Apparatus and method for coating injection medical device

Abstract

To provide prevention measures when handling a coating substance before and during introduction of the coating substance to an inlet tank.SOLUTION: An apparatus (1) for coating an injection medical device comprises an inlet tank (10) that can be filled with a coating substance, a delivery nozzle (80) configured to deliver said coating substance to an injection medical device, and a supply assembly (20) interposed between, and in fluid communication with, said inlet tank (10) and said delivery nozzle (80), said supply assembly being configured to withdraw the coating substance from said inlet tank (10) and to supply it to said delivery nozzle (80). The supply assembly (20) comprises at least one sterilization filter (30a, 30b) configured to filter the coating substance withdrawn from said inlet tank (10).SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an apparatus for coating an injectable medical device and to a method for coating such an injectable medical device. [Background technology]

[0002] As is well known, injection medical devices are widely used in the medical field. They generally comprise a glass cylinder whose inner surface is coated with a coating layer, and a sealing plunger that slidingly engages within the glass cylinder to deliver a drug to a patient by injection.

[0003] Such medical injection devices include syringes, cartridges, as well as auto-injectors or automatic injectors used for subcutaneous and / or intravenous administration of medications.

[0004] In this type of device, the inner surface of the syringe barrel is coated with a lubricious coating material, typically silicone oil-based, both to obtain the desired sliding properties of the plunger inside the barrel of the injectable medical device, to prevent wear on the syringe barrel surface, and to provide a protective layer between the medication and the barrel.

[0005] To apply the coating material, an apparatus is used that essentially consists of an inlet tank that can be filled with the coating material, a delivery nozzle connected to the inlet tank and configured to deliver the coating material and spray the coating material by a supply of compressed air, and a pump operably inserted between the inlet tank and the delivery nozzle and configured to suck the coating material towards the delivery nozzle.

[0006] The coating material delivered to the injection medical device must be sterile, i.e., free from biological contaminants. Typically, a pre-sterilized coating material is introduced into the inlet tank. The coating material is therefore either sterilized in situ before it is introduced into the inlet tank, or the coating material is purchased already pre-sterilized.

[0007] The applicant has noted that sterilizing the coating material before introducing it into the inlet tank creates a burden on the operator. Furthermore, handling the coating material in order to sterilize it before introducing it into the inlet tank creates a risk of contacting biological contaminants with the coating material, with consequent contamination of the coating material.

[0008] Applicant has also found that purchasing pre-sterilized coating material leads to increased costs and the risk of contamination of the coating material in the time that elapses between the supply of coating material and its introduction into the inlet tank. Summary of the Invention [Problem to be solved by the invention]

[0009] The applicant has therefore felt the need to adopt precautions when handling the coating material prior to and during its introduction into the inlet tank. [Means for solving the problem]

[0010] Applicant has realised that if an unsterilised coating material is introduced into the inlet tank and the coating material is sterilised while it is being fed from the inlet tank to the delivery nozzle, then both the feeding of the unsterilised coating material and the sterilisation of the coating material prior to introduction into the inlet tank can be avoided. Furthermore, all precautions that need to be taken to eliminate the risk of contamination of the coating material during its introduction into the inlet tank can be avoided.

[0011] The present invention therefore provides in a first aspect an apparatus for coating an injectable medical device, comprising: - an inlet tank that can be filled with the coating material a delivery nozzle configured to deliver the coating substance to an injection medical device; a supply assembly interposed between and in fluid communication with the inlet tank and the delivery nozzle, the supply assembly configured to remove coating material from the inlet tank and to supply it to the delivery nozzle; Equipped with The apparatus includes at least one sterile filter configured to filter coating material removed from the inlet tank.

[0012] According to the invention, the inlet tank is filled with non-sterile coating material, and filling of the inlet tank is therefore simplified and speeded up, as no precautions need to be taken to avoid contaminating the coating material with biological contaminants.

