System and method for cleaning medical containers

Abstract

The invention relates to a method for cleaning pharmaceutical containers (100), comprising: conveying a heated fluid through a cleaning circuit (21) to a cleaning nozzle (16) of at least one cleaning station (13); conveying the fluid dispensed by the purge nozzle (16) through the purge circuit (21) to a recovery tank (19); fluid is conveyed from the recovery tank (19) to a pre-cleaning nozzle (14) of the at least one pre-cleaning station (12) via a pre-cleaning conveying branch (35) of the pre-cleaning circuit (34). In case of a temporary stop of the cleaning system, the following functions are provided: interruption of the delivery of fluid to the pre-cleaning nozzle (14); fluidly communicating the recirculation branch (38) of the pre-purge circuit (34) with the pre-purge delivery branch (35) and the recovery tank (19); the fluid is recirculated between the recovery tank (19), the pre-purge delivery branch (35) and the recirculation branch (38) and heated as it is recirculated.

Description

Field of the Invention

[0001] The present invention relates to a system for cleaning pharmaceutical containers and a method for cleaning pharmaceutical containers. Background Art

[0002] Before being filled or packaged, pharmaceutical containers (such as syringes, cartridges, bottles, etc.) are subjected to a cleaning operation with a heated fluid (usually water heated to a relatively high temperature).

[0003] These cleaning operations can be carried out in a specific cleaning device having an inlet station, one or more cleaning stations, and an outlet station. The containers to be cleaned are continuously fed into the inlet station, cleaned at the cleaning stations, and then brought to the outlet station. In some cases, there may be a pre - cleaning station before the cleaning stations, where a pre - cleaning operation is performed on the containers.

[0004] To improve the energy efficiency of the cleaning operation and reduce the amount of fluid used, the fluid used in the cleaning stations is recycled for use in the pre - cleaning station.

[0005] In this regard, when the containers are cleaned, the fluid is recycled and fed into a recovery tank. The recovery tank includes a heater, typically a resistor, which is placed at the bottom of the tank to heat the recycled fluid before it is reused for the pre - cleaning operation. The newly heated fluid is sent from the recovery tank to the pre - cleaning station and, once used at the pre - cleaning station, is discharged from the device.

[0006] When the cleaning device has to be stopped (for example, due to a malfunction of the container transport device between the stations of the cleaning device, or for a layout change of the containers to be cleaned, or for any other reason, the supply of the heated fluid is interrupted), the fluid is sent from the cleaning stations to the recovery tank and from the pre - cleaning station to a discharge pipe. In this way, all the pipes required to convey the fluid are emptied, and the fluid continues to exist only in the recovery tank. The recovery tank heater remains activated to keep the fluid contained therein at an appropriate temperature and prevent it from cooling.

[0007] When the cleaning system is restarted, the supply of the heated fluid is reactivated, and the fluid contained in the recovery tank is conveyed to the pre - cleaning station.

[0008] The applicant points out that when the device is restarted, especially after a long downtime, the pipes of the cleaning system cool down and need to be heated up again before the containers can be cleaned and pre - cleaned.

[0009] In fact, the applicant has observed that when the heated fluid passes through the "cold" pipes, the fluid tends to cool down and lose its sterility, thereby losing its suitability for effectively cleaning and pre - cleaning the containers.

[0010] The applicant confirms that the heating of the pipes can be simply carried out by passing a heated fluid through the pipes until the fluid releases sufficient heat to the pipes to bring them to a predetermined temperature.

[0011] However, the applicant believes that in this way, it is necessary to reheat the fluid used to transfer heat to the pipes to bring it back to the temperature that ensures its sterility, thus prolonging the time required for the effective restart of the cleaning device.

[0012] Therefore, the applicant believes it is necessary to minimize the time required for the effective restart of the cleaning device as much as possible and realizes that this requirement can be achieved by preventing at least part of the pipes in the cleaning system from cooling excessively during system shutdown. Summary of the Invention

[0013] The applicant has found that by preventing at least part of the pipes in the cleaning system from cooling, the cleaning device can be reactivated more quickly after a temporary stop.

[0014] Therefore, in its first aspect, the present invention relates to a method for cleaning pharmaceutical containers, comprising:

[0015] Conveying a heated fluid through a cleaning circuit to a cleaning nozzle of at least one cleaning station; conveying the fluid dispensed by the cleaning nozzle through the cleaning circuit to a recovery tank; conveying the fluid from the recovery tank to a pre-cleaning nozzle of at least one pre-cleaning station through a pre-cleaning conveying branch of a pre-cleaning circuit;

[0016] Wherein, in the case of a temporary stop of the cleaning system, the following functions are provided:

[0017] Interrupting the conveyance of fluid to the pre-cleaning nozzle;

[0018] Putting a recirculation branch of the pre-cleaning circuit into fluid communication with the pre-cleaning conveying branch and the recovery tank;

[0019] Recirculating the fluid between the recovery tank, the pre-cleaning conveying branch and the recirculation branch,

[0020] And heating the fluid while the fluid is being recirculated.

[0021] In its second aspect, the present invention relates to a system for cleaning pharmaceutical containers, comprising:

[0022] At least one cleaning station, which includes a plurality of cleaning nozzles and a collecting device for collecting the fluid dispensed by the cleaning nozzles;

[0023] At least one pre-cleaning station, which includes a plurality of pre-cleaning nozzles and a collecting device for collecting the fluid dispensed by the pre-cleaning nozzles;

[0024] A fluid recovery tank;

[0025] A cleaning circuit that fluidly connects a fluid source to the cleaning nozzle and fluidly connects the fluid collection device of the at least one cleaning station to the recovery tank;

[0026] A pre - cleaning circuit that includes a pre - cleaning delivery branch and a pre - cleaning return branch. The pre - cleaning delivery branch is fluidly connected to the recovery tank and is selectively fluidly connected to the pre - cleaning nozzle. The pre - cleaning return branch fluidly connects the fluid collection device of the at least one pre - cleaning station to a discharge pipe;

[0027] A fluid heater that is provided on a part of the pre - cleaning delivery branch and is configured to heat the fluid flowing in that part of the pre - cleaning delivery branch;

[0028] Wherein, the pre - cleaning circuit further includes a recirculation branch that is fluidly connected to the recovery tank and is selectively fluidly connected to the pre - cleaning delivery branch;

[0029] Wherein, when the recirculation branch is fluidly connected to the pre - cleaning delivery branch, the pre - cleaning delivery branch is not fluidly connected to the pre - cleaning nozzle.

