Regulating valve for sealing a process chamber

Abstract

The invention describes a regulating valve (25, 26, 27, 126), preferably for sealing of a process chamber (2, 102), comprising a wall (201) in a connection path (81, 86) between the process chamber (2, 102) and a region adjacent to the process chamber (2, 102), rotatable about a rotation axis (R) between a blocking position and a passage position for passage of a sterile element. The rotatable wall (201) has on at least a first side (201a) relevant to the passage of the sterile element (F, T) a support (202, 212', 212'') for at least one sterile element (F, T), which extends in a direction perpendicular to the rotation axis (R) such that in the blocking position the rotatable wall (201) is approximately perpendicular to a feed direction (D) of the sterile element (F, T), while in the passage position the rotatable wall (201) is parallel to the feed direction (D) and the support (202, 212', 212'') serves as a connection between the two parts of the path (81, 86).

Description

Technical Field

[0001] This invention relates to control valves, preferably for sealing process chambers capable of being sterilized by superheated steam. The invention also relates to containers capable of being sterilized by superheated steam, including the valve, and methods for conveying sterile elements (e.g., bottles, vials, syringes, and cartridges or other sterile primary containers designed to aseptically contain pharmaceutical, biological, and vaccine substances) and their sterile closures (e.g., caps, rings, or plungers, or connectors to the aforementioned items) toward the interior and exterior of a sterilizable process chamber. Background Technology

[0002] The filling and finishing (so-called "fill-and-finish") process of containers (such as bottles, vials, syringes, and cartridges) is crucial in pharmaceutical manufacturing, especially for injectable drugs. A major challenge at this delicate stage is maintaining the sterility of the product. Unlike terminal sterilization, which involves handling pharmaceuticals in closed containers, "aseptic fill-and-finish" involves the risk of losing sterility because the drugs are dispensed from open containers. Therefore, to ensure sterility, filling and finishing must be carried out in a specially designed environment to prevent contamination.

[0003] National and international pharmaceutical guidelines set forth stringent requirements for the validation and production of the machinery used in this process. Production under aseptic conditions requires special care, and regulations mandate monitoring methods to ensure sterility during container filling and finishing processes and to prevent particulate and microbial contamination.

[0004] Currently, aseptic filling and finishing (the so-called "fill-to-finish") are carried out within systems equipped with restricted access barriers (RABS) or isolators. These devices create a closed environment for filling and sealing containers and are typically integrated with automated filling machines. Regulations impose stringent particulate and microbial requirements on these areas, setting strict limits for inactive particles during both static and cyclic periods, and requiring complete absence of microbial contamination.

[0005] Filling machines integrated into RABS or isolators must handle two components that come into direct and indirect contact, requiring special measures to prevent contamination of sterile products. Isolators, which can be closed or open, have access tubes for extraction and are designed to minimize the risk of contamination when performing the fill-to-complete process inside the isolator. They incorporate ventilated chambers with HEPA (High Efficiency Particulate Air) filters and HVAC (Heating, Ventilation, and Air Conditioning) systems to maintain controlled environmental conditions.

[0006] These isolators resemble small "cleanrooms," constructed from materials certified for use in sterile areas (such as stainless steel or plastic) and undergo rigorous qualification. The air within the isolators is filtered to reduce the number and size of dispersed particles, and a purification system, typically based on vaporized hydrogen peroxide, is used before production to reduce microbial load. This careful design enables effective cleaning and disinfection.

[0007] While current aseptic filling and finishing processes are advanced, several key issues remain. The primary technology used to reduce microbial load is hydrogen peroxide or vaporized hydrogen peroxide (VPHP or VHP) generators, which are considered essential for achieving a sterile state. However, this method is defined as "decontamination" rather than "sterilization" and exhibits significant limitations compared to systems such as steam sterilization, ionizing radiation, or ethylene oxide (ETO) chemical sterilization.

[0008] While VHP provides surface action, its penetration is low, it is highly dependent on prior surface cleaning processes, and is difficult to control; in fact, even a slight film of accumulated residue can adversely affect the effectiveness of the process. Furthermore, VHP residues can impair drug properties; therefore, it is essential to ensure thorough removal of any residue from indirect contact areas. This limitation makes VHP unsuitable for sterilizing components that come into direct contact with drugs and is generally only accepted for indirect contact surfaces in filling and sealing machines. Consequently, these components must be disassembled and individually steam-sterilized, resulting in longer production times and additional costs.

[0009] Transferring sterilized components (typically at a lower level of sterility) into the isolator carries the risk of loss of sterility due to exposure to air or handling. Complex and risky methods, such as using a Rapid Transfer Port (RTP) or employing isolator gloves for transfer and assembly, can be used to maintain sterility, but still present risks of residual contact, procedural errors, and violations of the "first-pass air" standard for sterile areas.

[0010] This situation becomes particularly acute for large components such as vibrating cups and hoppers, which, although sterilized in an autoclave, cannot be handled with gloves while the door is closed due to their size, thus compromising aseptic safety. In summary, the current system represents a reduction in risk, but is not entirely safe from an aseptic standpoint.

[0011] Italian patent application number 102023000024198, filed in the name of the same applicant, describes a dual-container system in which both containers are sterilized by superheated steam. The system sterilizes process instruments by means of an automatic and autonomous process, which greatly limits or eliminates the need for operator intervention during normal operation of the system, without the need for an auxiliary autoclave or gloves, because there is no preparation for operation under aseptic conditions.

