fluid.
The invention relates more particularly to a device for storage and transport, in particular a device specifically intended for transport. The invention also relates to a system for receiving and transferring a biopharmaceutical fluid comprising such a device, and a method for receiving and transferring under controlled pressure a biopharmaceutical fluid wherein such a system is used.
The term “biopharmaceutical fluid” is understood to mean a product of biotechnology (culture media, cell cultures, buffer solutions, artificial nutrition liquids, blood products and derivatives of blood products) or a pharmaceutical product or more generally a product intended for use in the medical field. Such a product is in liquid, paste, or possibly powder form. The invention also applies to other products subject to similar requirements concerning their packaging.
Flexible sterile bags intended for receiving a biopharmaceutical fluid are known. These flexible sterile bags are handled frequently in a large number of operations, for example during filling, freezing, storage, transport, thawing, draining, etc. In particular, during the transport phases, for example by boat, plane, or truck, there is a risk of the bag being damaged and its integrity compromised if it is not properly protected. Bag leakage can occur, resulting in a loss of the biopharmaceutical fluid it contains as well as a loss of sterility.
Also, in order to carry out the transport operations described above, it is known to use devices that allow receiving the bag containing the pharmaceutical fluid and then transporting it in a secure manner.
In a first known embodiment, a device comprises a rigid container in which is placed one or more bags filled with biopharmaceutical fluid. The device thus allows maintaining and protecting the bag or bags during transport. However, significant stresses can be generated in the bag, for example due to movement of the biopharmaceutical fluid inside it. In addition, when the bag comprises rigid elements such as ports or connectors for fill or discharge tubes, these can strike the inner wall of the container if there are impacts, vibrations, or turbulence during transport operations. This can exert significant mechanical stress at the wall of the bag, particularly at the sites for attachment of rigid tubing to the wall of the bag, which can be sufficient to rupture the bag or cause damage likely to compromise its integrity.
In a second embodiment, the device may further comprise bubble wrap and/or foam placed on the inner wall of the rigid container to prevent impacts between the bag and the container during transport. However, for cost reasons, it is often preferable to use containers of standard sizes for the transport of flexible bags of various sizes. Also, when the container is not of a size specifically adapted to that of the bag, free space remains between the inner wall of the container and the bag so that the bag is not properly held in place. This can occur as well when the container is adapted for a size of flexible bag having a certain predefined fill level but the bag is underfilled or overfilled relative to this predefined fill level. The bag is then able to move within the container under the effect of external stresses and can rupture when it strikes the container wall.
In a third embodiment, the device may consist of a protective shell in which the bag is suspended, thus distancing it from the inner wall of the shell. However, such a device is complex to implement because the shell must comprise internal means for suspending the bag. It is also necessary to ensure that no part of the bag is in contact with the shell, which can be tedious and time-consuming when the suspension of a large number of bags must be checked prior to transport.
There is therefore a need, in the specific field of the invention, to be able to transport bags of biopharmaceutical fluid easily and securely.
To resolve the stated problem, a first aspect of the invention relates to a device for transporting a biopharmaceutical fluid, comprising:
By means of this device, the bag can be held in place in the outer container and it is possible to better distribute the mechanical stresses the bag undergoes during its storage or transport within the container.
In various embodiments of the invention, one or more of the following arrangements may possibly be used, separately or in combination:
The invention also relates to a system for receiving and transferring under controlled pressure a biopharmaceutical fluid, comprising:
The invention also relates to a method for receiving and transporting a biopharmaceutical fluid, wherein:
The invention also relates to a method for receiving and transporting a biopharmaceutical fluid, wherein:
The invention also relates to a method for receiving and transferring a biopharmaceutical fluid, wherein a system is provided for receiving and transferring under controlled pressure a biopharmaceutical fluid, and when one wishes to transfer under controlled pressure the biopharmaceutical fluid from the inner chamber, the line for the injection of pressurized inflation gas and the inlet for the injection of pressurized inflation gas of the protective element are placed in fluid communication, then the pressurized inflation gas is injected into the protective element so that the inner bag is compressed and the pressure drains the biopharmaceutical fluid therein.
