Abstract
Method for the aseptic filling of a bag with a pharmaceutical product or liquid which comprises the following steps: a) a first step in which the cap is inserted in the inlet of the bag; b) a second step in which said cap is raised and the pharmaceutical product or liquid concerned is introduced; c) a third step in which the cap is re-inserted in the inlet of the bag; and d) a fourth step in which the cap and the inlet of the bag are welded.
Claims
1. A method to fill a bag with a pharmaceutical product or liquid, comprising: a) a first step in which a cap is inserted in an inlet of a bag producing a hermetic closure therebetween in a first, reversible hermetic closure position, which forms a hermetic seal, wherein the cap includes a cap flange extending laterally therefrom and a distal cylindrical extension containing a membrane at a distal end thereof, and the inlet includes an inlet flange extending laterally therefrom and an inlet channel vertically through the inlet, and wherein the distal extension is inserted in the inlet channel with an outer surface of the distal extension in contact with an inner surface of the inlet channel that contributes to the hermetic closure between the cap and the inlet; b) a second step in which the cap is moved to reverse the first, reversible hermetic closure position and a pharmaceutical product or liquid is introduced into the bag through the inlet channel; c) a third step in which the cap is re-inserted in the inlet of the bag with the distal extension inserted in the inlet channel, and an annular projection formed on an upper surface of the inlet flange is partially received in an annular recess formed on a lower surface of the cap flange, wherein the lower surface of the cap flange is separated from the upper surface of the inlet flange, producing the hermetic closure therebetween in a second, final hermetic closure position, which forms the hermetic seal; d) a fourth step in which the cap and the inlet of the bag are welded in the second, final hermetic closure position to produce a weld, wherein the annular projection fully encloses the annular recess and the lower surface of the cap flange extends parallel to and abuts against the upper surface of the inlet flange of the bag when welded in the second, final hermetic closure position; and e) transferring the cap and the bag into a sterile environment prior to performing steps b) and c).
2. A method according to claim 1, wherein the pharmaceutical product or liquid is selected from the group consisting of blood, plasma, serum, red blood cell solution, albumin solution, 1-antitrypsin solution, von Willebrand factor solution, solution comprising coagulation factors such as factor VII, factor VIII and factor IX, immunoglobulin solution, plasminogen solution, plasmin solution, antithrombin III solution, fibrinogen solution, fibrin solution, thrombin solution and combinations thereof.
3. A method according to claim 1, wherein the bag has a single inlet/cap structure which comprises an inlet and a cap and has two closure positions, a first position which provides a reversible hermetic closure and a second position which provides a final or irreversible hermetic closure by welding.
4. A method according to claim 1, wherein the pharmaceutical product or liquid has a volume and the bag has a total volume, wherein in the second step (step b)) the volume of pharmaceutical product or liquid introduced into the bag is between 1% and 100% of the total volume of the bag.
5. A method according to claim 1, wherein in the fourth step (step d)) the weld between the cap and the inlet of the bag is produced using heat or ultrasound.
6. A method according to claim 1, wherein in the fourth step (step d)), the weld between the cap and the inlet of the bag is produced between the inlet flange present on the inlet and the cap flange present on the cap.
7. A method according to claim 6, wherein in the fourth step (step d)) the weld between the cap and the inlet of the bag is produced in a strip in which the inlet flange additionally comprises at least one recess on the upper surface of the inlet flange.
8. A method according to claim 6, wherein in the fourth step (step d)) the weld between the cap and the inlet of the bag is produced as a strip in which the recess is positioned in the lower surface of the cap flange and the projection is positioned on the upper surface of the inlet flange.
9. A method according to claim 1, further comprising an additional step before the first step of the method (step a)) or between the first and second steps (steps a) and b), respectively), in which the cap and the bag are sterilized.
10. A method according to claim 9, wherein in the additional step the bag and the cap are sterilized using ultraviolet radiation, electron radiation (e-beam) or gamma radiation.
11. A method according to claim 1, wherein the sterile environment in which the second and third steps (steps b) and c) respectively) are carried out is achieved using horizontal laminar flow.
12. A method according to claim 1, wherein the first and/or the fourth step (steps a) and d) respectively) are performed in a sterile environment.