[0012] In addition, the above system can perform automatic cleaning like traditional systems (such as freeze-drying equipment) and ensure the absolute safety of the machine and all its components in the process chamber, making the filling and completion steps of bottles, syringes and cartridges extremely efficient, so much so that it can achieve production speeds comparable to traditional filling systems.

[0013] However, with conventional valves, manual operator intervention may be required to reassemble components during the movement of bottles or other primary containers into or out of the process chamber, thereby restoring the continuity of the guide path for the primary container or its closure.

[0014] Furthermore, conventional solutions fail to minimize the amount of air leaving the process chamber, creating problems with controlling chamber pressure and consequently, with the need to maintain overpressure requirements in sterile areas.

[0015] Thus, the presence of flanges, gloves, and manual assembly processes increases the risk of changes in the aseptic state of the process chamber, which is difficult to inspect and monitor anyway. Summary of the Invention

[0016] The purpose of this invention is to limit the escape of air from the chamber as much as possible and eliminate the above-mentioned disadvantages, thereby allowing the flow rate to be as constant as possible.

[0017] In the context of the aforementioned objectives, the present invention also aims to ensure perfect and definitive sterility of the machine and all its components.

[0018] Another object of the present invention is to provide a container that can be sterilized by superheated steam, which is economically competitive while ensuring the highest quality and sterility.

[0019] Another objective of the valve according to the invention is to allow such movement to occur in a single closed environment, traversing regions under different conditions such as temperature, pressure, and saturation, without the need for external intervention during process operation.

[0020] This objective, and these and other objectives, which will become clearer hereinafter, are achieved by a control valve according to the invention (preferably for sealing a process chamber), which includes one or more of the technical features described in the appended claims. The dependent claims correspond to possible different embodiments of the invention.

[0021] In particular, according to a first aspect, the present invention relates to a control valve, preferably for sealing a process chamber, comprising a wall rotatable about a rotation axis in a connection path between the process chamber and one of its adjacent regions, between a blocking position and a passage position for passage of a primary sterile container or its closure.

[0022] In other words, the valve blocks the path of sterile components (bottles, syringes, cartridges, caps for bottles, caps for syringes, etc.) into and / or out of the process chamber.

[0023] The rotatable wall extends in a direction perpendicular to the axis of rotation and has a support element for sterile products on at least the opposite first side.

[0024] The term "adjacent area" in relation to process chambers refers to those areas designed to be connected to the same process chamber via valves used to regulate inlets and outlets.

[0025] In the blocking position, the rotatable wall is approximately perpendicular to the feed direction of the sterile element; on the other hand, in the through position, it is parallel to the feed direction, and the support connects the two parts of the path.

[0026] According to a first embodiment, it is used to move bottles, syringes, or cartridges, and the support includes a frame having a support surface for primary sterile containers.

[0027] Advantageously, on the second side of the rotatable wall opposite to the first side, there are fins protruding from the plane of the rotatable wall for compensation relative to the support, which allows for a reduction in airflow from the inside of the container to the outside when the valve is in the through position, and vice versa.

[0028] According to a variant embodiment, the caps and seals for conveying bottles, syringes, or cartridges are provided with fastening elements that are symmetrically positioned on both sides of the rotatable wall with respect to the axis of rotation.

[0029] Another variation may include a fastening element for the lid and cap only on one side of the rotatable wall.

[0030] Another aspect of the present invention relates to a container capable of being sterilized by superheated steam, comprising, on a support frame:

[0031] - A sterile chamber for containing sterile elements of the primary container, designed for sterilization with saturated steam from the vaporization conduit;

[0032] - Having at least one first compensation chamber for compensating pressure, for containing the operating apparatus of the container;

[0033] - A first partition, sealed between the process chamber and the first compensation chamber; and

[0034] - Inlet and outlet, used for connection between the process chamber and its adjacent area, which are regulated by appropriate valves when opened and closed.

[0035] A notable feature of this container is that each valve has a wall that can rotate about a rotation axis, rotating between a blocking position and a position for the passage of sterile elements for the primary container, the passage position being in the connection path between one of the areas adjacent to the process chamber (i.e., those areas designed to connect to it via the aforementioned inlets and outlets).

[0036] The rotatable wall includes a support element on at least one opposite side for medical components such as bottles, syringes, or cartridges.

[0037] The rotatable wall extends in a direction perpendicular to the axis of rotation, such that in the blocking position it is approximately perpendicular to the feed direction of the sterile element; on the other hand, in the passing position it is parallel to the feed direction, thereby enabling the support to connect the two parts of the path.

[0038] The aforementioned support may include a frame having a support surface for a bottle, syringe, or cartridge, or a fastening element for sealing the cap or closure of a bottle, syringe, or cartridge.

[0039] In the first case, the rotatable wall has a flap protruding from the plane of the rotatable wall on a second side opposite to the first side. This protruding flap is used for compensation relative to the frame and is designed to reduce the area of ​​the passage cross-section.

[0040] In the second case, the fastening elements are positioned symmetrically on two opposite sides with respect to the axis of rotation.