In various embodiments of the method according to the invention, one and/or the other of the following arrangements may possibly be used, separately or in combination:
Several embodiments of the invention are now described with reference to the drawings, in which:
The following is a detailed description of several embodiments of the invention, accompanied with examples and with reference to the drawings. The invention is of course not limited to the embodiment(s) described, which are provided for the purposes of illustration, not limitation.
The invention relates to a device 1 for storing and transporting a biopharmaceutical fluid 2 (said device 1 being referred to below as “device”).
The device 1 comprises an inner bag 3 and an outer container 4.
The inner bag 3 is flexible and fluidtight. The inner bag 3 is formed from a wall 5 made of plastic. The wall 5 forms and defines an inner chamber 6, which can be flat (
In the embodiments shown in
As illustrated in
The deployed inner bag 3 has a capacity between 1 liter and 70 liters, in particular between 1 and 55 liters, depending on requirements and applications.
The inner bag 3 is provided with an orifice, meaning a passage 7 for filling with biopharmaceutical fluid 2, and an orifice, meaning a passage 8 for discharging biopharmaceutical fluid 2. In particular, the fill orifice 7 and the discharge orifice 8 are located adjacent to one another on the wall 5 of the inner bag 3 or at the common peripheral side edge 30.
The fill orifice 7 and the discharge orifice 8 of the inner bag 3 and of the wall 5 are respectively associated by fluidtight connections with a fill tube 9 having at the opposite end an inlet 10 for filling the inner chamber 6 with biopharmaceutical fluid 2 and a discharge tube 11 having at the opposite end an outlet 12 for draining the chamber 6 of biopharmaceutical fluid 2.
Alternatively, the inner bag 3 may comprise a single fill and discharge orifice. In this embodiment, a single tube acting as a tube for filling and discharging biopharmaceutical fluid in the chamber 6 is then associated by a fluidtight connection with the orifice of the inner bag 3. In yet another alternative, the inner bag 3 may comprise more than two fill and discharge orifices, and therefore more than two fill and/or discharge tubes.
“Fluidtight connection” is understood to mean a known structure, such that the wall 5 of the inner bag 3 and the tube 9, 11 in fluid communication with the orifice 7, 8 are associated with each other so as not to permit any passage at the connection between them, particularly of the biopharmaceutical fluid 2 or a gas or possible contaminants. The wall 5 of the inner bag 3 and the tubes 9, 11 may form a single inseparable whole or may be interconnected by systems of connectors.
“Tube” is understood to mean a hollow structure that is more or less long or short, the term also including a simple port.
The outer container 4 comprises at least an outer receptacle 13. The outer receptacle 13, made of plastic or other synthetic or metal material, may be formed from a wall 14 or even from a plurality of parts having the general form of solid or substantially solid panels which are flat or substantially flat, as well as connecting parts, reinforcing parts, accessories, etc.
As shown in the figures, the receptacle 13 may consist of a case or a rigid or semi-rigid shell. “Rigid or semi-rigid” is understood to mean that the outer receptacle 13 is of greater rigidity than the wall 5 of the inner bag 3.
More particularly, according to one configuration, the outer receptacle 13 has a parallelepipedic shape and the wall 14 comprises a lower wall 14a, an upper wall 14b, and a peripheral side wall 14c erected as four panels each pair being perpendicular or parallel to one another.
Under normal circumstances, the lower wall 14a and the upper wall 14b are arranged horizontally or substantially horizontally, while the peripheral side wall 14c is arranged vertically or substantially vertically, possibly flaring slightly outward from the transverse lower wall 14a. The description is given in reference to this situation. Also in reference to this situation are to be understood the words “horizontal,” “vertical,” “lower,” and “upper”.
According to one embodiment illustrated by
Moreover, according to this embodiment illustrated in
Alternatively, the outer receptacle 13 may comprise a single foldable wall 14 which when folded comprises, in addition to a lower wall 14a and a side wall 14c, also an upper wall 14b. In this variant, the upper wall 14b may be removable in order to be alternately closed or open.