[0013] Each sterile filter filters the coating material and removes biological contaminants from it while it is being supplied to the delivery nozzle by the inlet tank. Thus, filtering of the coating material is automatic and does not require any additional operator intervention, except for introducing the coating material into the inlet tank. Furthermore, the placement of the sterile filters in the supply assembly ensures that the coating material does not come into contact with the external environment after sterilization, eliminating any risk of contamination with biological contaminants.

[0014] In a second aspect thereof, the present invention provides a method for coating an injectable medical device, comprising the steps of: - Introducing the coating material into the inlet tank - Removing the coating material from the inlet tank - filtering the coating material after it has been removed from the inlet tank; - feeding the coating material to a delivery nozzle after the coating material has been filtered; - spraying said coating substance onto said delivery nozzle; - delivering the coating material to an injection medical device through the delivery nozzle after the coating material has been sprayed. Including, The method further relates to a method wherein filtering the coating material is performed by at least one sterilizing filter.

[0015] Throughout this specification and the appended claims, the term "sterile filter" is used to refer to a filter having a mesh size sufficiently fine to block and capture at least 99%, and preferably substantially 100%, of the bacteria present in the coating material.

[0016] The phrase "fluid communication," when referring to two or more components, is used to indicate that such components are hydraulically connected so that fluid can pass from one component to another, possibly after opening any valves interposed between the components.

[0017] The term "thermal insulator" is used to indicate a material that has a thermal conductivity less than or equal to 1 W / mK.

[0018] In at least one of the aforementioned aspects, the invention may have one or more of the following features, taken individually or optionally in combination with one another:

[0019] Preferably, the entire apparatus of the present invention, or at least the part of the apparatus upstream of the sterilizing filter, is disposed in a laminar flow hood to meet the environmental classification suitable for the production of sterile components (Class 5 of the ISO 14644-1 standard).

[0020] Preferably, the inlet tank is maintained at room temperature.

[0021] Preferably, the coating material is charged to the inlet tank at room temperature.

[0022] Preferably, the coating material is kept at room temperature in the inlet tank.

[0023] Preferably, a service member is provided that is configured to pressurize the coating material in the inlet tank.

[0024] Preferably, the service member is configured to apply a pressure to the coating material in the inlet tank that is sufficient to move the coating material from the inlet tank towards the sterilizing filter.

[0025] More preferably, the service member is configured to transfer the coating material from the inlet tank through the sterile filter.

[0026] Preferably, the coating material is 2 / s (10,000 cSt)

[0027] More preferably, the coating material has a thickness of 150 cm 2 / s (15000 cSt) or less.

[0028] In a particularly preferred embodiment, the viscosity is 110 cm 2 / s(11000cSt)~140cm 2 / s (14000 cSt), more preferably 120 cm 2 / s(12000cSt)~130cm 2 / s (13000cSt), for example, about 125cm 2 / s (12500cSt).

[0029] The applicant has developed a syringe with a diameter of approximately 10 cm, which is typically employed in injection medical devices. 2It has been found that by delivering a coating material with a viscosity an order of magnitude greater than the viscosity of 1000 cSt / s, the resulting coating on the injectable medical device more effectively maintains its lubricating properties over time, reducing the likelihood that the coating material will release particles into the injectable medical device and thus alter the properties of the pharmaceutical product injected by the injectable medical device.

[0030] Preferably, the inlet tank comprises at least one transparent wall through which the level of the coating substance inside the inlet tank can be seen without having to open the inlet tank.

[0031] Preferably, the at least one sterile filter has a mesh size of less than 0.50 μm.

[0032] Preferably, the at least one sterile filter has a mesh size greater than 0.08 μm.

[0033] In a particularly preferred embodiment, the mesh size of the at least one sterilizing filter is comprised between 0.10 μm and 0.35 μm, more preferably between 0.20 μm and 0.24 μm, for example about 0.22 μm.

[0034] Preferably, the delivery assembly comprises a delivery pump interposed between and in fluid communication with the at least one sterilizing filter and the delivery nozzle and configured to draw the coating material towards the delivery nozzle.