[0041] Preferably, the inlet and outlet are defined on the wall of the process chamber and include: an inlet opening for the bottles, syringes, and cartridges to be filled, which is regulated by an inlet valve when opened and closed; an inlet opening for the caps and closure caps of the filled bottles, syringes, and cartridges; and an outlet opening for the sealed bottles, syringes, and cartridges, which is generally located on one side of the process chamber opposite to the axis of symmetry of the container.

[0042] The inlet opening is regulated by an inlet valve when it is opened and closed, the outlet opening is regulated by an outlet valve when it is opened and closed.

[0043] The path includes a moving guide for transporting bottles, syringes, or cartridges between an inlet opening and an outlet opening, or a transport track for transporting caps and closures from a process chamber of a second container to a process chamber of a first container.

[0044] Therefore, the applicant has developed a container capable of being sterilized by superheated steam for filling and finishing bottles, syringes, and cartridges, as well as for providing caps to these bottles and seals to the syringes and cartridges, without the need for isolators or similar devices that force operators to remove and reinstall components or intervene in a sterile area with gloves. The container also allows for the sterilization of instrument components, thereby ensuring complete sterilization and purification of all components.

[0045] Advantageously, a pressurization device is provided to prevent potential damage to the equipment within the vessel due to pressure differences between the process chamber and adjacent areas. This device is configured to maintain the internal pressure of the first compensation chamber between a standard pressure and an operating pressure corresponding to the external pressure, in order to compensate for the pressure of superheated steam inside the sterile chamber.

[0046] Similarly, the container includes a second compensation chamber with compensated pressure, which has an inspection device for controlling the sterile chamber, and the second compensation chamber is sealed and separated from the sterile chamber by a second partition.

[0047] In addition, the second compensation chamber has an upper inlet to control the interior of the sterile chamber, thereby allowing the operator to easily operate inside the process chamber.

[0048] Thanks to this compensation system, the process chamber can be kept under extremely high pressure without damaging the instruments in adjacent areas.

[0049] Preferably, the process chamber is positioned between the first and second compensation chambers along the vertical extension direction of the container (approximately coinciding with the container's axis of symmetry). Therefore, the first partition is located in a horizontal plane perpendicular to this vertical direction.

[0050] Clearly, in the same manner as the first compensation chamber, the pressurization device of the second compensation chamber causes the internal pressure of the second compensation chamber to vary between the standard pressure and the operating pressure.

[0051] According to the first embodiment, the first container is used for the aseptic filling and completion of bottles, syringes and cartridges, which enter and leave the container in sequence; for this purpose, a device for filling bottles, syringes or cartridges will be provided inside the container.

[0052] In practice, the equipment for filling bottles, syringes, or cartridges is integrated inside a first container equipped with a process chamber, a first lower compensation chamber, and a second upper compensation chamber. The first compensation chamber is essentially a technical compartment, sealed to the process chamber (where the aseptic elements of the primary container are filled and sealed), but it compensates for pressure differences relative to the process chamber to prevent bellows deformation and mechanical stress between the two compartments under higher pressures. Similarly, the second compensation chamber (preferably equipped with an inspection device) is also equipped with an airtight separation device.

[0053] In this document, the terms “up” and “down” or “above” and “below” refer to the position of an element or a portion thereof relative to one of the horizontal planes in which the first or second separator is located.

[0054] According to an alternative embodiment, caps and suffixes for bottles, syringes, or cartridges are dispensed in a second container. The process chamber of the second container, which supplies the caps, is separated from the first and second compensation chambers. The upper compensation chamber has at least one transparent portion for inspecting the sterile chamber, while the lower compensation chamber houses the vibrating cup system. Caps are supplied via a cap storage unit upstream of the container using a metering valve system that dispenses caps into the process chamber of the first container in a controlled manner and adapted to the supply rate of the vibrating cup by means of a rotary butterfly valve.

[0055] Advantageously, the two containers are aseptically connected via a conduit cut off by an open and close valve, allowing caps or suffixes to be transported between the two containers without contamination issues, i.e., between the second container used for dispensing caps and suffixes and the first container (i.e., the container for aseptic filling and finishing of bottles, syringes, and cartridges, where a robotic arm will pick up the caps or suffixes and seal the corresponding bottles, syringes, and cartridges).

[0056] The vaporization conduit for the process chamber used for the aseptic filling and finishing of bottles, syringes, and cartridges is connected to a vaporization device. This vaporization device extends horizontally within the aseptic chamber, generally perpendicular to the vertical direction.

[0057] The second container for dispensing caps and closures for bottles, syringes, or cartridges preferably has the following inlets and outlets: an upper opening—which is regulated by an upper valve when opening and closing—for the cap to fall into the inlet of a vibrating cup located in a sterile chamber; and a lower opening—which is regulated by a lower valve when opening and closing—for transferring the cap leaving the vibrating cup to a container for aseptic filling and finishing of bottles, syringes, and cartridges, which is also connected to the sterile chamber.

[0058] The upper valve is a traditional type of high-sealing valve.

[0059] Another aspect of the invention relates to a system comprising at least two sterile containers under pressure, the first container and the second container being interconnected by conduits, wherein the first container is used for filling bottles, syringes, cartridges and other sterile products that must be filled and completed in their own sterile process chamber, and the second container is used for dispensing caps and sterile seals for the aforementioned container, which are then sent to the first container to be filled and sealed.