The outer receptacle 13 of the outer container 4 is adapted and intended for receiving the inner bag 3 (and therefore the inner chamber 6) in its entirety. Thus, the inner bag 3 (and therefore the inner chamber 6) is placed completely within, in other words inside of, the outer receptacle 13 and outer chamber 15, or symmetrically the receptacle 13 is placed so as to surround the exterior of the inner bag 3 (and therefore the inner chamber 6).
As a result, the outer receptacle 13 is larger than the inner bag 3, or symmetrically the inner bag 3 is smaller than the receptacle 13. This is true whether the inner bag 3 is empty of biopharmaceutical fluid 2 or filled with biopharmaceutical fluid 2. The outer container 4, and in particular the outer receptacle 13, may in particular be of large capacity in order to be able to receive a large amount of inner bags 3 filled with biopharmaceutical fluid 2. According to this embodiment, the container 4 may receive more than one inner bag 3, particularly more than five inner bags 3, or more particularly more than ten inner bags 3.
The adjectives “inner” and “outer”, respectively applied to the bag 3 and its constituent parts, to the container 4, and to the outer receptacle 13, reflect the fact that the receptacle 13 surrounds the exterior of the bag 3 placed completely within, in other words inside of, the receptacle 13. It is therefore in reference to this situation that the words “inner” and “outer” are to be understood.
In one embodiment, the outer receptacle 13 is at least partly transparent or translucent so as to allow viewing the inner bag 3 through its wall 14. In another embodiment, the receptacle 13 may also be at least partly, possibly entirely, opaque to light or to ultraviolet rays, for example to ensure optimal preservation of the biopharmaceutical product 2, particularly if the biopharmaceutical product 2 is a photosensitive product.
An expandable protective element 16 is arranged between the outer receptacle 13 of the outer container 4 and the inner bag 3. The expandable protective element 16 is able to be in two states, an expanded state and a non-expanded state.
In the expanded state, the expandable protective element 16 is expanded in volume. The inner bag 3 is then held in place in the outer receptacle 13, and the outer receptacle 13 is fully occupied by the protective element 16 and the inner bag 3. In particular, the expandable protective element 16 substantially surrounds the inner bag 3, meaning that the majority of the wall 5 of the inner bag 3 is in contact with the expandable protective element 16. In the non-expanded state, the protective element 16 is not expanded in volume, and the space within the outer receptacle 13 is at least partially unoccupied.
Once in the expanded state, the protective element 16 substantially fills the space between the inner bag 3 and the wall 14 of the receptacle 13. Thus, the expandable protective element 16 serves to maintain the inner bag 3 by compressing it, in particular in several directions, within the outer receptacle 13. It is further possible to eliminate concerns related to the dimensions of the inner bag 3 varying with the fill level of biopharmaceutical fluid 2, by adjusting the expansion of the expandable protective element 16.
The device 1 comprising the inner bag 3 and the protective element 16 is adapted to be in two extreme states:
As represented in
In addition, it should be understood that the outer receptacle 13 must always fulfill a function of containment and external retention of the inner bag 3 and the protective element 16, which requires that the expansion capacity of the outer receptacle 13, when the protective element 16 is in the expanded state, be limited, in particular very low. This can be achieved by choosing a rigid or semi-rigid wall 14 for the receptacle 13.
In a first embodiment, the expandable protective element 16 may comprise a flowable material, for example foam, adapted to expand in volume, particularly when subjected to certain conditions. For example, the expandable protective element 16 may be an expandable fluid which expands when dried, heat treated, chemically treated, or irradiated (a long as this method is compatible with the biopharmaceutical materials treated).
