Method and apparatus for sterilizing or disinfecting containers particularly for the primary packaging of pharmaceuticals

Abstract

The invention relates to a method and an apparatus for sterilizing or disinfecting containers, wherein mini-autoclaves (4) are continuously recirculated, each one dedicated to a respective container (C) (or to a respective set of a few containers) in order to sterilize it or disinfect it. These mini-autoclaves (4) travel on a closed path (P1+P2), along which the mini- autoclaves (4) are separated into their two main components (vessel 2 and cover 3) solely in order to allow the sterilized / disinfected container (C) to be removed and a new container (C) to be sterilized / disinfected to be inserted, preferably with hot or superheated water injected into the mini-autoclaves (4).

Description

[0001] METHOD AND APPARATUS FOR STERILIZING OR DISINFECTING CONTAINERS PARTICULARLY FOR THE PRIMARY PACKAGING OF PHARMACEUTICALS

[0002] The present invention relates to a method and an apparatus for sterilizing or disinfecting (preferably for terminal sterilization) of containers, particularly for the primary packaging of pharmaceuticals. The containers can be vials, bottles, ampoules or syringes, and are preferably already filled with a relevant pharmaceutical.

[0003] In the discussion below, the term "sterilization" means the process that leads to the elimination or destruction of all forms of microbial life (pathogens and non-pathogens, including spores). The term "disinfection" on the other hand means the process that leads to the elimination of most pathogens, reducing their number to safe levels for humans.

[0004] For the sterilization of containers of pharmaceuticals such as vials, ampoules, bottles and syringes, the use is known of autoclave-type heat treatment machines. A certain number of containers is placed in a plurality of trays or racks which are then inserted in the autoclave, where the desired treatment cycle is executed. One or more of these trays or racks can be inserted in the autoclave.

[0005] Such autoclaves can be quite deep, for example a few meters.

[0006] A first disadvantage of conventional sterilization apparatuses is the need to manually move the trays or racks, essentially by operators sliding them out and lifting them directly.

[0007] A further drawback is the footprint taken up by the abovementioned length of the autoclave, which requires the setting-up, in the areas adjacent to the entry / exit opening of the autoclave, of sliders for receiving and guiding the trays (or the racks) of corresponding, i.e. considerable, dimensions.

[0008] The aim of the present invention is to provide a method and an apparatus for sterilizing or disinfecting containers, particularly forpharmaceuticals, that are capable of improving the prior art in one or more of the above mentioned aspects.

[0009] Within this aim, an object of the invention is to provide a method and an apparatus for sterilizing or disinfecting that can be used in a production line of containers for pharmaceuticals or the like, such as vials, bottles, ampoules and syringes, for example for the terminal sterilization of sealed containers containing a pharmaceutical. In particular, an object of the invention is to provide a method and an apparatus for continuous sterilization or disinfection, that can operate at the production speed of a primary packaging line for pharmaceuticals.

[0010] Another object of the invention is to avoid manipulation (automatic or manual) of trays or racks for conventional autoclaves and sliders for receiving and / or guiding of such trays and racks.

[0011] Another object of the invention is to make it possible to ascertain the reliability of the sterilization or disinfection.

[0012] Furthermore, the present invention sets out to overcome the drawbacks of the background art in a manner that is alternative to any existing solutions.

[0013] Another object of the invention is to provide a method and an apparatus that are highly reliable, relatively easily implemented, and low cost.

[0014] This aim and these and other objects which will become more apparent hereinafter are achieved by a method according to claim 1, optionally provided with one or more of the characteristics of the dependent claims.

[0015] The aim and objects of the invention are likewise achieved by an apparatus according to claim 10, optionally provided with one or more of the characteristics of the dependent claims.

[0016] Further characteristics and advantages of the invention will become more apparent from the description of preferred, but not exclusive,embodiments of the invention, illustrated by way of non-limiting example in the accompanying drawings wherein:

[0017] - Figure 1 is a schematic plan view from above of an apparatus according to the invention with the conveyance paths highlighted;

[0018] - Figure 2 corresponds to Figure 1 with the paths of covers and vessels highlighted;

[0019] - Figure 3 is a unitary assembly (or mini-autoclave) used in the invention;

[0020] - Figure 4 is a cross-sectional view of the unitary assembly of the previous figure, during the step of creating the vacuum;

[0021] - Figure 5 shows the unitary assembly of Figure 3 during filling with hot or superheated water;

[0022] - Figure 6 shows the unitary assembly of the previous figure at the end of filling;

[0023] - Figure 7 shows the unitary assembly of the previous figure during drainage of the water;

[0024] - Figure 8 is a partial view of an embodiment of the carousels and star conveyors of the apparatus of Figure 1;

[0025] - Figure 9 is a detail view of the coupling carousel of the previous figure;

[0026] - Figure 10 is a detail view of the coupling carousel of Figure 8, at the angular portion where the container is received;

[0027] - Figure 11 is a detail view of the gripping members of the coupling carousel of Figure 9.