[0030] In the solution proposed by the applicant, in the case of a temporary stop of the cleaning system, the pre - cleaning delivery branch remains at the required temperature and the fluid circulating therein does not cool to a temperature lower than the fluid aseptic temperature. Thus, when the cleaning system is restarted, the pre - cleaning operation can be almost immediately reactivated.

[0031] Furthermore, since the pre - cleaning operation is carried out before the cleaning operation, when the cleaning system is restarted and during the pre - cleaning operation, the cleaning circuit can be restarted by, for example, flowing heated fluid through the cleaning circuit until the relevant pipes reach the temperature ensuring the sterility of the cleaning fluid. Since these operations can be carried out when pre - cleaning the container (at restart), they do not seriously delay the restart of the cleaning system.

[0032] The applicant has found that this not only allows the cleaning system to be quickly restarted in the case of a temporary stop, but also reduces the energy consumption of the cleaning system. Since it is not necessary to recirculate hot fluid in the cleaning circuit during a temporary stop of the cleaning system, the use of energy (usually electricity) to heat any recirculating fluid in the cleaning circuit can be avoided. Only when the cleaning system is restarted and while the container is being pre - cleaned, is heated fluid used to reactivate the cleaning circuit.

[0033] In this specification and the appended claims, when referring to the cleaning system, the term "fully operational" refers to the operating state of the cleaning system in which the container undergoes cleaning and pre - cleaning operations.

[0034] In this specification and the appended claims, when referring to the cleaning system, the term "temporary stop" refers to the operating state of the cleaning system, in which the container does not perform cleaning or pre-cleaning operations. The temporary stop of the cleaning system is a temporary and short-term operating state. The temporary stop of the cleaning system is an operating state different from a complete stop. In the latter operating state, the cleaning system stops for a much longer time.

[0035] In this specification and the appended claims, when referring to the cleaning system, the term "restart" refers to the operating state of the cleaning system that follows the temporary stop operating state and precedes the fully operational state.

[0036] Preferred features of the cleaning system and the cleaning method are described below, and each of these features can be provided individually or in combination with other features.

[0037] Preferably, the fluid source is configured to deliver fluid heated to a predetermined temperature.

[0038] Preferably, the fluid supplied by the fluid source is water, more preferably distilled water or demineralized water or permeate water, and the predetermined temperature is between 70°C and 90°C.

[0039] Preferably, in the case of a temporary stop of the cleaning system, the fluid supply to the cleaning nozzles is interrupted.

[0040] Preferably, in the case of a temporary stop of the cleaning system, the fluid contained in the fluid collection device of the cleaning station is drained into the recovery tank.

[0041] Preferably, the cleaning circuit includes a cleaning branch that is selectively in fluid communication with the fluid source and in fluid communication with the cleaning nozzles.

[0042] Preferably, in the case of a temporary stop of the cleaning system, the fluid supply to the cleaning branch is interrupted.

[0043] Preferably, when the recirculation branch is in fluid communication with the pre-cleaning delivery branch, the cleaning delivery branch is not in fluid communication with the fluid source.

[0044] Preferably, the cleaning circuit includes a cleaning return branch that places the fluid collection device of the at least one cleaning station in fluid communication with the recovery tank.

[0045] Preferably, in the case of a temporary stop of the cleaning system, fluid is discharged from the cleaning return branch into the recovery tank.

[0046] Thus, during the temporary stop of the cleaning system, the cleaning circuit is empty, i.e., there is no fluid in the cleaning circuit.

[0047] Preferably, the cleaning pump is installed on the cleaning return line, which increases the pressure of the fluid supplied by the fluid source.

[0048] The cleaning pump has the function of delivering fluid to the cleaning nozzle.

[0049] Preferably, the cleaning pump is installed on the cleaning delivery branch line.

[0050] Preferably, the pre - cleaning pump is installed on the pre - cleaning return line to increase the pressure of the fluid contained in the recovery tank.

[0051] The pre - cleaning pump has the function of delivering fluid from the recovery tank to the pre - cleaning nozzle.

[0052] Preferably, the pre - cleaning pump is installed on the pre - cleaning delivery branch line.

[0053] Preferably, heating the fluid during the fluid recirculation includes heating the fluid along the part of the pre - cleaning delivery branch line.

[0054] The function of the fluid heater is to heat the fluid circulating in the pre - cleaning loop during the pre - cleaning operation to a temperature that ensures the sterility of the fluid.

[0055] The fluid heater also has the function of heating the fluid recirculating between the recovery tank, the pre - cleaning delivery branch line, and the recirculation branch line during the temporary stop of the cleaning system to keep the fluid at a temperature ensuring sterility.

[0056] Preferably, the fluid heater is an electric immersion heater.

[0057] Preferably, the electric immersion heater is arranged inside the part of the pre - cleaning delivery branch line.

[0058] In this way, the fluid circulating in the pre - cleaning delivery branch line is heated when flowing through the part of the pre - cleaning delivery branch line where the fluid heater is located.

[0059] Preferably, the pre - cleaning pump is arranged between the recovery tank and the fluid heater.

[0060] Preferably, there is no fluid heater in the recovery tank.

[0061] The applicant has verified that by heating the fluid flowing in the pre - cleaning delivery branch line and avoiding using a fluid heater in the recovery tank, the temperature of the fluid can be changed more quickly to ensure better preparation of the cleaning system. In fact, the fluid heater acts on a smaller fluid volume, precisely on the fluid volume given by the fluid volume flowing in the part of the pre - cleaning delivery branch line. Otherwise, if the fluid heater is arranged in the recovery tank, the fluid heater would have to act on a larger volume of fluid, that is, on the fluid volume given by the fluid contained in the recovery tank.

[0062] Preferably, the cleaning delivery branch includes a main cleaning pipe in fluid communication with the fluid source and at least one cleaning distribution pipe in fluid communication with the main cleaning pipe and the cleaning nozzle.