According to this first exemplary embodiment, the expandable protective element 16 may be introduced or injected by any means in the non-expanded state into the outer receptacle 13. In particular, the expandable protective element 16 may be introduced into the receptacle before the inner bag 3 has itself been placed in the outer receptacle 13. Alternatively, the expandable protective element 16 may be introduced into the outer receptacle 13 after the inner bag 3 has been placed in the outer receptacle 13, the inner bag 3 then able to be empty or already filled with biopharmaceutical fluid 2. An injection orifice 17 may be located directly on the wall 14 of the receptacle 13, for the purpose of introducing the expandable protective element into the outer receptacle 13.
The following more particularly describes a second exemplary embodiment of the expandable protective element 16 according to the invention as represented in
According to this second exemplary embodiment, the expandable protective element 16 is an inflatable protective element. The expandable protective element 16 may then be formed from a wall 20 made of plastic. Similarly to its wall 20, the expandable protective element 16 is flexible and fluidtight. The wall 20 of the protective element 16 forms and thus defines a protective chamber 22.
As represented by
Still according to this second embodiment, the inner bag 3 may be previously arranged within the inflatable protective element 16 in the protective chamber 22, said inflatable protective element 16 then surrounding substantially the entire wall 5 of the inner bag 3 and the tubing associated with the inner bag 3 such as the fill tube 9 and discharge tube 11. In particular, the inflatable protective element 16 surrounds the majority of the two main wall portions 28 of the inner bag 3. The inflatable protective element 16 also surrounds the wall portion 5 of the inner bag 3 comprising the fill orifice 7 and the discharge orifice 8.
Still according to this second embodiment in which the expandable protective element 16 is an inflatable protective element, the inflatable protective element 16 may comprise at least a first portion 23a and a second portion 23b. In particular, the first portion 23a substantially surrounds the inner bag 3, and in particular the two main wall portions 28 of the inner bag 3. The second portion 23b substantially surrounds the fill orifice 7 and the discharge orifice 8 of the inner bag 3 as well as the fill tube 9 and the discharge tube 11. The second portion 23b of the inner bag 3 is thus adapted to receive the tubing while the first portion 23a of the inner bag 3 is adapted to receive the two main wall portions 28, which are flexible and fluidtight. The first portion 23a and second portion 23b constitute two separate portions of the inflatable protective element 16 and can be interconnected and delineated by any means. In particular, the first portion 23a and second portion 23b may comprise only between them an opening adapted to allow the passage of the fill tube 9 and the discharge tube 11 from the first portion 23a to the second portion 23b of the protective element 16.
Alternatively, as represented for example in
The inflatable protective element 16 is adapted and intended to be inflated by pressurized inflation gas G, in particular by air or an inert gas. Thus, the protective element 16 may alternatively be in an expanded state in which it is inflated, or in a non-expanded state in which it is not inflated. Also, in the non-expanded state, the protective element 16 is flat, meaning that it is empty or substantially empty of inflation gas G to the extent that its construction allows.
The deformability of the inflatable protective element 16 then results firstly from the shape of the protective element 16, typically enabling the transition from an empty and flat shape (
To fill the protective element 16 with inflation gas G, the protective element 16 is provided with an injection orifice 17, in other words a passage, for the injection of inflation gas G, in fluid communication with the protective element 16.
With the injection orifice 17 of the protective element 16 and the wall 20, there is associated by a fluidtight connection (this term is to be understood as explained above) an injection tube 18 (this term is to be understood as explained above) having at the opposite end an inlet 19 for the injection of inflation gas G into the protective element 16. Once the protective element 16 inflated by the inflation gas G, the injection orifice 17 or injection tube 18 may be sealed irreversibly, in particular by welding. Alternatively, the injection orifice 17 consists of a self-sealing valve. Such a valve makes it possible to seal the protective element 16 closed automatically once it is inflated.
Furthermore, the injection orifice 17, with the injection tube 18, may be arranged in, respectively may traverse, the wall 14 of the outer receptacle 13 with a fluidtight connection also formed on the wall 14. The passage of the injection tube 18 through the wall 14 allows inflating the protective element 16 with inflation gas G from outside the outer receptacle 13 and outer container 4, in particular after prior installation of the protective element 16 inside the outer receptacle 13. In addition, in the embodiment where the protective element 16 is integral to the wall 14 of the outer receptacle 13, the injection orifice 17 may be located directly on the wall 14 of the receptacle 13.