[0028] With reference to the figures, the apparatus for sterilizing or disinfecting according to a preferred embodiment of the invention is generally designated by the reference numeral 1. The apparatus 1 is particularly suitable for the sterilization (preferably terminal sterilization) or disinfection of containers such as vials, bottles, ampoules or syringes, for the primary packaging of pharmaceuticals and the like (for example, of humanbiological samples or of liquids for preservation or analysis of biological samples).

[0029] In the example shown in the drawings, the containers C to be sterilized or disinfected are vials and are preferably sealed and contain a pharmaceutical (for example, a vaccine). Such containers C originate from a primary packaging production line and are supplied, preferably continuously and one after another, at an entrance 1 a of the apparatus 1.

[0030] The apparatus 1 also comprises an exit lb for the containers C that have undergone sterilization or disinfection in the apparatus 1.

[0031] The apparatus 1 also comprises a plurality of vessels 2 and a plurality of corresponding covers 3 which, preferably, recirculate in the apparatus 1, along respective conveyance paths Pl and P2 which (at least partially) overlap with each other in the apparatus 1. The transport of the vessels 2 and of the covers 3 along the paths Pl and P2 occurs in phase, so that the covers 3 are always overlaid on the respective vessels 2 along a substantially vertical direction while they are being transported along the respective paths Pl and P2. The term "vertical direction" means a direction perpendicular to a resting plane of the apparatus 1 on the floor.

[0032] Each of the vessels 2 is configured to contain a single respective container C and can, therefore, have reduced dimensions (for example dimensions of the order of about ten centimeters in height, width and depth), i.e. considerably smaller than the dimensions of the trays or racks used in conventional sterilization autoclaves.

[0033] The vessels 2 are substantially beaker-shaped, i.e. substantially cylindrical with closed side walls 23 that surround an inner concavity, a lower supporting base 20 and an upper mouth 21 which is open.

[0034] The supporting base 20 is preferably closed with a non-return valve 52, as will be seen.

[0035] Inside the vessel 2 is a support 22 configured to support (and preferably retain) just one respective container C, for example a single vialas in the drawings. The container C is preferably kept, by the support 22, spaced apart from all the internal walls of the vessel 2.

[0036] In the preferred embodiments of the invention, each one of the vessels 2 of the apparatus 1 is configured to contain just one respective container C, i.e. not more than one container C.

[0037] In other embodiments, the vessels 2 and the internal supports 22 can be configured to contain a group of containers C, but still in the order of a few units (for example, no more than three), so as not to require excessive dimensions for the vessel 2, which could compromise the dimensional advantages of the invention with respect to conventional autoclave solutions.

[0038] The footprint of the vessels 2 in the diametric (i.e., horizontal) direction is preferably less than 15-20 centimeters and the maximum number of containers C that can be inserted mutually spaced apart inside the vessel 2 can be defined as a consequence, on the basis of the dimension of the individual container C or the capacity of the support 22. The discussion below will be limited to a description of the embodiment wherein the vessels 2 are configured to contain a single container C each.

[0039] Advantageously, the vessel 2 and / or the material of which it is made is thermally insulating, for example it has a thermal conductivity lower than 1.5 W / m / K at atmospheric pressure (1 atm) and at ambient temperature (20°C). Materials that are suitable for providing thermal insulation could be polystyrene, polyurethane, ceramic, Teflon, glass, fiberglass, cellular glass.

[0040] Furthermore, the entire vessel 2 is preferably free from metal parts. The supporting base 20 of each vessel 2 can comprise a passage opening 24 which can be open / closed by a lower valve 52 which is fixed to the base 20 at such passage opening 24.

[0041] The lower valve 52 is advantageously a non-retum valve, for example of the type comprising a sealing body 522 (ball-shaped or mushroomshaped) elastically pressed by a spring 523 against a passage port 524 in order to close it and prevent the fluid communication of the opening 24 withthe outside of the vessel 2. On the opposite side with respect to the sealing body 522, the port 524 of the valve 52 is passed through by a portion of a button 521 for forcing the distancing of the sealing body 522 from the port 524 against the action of the spring 523 and as a consequence opening the lower valve 52. The button 521 can be accessed from outside the vessel 2 and, to this end, it can protrude partially from a corresponding guide body 525 fixed to the lower valve 52. The transverse cross-section of the button 521 is such as to leave gaps for fluid to pass around the button 521, both through the port 524 and through the guide body 525. In the example shown, the shape of the button 521 is substantially prismatic, while the channel of the guide body within which the button 521 slides is cylindrical, with a circular cross-section.