13. A method according to claim 12, wherein the sterile environment is achieved using horizontal laminar flow.
14. A method of claim 1, further comprising using the inlet and the cap, wherein: the inlet and the cap have two closure positions that consist of the first, reversible hermetic closure position and the second, final hermetic closure position; and the second, final hermetic closure position is irreversible after the welding.
15. A method of claim 1, further comprising using the bag.
16. The method according to claim 1, wherein: the pharmaceutical product or liquid comprises a color; the pharmaceutical product or liquid comprises biological properties; and the method does not alter the color or the biological properties.
17. The method according to claim 1, further comprising inhibiting contamination of the pharmaceutical product or liquid.
18. The method according to claim 17, wherein biological contamination and/or contamination by particles resulting from the welding is prevented.
19. The method according to claim 1, wherein: the first step does not change a three-dimensional structure of the cap or the inlet; and the third step changes a three-dimensional structure of the cap or the inlet.
20. A method to fill a bag with a pharmaceutical product or liquid, comprising: inserting a cap in an inlet of a bag to form a reversible hermetic seal between the cap and the bag in a reversible configuration, wherein the cap includes a cap flange extending laterally therefrom and a distal cylindrical extension containing a membrane at a distal end thereof, and the inlet includes an inlet flange extending laterally therefrom and an inlet channel vertically through the inlet, and wherein the distal extension is inserted in the inlet channel with an outer surface of the distal extension in contact with an inner surface of the inlet channel that contributes to the hermetic closure between the cap and the inlet; moving the cap from the inlet to break the reversible hermetic seal in a sterile environment; filling the bag through the inlet channel with a pharmaceutical product or liquid in the sterile environment; re-inserting the cap in the inlet with the distal extension inserted in the inlet channel, and forming a new hermetic seal between the cap and the bag in a final configuration, wherein an annular projection formed on a lower surface of the cap flange is partially received within an annular recess formed within the inlet flange along an upper surface of the inlet flange, wherein the upper surface of the inlet flange is separated from the lower surface of the cap flange; and welding the cap to the inlet in the final configuration, wherein the annular projection fully encloses the annular recess wherein the lower surface of the cap flange extends parallel to and abuts against the upper surface of the inlet flange of the bag when welded in the final configuration.
21. The method of claim 20, wherein: inserting the cap in the inlet in the reversible configuration does not change a three-dimensional structure of the cap or the inlet; and welding the cap to the inlet in the final configuration changes the three-dimensional structure as an extension of the cap relative to the inlet is along a different plane than when the cap is inserted in the inlet in the reversible configuration.
Description
(1) For a better understanding, the present invention is described below with reference to the accompanying drawings, which are given as an example and which can in no circumstances limit the present invention. Equivalent or similar structures in different figures are indicated with the same numeral.
(2) FIG. 1 is a perspective view of an empty bag with the inlet/cap structure of the present invention required to implement the method for the aseptic filling of bags with a pharmaceutical product or liquid of the present invention. Said perspective view may relate to any of the embodiments which will be explained in more detail below and which are shown in the rest of the figures.
(3) FIG. 2 is a perspective view of a detail of the cap and the inlet of the bag shown in FIG. 1 separated and according to a first embodiment of the conjunction between the lower surface of the cap flange and the upper surface of the inlet flange.
(4) FIG. 3 is a perspective view of a detail of the cap shown in FIGS. 1 and 2 according to a first embodiment of the conjunction between the lower surface of the cap flange and the upper surface of the inlet flange.
(5) FIG. 4 is a perspective view of a detail of the inlet shown in FIGS. 1 and 2 according to a first embodiment of the conjunction between the lower surface of the cap flange and the upper surface of the inlet flange.
(6) FIG. 5 is a perspective view of a detail of an alternative embodiment of the inlet shown in FIG. 4.
(7) FIG. 6 is a cross section or central transverse section of the cap shown in FIG. 3 in a plane that passes through the semi-major axis of the ellipse described by the flange of said cap.
(8) FIG. 7 is a cross section or central transverse section of the inlet shown in FIG. 4 in a plane that passes through the semi-major axis of the ellipse described by the flange of said inlet.