According to the first or second exemplary embodiment described above, the expandable protective element 16 is preferably at least partly, possibly entirely, transparent or translucent so as to allow viewing the inner bag 3 through it, and in particular through the wall 20. In another embodiment, the expandable protective element 16 may also be at least partly, possibly entirely, opaque to light or to ultraviolet rays, for example to ensure optimal preservation of the biopharmaceutical product 2, particularly if the biopharmaceutical product 2 is a photosensitive product.
A same outer receptacle 13 may be of large capacity in order to accommodate multiple inner bags 3, each arranged and protected in an individual protective element 16. The device 1 thus enables the transport, for example in bulk or in a disorganized manner, of a large number of inner bags 3.
In a first embodiment which may be illustrated by
According to this embodiment, first the inner bag 3 empty of biopharmaceutical fluid 2 is placed inside the expandable protective element 16 which here is represented as an inflatable element. The expandable protective element 16 is thus in the non-expanded state, in particular uninflated, as is represented in
Then the expandable protective element 16 together with the inner bag 3 is placed within the receptacle 13. In particular, the outer receptacle 13 may comprise a removable wall such as for example an opening 29a, 29b, which can be opened to allow introducing the inner bag 3 into the outer chamber 15 formed by the outer receptacle 13 and the wall 14.
Alternatively, when the protective element 16 forms a protective strip, the protective element 16 may be arranged in the outer receptacle 13 before the inner bag 3. The protective element 16 then comprises at least one end, in particular two ends, projecting beyond the outer receptacle 13. The inner bag 3 is then itself arranged in the outer receptacle 13, in particular on the protective element 16. The end of the protective element 16, in particular the two ends, can then be folded over the upper portion of the inner bag 3 so that the protective element 16 surrounds the inner bag 3.
Next, the inner bag is filled with biopharmaceutical fluid 2. In the configuration where the expandable protective element 16 is an inflatable element, the expandable protective element 16 is then filled with inflation gas G. The inflation gas G may in particular be injected from the outside through the injection orifice 17.
When the expandable protective element 16 is in the expanded state, and is in particular filled with inflation gas G as represented in
The opening 29a, 29b of the outer receptacle 13 is then closed so that the outer receptacle 13 defines an outer chamber 15 which is at least closed, if necessary in a fluidtight manner. By closing the wall 14, the outer receptacle 13 slightly compresses the protective element 16 and the inner bag 3 so as to ensure satisfactory retention of the inner bag 3 in the outer receptacle 13.
In a second embodiment which may be illustrated by
According to this second embodiment, the tubes 9, 11 are thus located in a space separate from the flexible wall 5 of the inner bag 3 during transport. It is thus possible in particular to prevent the tubes 9, 11 from coming into contact with, for example bumping or rubbing against, the wall 5 of the inner bag 3 during transport of the inner bag 3. The tubes 9, 11 are also retained in the second compartment 25b, to prevent their exposure to bending or twisting forces which could compromise their integrity.
According to a third embodiment which may be illustrated by
To this end, in this third embodiment the fill inlet 10 and the discharge outlet 12 associated with the inner bag 3 are located outside the outer receptacle 13, so as to be easily accessible.
In addition, the inner bag 3 is distanced from the outer receptacle 13 so as not to hinder the passage of biopharmaceutical fluid 2 to the orifices 7 and 8. These structural arrangements contribute to the effectiveness and efficiency of the device 1 when emptying the inner bag 3.
The device 1 is arranged so that, when the expandable protective element 16 is introduced, and in particular when pressurized inflation gas G is injected into the compression chamber 16 in the case where the expandable protective element 16 is inflatable, the inner bag 3 can be compressed so that the biopharmaceutical fluid 2 therein is emptied through the discharge outlet 12 due to the pressure.
