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 bag with inlet/cap structure comprising: a cap with an oval cap flange extending laterally from the cap, and with a distal cylindrical extension that extends laterally from the cap and beyond the cap flange; a bag with an inlet, wherein the inlet comprises an inlet flange extending laterally from the inlet, and an inlet channel extending vertically through the inlet, wherein the distal cylindrical extension is inserted into the inlet channel, wherein the inlet channel forms a hermetic seal with the distal cylindrical extension when inserted therein; an upper surface on the inlet flange; a lower surface on the cap flange; a membrane at a distal end of the distal cylindrical extension; an annular continuous projection at or near a periphery of the cap flange or the inlet flange; and an annular continuous recess at or near the periphery of the cap flange when the inlet flange has the annular projection, or at or near the periphery of the inlet flange when the cap flange has the annular projection.
2. The inlet/cap structure according to claim 1, wherein the lower surface on the cap flange and the upper surface on the inlet flange are totally or partially conjoined.
3. The inlet/cap structure according to claim 1, wherein the annular continuous projection is on the lower surface of the cap flange, and the annular continuous recess is on the upper surface of the inlet flange.
4. The inlet/cap structure according to claim 1, wherein the annular continuous recess is on the lower surface of the cap flange, and the annular continuous projection is on the upper surface of the inlet flange.
5. The inlet/cap structure according to claim 1, further comprising the cap inserted in the inlet of the bag, and wherein the annular continuous projection and the annular continuous recess form a contact strip.
6. The inlet/cap structure according to claim 1, wherein the inlet flange and cap flange are of an equivalent shape and are of an equivalent or approximately equivalent size.
7. The inlet/cap structure according to claim 1, wherein the inlet flange and the cap flange are both oval in shape.
8. The inlet/cap structure according to claim 1, wherein the lower surface of the cap flange extends parallel to and is separated from the upper surface of the inlet flange.
9. The inlet/cap structure according to claim 1, wherein the lower surface of the cap flange extends parallel to and abuts against the upper surface of the inlet flange.
10. The inlet/cap structure according to claim 1, wherein the annular continuous projection fully encloses the annular continuous recess.
11. The inlet/cap structure of claim 1, further comprising a weld between the cap and the inlet, wherein said weld causes a reversible hermetic closure position to become an irreversible hermetic closure position.
12. The inlet/cap structure of claim 1, wherein the inlet/cap structure has a reversible hermetic closure position.
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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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) FIGS. 16 to 20 show general views of the four steps of the method of the present invention for the two embodiments explained in FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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 FIGS. 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.