(9) FIG. 8 is a cross section or central transverse section of the inlet shown in FIG. 5 in a plane that passes through the semi-major axis of the ellipse described by the flange of said inlet.
(10) FIG. 9 is a perspective view of a detail of the cap and the inlet of the bag shown in FIG. 1 separated and according to a second embodiment of the conjunction between the lower surface of the cap flange and the upper surface of the inlet flange.
(11) FIG. 10 is a perspective view of a detail of the cap shown in FIGS. 1 and 9 according to a second embodiment of the conjunction between the lower surface of the cap flange and the upper surface of the inlet flange.
(12) FIG. 11 is a perspective view of a detail of the inlet shown in FIGS. 1 and 9 according to a second embodiment of the conjunction between the lower surface of the cap flange and the upper surface of the inlet flange.
(13) FIG. 12 is a perspective view of a detail of an alternative embodiment of the inlet shown in FIG. 11.
(14) FIG. 13 is a cross section or central transverse section of the cap shown in FIG. 10 in a plane that passes through the semi-major axis of the ellipse described by the flange of said cap.
(15) FIG. 14 is a cross section or central transverse section of the inlet shown in FIG. 11 in a plane that passes through the semi-major axis of the ellipse described by the flange of said inlet.
(16) FIG. 15 is a cross section or central transverse section of the inlet shown in FIG. 12 in a plane that passes through the semi-major axis of the ellipse described by the flange of said inlet.
(17) FIG. 16 is a diagrammatic view of the first step (step a)) of the method for the aseptic filling of a bag with a pharmaceutical product or liquid of the present invention. This diagrammatic view may correspond to any of the embodiments which will be explained in greater detail below and which appear in the rest of the figures.
(18) FIG. 17 is a diagrammatic view of the second step (step b)) of the method for the aseptic filling of a bag with a pharmaceutical product or liquid of the present invention, according to the first embodiment of the conjunction between the lower surface of the cap flange and the upper surface of the inlet flange, that is, according to the inlet/cap structure shown in FIG. 2 to 8. In this figure, the narrow arrow which has no numeral denotes or represents the action of filling the bag with the pharmaceutical product or liquid carried out in the second step (step b)) of the method of the present invention.
(19) FIG. 18 is a diagrammatic view of the second step (step b)) of the method for the aseptic filling of a bag with a pharmaceutical product or liquid of the present invention, according to the second embodiment of the conjunction between the lower surface of the cap flange and the upper surface of the inlet flange, that is, according to the inlet/cap structure shown in FIG. 9 to 15. In this figure, the narrow arrow with no numeral denotes or represents the action of filling the bag with the pharmaceutical product or liquid carried out in the second step (step b)) of the method of the present invention.
(20) FIG. 19 is a diagrammatic view of the third step (step c)) of the method for the aseptic filling of a bag with a pharmaceutical product or liquid of the present invention in which it can be seen that the cap has been newly inserted in the inlet of the bag and that said bag already contains the pharmaceutical product or liquid. This diagrammatic view may relate to any of the embodiments which will be explained in greater detail below and which are shown in the rest of the figures.
(21) FIG. 20 is a diagrammatic view of the fourth step (step d)) of the method for the aseptic filling of a bag with a pharmaceutical product or liquid of the present invention. This diagrammatic view may relate to any of the embodiments which will be explained in more detail below and are show in the rest of the figures.
(22) FIG. 21 is a cross section or transverse section of a view in detail of the inlet/cap structure seen in the first and third steps of the method of the present invention (steps a) and c)). Said inlet/cap structure is according to the first embodiment, that is, according to the inlet/cap structure shown in FIG. 2 to 8.
(23) FIG. 22 is a cross section or transverse section of a view in detail of the inlet/cap structure seen in the fourth step of the method of the present invention (step d)). Said inlet/cap structure is according to the first embodiment, that is, according to the inlet/cap structure shown in FIG. 2 to 8.
(24) FIG. 23 is a cross section or transverse section of a view in detail of the inlet/cap structure seen in the first and third steps of the method of the present invention (steps a) and c)). Said inlet/cap structure is according to the second embodiment, that is, according to the inlet/cap structure shown in FIG. 9 to 15.