[0042] Each one of the covers 3 is configured to be coupled in a fluid-tight or, more preferably, gas-tight manner with the mouth 21 of a respective vessel 2 and so form a unitary assembly 4. Either or both of the cover 3 and the respective vessel 2 can comprise, to this end, an annular gasket 21a which, in the example shown in the drawings, is a gasket suitable to effect an axial seal and is supported by the mouth 21 of the vessel 2 so as to be sandwiched between the cover 3 and the vessel 2.

[0043] The cover 3 can advantageously be shaped like an upside-down beaker, i.e. substantially cylindrical, with closed side walls 33 that surround an inner concavity, with an upper base wall 30 and with a lower mouth 31. The lower mouth 31 is the portion of the cover 3 that is configured to be coupled fluid-tightly or gas-tightly with the mouth 21 of the vessel 2.

[0044] The upper base wall 30 of each container 3 comprises preferably a passage opening 34 which can be opened / closed by an upper valve 53 which is fixed to the upper base wall 30 at such passage opening 34.

[0045] The upper valve 53 is also advantageously a non-return valve, for example identical to the lower valve 52. In particular, the upper valve 53 comprises a sealing body 532 (ball-shaped or mushroom-shaped) which iselastically pressed by a spring 533 against a passage port 534 in order to close it and prevent the fluid communication of the opening 34 with the outside of the container 3. On the opposite side with respect to the sealing body 532, the port 534 of the upper valve 53 is passed through by a portion of a button 531 for forcing the distancing of the sealing body 532 from the port 534 against the action of the spring 533 and as a consequence opening the valve 53. The button 531 can be accessed from outside the cover 3 and, to this end, it can protrude partially from a corresponding guide body 535 fixed to the valve 53. The transverse cross-section of the button 531 is such as to leave gaps for fluid to pass around the button 531, both through the port 534 and through the guide body 535. In the example shown, the shape of the button 531 is substantially prismatic, while the channel of the guide body 535 within which the button 531 slides is cylindrical, with a circular cross-section.

[0046] To (temporarily) secure the cover 3 and the vessel 2 to each other and so obtain the unitary assembly 4, fixing means are provided which, in the preferred embodiment illustrated in the drawings, can be implemented with one or more claws 36 mounted on the cover 3 and configured to hook onto a corresponding undercut 25 in the vessel 2, for example provided on its side wall 23 in the region around the mouth 21. Each cover 3 is temporarily fixed to a respective vessel 2 along a segment where the first and second conveyance paths Pl, P2 overlap.

[0047] The claws 36 can belong to a grapple 35 formed by a plurality of said claws 36 which can be moved mutually closer and apart with respect to a central axis A of the cover 3 and of the unitary assembly 4.

[0048] The claws 36 are pivoted on the side wall 33 of the cover 3 and are elastically pressed into the nearer position by elastic means, such as the three helical springs illustrated above the base wall 30. The elastic means apply an elastic force against a command slider parallel to the upper base wall 30 and movable coaxially to the central axis A of the cover 3. Each claw 36 ispivoted to a respective linkage, which is in turn pivoted on a respective hinge eyelet of the command slider.

[0049] In other embodiments, not shown, the fixing means can provide the constraint between the vessel 2 and the cover 3 using other snap-acting coupling means, or by interference fit, or by friction (for example, with a threaded coupling).

[0050] The unitary assembly 4 obtained with the temporary fixing has an internal chamber 5 defined between the cover 3 and the vessel 2, which is preferably thermally insulated, for example by virtue of the structural characteristics and / or materials of the cover 3 and of the vessel 2. In particular, the internal chamber 5 is defined by the inner concavity of the cover 3 and by the inner concavity of the vessel 2, which face each other.

[0051] In the preferred embodiment described herein, both of the conveyance paths Pl and P2 of the vessels 2 and of the covers 3 are closed paths, i.e. the vessels 2 and the covers 3 continue recirculating in the apparatus 1, while remaining axially separate along a portion of the paths and rigidly coupled in the remaining portion in order to form the unitary assemblies 4. However, in other embodiments of the invention, the first conveyance path Pl of the vessels 2 can be open at the entrance la and at the exit lb, i.e. the containers C are fed to the entrance la and leave by the exit lb while they remain in the respective vessels 2. In this case, the vessels 2 can also perform the function of transport puck for the containers C outside of the apparatus 1, i.e. in the rest of the production or packaging line.