[0035] Preferably, the feed pump is a positive displacement pump.

[0036] Preferably, the supply assembly includes a plurality of heating elements configured to heat the coating material withdrawn from the inlet tank before being delivered by the delivery nozzle. Indeed, applicants have found that coating material flows more easily through the various conduits and components of the apparatus of the present invention when heated, particularly when high viscosity coating materials are used, as in preferred embodiments of the present invention.

[0037] Preferably, the supply assembly comprises a first storage tank interposed between and in fluid communication with the first sterile filter and the delivery nozzle, the first storage tank configured to receive and temporarily store the coating material removed from the inlet tank and intended to be supplied to the delivery nozzle.

[0038] Preferably, the first storage tank may be set to a filled state in which the first storage tank receives and stores the coating material removed from the inlet tank.

[0039] The ability to store already sterilized coating material in the first storage tank allows the coating material to be supplied to the delivery nozzle while work is being performed on the inlet tank (e.g., cleaning or filling work) or on the first sterile filter (e.g., cleaning or replacement work).

[0040] Preferably, a first fill level detector is provided which is arranged to measure the level of the coating substance in the first storage tank.

[0041] Preferably, the first fill level detector comprises a load cell configured to measure the pressure of the coating material in the first storage tank.

[0042] Preferably, the first storage tank may be set to a reduced pressure state in which the coating material stored in the first storage tank is maintained at a pressure below atmospheric pressure.

[0043] Preferably, such pressure is comprised between 5 kPa (50 mbar) and 40 kPa (400 mbar), more preferably between 10 kPa (100 mbar) and 30 kPa (300 mbar), for example about 20 kPa (200 mbar).

[0044] By reducing the pressure of the coating material in the first storage tank for a certain period of time, it is possible to remove any air bubbles that may form after the coating material passes through the first sterilizing filter. Such a measure is particularly useful when the coating material has a particularly high viscosity, a situation that makes the formation of air bubbles more likely to occur.

[0045] Preferably, when the first storage tank is under vacuum, it is tightly sealed to the other components of the apparatus of the present invention.

[0046] Preferably, the first storage tank may be set to a heated state in which the coating material stored in the first storage tank is heated to a temperature of 100°C or higher, preferably 120°C.

[0047] Heating the coating material in the first storage tank improves the rheological properties of the coating material, particularly when the coating material has a high viscosity, and facilitates its delivery to the delivery nozzle. The improved rheological properties of the coating material allow the coating material to be delivered more uniformly and accurately from the delivery nozzle, thereby providing a uniform, thin layer of coating material on the medical device.

[0048] Preferably, the supply assembly comprises at least one first heating element configured to heat the coating substance stored in the first storage tank.

[0049] The first heating element can be any element configured to emit thermal energy and in heat exchange relationship with the coating material stored in the first storage tank.

[0050] Preferably, the at least one first heating element is disposed within a first thermal jacket that is at least partially made from insulating material and that is located externally of the first storage tank.

[0051] The first heating element may comprise, for example, one or more electrical resistors or one or more conduits formed in or associated with the first thermal jacket through which a heating fluid is circulated.

[0052] In an alternative embodiment, the first heating element is a heating coil (eg, an electrical resistor, or a conduit through which a suitable heating fluid is circulated) located inside the first storage tank.

[0053] Preferably, the first storage tank is removable from the first thermal jacket.

[0054] In this way, maintenance or cleaning operations can be easily carried out on the first storage tank.

[0055] Preferably, a first temperature sensor is associated with the first storage tank so that the temperature reached by the coating material inside the first storage tank can be monitored.

[0056] Preferably, the first storage tank may be set to a supply state in which the coating material stored in the first storage tank is taken from the first storage tank and supplied to the delivery nozzle.

[0057] Preferably, in the aforementioned supply conditions, the coating material stored in the first storage tank is at a pressure above atmospheric pressure.

[0058] Preferably, such pressure is less than 250 kPa (2.5 bar), more preferably less than 200 kPa (2 bar).