(25) FIG. 24 is a cross section or transverse section of a view in detail of the inlet/cap structure seen in the fourth step of the method of the present invention (step d)). Said inlet/cap structure is according to the second embodiment, that is, according to the inlet/cap structure shown in FIG. 9 to 15.
(26) FIG. 1, as explained earlier, is a perspective view of a bag with the inlet/cap structure of the present invention which may correspond to any of the embodiments which will be explained in more detail below and which appear in rest of the figures. Said FIG. 1 shows a bag -1- for use in the method of the present invention. Said bag -1- comprises an inlet/cap structure -2- formed by a cap -3- and an inlet -4-. Specifically, FIG. 1 shows an embodiment in which said cap -3- is inserted or fixed in said inlet -4- producing a hermetic closure and thus would or could correspond to the first step (step a)) of the method of the present invention.
(27) With regard to the inlet/cap structure -2- shown in said FIG. 1, the two most preferred embodiments thereof are explained below, which are differentiated by the conjunction between the lower surface of the flange -5- of the cap -3- and the upper surface of the flange -6- of the inlet -4-.
(28) In the first of said embodiments, which is shown in FIG. 2 to 8, the conjunction between the inlet -4- and the cap -3- is produced by means of a crown -7- present on the flange -5- of said cap -3- and a recess -8- present on the flange -6- of said inlet -4-.
(29) The inlet/cap structure present on the bag -1- and shown in FIG. 1 can be seen in detail in FIG. 2, according to the first embodiment of said inlet/cap structure. In this case, the cap -3- has been represented separated from the inlet -4-, so that the structure of the contact surfaces of the flanges -5- and -6- can be seen. As can be seen, the cap -3- has an actuation key -9- in the upper portion thereof which normally has a weakened zone in the contact thereof with the rest of the cap structure and, thus, can be removed or actuated by the user by a mechanical action (rotation thereof, for example) when the bag is to be used. Contiguous with said key -9-, the cap -3- comprises an oval-shaped flange -5- which extends in a crown -7- of smaller diameter, which is also oval, (that is, with a continuous projection on the lower surface thereof which runs round said lower surface at the periphery thereof describing the same oval shape as the flange -5-). The flange -5- has a distal cylindrical extension -12- which in turn has a membrane -11- at the end thereof.
(30) The inlet -4- in turn has an oval-shaped flange -6- which has an upper surface with a continuous recess -8- which runs round the periphery thereof describing the same oval shape as the flange -6-. There may be additional structures in said upper surface of the flange -6-, for example the two semi-elliptical recesses that can be seen in FIG. 2. Said additional structures respond to various design needs, for example, to save and optimise material. Finally, the channel -10- of the inlet -4- can be seen in the centre of the flange -6-.
(31) FIGS. 3 and 4 show the cap -3- and the inlet -4-, respectively, in detail. The structural details that can be seen or distinguished in said figures are the same as can be seen in FIG. 2. Thus the cap -3- in FIG. 3 has an actuation key -9- in the upper portion thereof which normally can be removed or actuated by the user by mechanical action (rotation, for example) when the bag is to be used. Contiguous with said key -9-, the cap -3- comprises an oval-shaped flange -5- which extends in a crown -7- of smaller diameter and also oval (that is, the lower surface thereof has a continuous projection which runs round said lower surface at the periphery thereof describing the same oval shape as the flange -5-). The flange -5- has a distal cylindrical extension -12- which in turn has a membrane -11- at the end thereof. In FIG. 4, the inlet -4- has an oval-shaped flange -6- which has an upper surface with a continuous recess -8- which runs round said upper surface at the periphery thereof describing the same oval shape as the flange -6-. There may be additional structures on said upper surface of the flange -6-, such as the two semi-elliptical recesses that can be seen in FIG. 4 (positioned between the recess -8- and the channel -10-). Said additional structures respond to various design needs, for example, to save or optimise materials. Finally, the channel -10- of the inlet -4- can be seen in the centre of the flange -6-.