[0052] In any case, the apparatus 1 comprises a coupling station 101 which is configured to couple each cover 3 to a corresponding vessel 2 in order to temporarily fix them using the fixing means 35, and so form the unitary assembly 4. The coupling station 101 is positioned along the overlapping segment of the conveyance paths Pl and P2.

[0053] Preferably, the coupling station 101 is a carousel 110 which rotates continuously about a central axis 111 thereof. The central axis 111 isoriented vertically.

[0054] The coupling carousel 110 is provided with a plurality of gripping members 112-113 which rotate together with the carousel 110 about the central axis 111 and which are mutually angularly equidistant about that axis 111. In particular, for each angular position about the axis 111 of the carousel, the gripping members can comprise a recess 112 which is configured to accommodate a vessel 2 and, in a coaxially higher position with respect to the recess 112, they can comprise upper grippers 113 which are configured to grip a cover 3 and to move it substantially parallel to the axis of rotation 111 in order to bring it to the vessel 2 held in the recess 112.

[0055] The coupling carousel 110 also comprises an annular support base 118, which can rotate together with the carousel 110 about the central axis 111 and comprises optional venting holes 119 which are associated with respective recesses 112 and are suitable to allow the venting of air contained in the internal chambers 5 through the lower valves 52, if necessary.

[0056] At the coupling station 101, as in the embodiment shown, or immediately downstream of the station 101, the apparatus 1 comprises an injection system 115 which is positioned at or downstream of the coupling station (101) and is configured to inject, through injection means, a sterilizing or disinfecting substance into the internal chamber 5 of each one of the unitary assemblies 4 that pass through the coupling station 101. Only one of these injection means is shown in the drawings, for the sake of simplicity.

[0057] In the preferred embodiments of the invention, the sterilizing or disinfecting substance is, or comprises, water, conveniently heated to a temperature of at least 80°C, for example above 90°C. Preferably, said substance is pressurized hot water, and in particular is superheated water. Superheated water can be obtained by heating water under pressure in the apparatus 1 so as to bring it to a temperature above its boiling point (therefore above 100°C), preferably a temperature of at least 120°C, forexample 130°C, prior to being injected, optionally together with steam, by the injection system 115.

[0058] The hot or superheated water thus obtained can be injected (in particular, in the mixed water / steam state) through the injection system 115 into the internal chamber 5 of the unitary assemblies 4, by opening the upper valve 53 (while the lower valve 52 remains closed).

[0059] In an alternative embodiment, not shown, the injection means are arranged below the support ring 118 and the hot or superheated water is injected through the lower valve 52, keeping the upper valve 53 closed.

[0060] In other embodiments, not shown, the sterilizing or disinfecting substance can be saturated steam or hot humid air.

[0061] Returning to the embodiment in the figures, once the predefined quantity of hot or superheated water is injected into the internal chamber 5, the upper valve 53 is closed, so as to prevent steam from escaping the internal chamber and maintain the hot or superheated water within the chamber 5, preferably at a pressure above atmospheric pressure. The unitary assembly 4 is thus a mini-autoclave.

[0062] The walls 20, 23, 30, 33 of the internal chamber 5, conveniently insulated or made of thermally insulating material, are configured to maintain this temperature at least for a predefined time calculated to sterilize (or at least to disinfect) the container C and, preferably, also its contents (so achieving a terminal sterilization).

[0063] The injection system 115 can comprise a plurality of filling taps 116, evenly spaced around the axis of rotation 111 of the coupling carousel 110 and rotatable together with the carousel 110 so as to be coupled to respective unitary assemblies 4 through the upper non-retum valve 53. In particular, each filling tap 116 is arranged coaxially above a respective grip means 112-113 and advantageously comprises an abutment surface (not shown) for pressing the button 531 of the upper valve 53 in order to open it, before supplying the hot or superheated water.The taps are also axially mobile in a direction parallel to the axis of rotation 111 of the carousel 110. In particular, the coupling station 101 comprises fixed cams 117b which surround the axis of rotation 111 and against which respective cam-followers of the taps 116 are kept engaged (for example, by a spring). Similar fixed cams 117a are preferably also provided, in order to allow the axial movement of the upper grippers 113, again parallel to the axis of rotation 111 of the carousel 110.

[0064] Optionally, the taps 116 can also be connected to a vacuum generator in order to be capable of emptying the internal chamber 5 of the air contained in it, as shown in Figure 4. Preferably, air is extracted from the internal chamber 5 of each unitary assembly prior to injection of the sterilizing or disinfecting substance, such as the hot or superheated water.

[0065] To feed the hot or superheated water, the filling taps 116 are in fluid connection with a pressurized plumbing circuit which is connected to the exit of a boiler.