[0060] In other words, the system comprises one or more sealed chambers in which superheated steam sterilization can be used instead of VHP purification. Within these process chambers, pressure and temperature can be increased to achieve true sterilization without affecting filling automation and equipment within the chambers. Thus, the system no longer resembles a traditional isolator but is capable of withstanding pressures exceeding three absolute bar and temperatures above the sterilization temperature (as specified).

[0061] The applicant has recognized that a system configured in this way is an effective example of addressing the limitations of the VHP purification process and subsequent procedures that introduce "autoclaving" components, but it is also a good solution with low complexity that allows older production sites to comply with current guidelines.

[0062] The basic feature of this system is that the first and second containers are interconnected by a pipe having an inlet valve or bottom valve manufactured as described above, located between the outlet opening of the process chamber of the first container and the bottom opening of the process chamber of the second container.

[0063] Furthermore, because the pressure and temperature in this system can be increased, it can be sterilized with superheated steam and is suitable for so-called "clean-in-place" (i.e., in technical terms, the process of cleaning the interior of equipment without disassembling or removing equipment parts, "CIP"), whether hot or cold. And because the system can sterilize with saturated steam, it eliminates the need for VHP purification, and primarily eliminates the need for inserting and managing parts that come into direct and indirect contact with the product, as well as the need for aseptic removal and reassembly after "autoclaving".

[0064] This invention provides further protection with a method for sterilizing a container used for filling sterile containers for injectable drugs, the method comprising the following steps:

[0065] - By rotating the rotatable wall of the valve from the pass position to the block position, the passage between the process chamber and its adjacent area is closed, thereby isolating the process chamber;

[0066] - The process chamber isolated in this manner is evacuated, and the first compensation chamber is evacuated at the same time (and, if necessary, the second compensation chamber is also evacuated if one is provided).

[0067] - Inject saturated vapor into the vacuum process chamber until the validated sterilization cycle is completed.

[0068] Advantageously, after injecting superheated steam into the vacuum process chamber, the process can be repeated in a vacuum, and then superheated steam can be injected again. This process can be repeated cyclically until the sterile chamber is gradually and completely saturated.

[0069] Subsequently, in order to allow both the sterile elements of the primary container and the airflow (from one or more channels) to enter and exit the process chamber, the rotatable wall is rotated again to move it to the pass position.

[0070] In practice, during the cleaning or sterilization step, valves upstream and downstream of the guides used to move bottles, syringes, or cartridges are closed, isolating the process chamber from the external environment. Once sterility is achieved, the valves open, and the chamber maintains its sterility through a positive pressure gradient due to overpressure. By opening the valves, the various areas of the container are connected, and alignment of the guides used to move the bottles is allowed, creating a single path for the bottles to enter the filling chamber. Attached Figure Description

[0071] Further features and advantages of the invention will become more apparent in the following detailed description, with reference to a preferred, non-limiting embodiment of the control valve, which is illustrated by way of example and with the aid of the accompanying drawings and does not limit the scope of the invention, wherein:

[0072] Figure 1 A perspective view of system 100 is shown. System 100 includes two containers 1 and 101 capable of being sterilized by superheated steam for filling and sealing vials F for injectable drugs to be sealed by sterile caps T. System 100 has portions designed to reproduce the interior of process chamber 2, the interior of a second compensation chamber 105, and the interior of conduit 14 or 114 for connecting between process chambers 2 and 102 of the two containers 1 and 101.

[0073] Figure 1A It shows Figure 1 First magnification Figure 1A ;

[0074] Figure 1B It shows Figure 1 Second magnification Figure 1B ;

[0075] Figure 2 It shows Figure 1The system 100 is cut by a plane that passes through the vertical direction Z and is perpendicular to the XY plane;

[0076] Figure 3 It shows Figure 1 The second container 101 of the system 100 is cut by another plane that is perpendicular to the vertical direction Z and relative to the XY plane;

[0077] Figure 4 A perspective view of the inlet valve 27 in the through position is shown;

[0078] Figure 5 A perspective view of the inlet valve 25 (or valve 27) in the blocked position is shown;

[0079] Figure 6A and 6B A perspective view of the inlet valve 26 (or lower valve 126) in the through position and the blocking position is shown respectively. Detailed Implementation

[0080] The above figures illustrate a preferred embodiment of a control valve according to the invention (preferably for sealing process chambers 2 and 102), generally identified by reference numerals 25, 26, 27 or 126, and including a wall 201 in a connection path 81 or 86 between process chamber 2 or 102 and one of the regions adjacent to the process chamber, which is rotatable about a rotation axis R by means of an actuator 200 between a blocking position and a position for the passage of sterile products F and T.

[0081] The rotatable wall 201 has supports 202 or 212' and 212'' on at least the associated first side 201a for supporting sterile elements F and T. Furthermore, the rotatable wall 201 extends in a direction perpendicular to the axis of rotation R, such that in the blocking position (at... Figure 5 and Figure 6B (As shown more clearly in the image), it is approximately perpendicular to the feed direction D of the sterile elements F and T ( Figure 1A and Figure 1B ), and through location ( Figure 4 and Figure 6A ), which is parallel to the feed direction D; in this position, support members 202 or 212' and 212'' are used to connect the two parts of path 81 or 86.