According to this embodiment, the device 1 is such that it comprises or is able to be associated with a discharge member. The discharge member is itself adapted so that, at least when discharging the biopharmaceutical fluid 2, the discharge orifice 8 is located in the lower portion of the inner bag 3 and of the inner chamber 6 and, in particular, the lowermost portion. This is intended to facilitate draining the inner bag 3 and to ensure that, for safety reasons, the air in the upper portion of the inner bag 3 and inner chamber 6 cannot exit through the discharge orifice 8.
According to one possible embodiment illustrated in
Alternatively, the discharge member 32 could also be a suspension element for the device 1, located opposite the discharge orifice 8, such as a suspension eyelet (not shown) provided in the upper portion of the outer receptacle 13, or possibly in the upper portion of the inner bag 3 when these are inclined. The device 1 can thus be arranged vertically with the discharge orifice 8 downward.
As illustrated by
These embodiments of the discharge member 32a, 32b, suitable for ensuring that at least when discharging the biopharmaceutical fluid 2, the discharge orifice 8 is located in the lower portion, in particular the lowermost portion, of the inner bag 3, do not exclude other embodiments.
It is understood that the terms “downward” and “upward”, “lower” and “upper” as applied to the inner bag 3, the expandable protective means 16, the container 4, and the receptacle 13, are understood to have their usual meaning and are in relation to the device 1 when arranged for discharging the biopharmaceutical fluid 2 by gravity.
It is possible to empty an inner bag 3, such as the one described, of the quantity of biopharmaceutical fluid 2 in its chamber 6 by compressing it, with no need to provide a pump, such as a peristaltic pump, associated with the discharge tube 11 or the discharge outlet 12. In particular, when the protective element 16 is an inflatable element, the inflation gas G can be injected so that the pressure of the biopharmaceutical fluid 2 in the discharge outlet 12 remains substantially constant during the discharge.
According to one configuration, a head loss-inducing element 36 such as a filter may also be associated with the discharge tube 11 or the discharge outlet 12.
The invention also relates to a system 40 for receiving and transferring under controlled pressure a biopharmaceutical fluid 2, comprising the device 1 and a method for receiving and transferring under controlled pressure a biopharmaceutical fluid 2 wherein the system 40 is provided and used.
As represented in
The system 45 then comprises a member 38 suitable for delivering the expandable protective element 16 or the pressurized inflation gas G when said member is an inflatable element. According to this embodiment, the system 45 comprises a source 37 of pressurized inflation gas G and a line 39 for the injection of pressurized inflation gas G, able to be associated in fluid communication or being associated in fluid communication with the outlet of the pressurized inflation gas G injection orifice 17 of the device 1.
The system 45 also comprises a control and management member 42. The control and management member 42 may for example be a pressure controller for the pressurized inflation gas G in the injection line 39, ordering the injection of inflation gas G when desired and controlling the injection at the desired pressure. Such a member 42 may be a pressure gauge, an adjustable valve, and/or a control line between them.
If the expandable protective element 16 is an inflatable element, the pressurized inflation gas G is supplied at a pressure at least equal to 100 mbar and at most equal to 1500 mbar. More particularly, and depending on requirements, this pressure is at least equal to 1000 mbar, more particularly at least equal to 700 mbar.
The system 40 for receiving and transferring under controlled pressure a biopharmaceutical fluid 2 also comprises, or there is associated with the system 40, a fill line 43 and a discharge line 44 which are adapted to be associated in fluid communication or are associated in fluid communication with the outlet respectively of the fill orifice 7 and the discharge orifice 8 of the device 1.
The method for receiving, transporting, and transferring under controlled pressure a biopharmaceutical fluid 2 according to the invention is such that a system 40 as described is initially provided in the state empty of biopharmaceutical fluid 2. The inner bag 3 is then placed in the outer receptacle 13, the expandable protective element 16 in the non-expanded state then being arranged between the inner bag 3 and the outer receptacle 13. Alternatively, the inner bag 3 may be placed in the outer receptacle 13, without the outer receptacle 13 initially comprising the expandable protective element 16. Also provided is the biopharmaceutical fluid 2 to be received and transferred under controlled pressure. Also provided is the member 38 adapted and intended for delivering the expandable protective element 16 or the pressurized inflation gas G.