(32) FIG. 5 shows an alternative embodiment of the inlet -4- of FIG. 4, in which the upper surface of the flange -6- does not have the two semi-elliptical recesses but instead said upper surface is completely conjoined with the lower surface of the flange -5- shown in FIGS. 2 and 3 for the cap -3-. As in FIG. 4, the inlet -4- has a continuous recess -8- on the upper surface of the oval flange -6- which runs round said upper surface at the periphery thereof describing the same oval shape as the flange -6-; and the channel -10- of said inlet can be seen in the centre of the flange -6-.
(33) The cross section or central transverse section of the cap -3- shown in FIG. 3 can be seen in FIG. 6. It can be seen in this FIG. 6 that said cap comprises a central cylindrical zone formed by the channel -14- inside the distal cylindrical extension -12- which allows the hermetic closure to be produced between the inlet and the cap. In the upper portion of said cylindrical structure the actuation key -9- is positioned which can be removed by the user by mechanical action (rotation thereof, for example) as mentioned earlier. Said key -9- is connected to said distal cylindrical extension -12- by means of a weakened zone -15-, that is, a zone where the amount of material in the wall is less and therefore allows easy rotation thereof. As can be seen in FIG. 6, the channel -14- extends inside the key -9- but has a larger diameter. Below said key -9-, after said weakened zone -15-, the flange -5- is situated which extends in a crown -7- of smaller diameter and also oval. Finally, at the end of the distal cylindrical extension -12-, there is a membrane -11-.
(34) FIG. 7 shows a cross section or central transverse section of the inlet -4- shown in FIG. 4 and the same structures or details as in said FIG. 4 can therefore be seen. In FIG. 7 it can be seen that the flange -6- of the inlet -4- has on the upper surface thereof a continuous recess -8- which runs round said upper surface at the periphery thereof describing the same oval shape as the flange -6-. As mentioned for FIG. 4, there may be additional structures on said upper surface of the flange -6-, for example, the two recesses located between the recess -8- and the channel -10-. Said additional structures respond to various design needs, for example, saving or optimising materials. Finally, the channel -10- of the inlet -4- can be seen in the centre of the flange -6-.
(35) FIG. 8 shows a cross section or central transverse section of the inlet -4- shown in FIG. 5, that is, an alternative embodiment of the inlet compared with that shown in FIG. 7. As in the case of FIGS. 4 and 5, the only difference between FIGS. 7 and 8 is that the inlet -4- shown in FIG. 8 does not have the two recesses located between the channel -10 and the recess -8- on the flange -6-. The upper surface of the flange -6- shown in FIG. 8 is therefore completely conjoined with the lower surface of the flange -5- shown in FIG. 6.
(36) In the second of the embodiments mentioned above, which is shown in FIG. 9 to 15, the conjunction between the inlet -4- and the cap -3- is produced by means of a recess -16- present on the flange -5- of said cap -3- and a crown -17- present on the flange -6- of said inlet -4-.
(37) FIG. 9 shows in detail the inlet/cap structure present on the bag -1- and shown in FIG. 1, according to the second embodiment of said inlet/cap structure. In this case, the cap -3- has been represented separated from the inlet -4-, so as to show the structure of the contact surfaces of the flanges -5- and -6-. As can be seen, the cap -3- has an actuation key -9- in the upper portion thereof, which normally has a weakened zone in the contact thereof with the rest of the cap structure and can therefore be removed or actuated by the user by mechanical action (rotation thereof, for example) when the bag is to be used. Contiguous with said key -9-, the cap -3- comprises an oval-shaped flange -5- which has a lower surface with a continuous recess -16- which runs round said lower surface at the periphery thereof describing the same oval shape as the flange -5-. The flange -5- has a distal cylindrical extension -12- which in turn has a membrane -11- at the end thereof.
(38) The inlet -4- in turn has an oval-shaped flange -6- which extends in a crown -17- of smaller diameter but also oval (that is, on the upper surface thereof, the flange -6- of the inlet -4- has a continuous projection which runs round said upper surface at the periphery thereof describing the same oval shape as the flange -6-). On said upper surface of the flange -6- there may be additional structures, for example the two circular recesses that can be seen in FIG. 9 (located between the crown -17- and the channel -10-). Said additional structures respond to various design needs, for example saving or optimising materials. Finally, the channel -10- of the inlet -4- can be seen in the centre of the flange -6-.