[0059] In this way, the evacuation of the coating material from the first storage tank is facilitated and the risk of cavitation of the feed pump is reduced.

[0060] Preferably, the first storage tank is selectively settable to a filling state or a dispensing state.

[0061] Preferably, the first storage tank is selectively settable to a filling state, a depressurized state, a heated state, or a supply state.

[0062] Preferably, the supply assembly comprises a second storage tank interposed between and in fluid communication with the second sterilizing filter and the delivery nozzle, the second storage tank configured to receive and temporarily store the coating material removed from the inlet tank and intended to be supplied to the delivery nozzle.

[0063] Preferably, the second storage tank may be set to a filled state in which the second storage tank receives and stores the coating material removed from the inlet tank.

[0064] The ability to store already sterilized coating material in the second storage tank allows for the coating material to be supplied from the inlet tank to the second storage tank while the first storage tank is in a state unsuitable for receiving the coating material, such as under reduced pressure, heating, or supply conditions. Furthermore, it is possible to supply coating material from the second storage tank to the delivery nozzle while the first storage tank is being filled with more coating material, or possibly while the first storage tank is being replaced, or while work is being performed on the inlet tank (e.g., cleaning or filling work) or on the first sterilizing filter (e.g., cleaning or replacement work).

[0065] By providing two storage tanks, it is therefore possible for one of such storage tanks to be filled with coating material coming from the inlet tank while the other pre-filled storage tank supplies coating material to the delivery nozzle and vice versa, or for cleaning or replacement operations to be carried out on such storage tanks or on the respective sterilizing filters if a respective sterilizing filter is provided upstream of each storage tank, thus achieving a substantially continuous supply of coating material to the delivery nozzle.

[0066] In some embodiments, the delivery assembly includes a single sterile filter disposed downstream of the inlet tank and upstream of the two storage tanks.

[0067] Preferably, a second fill level detector is provided, configured to measure the level of the coating substance in the second storage tank.

[0068] Preferably, the second fill level detector comprises a load cell configured to measure the pressure of the coating material in the second storage tank.

[0069] Preferably, the second storage tank may be set to a reduced pressure state in which the coating material stored in the second storage tank is maintained at a pressure below atmospheric pressure.

[0070] Preferably, such pressure is comprised between 5 kPa (50 mbar) and 40 kPa (400 mbar), more preferably between 10 kPa (100 mbar) and 30 kPa (300 mbar), for example about 20 kPa (200 mbar).

[0071] The reduced pressure on the coating material in the second storage tank allows for the removal of air bubbles that form after the coating material passes through a second sterilizing filter or a single sterilizing filter, which may be provided upstream of the two storage tanks.

[0072] Preferably, when the second storage tank is under vacuum, it is tightly sealed to the other components of the apparatus of the present invention.

[0073] Preferably, the second storage tank may be set to a heated state, in which the coating material stored in the second storage tank is heated to a temperature of 100°C or higher, preferably 120°C.

[0074] Heating the coating material in the second storage tank improves the rheological properties of the coating material, as explained above with reference to the first storage tank.

[0075] Preferably, the supply assembly includes at least one second heating element configured to heat the coating substance stored in the second storage tank.

[0076] The second heating element can be any element configured to emit thermal energy and in heat exchange relationship with the coating material stored in the second storage tank.

[0077] Preferably, the at least one second thermal element is disposed within a second thermal jacket that is at least partially made from insulating material and that is located outside the second storage tank.

[0078] The second heating element may comprise, for example, one or more electrical resistors or one or more conduits formed in or associated with the second thermal jacket through which a heating fluid is circulated.

[0079] In an alternative embodiment, the second heating element is a heating coil (eg, an electrical resistor, or a conduit through which a suitable heating fluid is circulated) located inside the second storage tank.

[0080] Preferably, the second storage tank is removable from the second thermal jacket so that, for example, maintenance or cleaning work can be carried out.

[0081] Preferably, a second temperature sensor is associated with the second storage tank so that the temperature reached by the coating material inside the second storage tank can be monitored.