[0066] Downstream of the coupling station 101, with respect to the conveyance direction of the paths Pl and P2, is a holding system 140 configured to maintain the internal chambers 5 of the unitary assemblies 4 filled with the above mentioned sterilizing or disinfecting substance for a predefined time sufficient to sterilize (or at least disinfect) the containers C contained in the internal chambers 5.

[0067] These means for maintaining the sterilizing or disinfecting substance inside the internal chambers 5 can be implemented using a FIFO (First In, First Out) buffer station, in which the unitary assemblies 4 are kept for the above mentioned predefined time or for at least a (major) portion of such predefined time. This buffer station can be provided by way of a special "lengthened" conveyance path of the unitary assemblies 4, which therefore are not directly fed to the subsequent station after the filling step.

[0068] As an alternative or in addition to the buffer station, a microwave oven (or tunnel) can be used, which is configured to heat the water contained inthe internal chambers 5 or keep it at the set temperature, and advantageously to perform a terminal sterilization of the respective container C, so reducing the time necessary for the sterilization.

[0069] Downstream of the holding system 140, the apparatus 1 comprises a draining station 102 configured to remove the sterilizing or disinfecting substance from each one of the unitary assemblies 4, in particular after sterilization or disinfection is complete. In particular, the water and the steam kept thermally insulated by the unitary assembly 4 inside the chamber 5 and / or by the microwave oven are drained outward, preferably through the passage opening 24 and the lower valve 52.

[0070] The draining station 102 comprises a draining carousel 120 which can rotate continuously about its central rotation axis 121, which is parallel to the axis 111.

[0071] The draining carousel 120 is optionally provided with a plurality of cooling taps 125, which are integral in rotation with the carousel. The taps 125 are evenly spaced around the axis of rotation 121 of the draining carousel 120 so that each one can be coupled with a respective unitary assembly 4 through the upper non-retum valve 53.

[0072] The cooling taps 125 are connected to a cold water supply circuit (not shown), for example water at a temperature of less than 20°C.

[0073] The cooling taps 125 are preferably vertically movable toward or away from an annular support base 128 which is integral in rotation with the carousel 120 about the axis 121 and which is configured to support the unitary assemblies 4 from below while they rotate about the axis 121.

[0074] The draining carousel 120 also comprises a plurality of gripping members which rotate together with the draining carousel 120 about the central axis 121 and which are evenly spaced around that axis 121. In particular, for each angular position about the axis 121 of the carousel, the gripping members can comprise a recess 122 which is configured to accommodate a respective unitary assembly 4 from those arriving from theholding system 140.

[0075] In the supporting base 128 there is, for each recess 122, a drain hole 129. Each drain hole 129 is positioned so as to be in fluid connection with, on one side, the passage opening 24 of the unitary assembly 4 entrained by the corresponding recess 122 and with its lower valve 52. On the other side, the drain hole 129 is in communication with a plumbing recirculation circuit (not shown). The plumbing recirculation circuit is configured to direct at least a portion of the water drained from the unitary assemblies 4 (through the drain holes 129) toward means for purifying and / or filtering that water and to deliver it to the abovementioned boiler, so as to be able to re-inject this water at the coupling station 101 into the unitary assemblies 4 containing new containers C.

[0076] At each drain hole 129, the draining carousel 120 comprises means of opening the lower valve 52, for example an electrically-actuated presser configured to engage the protruding portion of the button 521.

[0077] The hot or superheated water originally contained in the unitary assemblies 4 will thus be drained out while the unitary assemblies 4 transported by the draining station 102 will rotate together with the draining carousel 120 about the central axis 121.

[0078] Preferably, however, in the draining carousel 120 the containers C will also be cooled by injecting cold water into the respective unitary assemblies 4 through the cooling taps 125. The cold water can be injected while keeping the lower valve 52 closed (at least for an initial period of time), or it can be opened at the same time as the cold water is injected. In the latter case, the injection of the cold water could be carried out to drain the sterilizing or disinfecting substance (such as the hot or superheated water described above) from each unitary assembly 4, by opening the valves in both the vessel 2 and the cover 3 and injecting the cold water through one of such valves into the internal chamber 5 to displace the sterilizing or disinfecting substance through the other valve.The lower valve 52 can in any case be closed after a certain time during the rotation of the draining carousel 102, so as to keep the cooling water in the internal chamber 5 of the unitary assemblies 4 that exit from the draining station 102, and so continue the cooling of the containers C inside the unitary assemblies 4.

[0079] The draining station 102 can optionally also comprise means for measuring the temperature of the water and / or steam discharged from each unitary assembly 4 as soon as the lower valve 52 is opened. For example, there can be a temperature sensor (not shown) at each of the discharge holes 129 in the draining carousel 120.