[0082] Specifically, paths 81 and 86 are the relative trajectories depicted by the moving guide 81 of bottle F and the conveying track 86 of cap T, respectively. Therefore, these paths also include extensions of guide 81 upstream and downstream of container 1, i.e., extensions upstream and downstream of valves 25 and 27.

[0083] The rotatable wall 201 is mounted on the wall of the chamber 2 or on the pipe 14 (114) by means of a frame 207, the innermost circumference of the frame 207 defining the diameter of the openings 21, 22 or 23.

[0084] Process chamber 2 or 102, containing the sterile element to be processed (i.e., bottle F of container 1 or cap T of container 101), is airtightly separated from first compensation chamber 3 or 103 by means of first partition 4 or 104, and airtightly separated from second compensation chamber 5 or 105 by means of second partition 6 or 106. All partitions 4, 6, 104 or 106 are tightly sealed. Figure 2 and Figure 3 ).

[0085] As already noted, process chamber 2 or 102 has inlets and outlets that allow connection to adjacent areas, which are regulated by corresponding valves 25, 26, 27, 125 and 126 when opening and closing.

[0086] like Figure 4 As shown, the support is a frame 202, which has a support surface 202a for the bottle F.

[0087] According to this embodiment, the rotatable wall 201 has a wing 203 on a second side 201b opposite to the first side 201a. The wing 203 protrudes from the plane of the wall 201 to compensate for the imbalance caused by the support 202 during the rotation of the wall 201 about the axis R, and to reduce the area available for airflow. Figure 5 ).

[0088] Bottle F originates from the storage unit area and is transported along path 81 towards the storage area in the feed direction D, where it is first cut off by valves 25 and 27 that connect the regulating process chamber 2 to the adjacent external area.

[0089] The path interrupted by the presence of valve 25 or 27 is partially missing at valve 25 or 27. When the rotatable wall 201 rotates to the pass position, the missing portion is replaced by the bracket 202.

[0090] Conversely, at the blocking position of wall 201, the flow of bottle F along direction D is forced to stop.

[0091] On the other hand, according to Figure 6A and Figure 6B In an exemplary embodiment, the support includes fastening elements 212' and 212'' for the cover T, which are symmetrically positioned with respect to the axis of rotation R on a first side 201a and a second side 201b opposite to the first side 201a.

[0092] Even though the operating principle is the same along the path 86 cut off by valve 26 (126), the feed direction D also includes the transport of the caps T in pairs.

[0093] The container 1 or 101, which can be sterilized by superheated steam, is preferably used for filling bottles, syringes and cartridges F, and is sealed with a cap T or other seal; the container 1 or 101 includes a process chamber 2 or 102 on a support frame 15 or 115 for accommodating the equipment to be sterilized, the process chamber 2 or 102 being sterilized by superheated steam using a vaporization pipe 20 or 120.

[0094] There are also two compensation chambers 3 and 5 or 103 and 105: a first compensation chamber 3 or 103 for accommodating instrument 10 or 110, and a second compensation chamber 5 or 105. To separate process chamber 2 or 102 from compensation chambers 3 and 5 or 103 and 105, a first partition 4 or 104 (airtightly located between process chamber 2 or 102 and the first compensation chamber 3 or 103) and a second partition 6 or 106 (airtightly located between process chamber 2 or 102 and the second compensation chamber 5 or 105) are provided. Container 1 or 101 has inlets and outlets 21 and / or 22 and / or 23 and / or 121 and / or 123 for connecting process chamber 2 or 102 to its adjacent area. These inlets and outlets are designed to connect to process chamber 2 or 102 and are regulated by corresponding valves 25 and / or 26 and / or 27 and / or 126 when opened and closed. Each of these valves 25 and / or 26 and / or 27 and / or 126 has a wall 201 in a connection path 81 or 86 between the process chamber 2 or 102 and one of its adjacent areas, which is rotatable about a rotation axis R between a blocking position and a position for passage of sterile element F or T.

[0095] According to the first variant, the rotatable wall 201 has a support 202 for the bottle F on one side. The support 202 extends in a direction perpendicular to the axis of rotation R, and thus moves along the entire side of the wall 201. In this case, on the second side 201b opposite the first side 201a of the rotatable shelf 201, a wing 203 protruding from the plane of the rotatable wall 201 is provided to compensate relative to the shelf 202 and reduce the area available for air passage.

[0096] Alternatively, the rotatable wall 201 has supports 212' and 212'' for the cover T on both sides, i.e., fastening elements 212' and 212''; the fastening elements 212' and 212'' are symmetrically positioned on the first side 201a and the second side 201b opposite to the first side 201a with respect to the axis of rotation R. In this case, the fastening elements (supports) 212' and 212'' also extend in a direction perpendicular to the axis of rotation R. Figure 6A ).

[0097] Thus, whether it has a single support 202 or double supports 212' and 212'', in the blocking position, the rotatable wall 201 is approximately perpendicular to the feed direction D of the sterile elements F and T, while in the through position, it is parallel to the feed direction D, and the supports 202 or 212' and 212'' are used to connect two parts of the paths 81 or 86 respectively.

[0098] Basically, system 100 includes two containers 1 and 101, which are used for aseptic filling and finishing of vials F and for dispensing sealing caps T to vials F for injectable drugs, respectively. The two containers 1 and 101 are interconnected by a conduit 14 (or 114) having an inlet valve 26 (or lower valve 126) between an inlet opening 22 of process chamber 2 and a lower opening 123 of process chamber 102.