[0082] Preferably, the second storage tank may be set to a supply state in which the coating material stored in the second storage tank is taken from the second storage tank and supplied to the delivery nozzle.

[0083] Coating material, suitably filtered, degassed and heated, can thus be fed from the second storage tank to the delivery nozzle while the first storage tank is filled, depressurized or heated.

[0084] Preferably, in the aforementioned supply conditions, the coating material stored in the second storage tank is at a pressure above atmospheric pressure.

[0085] Preferably, such pressure is less than 250 kPa (2.5 bar), more preferably less than 200 kPa (2 bar), to facilitate discharge of the coating material from the second storage tank and reduce the risk of cavitation of the feed pump.

[0086] Preferably, the second storage tank is selectively settable to a filling state or a dispensing state.

[0087] Preferably, the second storage tank is selectively settable to a filling state, a depressurized state, a heated state, or a supply state.

[0088] Preferably, a control unit is operatively connected to the first and second storage tanks.

[0089] Preferably, the control unit is configured to set the first storage tank to the supply state when the second storage tank is in the fill state.

[0090] Preferably, the control unit is configured to set the first storage tank to the supply state when the second storage tank is in a reduced pressure state.

[0091] Preferably, the control unit is configured to set the first storage tank to the supply state when the second storage tank is in the heating state.

[0092] Preferably, the control unit is configured to set the second storage tank to the supply state when the first storage tank is in the fill state.

[0093] Preferably, the control unit is configured to set the second storage tank to the supply state when the first storage tank is in a reduced pressure state.

[0094] Preferably, the control unit is configured to set the second storage tank to the supply state when the first storage tank is in the heating state.

[0095] Preferably, the control unit is configured to control the first heating element based on a signal received from the first temperature sensor.

[0096] Preferably, the control unit is configured to control the second heating element based on a signal received from the second temperature sensor.

[0097] Preferably, the control unit is configured to switch the first storage tank from a heating state to a supply state based on a signal received from the first temperature sensor.

[0098] Preferably, the control unit is configured to switch the second storage tank from a heating state to a supply state based on a signal received from the second temperature sensor.

[0099] Preferably, the control unit is configured to switch the first storage tank from a filled state to a depressurized state based on a signal received from the first fill level detector.

[0100] Preferably, the control unit is configured to switch the second storage tank from a filled state to a depressurized state based on a signal received from the second fill level detector.

[0101] Preferably, the control unit is configured to switch the first storage tank from a supply state to a filling state based on a signal received from the first fill level detector.

[0102] Preferably, the control unit is configured to switch the second storage tank from a supply state to a filling state based on a signal received from the second fill level detector.

[0103] Preferably, the supply assembly comprises a first fluid circuit having a first end connected to the inlet tank, a second end connected to the first storage tank, and a third end connected to the second storage tank.

[0104] Preferably, the supply assembly includes a second fluid circuit having a first end connected to the first storage tank, a second end connected to the second storage tank, and a third end connected to the delivery nozzle.

[0105] Preferably, the first fluid circuit comprises a first conduit connecting the inlet tank to the first sterile filter, a second conduit connecting the first sterile filter to the first storage tank, a third conduit connecting the inlet tank to the second sterile filter, and a fourth conduit connecting the second sterile filter to the second storage tank.

[0106] Preferably, the first conduit and the third conduit may be completely separate from each other or may share a common conduit branch.

[0107] Preferably, the feed pump belongs to the second fluid circuit.

[0108] Preferably, a first conduit of a second fluid circuit connects said first storage tank to said feed pump.

[0109] Preferably, a second conduit of a second fluid circuit connects said second storage tank to said feed pump.

[0110] Preferably, a third conduit of the second conduit connects the feed pump to the delivery nozzle.

[0111] Preferably, the supply assembly includes at least one thermal jacket removably mounted around at least a portion of the second fluid circuit.