(39) FIGS. 10 and 11 show the cap -3- and the inlet -4-, respectively, in detail. The structural details that can be seen or distinguished in said figures are the same as can be seen in FIG. 9. Thus, in FIG. 10 the cap -3- has an actuation key -9- in the upper portion thereof which can normally be removed or actuated by the user by mechanical action (for example, rotation) when the bag is to be used. Contiguous to said key -9-, the cap -3- comprises an oval-shaped flange -5- which has a continuous recess -16- on the lower surface thereof which runs round said lower surface at the periphery thereof describing the same oval shape as the flange -5-. The flange -5- has a distal cylindrical extension -12- which in turn has a membrane -11- at the end thereof. In FIG. 11, the inlet -4- has an oval-shaped flange -6- which extends in a crown -17- of smaller diameter but also oval (that is, flange -6- of the inlet -4- has a continuous projection on the upper surface thereof which runs round said upper surface at the periphery thereof describing the same oval shape as the flange -6-). There may be additional structures on said upper surface of the flange -6-, for example the two circular recesses that can be seen in FIG. 11 (located between the crown -17- and the channel -10-). Said additional structures meet various design needs, for example to save or optimise materials. Finally, the channel -10- of the inlet -4- can be seen in the centre of the flange -6-.
(40) FIG. 12 shows an alternative embodiment of the inlet -4- of FIG. 11 in which the upper surface of the flange -6- does not have the two circular recesses but instead said upper surface is completely conjoined to the lower surface of the flange -5- shown in FIGS. 9 and 10 for the cap -3-. As in the case of FIG. 11, the inlet -4- has on the upper surface of the oval flange -6- a crown -17- of smaller diameter but also oval (that is, the flange -6- of the inlet -4- on the upper surface thereof has a continuous projection which runs round said upper surface at the periphery thereof describing the same oval shape as the flange -6-); and the channel -10- of said inlet can be seen in the centre of the flange -6-.
(41) FIG. 13 shows a cross section or central transverse section of the cap -3- shown in FIG. 10. In FIG. 13, it can be seen that said cap comprises a central cylindrical zone formed by the channel -14- inside the distal cylindrical extension -12- which allows the hermetic closure to be produced between the inlet and the cap. The actuation key -9- is situated on the upper portion of said cylindrical structure which key can be removed by the user by mechanical action (rotation thereof, for example) as mentioned earlier. Said key -9- is connected to the above-mentioned distal cylindrical extension -12- by a weakened zone -15-, that is, a zone where the amount of material in the wall is less and therefore allows easy rotation thereof. As can be seen in FIG. 13, the channel -14- extends inside the key -9- but has a larger diameter. Below said key -9-, after said weakened zone -15-, the flange -5- is situated which has, on the lower surface thereof, the recess -16- (a continuous recess which runs round said lower surface at the periphery thereof describing the same oval shape as the flange -5-). Finally, there is a membrane -11- at the end of the distal cylindrical extension -12-.
(42) FIG. 14 is a cross section or central transverse section of the inlet -4- shown in FIG. 11 and the same structures or details can therefore be seen as in said FIG. 11. In FIG. 14 it can be seen that the flange -6- of the inlet -4- which extends on the upper surface thereof in a crown -17- of smaller diameter but also oval (that is the flange -6- of the inlet -4- has a continuous projection on the upper surface thereof which runs round said upper surface at the periphery thereof describing the same oval shape as the flange -6-). As mentioned earlier for FIG. 11, there may be additional structures on said upper surface of the flange -6-, for example, the two recesses located between the recess -8- and the channel -10-. Said additional structures meet various design needs, for example to save or optimise material. Finally, the channel -10- of the inlet -4- can be seen in the centre of the flange -6-.
(43) FIG. 15 shows a cross section or central transverse section of the inlet shown in FIG. 12, that is, an alternative embodiment of the inlet compared with the one shown in FIG. 14. As in the case of FIGS. 11 and 12, the only difference between FIGS. 14 and 15 is that the inlet -4- shown in FIG. 15 does not have on the flange -6- the two recesses located between the channel -10- and the crown -17-. The upper surface of the flange -6- shown in FIG. 15 is therefore completely conjoined to the lower surface of the flange -5- shown in FIG. 13.