[0063] When the cleaning system is in full use, the fluid from the fluid source flows along the main cleaning pipe, reaches the cleaning supply pipe, and then reaches the cleaning nozzle.

[0064] Preferably, an inlet valve is provided on the cleaning delivery branch and is switchable between an open position and a closed position. In the open position, the inlet valve puts the source in fluid communication with the cleaning delivery branch. In the closed position, the inlet valve interrupts the fluid communication between the source and the cleaning delivery branch.

[0065] Preferably, when the cleaning system is in full use, the inlet valve is in the open position and the fluid is dispensed from the cleaning nozzle onto the container to be cleaned.

[0066] Preferably, in the case of a temporary stop of the cleaning system, the inlet valve is in the closed position and no fluid is dispensed from the cleaning nozzle onto the container to be cleaned.

[0067] Preferably, the inlet valve is an electromagnetic valve.

[0068] Preferably, a cleaning pump is installed on the main cleaning pipe.

[0069] Preferably, the inlet valve is inserted between the fluid source and the cleaning pump.

[0070] Preferably, a recirculation valve is provided between the recirculation branch and the pre - cleaning delivery branch, and the recirculation valve is switchable between an open position and a closed position. In the open position, the recirculation valve provides fluid communication between the pre - cleaning delivery branch and the recirculation branch. In the closed position, the recirculation valve interrupts the fluid communication between the pre - cleaning delivery branch and the recirculation branch.

[0071] Preferably, when the cleaning system is in full use, the recirculation valve is in the closed position and no fluid is introduced into the recirculation branch.

[0072] Preferably, in the case of a temporary stop of the cleaning system, the recirculation valve is in the open position and the fluid from the pre - cleaning delivery branch is fed into the recirculation branch and reaches the recovery tank.

[0073] Preferably, the recirculation valve is an electromagnetic valve.

[0074] Preferably, when the recirculation valve is in the open position, the inlet valve is in the closed position, and when the recirculation valve is in the closed position, the inlet valve is in the open position.

[0075] Preferably, the pre-cleaning conveying branch includes a pre-cleaning main pipe fluidly connected to the recovery tank, and at least one pre-cleaning distribution pipe fluidly connected between the pre-cleaning main pipe and the pre-cleaning nozzles.

[0076] Preferably, a part of the pre-cleaning conveying branch where the fluid heater is arranged is made of a part of the pre-cleaning main pipe.

[0077] When the cleaning system is in full use, the fluid from the recovery tank flows along the pre-cleaning main pipe, reaches the pre-cleaning distribution pipe, and then reaches the pre-cleaning nozzles.

[0078] Preferably, a pre-cleaning distribution valve is arranged on the pre-cleaning distribution pipe and switches between an open position and a closed position. In the open position, the pre-cleaning distribution valve fluidly connects the pre-cleaning main pipe and the pre-cleaning distribution pipe. In the closed position, the pre-cleaning distribution valve interrupts the fluid connection between the pre-cleaning main pipe and the pre-cleaning distribution pipe.

[0079] Preferably, when the cleaning system is in full use, the pre-cleaning distribution valve is in the open position, and the fluid is distributed from the pre-cleaning nozzles onto the container to be pre-cleaned.

[0080] Preferably, in the case of a temporary stop of the cleaning system, the pre-cleaning distribution valve is in the closed position, and no fluid is distributed from the pre-cleaning nozzles onto the container to be pre-cleaned.

[0081] Preferably, the pre-cleaning distribution valve is an electromagnetic valve.

[0082] Preferably, when the pre-cleaning distribution valve is in the open position, the recirculation valve is in the closed position.

[0083] Preferably, when the pre-cleaning distribution valve is in the closed position, the recirculation valve is in the open position.

[0084] In this way, the fluid from the recovery tank can reach the pre-cleaning nozzles without reaching the recirculation branch, or can reach the recirculation branch without reaching the pre-cleaning nozzles.

[0085] Preferably, the pre-cleaning pump is installed on the pre-cleaning main pipe.

[0086] Preferably, the pre-cleaning pump is installed between the recovery tank and the pre-cleaning distribution valve.

[0087] Preferably, the fluid heater is arranged on the pre-cleaning main pipe of the pre-cleaning conveying branch.

[0088] Preferably, the fluid heater is installed between the pre-cleaning pump and the pre-cleaning distribution valve.

[0089] Preferably, the cleaning circuit and the pre-cleaning circuit are fluidly connected to each other only through the recovery tank.

[0090] Preferably, when the cleaning system is in full use, the cleaning circuit supplies fluid to the pre-cleaning circuit through the recovery tank.

[0091] Preferably, in the case where the cleaning system is temporarily stopped, the cleaning circuit does not supply fluid to the pre-cleaning circuit.

[0092] Preferably, the cleaning delivery branch includes an auxiliary pipe that is in fluid communication with the discharge pipe and selectively in fluid communication with the cleaning main pipe.

[0093] Preferably, an auxiliary valve is provided between the auxiliary pipe and the cleaning main pipe, and the auxiliary valve switches between an open position and a closed position. In the open position, the auxiliary valve puts the auxiliary pipe and the cleaning main pipe in fluid communication, and in the closed position, the auxiliary valve interrupts the fluid communication between the cleaning main pipe and the auxiliary pipe.

[0094] Preferably, when the cleaning system is restarted after a temporary stop and before the cleaning system is in full use, the pre-cleaning delivery branch is in fluid communication with the pre-cleaning nozzles, and the cleaning main pipe is in fluid communication with the auxiliary pipe.

[0095] In this way, during the restart of the cleaning system, the container is pre-cleaned while at least a part of the cleaning delivery branch is heated to a temperature that allows the fluid to remain sterile.

[0096] When the cleaning main pipe is heated to the correct temperature, the auxiliary valve is placed in the closed position to allow the activation of the cleaning nozzles and the full utilization of the cleaning system.