When one wishes to receive biopharmaceutical fluid 2 in the device 1, one may first purge the gas from the fill line 43. Then the inner chamber 6 of the inner bag 3 is filled with biopharmaceutical fluid 2 via the fill inlet 10, in particular through the opening 29 of the outer receptacle 13, and then the fill inlet 10 is placed in the closed state, the discharge outlet 12 also being in the closed state.
Next, the protective element 16 is introduced or the protective element 16 is inflated, the fill inlet 10 and the discharge outlet 12 being in the closed state. In particular, in order to inflate the protective element 16, the line 39 for injecting pressurized inflation gas G and the inlet 19 for injecting pressurized inflation gas G of the outer receptacle 13 are placed in fluid communication. Alternatively, in the embodiment wherein the expandable protective element 16 is not initially comprised in the outer receptacle 13, the expandable protective element in the non-expanded state is introduced into the outer receptacle 13 via the injection line 39. As specified above, the expandable protective element 16 can then transition from the non-expanded state to the expanded state, for example when it is subjected to heat treatment.
The device 1 can then be detached from the system 40 so that the device 1 can be used to transport the inner bag 3 after the protective element 16 is in the expanded state as described above. In particular, the device 1 can be loaded onto a ship, truck, or aircraft in order to transport the inner bag 3.
After transport, when one wishes to transfer under controlled pressure the biopharmaceutical fluid 2 from the inner chamber 6 of the inner bag 3, the inner bag 3 can be compressed by further increasing the expansion of the expandable protective element 16. In particular, in the case where the expandable protective element 16 is an inflatable element, the line 39 for the injection of pressurized inflation gas G of the system 40 and the inlet 19 for injecting pressurized inflation gas G of the outer receptacle 13 are placed in fluid communication, in particular by means of the opening 29a, 29b of the outer receptacle 13, and the discharge outlet 12 is placed in the open state. Then the pressurized inflation gas G is injected into the inflatable protective element 16 between the outer receptacle 13 and the inner bag 3, so as to compress the inner bag 3 and empty it of the biopharmaceutical fluid 2 therein due to this pressure.
A head loss-inducing element such as a filter 36 may be placed in fluid communication with the discharge tube 11 or the discharge outlet 12. Also, when draining, the discharge orifice 8 may be positioned in the lower portion, in particular the lowermost portion, of the inner bag 3, with the aid of the discharge member 32 adapted for this purpose.
One can thus empty the inner bag 3 of all the biopharmaceutical fluid 2. Once the transfer under controlled pressure of the biopharmaceutical fluid 2 is complete, the inner bag 3 and the protective element 16 may be removed from the outer receptacle 13. The inner bag 3, the protective element 16, and the container 4 may be discarded, as they are disposable. Alternatively, the protective element 16 and the container 4 may be reused for the future transport of other bags.
The method described above may be carried out only in part, as the steps described above can be performed independently from each other. In particular, the inner bag 3 can be arranged in the outer receptacle 13 when it is already filled with biopharmaceutical fluid 2. Similarly, the protective element 16 could also be arranged in the outer receptacle 13 when it is already in the expanded state, and in particular in the inflated state. According to this alternative, one may then carry out only the emptying step of the method with the system 40. According to another alternative, one may carry out only the receiving of biopharmaceutical fluid 2 according to the method with the system 40, and not carry out the emptying step as indicated above.
Of course, the invention is not limited to the embodiments described above and provided only as examples. It encompasses the various modifications, alternative forms, and other variants conceivable to a skilled person within the context of the invention, and in particular any combinations of the various modes of operation described above, which may be taken separately or in combination.
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| PCT/FR2016/050526 | 3/8/2016 | WO | 00 |
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| WO2016/142618 | 9/15/2016 | WO | A |
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