(44) FIG. 16 to 20 show general views of the four steps of the method of the present invention for the two embodiments explained in FIG. 1 to 15.
(45) Specifically, FIG. 16 shows the first step (step a)) of the method for the aseptic filling of bags with pharmaceutical products or liquids of the present invention. In this figure the bag -1- with the inlet/cap structure -2- formed by a cap -3- and an inlet -4- can be seen. The wide black arrow with no numeral indicates the action of inserting the cap -3- in the inlet -4- to produce a reversible hermetic closure. In the embodiment shown in FIG. 16, said action or movement consists of a translation in the direction of the central axis of the channel of the inlet, which allows a reversible hermetic closure due to the grip produced between the distal cylindrical extension -12- of the cap -3- and the walls of the channel -10- of the inlet -4-. As explained earlier, the diagrammatic view in FIG. 16 may correspond to any of the embodiments described earlier and shown in FIG. 1 to 15.
(46) FIG. 17 shows the second step (step b)) of the method for the aseptic filling of bags with pharmaceutical products or liquids of the present invention for a bag with an inlet/cap structure according to the first embodiment, that is, the one shown in FIG. 2 to 8. FIG. 17 shows how the cap -3- is raised, separating it from the inlet -4- present in the bag -1-, that is, the hermetic closure produced in the first step (step a)) of the method of the present invention (the action denoted by the wide black arrow with no numeral) is opened. When the cap -3- is raised, in this figure, the distal cylindrical extension -12- not visible in FIG. 16 because it is inserted in the channel -10- of the inlet -4- can be seen. The crown -7- of the cap -3- can also be seen in this figure. In FIG. 17, the narrow arrow indicates the action of introducing the pharmaceutical product or liquid concerned into the bag -1-.
(47) FIG. 18 shows the second step (step b)) of the method for the aseptic filling of bags with pharmaceutical products or liquids of the present invention, but in this case for a bag with the inlet/cap structure according to the second embodiment, that is, the one shown in FIG. 9 to 15. FIG. 18 shows how the cap -3- is raised, separating it from the inlet -4- present in the bag -1-, that is, opening the hermetic closure produced in the first step (step a)) of the method of the present invention (the action denoted by the wide black arrow with no numeral) When the cap -3- is raised, the distal cylindrical extension -12-, which is not visible in FIG. 16 because it is inserted in the channel -10- of the inlet -4-, can be seen. This figure also shows the crown -17- of the inlet -4-. In FIG. 18 the narrow arrow indicates the action of introducing the pharmaceutical product or liquid concerned into the bag -1-.
(48) FIG. 19 shows the third step (step c)) of the method for the aseptic filling of bags with pharmaceutical products or liquids of the present invention. This figure shows that the bag -1- contains a given amount of the pharmaceutical product or liquid concerned (persons skilled in the art will understand that the amount of pharmaceutical product or liquid shown in FIG. 19 may vary widely without affecting the spirit of the present invention). Moreover, in this figure, the wide black arrow with no numeral indicates the action of inserting the cap -3- in the inlet -4- to produce a reversible hermetic closure. As explained earlier, the diagrammatic view of FIG. 19 may correspond to any of the embodiments described earlier and shown in FIG. 1 to 15.
(49) FIG. 20 shows the fourth step (step d)) of the method for the aseptic filling of bags with pharmaceutical products or liquids of the present invention. This figure shows a bag -1- in which the weld between the flange -5- of the cap -3- and the flange -6- of the inlet -4- has been carried out. This fact can be appreciated due to the smaller distance observed between said flanges compared with that observed when the reversible hermetic closure is produced in the first and third steps (steps a) and c)) of the method of the present invention. As explained earlier, the diagrammatic view of FIG. 20 may correspond to any of the embodiments described earlier and shown in FIG. 1 to 15.