[0097] In addition, by filling the pre-cleaning circuit at least partially with water, pressure surges that cause mechanical damage to the circuit pipes, which are commonly referred to as "water hammers", are greatly reduced during restart. BRIEF DESCRIPTION OF THE DRAWINGS

[0098] With reference to the accompanying drawings and for illustrative and non-limiting purposes, the following detailed description of the preferred embodiments of the present invention will make the further features and advantages of the present invention clearer. In these drawings:

[0099] Figure 1 The cleaning system according to the present invention in a first operating state is schematically shown;

[0100] Figures 2 to 6 Schematically shown Figure 1 the cleaning system in a further operating state in;

[0101] Figure 7 Denotes Figure 1 the details of the cleaning system in; and

[0102] Figure 8Indicates Figure 1 A connection diagram between some components of the cleaning system in Detailed implementation method

[0103] The cleaning system according to the present invention is shown as Figure 1 number 10 in

[0104] System 10 includes a conveyor 11 configured to transport pharmaceutical containers 100 along a conveyor line.

[0105] System 10 further includes a pre - cleaning station 12 and a cleaning station 13. As Figures 1 to 6 shown, the conveyor 11 passes through the pre - cleaning station 12 and the cleaning station 13, so that the pharmaceutical container 100 passes through the pre - cleaning station 12 and the cleaning station 13 in sequence.

[0106] The pre - cleaning station 12 includes a plurality of pre - cleaning nozzles 14 configured to distribute fluid onto the container 100. The pre - cleaning nozzles 14 are positioned such that they can distribute fluid onto all surfaces of the container 100 to be pre - cleaned. For example, the pre - cleaning nozzles 14 can be arranged in an array along the path followed by the conveyor 11 and distribute fluid along multiple different distribution directions.

[0107] In the pre - cleaning station 12, there is a collection device 15 configured to collect the fluid distributed by the pre - cleaning nozzles 14 during the pre - cleaning operation of the container 100. For example, the collection device 15 can be implemented by one or more collection tanks provided within the pre - cleaning station 12.

[0108] The pre - cleaning station 12 has the function of performing preventive cleaning on the container 100.

[0109] The cleaning station 13 is arranged along the conveyor line followed by the conveyor 11 after the pre - cleaning station 12. The container 100 leaving the pre - cleaning station 12 enters the cleaning station 13.

[0110] The cleaning station 13 includes a plurality of cleaning nozzles 16 configured to distribute fluid onto the container 100. The cleaning nozzles 16 are positioned such that they can distribute fluid onto all surfaces of the container 100 that need to be cleaned. For example, the cleaning nozzles 16 can be arranged in an array along the path followed by the conveyor 11 and distribute fluid along multiple different distribution directions.

[0111] In the cleaning station 13, there is a collection device 17 configured to collect the fluid distributed by the cleaning nozzles 16 during the cleaning operation of the container 100. For example, the collection device 17 can be implemented by one or more collection tanks provided within the cleaning station 13.

[0112] The pre - cleaning station 12 and the cleaning station 13 can be the same in structure.

[0113] System 10 further includes a fluid source 18 heated to a predetermined temperature, a recovery tank 19, and one or more fluid discharge pipes 20.

[0114] To supply fluid to the cleaning nozzle 16, system 10 includes a cleaning circuit 21 that selectively places the source 18 in fluid communication with the cleaning nozzle 16. The cleaning circuit 21 also selectively places the collection device 17 of the cleaning station 13 in fluid communication with the recovery tank 19.

[0115] The cleaning circuit 21 includes a cleaning delivery branch 22 extending between the source 18 and the cleaning nozzle 16. The cleaning delivery branch 22 includes a cleaning main pipe 23 connected to the source 18, and a cleaning distribution pipe 24 connected to the cleaning main pipe 23 and the cleaning nozzle 16. The cleaning delivery branch 22 further includes an auxiliary pipe 25 that is in fluid communication with one of the discharge pipes 20 and selectively in fluid communication with the cleaning main pipe 23.

[0116] A cleaning pump 26 for regulating the flow rate or pressure is provided on the cleaning main pipe 23 after the source 18. The cleaning pump 26 pushes the fluid into the cleaning delivery branch 22 to ensure the correct fluid flow rate and delivery pressure from the cleaning nozzle 16. An inlet valve 27 that can be switched between an open state and a closed state is also provided between the cleaning pump 26 and the source 18. In the open state, the inlet valve 27 allows fluid to flow from the source 18 to the cleaning pump 26, and in the closed state, the inlet valve 27 interrupts the flow of fluid from the source 18 to the cleaning pump 26. The inlet valve 27 is an electromagnetic valve.

[0117] On the cleaning distribution pipe 24, between the cleaning main pipe 23 and the cleaning nozzle 16, there is a cleaning distribution valve 28 that can be switched between an open state and a closed state. In the open state, the cleaning distribution valve 28 allows fluid to flow from the cleaning main pipe 23 to the cleaning nozzle 16, and in the closed state, the cleaning distribution valve 28 interrupts the flow of fluid from the cleaning main pipe 23 to the cleaning nozzle 16. The cleaning distribution valve 28 is disposed adjacent to the cleaning main pipe 23. The cleaning distribution valve 28 is an electromagnetic valve.

[0118] On the auxiliary pipe 25, between the cleaning main pipe 23 and the discharge pipe 20, there is an auxiliary valve 29 that can be switched between an open state and a closed state. In the open state, the auxiliary valve 29 allows fluid to flow from the cleaning main pipe 23 to the discharge pipe 20, and in the closed state, the auxiliary valve 29 interrupts the flow of fluid from the cleaning main pipe 23 to the discharge pipe 20. The auxiliary valve 29 is disposed adjacent to the cleaning main pipe 23. The auxiliary valve 29 is an electromagnetic valve.

[0119] The cleaning delivery branch 22 further includes a tank filling pipe 30 that selectively places the source 18 in fluid communication with the recovery tank 19. The tank filling pipe 30 is connected to the cleaning main pipe 23 between the cleaning pump 26 and the cleaning nozzle 16. The tank filling pipe 30 is interposed between the cleaning pump 26, the cleaning distribution valve 28, and the auxiliary valve 29. Inside the recovery tank 19, there is a spray ball 31 hydraulically connected to the tank filling pipe 30.