[0080] The apparatus 1, furthermore, advantageously comprises a control system which is configured to compare, with a predefined threshold, the difference between the measured discharge temperature and the injection temperature, i.e. between the temperature of the drained water / steam (measured at the draining station 102 by the measurement means) and the temperature of the water / steam injected at the coupling station 101.

[0081] In this manner, the control system can determine whether the container C has been correctly sterilized (or at least disinfected) on the basis of the comparison of said difference with said predefined threshold, i.e. the control system can determine whether the sterilization or disinfection was successful based on whether a predefined temperature difference threshold is exceeded. If the difference is greater than the threshold, then the temperature of the water / steam contained in the internal chamber 5 has dropped excessively during the transport from the coupling station 101 to the draining station 102 and, therefore, the sterilization or disinfection will be deemed not to have been executed effectively.

[0082] Advantageously, all the vessels 2 comprise an identification code affixed thereto which can be read, i.e. scanned, optically or electromagnetically (for example, with an optical scanner) so as to be able to uniquely identify each vessel 2 along the first conveyance path Pl andrecognize it as possibly containing a container C that has not been correctly sterilized or disinfected, by means of the above mentioned control system to which the scanned data is transmitted. As an alternative or in addition, the cover 3 can have an identification code affixed thereto.

[0083] If the difference in temperature detected by the control system is greater than the above predefined threshold, then the control system is configured to identify, with the reading of the code done, for example, upstream of the exit lb, the vessel 2 and / or the cover 3 of the "defective" unitary assembly 4 and then perform one of the following operations:

[0084] - removing the vessel and / or cover identified as defective from the respective conveyance path P1 / P2;

[0085] - retaining the vessel 2 and / or cover 3 identified as defective on the respective conveyance path P1 / P2 while preventing the insertion of a new container C or group of containers C to be sterilized or disinfected in that vessel 2 at the coupling station 101;

[0086] - retaining the vessel 2 and / or cover 3 identified as defective on the respective conveyance path P1 / P2 for a certain number of operating cycles and, if the control system again finds a value above the temperature difference threshold, prevent the insertion of a new container C or group of containers C to be sterilized or disinfected in that vessel 2 at the coupling station 101.

[0087] The container C or the group of containers C contained within the affected unitary assembly 4 (i.e. the unitary assembly found to be defective) will in any case be discarded after the exit lb.

[0088] The apparatus 1 also comprises a decoupling station 103 positioned downstream of the draining station 102, and configured to drain any water still contained in the chambers 5 of the unitary assemblies 4 and in any case to disassemble the unitary assemblies 4, by separating the covers 3 from the respective vessels 2.

[0089] The decoupling station 103 and the draining station 102 can beintegrated in a single station, for example in a single carousel. However, in the preferred embodiments of the invention, the stations 103 and 102 are separate stations.

[0090] The decoupling station 103 comprises a decoupling carousel 130 which can rotate continuously about a central axis 131 thereof and which also comprises a plurality of gripping members which rotate together with the decoupling carousel 130 about the central axis 131. These gripping members are similar to the members of the coupling carousel 110 and therefore will not be described.

[0091] The decoupling carousel 130 also comprises an annular base 138 for resting the vessels 2 of the unitary assemblies 4, along which there can be outflow holes 139 for the remaining water contained in the unitary assemblies 4. These outflow holes 139 are configured to be coupled with the lower valves 52 of the unitary assemblies 4 and can be in fluid connection with the recirculation circuit mentioned above.

[0092] The apparatus 1 also comprises transfer starwheels 201, 202, 203 and 204 for transferring the unitary assemblies 4 (coupled or axially separated) from one carousel to another and between the group of carousels 110-120-130 and the holding system 140, as shown in Figure 1.

[0093] One of these transfer starwheels is positioned downstream of the decoupling carousel 130 adjacent to the coupling carousel 110, and is an interface starwheel 203, which can rotate continuously about its own axis and which connects the decoupling carousel 130 with the coupling carousel 110. The entrance la and the exit lb of the apparatus 1 are arranged at the interface starwheel 203. With such functional connection with the coupling station 101, the decoupling station 103 can return at least the covers 3, and preferably also the vessels 2, to the coupling station 101.

[0094] The interface starwheel 203 is configured to transport, along the respective paths Pl and P2, the vessels 2 and the covers 3 (previously decoupled by the station 103), keeping them axially separate, in order toallow the containers C inside the vessel to be removed at the exit lb and new containers C to be inserted at the entrance 1 a.

[0095] At the entrance la and at the exit lb of the apparatus there can be further star conveyors for supplying and removing containers C, respectively, or linear conveyors.

[0096] The operation of the invention is evident from the foregoing description.