(50) FIG. 21 shows a cross section or transverse section of a view in detail of the inlet/cap structure -2- seen in the first and third steps of the method of the present invention (steps a) and c)) for a bag with an inlet/cap structure according to the first embodiment, that is, the one shown in FIG. 2 to 8. This figure shows the inlet/cap structure -2- in the first closure position, that is, producing a reversible hermetic closure in which the distal cylindrical extension -12- of the cap -3- is inserted in the channel -10- of the inlet -4-. It also shows how the crown -7- of flange -5- of the cap -3- makes contact with the recess -8- of the flange -6- of the inlet -4- establishing a contact strip -13-. In this figure, the channel -14- of the cap -3-, of which the continuation with the channel -10- of the inlet -4- is interrupted by the presence of the membrane -11-, can also be seen. Finally, FIG. 21 also shows the actuation key -9- which can be removed by the user by mechanical action (for example, rotation thereof) when the bag is to be used. This figure shows how the reversible hermetic closure produced between the distal cylindrical extension -12- of the cap -3- and the channel -10- of the inlet -4- is positioned between the weld zone (contact strip -13-) and the contents of the bag, thus preventing or contributing to prevent any loose particles produced during the welding process from entering.
(51) FIG. 22 shows a cross section or transverse section of a view in detail of the inlet/cap structure -2- seen in the fourth step of the method of the present invention (step d)), that is, when the cap -3- and the inlet -4- have already been welded at the contact strip -13-, for a bag with the inlet/cap structure according to the first embodiment, that is, the one shown in FIG. 2 to 8. Said weld is observed by the enclosure or embedding of the crown -7- present on the flange -5- of the cap -3- in the peripheral recess -8- present on the flange -6- of the inlet -4-. The remaining structures that can be seen in this figure are those already explained for FIG. 21.
(52) The insertion or introduction of the distal cylindrical extension -12- of the cap -3- in the channel -10- of the inlet -4-, together with the fact that the weld is produced between the flanges, more preferably on the contact strip -13-, allows to ensure that the pharmaceutical product or liquid introduced into the bag -1- is not contaminated with particles produced or generated during welding.
(53) FIG. 23 shows a cross section or transverse section of a view in detail of the inlet/cap structure seen in the first and third steps of the method of the present invention (steps a) and c)) for a bag with the inlet/cap structure according to the second embodiment, that is, the one shown in FIG. 9 to 15. The inlet/cap structure -2- is seen in this figure in the first closure position, that is, producing a reversible hermetic closure in which the distal cylindrical extension -12- of the cap -3- is inserted in the channel -10- of the inlet -4-. Additionally, it also shows how the crown -17- of the flange -6- of the inlet -4- makes contact with the recess -16- of the flange -5- of the cap -3- establishing a contact strip -13-. This figure also shows the channel -14- of the cap -3-, of which the continuation with the channel -10- of the inlet -4- is interrupted by the presence of the membrane -11-. Finally, FIG. 23 also shows the actuation key -9- which can be removed by the user by mechanical action (rotation thereof, for example) when the bag is to be used. This figure shows how the reversible hermetic closure produced between the distal cylindrical extension -12- of the cap -3- and the channel -10- of the inlet -4- is positioned between the weld zone (contact strip -13-) and the contents of the bag, thus preventing or contributing to prevent any loose particles produced during the welding process from entering.
(54) FIG. 24 shows a cross section or transverse section of a view in detail of the inlet/cap structure -2- seen in the fourth step of the method of the present invention (step d)), that is, when the cap -3- and the inlet -4- have already been welded at the contact strip -13-, for a bag with the inlet/cap structure according to the second embodiment, that is, the one shown in FIG. 9 to 15. Said weld can be seen by the enclosure or embedding of the crown -17- present on the flange -6- of the inlet -4- in the peripheral recess -16- of the flange -5- of the cap -3-. The rest of the structures that can be seen in this figure are those already explained for FIG. 23.
(55) The insertion or introduction of the distal cylindrical extension -12- of the cap -3- in the channel -10- of the inlet -4-, together with the fact that the weld is produced between the flanges, more preferably at the contact strip -13- ensures that the pharmaceutical product or liquid introduced into the bag -1- is not contaminated with particles produced or generated during welding.