[0120] On the tank filling pipe 30 between the cleaning main pipeline 23 and the spray ball 31, there is a tank valve 32 that switches between an open state and a closed state. In the open state, the tank valve 32 allows fluid to flow from the cleaning main pipeline 23 to the spray ball 31, and in the closed state, the tank valve 32 interrupts the fluid flow from the cleaning main pipeline 23 to the spray ball 31. The tank valve 32 is disposed adjacent to the cleaning main pipe 23. The tank valve 32 is an electromagnetic valve.

[0121] The cleaning circuit 21 further includes a cleaning return branch 33 that places the collection device 17 of the cleaning station 13 in fluid communication with the recovery tank 19. A return pump (not shown) may be provided on the cleaning return branch 33.

[0122] The pre - cleaning nozzle 14 is supplied with fluid introduced from the collection device 17 of the cleaning station 13 into the recovery tank 19.

[0123] For this purpose, the system 10 includes a pre - cleaning circuit 34. The pre - cleaning circuit 34 selectively places the recovery tank 19 in fluid communication with the pre - cleaning nozzle 14. The pre - cleaning circuit 34 also selectively places the collection device 15 of the pre - cleaning station 12 in fluid communication with one of the discharge pipes 20.

[0124] The pre - cleaning circuit 34 includes a pre - cleaning delivery branch 35 that runs between the recovery tank 19 and the pre - cleaning nozzle 14. The pre - cleaning delivery branch 35 includes a pre - cleaning main pipe 36 connected to the recovery tank 19 and a pre - cleaning distribution pipe 37 connected to the pre - cleaning main pipe 36 and the pre - cleaning nozzle 14.

[0125] The pre - cleaning circuit further includes a recirculation branch 38 that selectively communicates with the pre - cleaning delivery branch 35 and selectively communicates with one of the recovery tank 19 or the discharge pipe 20. The recirculation branch 38 includes a recirculation pipe 39 that extends from the pre - cleaning main pipe 36 to one of the recovery tank 19 and the plurality of discharge pipes 20.

[0126] A pre - cleaning pump 40 for adjusting the flow rate or pressure is provided on the pre - cleaning main pipe 36 after the recovery tank 19. The pre - cleaning pump 40 draws fluid from the recovery tank 19 and pushes it into the pre - cleaning delivery branch 35 to ensure the correct fluid flow rate and delivery pressure from the pre - cleaning nozzle 14. The pre - cleaning pump 40 is located near the recirculation tank 19.

[0127] The fluid heater 41 acts on the pre - cleaning main pipe 36 after the pre - cleaning pump 40 to heat the fluid drawn from the recovery tank 19.

[0128] As Figure 7 shown, the fluid heater 41 is disposed within a portion 36a of the pre - cleaning main pipe 36. This portion 36a includes a fluid inlet 36b and a fluid outlet 36c. The fluid heater 41 includes an immersion heating element 42 disposed between the fluid inlet 36b and the fluid outlet 36c. The fluid entering the pre - cleaning main pipe portion 36a through the fluid inlet 36b wraps around the heating element 42, enabling the heating element 42 to generate heat to the fluid, thereby heating the fluid. Then, the heated fluid is discharged from the fluid outlet 36c of the portion 36a. In a preferred embodiment of the present invention, the heating element 42 is a resistor having an extension of preferably about 50 centimeters within the portion 36a. Preferably, the maximum power borne by the fluid heater 41 is 5 kW. The fluid heater 41 is controlled by a power controller 43 for resistive loads (as Figure 7 shown).

[0129] On the pre - cleaning distribution pipe 37, between the pre - cleaning main pipe 36 and the pre - cleaning nozzle 14, there is a pre - cleaning distribution valve 44 that switches between an open state and a closed state. Wherein, in the open state, the pre - cleaning distribution valve 44 allows fluid to flow from the pre - cleaning main pipe 36 to the pre - cleaning nozzle 14, and in the closed state, the pre - cleaning distribution valve 44 interrupts the fluid flow from the pre - cleaning main pipe 36 to the pre - cleaning nozzle 14. The pre - cleaning distribution valve 44 is disposed adjacent to the pre - cleaning main pipe 36. The pre - cleaning distribution valve 44 is a solenoid valve.

[0130] On the recirculation pipe 39, between the pre - cleaning main pipe 36 and the recovery tank 19 and the discharge pipe 20, there is a recirculation valve 45 that switches between an open state and a closed state. Wherein, in the open state, the recirculation valve 45 allows fluid to flow from the pre - cleaning main pipe 36 to the recovery tank 19 and the discharge pipe 20, and in the closed state, the recirculation valve 45 interrupts the fluid flow from the pre - cleaning main pipe 36 to the recovery tank 19 and the discharge pipe 20. The recirculation valve 45 is disposed adjacent to the pre - cleaning main pipe 36. The recirculation valve 45 is a solenoid valve.

[0131] On the recirculation pipe 39, between the recirculation valve 45 and the recovery tank 19, there is a recovery valve 46 that can switch between an open state and a closed state. Wherein, in the open state, the recovery valve 46 allows fluid to flow towards the recovery tank 19, and in the closed state, the recovery valve 46 interrupts the fluid flow towards the recovery tank 19. The recovery valve 46 is disposed adjacent to the recovery tank 19. The recovery valve 46 is a solenoid valve.

[0132] On the recirculation pipe 39, between the recirculation valve 45 and the discharge pipe 20, there is a first discharge valve 47 that can be switched between an open state and a closed state. In the open state, the first discharge valve 47 allows fluid to flow towards the discharge pipe 20, and in the closed state, the first discharge valve 47 interrupts the fluid flow towards the discharge pipe 20. The first discharge valve 47 is adjacent to the discharge pipe 20. The first discharge valve 47 is an electromagnetic valve.

[0133] The pre - cleaning circuit 34 further includes a pre - cleaning return branch 48 that connects the collection device 15 of the pre - cleaning station 12 to the discharge pipe 20. A return pump (not shown) can be provided on the pre - cleaning return branch 48.

[0134] The recovery tank 19 is also selectively hydraulically connected to the discharge pipe 20. In this regard, an outlet pipe 49 connects the recovery tank 19 to the discharge pipe 20. On the discharge pipe 49, there is a second discharge valve 50 that can be switched between an open state and a closed state. In the open state, the second discharge valve 50 allows fluid to flow from the recovery tank 19 to the discharge pipe 20, and in the closed state, the second discharge valve 50 interrupts the fluid flow from the recovery tank 19 to the discharge pipe 20. The second discharge valve 50 is an electromagnetic valve.