[0099] In this regard, the inlets and outlets 21, 22, and 23 defined on the wall of the process chamber 2 are: an inlet opening 21 for the bottle F to be filled, which is regulated by an inlet valve 25 when opening and closing; an inlet opening 22 for sealing the cap T of the filled bottle F, which is regulated by an inlet valve 26 when opening and closing; and an outlet opening 23 for the sealed bottle F, which is located approximately on the opposite side of the axis of symmetry of the process chamber 2 with respect to the container 1, which is regulated by an outlet valve 27 when opening and closing.

[0100] Based on the described example, the two valves 26 and 126 are identical, and obviously, the two pipes 14 and 114 are also identical: pipe 14 (also referred to as 114) is simply a collection of two half-pipes (14 and 114) relative to containers 1 and 101, the two half-pipes originating from their respective process chambers 2 and 102 and connected or separated by valve 26 (identical to valve 126).

[0101] As described in Italian patent application number 102023000024198, bottle F is filled in process chamber 2 of first container 1, and cap T is positioned. In container 1, inlet and outlet are defined on the vertical wall of process chamber 2, or more precisely, on the circular vertical wall defining chamber 2.

[0102] In process chamber 2, bottles F are transported by means of a moving guide 81, through which bottles F enter and exit. Continuous movement of the guide allows bottles F to be filled sequentially, and then caps T are positioned on the filled bottles; on the other hand, caps T from the second process chamber 102 of the second container 101 enter the interior of chamber 2 via a conveying track 86.

[0103] Basically, the path of bottle F between inlet opening 21 and outlet opening 23 is achieved by moving guide 81, while the path of cap T between process chamber 102 and process chamber 2 can be replaced by conveyor track 86.

[0104] Figure 1 As shown, if valves 25 and 27 are located at the corresponding openings 21 and 23, on the other hand, inlet valve 26 is installed in the middle part of the pipe 14 connecting the first container 1 and the second container 101, which is generally similar to the inventive concept expressed herein, with the aim of allowing the dispensing of the cap T for sealing the bottle F.

[0105] Therefore, neither path 81 nor 86 has a portion located at openings 21 and 23 (or valves 25 and 27) in the wall of process chamber 2 or at valve 26 (126) in pipe 14 (114).

[0106] In detail, the moving guide 81 is composed of a pair of helical screws 81.

[0107] Of particular emphasis is that each of valves 25 and 27 includes a wall 201 that is rotatable about the axis of rotation R between a blocking position and a position for the bottle F to pass along path 81 (i.e., along the moving guide 81) for the connection between process chamber 2 and its adjacent area.

[0108] The rotatable wall 201 has a shelf 202 for supporting the bottle F on at least one opposite side. The shelf 202 extends in a direction perpendicular to the axis of rotation R, such that in the blocking position, the rotatable wall 201 is approximately perpendicular to the feeding direction D of the bottle (from the storage unit area to the storage area), while in the passing position, the wall 201 is parallel to the feeding direction D, and the shelf connects the two parts of the moving guide 81 that are interrupted at the openings 21 and 23 (i.e. at the valves 25 and 27).

[0109] For balance reasons and to reduce airflow during the rotation of wall 201 around axis R, a wing 203 protruding from its plane is provided on the second side 201b of wall 201 opposite to the first side 201a.

[0110] On the other hand, the cover T is transported into the process chamber 2 by means of a conveyor track 86, which extends inside the pipe 14 and connects the two containers 1 and 101.

[0111] Valve 26 (same as 126) also includes wall 201, which is rotatable about the axis of rotation R between a blocking position and a position for the cover T to pass through on path 86 (i.e. along conveyor track 86) for connection between the two process chambers 2 and 102.

[0112] In this case, the rotatable wall 201 has two fastening elements 212' and 212'' for the same number of covers T, which are symmetrically positioned on the first side 201a and the second side 201b opposite to the first side 201a with respect to the axis of rotation R.

[0113] Fastening elements 212' and 212'' extend in a direction perpendicular to the axis of rotation R, such that in the blocking position, the rotatable wall 201 is approximately perpendicular to the feed direction D of the cover T (which extends from the second process chamber 102 to the first process chamber 2, inside pipe 14 or 114); while in the through position, the rotatable wall 201 is parallel to the feed direction D, and the fastening elements 212' and 212'' connect the two parts of the delivery track 86 that are interrupted at valve 26 (126).

[0114] The process chamber 2 contains a filling head 82, which supports a needle 83 for injecting the selected liquid to fill the bottle F. The filling head 82 itself is of a known type. A robotic arm 84, also of a known type, is also installed inside the process chamber 2. It picks up a cap T to be positioned on the bottle F and positions the cap T on the filled bottle F, thereby sealing it.

[0115] refer to Figure 3 The container 101, which is used to distribute the lid T to the container 1 by means of the conveyor rail 86, has two inlets and outlets: an upper opening 121 and a lower opening 123.

[0116] The inlet opening 121 is used for the cover T to fall onto the vibrating cup 108 (the type of which is known) located in the process chamber 102.

[0117] The lower opening 123 is defined by the intersection of the cylindrical wall of the pipe 14 (114) and another cylindrical wall of the process chamber 102, and allows the lid T exiting from the vibrating cup 108 to be dispensed toward the first container 1.