[0112] The ability to remove the thermal jacket from the portion of the second fluid circuit in which it is installed allows for easy disassembly of that portion of the circuit, which is necessary to be able to perform periodic cleaning operations on that portion of the circuit, particularly when the coating material used is high-viscosity silicone.

[0113] Preferably, the supply assembly includes at least one third heating element configured to heat at least a portion of the second fluid circuit.

[0114] The third heating element makes it possible to maintain the coating material in the second fluid circuit at a temperature that optimizes the rheological properties of the coating material, promoting its flow in the second fluid circuit and uniform spraying from the delivery nozzle.

[0115] Preferably, the at least one third heating element is disposed inside the at least one thermal jacket.

[0116] Preferably, the at least one third heating element comprises an electrical resistor.

[0117] Preferably, the delivery assembly includes at least one temperature sensor associated with the thermal jacket.

[0118] Preferably, the temperature sensor is integrated into the at least one thermal jacket.

[0119] Preferably, the control unit is configured to control said at least one third heating element based on a signal received by the respective temperature sensor.

[0120] In a particularly preferred embodiment, a first thermal jacket is provided on the first conduit of the second fluid circuit.

[0121] Preferably, a second thermal jacket is provided on the second conduit of the second fluid circuit.

[0122] Preferably, a third thermal jacket is provided on the third conduit of the second fluid circuit.

[0123] Thus, all conduits connecting the first and second storage tanks to the supply pump and the latter to the delivery nozzle can be disassembled and cleaned by providing each such conduit with a respective removable thermal jacket, and then replaced or reassembled as the case may be.

[0124] Preferably, the first and second conduits of the second fluid circuit have equal lengths.

[0125] Preferably, the first and second conduits of the second fluid circuit have equal fluid passage cross-sections.

[0126] Preferably, the first and second conduits of the second fluid circuit have a constant fluid passage cross-section along them.

[0127] In this way, the properties of the coating material delivered from the first storage tank or the second storage tank to the delivery nozzle do not change.

[0128] Preferably, the inlet tank is at atmospheric pressure when the coating material is added to the inlet tank.

[0129] Preferably, removing the coating material from the inlet tank includes pressurizing the inlet tank.

[0130] Preferably, filtering the coating material after it is removed from the inlet tank comprises pressurizing the inlet tank to force the coating material through a sterile filter.

[0131] Preferably, the coating material removed from the inlet tank is heated as it is fed to the delivery nozzle while maintaining the inlet tank at room temperature.

[0132] Preferably, the coating material removed from the inlet tank is filtered while maintaining it at room temperature and then heated.

[0133] Preferably, the coating material taken from the inlet tank and intended to be fed to the delivery nozzle is selectively introduced into the first storage tank or the second storage tank.

[0134] Preferably, selective introduction of the coating material into the first storage tank or the second storage tank is accomplished by depressurizing the inlet tank.

[0135] Preferably, the coating material stored in the first storage tank is maintained at a pressure of less than 250 kPa (2.5 bar), more preferably less than 200 kPa (2 bar), when the coating material is delivered from the first storage tank to the delivery nozzle.

[0136] Preferably, the pressure of the coating material stored in the first storage tank is maintained at a value above atmospheric pressure when the coating material is delivered from the first storage tank to the delivery nozzle.

[0137] Preferably, the pressure of the coating material stored in the second storage tank is maintained at less than 250 kPa (2.5 bar), more preferably less than 200 kPa (2 bar), when the coating material is delivered from the second storage tank to the delivery nozzle.

[0138] Preferably, the pressure of the coating material stored in the second storage tank is maintained at a value above atmospheric pressure when the coating material is delivered from the second storage tank to the delivery nozzle.

[0139] Preferably, supplying the coating material to the delivery nozzle comprises selectively supplying the coating material to the delivery nozzle from either the first storage tank or the second storage tank.

[0140] Preferably, a reduced pressure is created in the first storage tank prior to feeding the coating substance from the first storage tank to the delivery nozzle.