[0135] The operation of the system 10 is managed and controlled by a command and control unit 51 (such as a microprocessor).

[0136] The activation of the pump, the electromagnetic valves, and the fluid heater 41 is controlled by the command and control unit 51.

[0137] As Figure 8 Schematically shown, the command and control unit 51 is in electrical signal and actuation connection with the cleaning pump. The command and control unit 51 is also in electrical signal and actuation connection with the inlet valve 27. The command and control unit 51 is also in electrical signal and actuation connection with the cleaning distribution valve 28. The command and control unit 51 is also in electrical signal and actuation connection with the auxiliary valve 29. The command and control unit 51 is also in electrical signal and actuation connection with the tank valve 32. The command and control unit 51 is also in electrical signal and actuation connection with the pre - cleaning pump 40. The command and control unit 51 is also in electrical signal and actuation connection with the fluid heater 41. The command and control unit 51 is also in electrical signal and actuation connection with the pre - cleaning distribution valve 44. The command and control unit 51 is also in electrical signal and actuation connection with the recirculation valve 45. The command and control unit 51 is also in electrical signal and actuation connection with the recovery valve 46. The command and control unit 51 is also in electrical signal and actuation connection with the first discharge valve 47. The command and control unit 51 is also in electrical signal and actuation connection with the second discharge valve 50.

[0138] A method for cleaning a pharmaceutical container according to the present invention will be described hereinafter with explicit reference to the above - mentioned cleaning system 10. Obviously, such a method can be implemented by a cleaning system that is not necessarily the same as the above.

[0139] Figure 1 Shows the full use of the cleaning system, i.e., the steady-state use condition where the container 100 is picked up and cleaned. In Figure 1 it, the pipes through which the fluid flows are represented by thick lines.

[0140] In this case, the fluid heated from the source 18 to the sterilization temperature is introduced into the cleaning delivery branch 22 and reaches the cleaning nozzle 16, and the fluid is distributed onto the container 100 by the cleaning nozzle 16 (which has been pre-cleaned as described in more detail below). For this purpose, the inlet valve 27 is in the open position, and the cleaning pump 26 is activated. The tank valve 32 is in the closed position. The auxiliary valve 29 is in the closed position. The cleaning distribution valve 28 is in the open position. In this case, the heated fluid from the source 18 flows through the cleaning main pipe 23, reaches and flows through the cleaning distribution pipe 28, and is discharged through the cleaning nozzle 16.

[0141] In the full-use state, the fluid distributed by the cleaning nozzle 16 is collected in the collection device 17 of the cleaning station 13 and reaches the recovery tank 19 through the cleaning return branch 33.

[0142] The fluid is introduced from the recovery tank 18 into the pre-cleaning circuit 34, reaches the pre-cleaning nozzle 14 and is distributed by it. For this purpose, the pre-cleaning pump 40 is opened, and the fluid heater 41 is powered on. The pre-cleaning distribution valve 37 is in the open position. The recirculation valve 45 is in the closed position. The recovery valve 46 and the first discharge valve 47 can be in the open or closed position (preferably in the closed position) because no fluid reaches them from the recirculation branch 38. In this case, the fluid from the recovery tank 19 passes through the pre-cleaning main pipe 36, is heated by the fluid heater 41 in the section 36a of the pre-cleaning main pipe 36, reaches and passes through the pre-cleaning distribution pipe 37, and then is discharged from the pre-cleaning nozzle 14.

[0143] In the full-use state, the fluid distributed by the pre-cleaning nozzle 14 is collected in the collection device 15 of the pre-cleaning station 12 and reaches the discharge port through the pre-cleaning return branch 48.

[0144] Therefore, the heated fluid used for cleaning the container 100 is reused and reheated for the pre-cleaning of the container 100. The temperature of the fluid discharged from the source 18 ensures the sterility of the fluid. Similarly, the temperature at which the fluid heater 41 heats the fluid from the recovery tank 19 ensures the sterility of the fluid. Preferably, the temperature of the fluid discharged from the source 18 is equal to the temperature at which the fluid heater 41 heats the fluid. When using water (distilled water, demineralized water, or permeated water), this temperature is about 80 °C.

[0145] Figure 2 Shows the temporary stop state of the cleaning system 10, i.e., the temporary suspension state of the cleaning and pre-cleaning operations of the container 100.

[0146] In this case, the fluid supply from the pre-cleaning nozzle 14 and the cleaning nozzle 16 is interrupted, and the fluid is recycled between the recovery tank 19, the pre-cleaning delivery branch 35, and the recirculation branch 38 and heated to a temperature ensuring sterility. The temperature to which the recirculating fluid is heated is preferably equal to the temperature to which the fluid is heated during the full use of the cleaning system.

[0147] For this purpose, the pre-cleaning pump 40 is turned on, and the fluid heater 41 is energized. The pre-cleaning distribution valve 37 is in the closed position. The recirculation valve 45 is in the open position. The recovery valve 46 is in the open position. The first discharge valve 47 is in the closed position. In this case, the fluid from the recovery tank 19 flows through the pre-cleaning main pipe 36, is heated by the fluid heater 41 in the portion 36a of the pre-cleaning main pipe 36, reaches and flows through the recirculation pipe 39, and then returns to the recovery tank 19.

[0148] In this case, the inlet valve 27 is in the closed position, and the cleaning pump 26 is deactivated. Therefore, no fluid flows within the cleaning circuit 21. The fluid present in the cleaning circuit 21 when the inlet valve 27 is closed and the cleaning pump 26 is off (i.e., when the cleaning system is stopped) is collected in the collecting device 17 of the cleaning station 13 and discharged into the recovery tank 19 through the cleaning return branch 33.