[0118] Each of valves 121 and 123 is regulated when open and closed by an upper valve 125 (which is not of the type according to the invention) and a lower valve 126 (which is the same as the inlet valve 26), respectively.

[0119] More specifically, the conveyor rail 86 collects the lid T downstream of the vibrating cup 108 and facilitates guided sliding to the inlet opening 22 of the first container 1 (if permitted by the lower valve 126, i.e., 26) via the conduit 14 (114) on which the rail 86 is mounted.

[0120] As described above regarding the configuration of container 101, since the lid storage unit 112 is located above the process chamber 102, the lid T enters the chamber 102 through the neck 102a under the action of gravity, supplying the vibrating cup 108 below.

[0121] In use, the two containers 1 and 101 are interconnected via a pipe 14 (114) regulated by an inlet valve 26 (i.e., lower valve 126). The two containers 1 and 101 are positioned such that the process chamber 2 of the first container 1 is located below the process chamber 102, which facilitates the descent of the lid T on the conveyor track 86. For this purpose, the support leg 15 of container 1 is shorter than the support leg 115 of container 101.

[0122] The actuator 200 rotates the wall 201 about the axis R, moving the valves 25, 26 and 27 to the blocking position, thereby isolating the process chambers 2 and 102 of containers 1 and 101 from their adjacent areas; the isolated chambers 2 and 102 are initially evacuated.

[0123] Saturated steam is then injected into process chambers 2 and 102 to perform a validated sterilization cycle.

[0124] In order to allow sterile elements F and / or T and / or airflow from one or more of inlets and outlets 21, 22 and 23 into and out of process chambers 2 and / or 102, actuator 200 rotates the rotatable wall 201 of valves 25, 26 (126) and 27 to move them to the pass position.

[0125] As can be seen from the above description, this invention achieves its intended purpose and objectives. In particular, it should be noted that this invention manufactures a container that can be sterilized by superheated steam, which represents an effective alternative to isolators purified by VHP generators or similar systems, and is easier to control and use.

[0126] In particular, the manufacture of valves with integrated geometry for sliding of bottles, syringes, cartridges, caps and similar components (i.e. racks and fasteners) creates continuity of movement of medical components, effectively ensuring a “bridge” between the movement guides and delivery tracks between the various parts outside and inside the process chamber, significantly limiting air escape from the chamber and providing optimal flow constantness.

[0127] In this way, the perfect and guaranteed sterility of the machine and all its components is ensured.

[0128] Another advantage of the present invention is that it provides a container that can be sterilized by superheated steam, which is economically competitive while ensuring the highest quality and sterility.

[0129] Another advantage of the invention described herein is that the use of these valves eliminates manual intervention from the outside, and the number of automatic movements required to restore the continuity of the guide path is reduced to a single movement for each valve.

[0130] Furthermore, due to the reduced air passage area between the process chamber and adjacent chambers, the aforementioned valve allows for easy control of the internal pressure of the chamber, as it ensures the passage of sterile elements and integrated support elements, and minimizes the airflow into or out of the process chamber.

[0131] Another advantage of this regulating valve is that it allows for the sterilization of components required for mobile medical sterile components in container 1 without operator intervention and without the need to provide gloves.

[0132] Furthermore, the valve according to the invention allows the aforementioned sterile medical components to move, even when traversing environments with varying temperatures, pressures, saturations, and other conditions, without requiring external intervention during process operation.

[0133] The invention described herein can be modified and adjusted in various ways without departing from the scope of the inventive concept.

[0134] Furthermore, all details of the present invention may be replaced by other technically equivalent elements.

[0135] In practice, the materials and dimensions used can be of any type as needed, as long as they are consistent with their production purpose.

Claims

1. A regulating valve (25, 26, 27, 126), preferably for sealing a process chamber (2, 102), comprising a wall (201) rotatable about a rotation axis (R) in a connection path (81, 86) between the process chamber (2, 102) and a passage position for a sterile element (F, T) for injectable drugs; The rotatable wall (201) has at least one support (202, 212', 212'') for at least one of the sterile elements (F, T) on the relevant first side (201a), the support (202, 212', 212'') extending in a direction perpendicular to the axis of rotation (R); Such that in the blocking position, the rotatable wall (201) is substantially perpendicular to the feed direction (D) of the sterile element (F, T); and in the passing position, the rotatable wall (201) is parallel to the feed direction (D), and the supports (202, 212', 212'') are used to connect the two parts of the path (81, 86).

2. The valve (25, 26, 27, 126) according to claim 1, wherein, The support (202) includes a bracket (202) having a support surface (202a) for at least one of the sterile elements (F).

3. The valve (25, 26, 27, 126) according to claim 2, wherein, The rotatable wall (201) has a wing (203) on a second side (201b) opposite to the first side (201a), the wing (203) protruding from the plane of the rotatable wall (201) for compensating relative to the shelf (202) and reducing the area of ​​the passage cross section.

4. The valve (25, 26, 27, 126) according to claim 1, wherein, The support (212', 212'') includes fastening elements (212', 212'') for at least one of the sterile elements (T), the fastening elements (212', 212'') being symmetrically positioned with respect to the axis of rotation (R) on the first side (201a) and the second side (201b) opposite to the first side (201a).