[0097] Basically, the invention continuously recirculates dedicated miniautoclaves, each one dedicated to a respective container C (or to a respective set of a few containers) in order to sterilize it or disinfect it. These miniautoclaves travel along a closed path formed by the conveyance paths Pl and P2, which comprises arcuate segments defined by the rotation of the gripping members of the various carousels 110, 120, 130 and star conveyors 201-204 about the respective central rotation axes. Along this closed path, the mini-autoclaves are separated into their two main components (vessel 2 and cover 3) solely in order to allow the sterilized / disinfected container C to be removed and a new container C, to be sterilized / disinfected, to be inserted.

[0098] The invention, thus conceived, is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims. Moreover, all the details may be substituted by other, technically equivalent elements.

[0099] In practice, the materials used, as well as the contingent shapes and dimensions, may be any according to the requirements and to the state of the art.

[0100] The disclosures in Italian Patent Application No. 102025000001875 from which this application claims priority are incorporated herein by reference.

[0101] Where technical features mentioned in any claim are followed by reference signs, such reference signs have been inserted for the sole purposeof increasing the intelligibility of the claims and accordingly such reference signs do not have any limiting effect on the interpretation of each element identified by way of example by such reference signs.

Claims

CLAIMS1. A method for sterilizing or disinfecting containers (C), particularly containers used for primary packaging of pharmaceuticals, the method comprising:- inserting each container, or a set of containers (C), into a respective vessel (2);- conveying said vessels (2) along a first conveyance path (Pl);- conveying a plurality of covers (3) along a second conveyance path (P2), said first and second conveyance paths (Pl, P2) being partially overlapping;- temporarily fixing each cover (3) to a respective vessel (2) along a segment where said first and second conveyance paths (Pl, P2) overlap, to form a unitary assembly (4) having a closed internal chamber (5) defined between said cover and said vessel;- injecting a sterilizing or disinfecting substance into said internal chamber (5) of each unitary assembly (4);- maintaining the internal chambers (5) of said unitary assemblies with said sterilizing or disinfecting substance for a time sufficient to sterilize or disinfect the containers within the internal chambers;- draining the sterilizing or disinfecting substance from each unitary assembly (4) after sterilization or disinfection is complete; and- separating said covers (3) from said vessels (2) of the unitary assemblies.

2. The method according to claim 1, wherein said sterilizing or disinfecting substance comprises hot water at a temperature of at least 80°C or superheated water, and wherein, during said step of maintaining said internal chambers filled, steam is prevented from escaping the internal chamber, preferably so as to maintain a pressure above atmospheric pressure within said chamber.

3. The method according to the preceding claim, wherein said internalchamber is thermally insulated, and wherein at least one of said cover and said vessel comprises a non-retum valve (52, 53), which is preferably configured to maintain the pressure within the internal chamber (5) above atmospheric pressure.

4. The method according to one or more of the preceding claims, further comprising, prior to said step of injecting the sterilizing or disinfecting substance, extracting air from said internal chamber of each unitary assembly.

5. The method according to one or more of the preceding claims, wherein said time for which the internal chambers remain filled with the sterilizing or disinfecting substance corresponds to the time said unitary assemblies spend within a buffer region of said overlapping conveyance paths, or inside a micro wave oven arranged along said overlapping paths.

6. The method according to one or more of the preceding claims, wherein at least one of said first conveyance path (Pl) and said second conveyance path (P2) is a closed path along which said vessels (2) and said covers (3), respectively, are continuously recirculated.

7. The method according to one or more of claims 2-6, further comprising:- measuring a first temperature of the sterilizing or disinfecting substance injected into the internal chamber during the injecting step;- measuring a second temperature of the substance drained from the unitary assembly during said draining step;- comparing the first and second temperatures and, if the temperature difference exceeds a predetermined threshold, identifying at least one of the vessel and the cover of the affected unitary assembly, andexecuting one of the following actions:- removing the identified vessel and / or cover from the respective conveyance path;- retaining the identified vessel and / or cover in the respectiveconveyance path while preventing insertion of new containers into the vessel; and- discarding the container or group of containers contained within the affected unitary assembly.

8. The method according to the preceding claim, wherein said step of identifying comprises optically or electromagnetically scanning an identification code affixed to the vessel and / or cover, and transmitting the scanned data to a control system.

9. The method according to one or more of the preceding claims, wherein said draining step comprises opening valves in both the vessel and the cover, and injecting cold water, preferably at a temperature lower than 20°C, through one of the valves into the internal chamber to displace the sterilizing or disinfecting substance through the other valve.