[0149] This state continues until the cleaning system is restarted. At restart, the fluid flowing within the pre-cleaning delivery branch 35 and the pipes of the pre-cleaning delivery branch 35 are at a temperature ensuring the sterility of the fluid. In fact, it should be noted that in the drawings, for purposes of representation, the pre-cleaning distribution pipe 37 is depicted as having an extension slightly smaller than that of the pre-cleaning main pipe 36. In a preferred embodiment of the present invention, the extension of the pre-cleaning distribution pipe 37 is much smaller than that of the pre-cleaning main pipe 36. Preferably, the overall volume of the pre-cleaning distribution pipe 37 is at least 3 times smaller than the overall volume of the pre-cleaning main pipe 36, more preferably, the overall volume of the pre-cleaning distribution pipe 37 is at least 5 times smaller than the overall volume of the pre-cleaning main pipe 36, more preferably, the overall volume of the pre-cleaning distribution pipe 37 is at least 8 times smaller than the overall volume of the pre-cleaning main pipe 36, more preferably, the overall volume of the pre-cleaning distribution pipe 37 is at least 12 times smaller than the overall volume of the pre-cleaning main pipe 36.

[0150] As Figure 3 shown, wherein the pipes through which the fluid flows are shown in thicker lines, at restart, the pre-cleaning circuit 34 returns to the same state as in the full use state (as described above).

[0151] Upon restart, the temperature of the cleaning delivery branch 22 is lower than the temperature ensuring the sterility of the fluid. Therefore, before the fluid is dispensed from the cleaning nozzle 16, the cleaning delivery branch 22 is heated to the temperature ensuring the sterility of the fluid. This operation is performed by flowing the heated fluid from the source 18 into the cleaning main pipe 23 and discharging the fluid into the discharge pipe 20 until the cleaning main pipe 23 reaches the temperature ensuring the sterility of the fluid. When this operation occurs, the container 100 is pre-cleaned. Also, in the drawings, for illustrative purposes, the cleaning distribution pipe 24 is depicted as having an extension slightly smaller than that of the cleaning main pipe 23. In a preferred embodiment of the present invention, the extension of the cleaning distribution pipe 24 is much smaller than that of the cleaning main pipe 23. Preferably, the total volume of the cleaning distribution pipe 24 is at least 3 times smaller than the total volume of the cleaning main pipe 23, more preferably, the total volume of the cleaning distribution pipe 24 is at least 5 times smaller than the total volume of the cleaning main pipe 23, more preferably, the total volume of the cleaning distribution pipe 24 is at least 8 times smaller than the total volume of the cleaning main pipe 23, more preferably, the total volume of the cleaning distribution pipe 24 is at least 12 times smaller than the total volume of the cleaning main pipe 23.

[0152] During restart, the cleaning delivery branch 22 is heated as follows. The inlet valve 27 is in the open position, and the cleaning pump 26 is activated. The tank valve 32 is in the closed position. The auxiliary valve 29 is placed in the open position. The cleaning distribution valve 28 is in the closed position. In this case, the heated fluid from the source 18 flows through the cleaning main pipe 23, reaches and flows through the auxiliary pipe 25, and is discharged into the discharge pipe 20.

[0153] When the cleaning delivery branch 22 is heated to the temperature required to ensure the sterility of the fluid, the cleaning circuit 21 also returns to the same state as the fully operational state (as described above).

[0154] After the cleaning system 10 has completely stopped and no fluid is flowing into the cleaning system, or when the cleaning system is first started, the pipes of the cleaning system must be heated before the cleaning system is put into full use.

[0155] Figures 4 to 6 A series of operations for heating the pipes of the cleaning system to the temperature ensuring the sterility of the fluid are shown.

[0156] As Figure 4As shown, the pipes through which the fluid flows are represented by thicker lines. The heated fluid from source 18 is first fed into the recovery tank 19 to heat the recovery tank 19. For this purpose, the inlet valve 27 is placed in the open position, and the cleaning pump 26 is activated. The tank valve 32 is in the open position. The auxiliary valve 29 is placed in the closed position. The cleaning distribution valve 28 is in the closed position. The pre-cleaning pump 40 is deactivated. The second discharge valve 50 is in the open position. In this case, the heated fluid from source 18 passes through a part of the cleaning main pipe 23, through the tank filling pipe 30 to the spray ball 31, where the spray ball 31 distributes the heated fluid into the recovery tank 19. The fluid entering the recovery tank 19 is discharged into the discharge pipe 20.

[0157] When the recovery tank 19 reaches the temperature ensuring the sterility of the fluid, sufficient fluid is supplied from source 18 to the recovery tank 19 to maintain a constant liquid level in the recovery tank 19. The heated fluid conveyed from source 18 to the recovery tank 19 is conveyed into the pre-cleaning conveying branch 35 until the pre-cleaning conveying branch 35 reaches the temperature ensuring the sterility of the fluid. This situation is as Figure 5 shown. In this case, the inlet valve 27 is in the open position, and the cleaning pump 26 is in the activated state. The tank valve 32 is in the open position. The auxiliary valve 29 is placed in the closed position. The cleaning distribution valve 28 is in the closed position. The pre-cleaning pump 40 is activated. The second discharge valve 50 is in the closed position. The fluid heater 41 is powered on. The pre-cleaning distribution valve 37 is in the closed position. The recirculation valve 45 is in the open position. The recovery valve 46 is in the closed position. The first discharge valve 47 is in the open position. In this case, the fluid introduced into the recovery tank 19 and directly from source 18 passes through the pre-cleaning main pipe 36, is heated by the fluid heater 41 in part 36a of the pre-cleaning main pipe 36, reaches and passes through the recirculation pipe 39, and then is discharged into the discharge pipe 20.

[0158] As Figure 6 shown, when the pre-cleaning conveying branch 35 reaches the temperature sufficient to ensure the sterility of the fluid, the heated fluid is fed from source 18 into the cleaning conveying branch 22 to keep the recovery tank 19 and the pre-cleaning conveying branch 35 at the reached temperature. In this case, the inlet valve 27 is in the open position, and the cleaning pump 26 is in the activated state. The tank valve 32 is in the closed position. The auxiliary valve 29 is placed in the open position. The cleaning distribution valve 28 is in the closed position. The pre-cleaning pump 40 is activated. The second discharge valve 50 is in the closed position. The fluid heater 41 is powered on. The pre-cleaning distribution valve 37 is in the closed position. The recirculation valve 45 is in the open position. The recovery valve 46 is in the open position. The first discharge valve 47 is in the closed position. In this case, the pre-cleaning circuit 34 enters the same usage state as the temporary stop state (as described above), and the cleaning circuit 21 enters the same usage state as the restart state (as described above).