5. A container (1, 101) capable of being sterilized by superheated steam, preferably for filling and sealing sterile elements (F, T) for injectable drugs, comprising on a support frame (15, 115): The process chambers (2, 102) are designed to be sterilized using superheated steam contained in vaporization pipes (20, 120) for the equipment to be sterilized; The first compensation chamber (3, 103), which is under compensation pressure, is used to contain instruments (10, 110) to be sterilized. A first partition (4, 104) is hermetically located between the process chamber (2, 102) and the first compensation chamber (3, 103); and Inlet / outlet (21, 22, 23, 121, 123) is used for connection between the process chamber (2, 102) and the area adjacent to the process chamber (2, 102). The inlet / outlet (21, 22, 23, 121, 123) is designed to connect to the process chamber (2, 102). The inlet / outlet (21, 22, 23, 121, 123) is regulated by corresponding valves (25, 26, 27, 126) when opening and closing. Each of the valves (25, 26, 27, 126) includes a wall (201) that is rotatable about a rotation axis (R) in a connection path (81, 86) between the process chambers (2, 102) and one of the adjacent regions of the process chamber (102) between a blocking position and a passage position for the passage of the sterile elements (F, T). The rotatable wall (201) has supports (202, 212', 212'') on at least one opposite side, the supports (202, 212', 212'') for sterile elements (F, T) and extending in a direction perpendicular to the axis of rotation (R); Such that, at the blocking position, the rotatable wall (201) is substantially perpendicular to the feed direction (D) of the sterile element (F, T); and At the passing position, the rotatable wall (201) is parallel to the feed direction (D), and the supports (202, 212', 212'') are used to connect the two parts of the path (81, 86).

6. The container (1) according to claim 5, wherein, The support (202) includes a frame (202) having a support surface for at least one of the sterile elements (F).

7. The container (1) according to claim 6, wherein, The rotatable wall (201) has a wing (203) on a second side (201b) opposite to the first side (201a), the wing (203) protruding from the plane of the rotatable wall (201) for compensating relative to the frame (202) and reducing the passage cross section.

8. The container (1) according to claim 6 or 7, wherein, The inlets and outlets (21, 22, 23) are defined on the wall of the process chamber (2) and include: The inlet opening (21) for the bottles (F) to be filled is regulated by the inlet valve (25) when it is opened and closed; The inlet opening (22) for sealing the cap (T) of the filled bottle (F) is regulated by the inlet valve (26) when opening and closing; The outlet opening (23) for the sealed bottle (F) is located approximately on the opposite side of the process chamber (2) relative to the axis of symmetry of the container (1), and the outlet opening (23) is regulated by an outlet valve (27) when opening and closing. The paths (81, 86) include a moving guide (81) for transporting the bottle (F) between the inlet (21) and the outlet (23); or A transport track (86) for the lid (T) between the process chamber (102) of the second container (101) and the process chamber (2) of the first container (1).

9. The container (1) according to claim 5, wherein, The support (212', 212'') includes fastening elements (212', 212'') for fastening the sterile element (T), the fastening elements (212', 212'') being symmetrically positioned on a first side (201a) and a second side (201b) opposite to the first side (201a) with respect to the axis of rotation (R).

10. A system (100) comprising at least two containers (1, 101) capable of being sterilized by superheated steam according to any one of claims 5 to 9, said containers (1, 101) being used for filling and sealing sterile elements (F, T) for injectable drugs, wherein, The first container (1) is used for filling bottles (F), syringes and cartridges, and is designed to be filled and completed inside the relevant process chamber (2). The second container (101) is used for dispensing caps (T) and seals for bottles (F), syringes and cartridges, and is designed to be dispensed into the first container (1). The first container (1) and the second container (101) are interconnected by pipes (14, 114) having an inlet valve (26) or a lower valve (126) between the lower opening (123) of the process chamber (102) of the second container (101) and the inlet opening (22) of the process chamber (2) of the first container (1). The inlet valve (26) or the lower valve (126) is made according to any one of claims 1 to 4.

11. A method for sterilizing containers (1, 101) according to any one of claims 5 to 9, comprising the following steps: - Close the inlet / outlet (21, 22, 23, 121, 123) between the process chamber (2, 102) of the pressurized container (1, 101) and the area adjacent to the process chamber (2, 102), and rotate the rotatable wall (201) of the valve (25, 26, 27, 126) from the through position for the sterile element (F, T) for injectable drugs to the blocking position for the sterile element (F, T), thereby isolating the process chamber (2, 102); the valve (25, 26, 27, 126) is installed in the connection path (81, 86) between the process chamber (2, 102) and the area adjacent to the process chamber (2, 102); - Evacuate the isolated process chambers (2, 102) to a vacuum, and simultaneously evacuate the first compensation chamber (3, 103); - Inject saturated vapor into the vacuum process chamber (2, 102) until the end of the validated sterilization cycle.

12. The method according to claim 11, comprising the following steps: Rotate the rotatable wall (201) of the valve (25, 26, 27, 126) to move it to the pass position, thereby allowing the sterile element (F, T) and / or air from one or more of the inlets and outlets (21, 22, 23) to flow into and out of the process chamber (2, 102). The airflow varies according to the pressure difference between the interior of the process chamber (2, 102) and the region adjacent to the process chamber (2, 102).

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