10. An apparatus (1) for sterilizing or disinfecting containers, particularly for performing the method according to one or more of the preceding claims, the apparatus comprising:- an entrance (la) for supplying containers (C) to be sterilized or disinfected, and an exit (lb) for discharging sterilized or disinfected containers (C);- a plurality of vessels (2), each configured to receive a container or a group of containers;- a plurality of covers (3), wherein at least one of said covers (3) or said vessels (2) comprises fixing means (35) configured to temporarily secure a cover (3) to a vessel (2) to form a unitary assembly (4) having a closed internal chamber (5) defined between the cover (3) and the vessel (2);- a first conveyance path (Pl) for transporting said vessels from said entrance (la) toward said exit (lb);- a second conveyance path (P2) for transporting said covers (3), the second conveyance path (P2) partially overlapping said first conveyance path;22- a coupling station (101), positioned along the overlapping portion of the conveyance paths, configured to couple each cover (3) to a corresponding vessel (2) using the fixing means (35) to form the unitary assembly (4);- an injection system (115), positioned at or downstream of the coupling station (101), configured to inject a sterilizing or disinfecting substance into the internal chamber (5) of each unitary assembly;- a holding system (140) configured to maintain the internal chambers filled with said sterilizing or disinfecting substance for a time sufficient to sterilize or disinfect the containers;- a draining station (102), positioned downstream of said holding system (140), configured to remove the sterilizing or disinfecting substance from each internal chamber (5); and- a decoupling station (103), positioned downstream of said draining station (102), configured to separate said covers from said vessels of the unitary assemblies.

11. The apparatus according to the preceding claim, wherein said sterilizing or disinfecting substance comprises hot water at a temperature of at least 80°C or superheated water, wherein said internal chamber of each unitary assembly is thermally insulated, and wherein at least one of said cover and said vessel comprises a valve (52, 53) configured to prevent steam from escaping the internal chamber and to maintain, preferably within said chamber, a pressure greater than atmospheric pressure.

12. The apparatus according to the preceding claim, wherein said valve (52, 53) is a non-retum valve configured to be engaged by a filling tap (115) of the coupling station (101), said filling tap (115) being adapted to inject hot or superheated water into said internal chamber through said nonreturn valve (52, 53).

13. The apparatus according to one or more of claims 10-12, wherein said decoupling station (103) is functionally connected to said coupling23station (101) to return at least said covers (3), and preferably also said vessels (2), to the coupling station (101).

14. The apparatus according to one or more of claims 10-13, wherein said coupling station (101), the draining station and the decoupling station respectively comprise at least one coupling carousel (110), at least one draining carousel (120), and at least one decoupling carousel (130), each carousel being rotatable, preferably with continuous motion, about a respective central rotation axis (111, 121, 131), and each carousel being equipped with a plurality of gripping members (112, 122, 132) angularly spaced around the respective rotation axis, wherein said first and second conveyance paths comprise arcuate segments defined by the rotation of said gripping members (112, 122, 132) about the respective central rotation axes (111, 121, 131).

15. The apparatus according to claims 12 and 14, wherein said coupling carousel (110) comprises a plurality of said filling taps (115), evenly spaced around the rotation axis (111) of the coupling carousel and configured to sequentially engage the unitary assemblies (4) through the non-return valves (52, 53), said filling taps (115) being in fluid connection with a pressurized plumbing circuit supplied by a boiler, and wherein said draining carousel (120) comprises a plurality of cooling taps (125), evenly spaced around the rotation axis (121) of the draining carousel (120) and configured to sequentially engage said unitary assemblies (4) through the non-return valves (52, 53), said cooling taps (125) being in fluid connection with a cold water supply circuit.

16. The apparatus according to the preceding claim, wherein said draining carousel (120) comprises a plumbing recirculation circuit configured to direct at least a portion of the drained water from said unitary assemblies to a purification unit for filtering and / or purifying the water before delivering it to said boiler.

17. The apparatus according to one or more of claims 10-16, wherein24said coupling station (101) is connected to said draining station (102) via a conveyor configured to transport said unitary assemblies to a treatment zone defined at least by one of:- a buffer station configured to accumulate said unitary assemblies in a FIFO queue; and- a microwave heating station configured to heat said sterilizing or disinfecting substance within the internal chambers.

18. The apparatus according to claim 11 and one or more of claims 12-17, wherein said draining station (102) comprises a temperature sensor configured to measure the temperature of water and / or steam discharged from each unitary assembly, and wherein said apparatus further comprises a control system configured to compare the measured discharge temperature to the injection temperature of the hot or superheated water, and to determine whether sterilization or disinfection was successful based on whether a predefined temperature difference threshold is exceeded.

19. The apparatus according to the preceding claim, wherein each vessel (2) comprises an identification code configured to be scanned for identifying vessels whose temperature difference exceeds the threshold.

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