[0159] When the pipes of the cleaning system reach the temperature ensuring the sterility of the fluid, the cleaning system enters the fully operational state.

Claims

1. A method for cleaning a pharmaceutical container (100), comprising: delivering a heated fluid through a cleaning circuit (21) to a cleaning nozzle (16) of at least one cleaning station (13); delivering the fluid dispensed from the cleaning nozzle (16) through the cleaning circuit (21) to a recovery tank (19); delivering fluid from the recovery tank (19) to a pre - cleaning nozzle (14) of at least one pre - cleaning station (12) through a pre - cleaning delivery branch (35) of a pre - cleaning circuit (34); wherein, in the case of a temporary stop of the cleaning system, the following functions are provided: interrupting the delivery of fluid to the pre - cleaning nozzle (14); fluid - connecting a recirculation branch (38) of the pre - cleaning circuit (34) to the pre - cleaning delivery branch (35) and the recovery tank (19); recirculating fluid among the recovery tank (19), the pre - cleaning delivery branch (35), and the recirculation branch (38), and heating the fluid while the fluid is recirculating.

2. The method according to claim 1, wherein In the case of a temporary stop of the cleaning system, stopping the delivery of fluid to the cleaning nozzle (16).

3. The method according to claim 1 or 2, wherein Heating the fluid while the fluid is recirculating includes heating the fluid along a part of the pre - cleaning delivery branch (35).

4. A system (10) for cleaning a pharmaceutical container, comprising: at least one cleaning station (13), the at least one cleaning station (13) including a plurality of cleaning nozzles (16) and a collecting device (17) for collecting the fluid dispensed from the cleaning nozzles (16); at least one pre - cleaning station (12), the at least one pre - cleaning station (12) including a plurality of pre - cleaning nozzles (14) and a collecting device (15) for collecting the fluid dispensed from the pre - cleaning nozzles (14); a fluid recovery tank (19); a cleaning circuit (21), the cleaning circuit (21) fluid - connecting a fluid source (20) to the cleaning nozzles (16) and fluid - connecting the fluid collecting device (17) of the at least one cleaning station (13) to the recovery tank (19); a pre - cleaning circuit (34), the pre - cleaning circuit (34) including a pre - cleaning delivery branch (35) and a pre - cleaning return branch (48), the pre - cleaning delivery branch (35) being fluid - connected to the recovery tank (19) and selectively fluid - connected to the pre - cleaning nozzles (14), and the pre - cleaning return branch (48) fluid - connecting the fluid collecting device (15) of the at least one pre - cleaning station (12) to a discharge pipe (20); a fluid heater (41), the fluid heater (41) being disposed on a part of the pre - cleaning delivery branch (35) and configured to heat the fluid flowing in a part of the pre - cleaning delivery branch (35); wherein the pre - cleaning circuit (34) further includes a recirculation branch (38), the recirculation branch (38) being fluid - connected to the recovery tank (19) and selectively fluid - connected to the pre - cleaning delivery branch (35); Wherein, when the recirculation branch (38) is in fluid communication with the pre-cleaning delivery branch (35), the pre-cleaning delivery branch (35) is not in fluid communication with the pre-cleaning nozzle (14).

5. The cleaning system (10) according to claim 4, wherein, The cleaning circuit (21) includes a cleaning delivery branch (22) and a cleaning return branch (33). The cleaning delivery branch (22) is selectively in fluid communication with the fluid source (20) and in fluid communication with the cleaning nozzle (16). The cleaning return branch (33) fluidly connects the fluid collection device (17) of the at least one cleaning station (13) to the recovery tank (19).

6. The cleaning system (10) according to claim 5, wherein, When the recirculation branch (38) is in fluid communication with the pre-cleaning delivery branch (35), the cleaning delivery branch (22) is not in fluid communication with the fluid source (20).

7. The cleaning system (10) according to any one of claims 4 to 6, wherein, The fluid source (20) is configured to dispense fluid heated to a predetermined temperature.

8. The cleaning system (10) according to any one of claims 4 to 7, wherein, A recirculation valve (45) is provided between the recirculation branch (38) and the pre-cleaning delivery branch (35). The recirculation valve (45) switches between an open position and a closed position. In the open position, the recirculation valve (45) puts the pre-cleaning delivery branch (35) in fluid communication with the recirculation branch (38). In the closed position, the recirculation valve (45) interrupts the fluid communication between the pre-cleaning delivery branch (35) and the recirculation branch (38).

9. The cleaning system (10) according to any one of claims 4 to 8, wherein, The pre-cleaning delivery branch (35) includes a pre-cleaning main pipe (36) and at least one pre-cleaning distribution pipe (37). The pre-cleaning main pipe (36) is in fluid communication with the recovery tank (19). The at least one pre-cleaning distribution pipe (37) is in fluid communication with the pre-cleaning main pipe (36) and the pre-cleaning nozzle (14). A pre-cleaning distribution valve (44) is provided on the pre-cleaning distribution pipe (37) and switches between an open position and a closed position. Wherein, in the open position, the pre-cleaning distribution valve (44) puts the pre-cleaning main pipe (36) in fluid communication with the pre-cleaning distribution pipe (37). In the closed position, the pre-cleaning distribution valve (44) interrupts the fluid communication between the pre-cleaning main pipe (36) and the pre-cleaning distribution pipe (37).

10. The cleaning system (10) according to claims 8 and 9, wherein, When the recirculation valve (45) is in the open position, the pre-cleaning distribution valve (44) is in the closed position, and when the recirculation valve (45) is in the closed position, the pre-cleaning distribution valve (44) is in the open position.

11. The cleaning system (10) according to claims 4 and 9, wherein, The fluid heater (41) is provided on the pre-cleaning main pipe (36) of the pre-cleaning delivery branch (35).

12. The cleaning system (10) according to any one of claims 4 to 11, wherein, The cleaning circuit (21) and the pre-cleaning circuit (34) are only in fluid communication with each other through the recovery tank (19).

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