[0141] Preferably, creating a reduced pressure in the first storage tank comprises bringing the pressure of the coating substance in the first storage tank to a value below atmospheric pressure, preferably comprised between 5 kPa (50 mbar) and 40 kPa (400 mbar), even more preferably comprised between 10 kPa (100 mbar) and 30 kPa (300 mbar), for example about 20 kPa (200 mbar).

[0142] Preferably, the reduced pressure state in the first storage tank is maintained for a time comprised between 5 and 30 minutes.

[0143] Preferably, a single vacuum cycle is performed on the first storage tank, with the vacuum maintained for a minimum period of 20 minutes.

[0144] Alternatively, several depressurization cycles (eg, 3-4 cycles) can be performed on the first storage tank, with the pressurized state maintained for about 5 minutes during each depressurization cycle.

[0145] Preferably, before creating the reduced pressure in the first storage tank, the first storage tank is tightly sealed from the inlet tank and from the delivery nozzle.

[0146] Preferably, a reduced pressure is created in the second storage tank prior to feeding the coating material from the second storage tank to the delivery nozzle.

[0147] Preferably, creating a reduced pressure in the second storage tank comprises bringing the pressure of the coating substance in the second storage tank to a value below atmospheric pressure, preferably comprised between 5 kPa (50 mbar) and 40 kPa (400 mbar), even more preferably comprised between 10 kPa (100 mbar) and 30 kPa (300 mbar), for example about 20 kPa (200 mbar).

[0148] Preferably, the reduced pressure state in the second storage tank is maintained for a time comprised between 5 and 30 minutes.

[0149] Preferably, a single vacuum cycle is performed on the second storage tank, with the vacuum maintained for a minimum of 20 minutes.

[0150] Alternatively, several depressurization cycles (eg, 3-4 cycles) can be performed on the second storage tank, with the pressurized state maintained for about 5 minutes during each depressurization cycle.

[0151] Preferably, before creating the reduced pressure in the second storage tank, the second storage tank is tightly sealed from the inlet tank and from the delivery nozzle.

[0152] Preferably, the first storage tank is heated prior to delivering the coating material from the first storage tank to the delivery nozzle.

[0153] Preferably, the coating material stored in the first storage tank is heated to a temperature of at least 100°C, more preferably 120°C, prior to supplying the coating material from the first storage tank to the delivery nozzle.

[0154] Preferably, the second storage tank is heated prior to delivering the coating material from the second storage tank to the delivery nozzle.

[0155] Preferably, the coating material stored in the second storage tank is heated to a temperature of at least 100°C, more preferably 120°C, prior to supplying the coating material from the second storage tank to the delivery nozzle.

[0156] Preferably, the first storage tank is heated after creating the reduced pressure in the first storage tank.

[0157] Preferably, the second storage tank is heated after creating the reduced pressure in the second storage tank.

[0158] Preferably, supplying the coating material from the first storage tank to the delivery nozzle includes pressurizing the first storage tank after creating the reduced pressure in the first storage tank.

[0159] Preferably, supplying the coating material from the second storage tank to the delivery nozzle includes pressurizing the second storage tank after creating the reduced pressure in the second storage tank.

[0160] Features and advantages of the present invention will emerge from the following detailed description of some illustrative embodiments thereof, given by way of non-limiting example only, such description being made with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0161] [Figure 1] 1 is a schematic diagram of an apparatus for coating an injectable medical device, according to an embodiment of the present invention. [Figure 2] FIG. 2 is a schematic diagram of a first detail of the device of FIG. 1; [Figure 3] FIG. 2 is a schematic diagram of a second detail of the device of FIG. 1; [Figure 4] FIG. 2 is a schematic diagram of a third detail of the device of FIG. 1; DETAILED DESCRIPTION OF THE INVENTION

[0162] The apparatus for coating injectable medical devices, which is the subject of the present invention, is shown diagrammatically in FIG.

[0163] The apparatus 1 comprises an inlet tank 10 which can be filled with coating substance by an operator.

[0164] The inlet tank 10 is provided with an access sleeve 11 through which the coating material can be introduced.

[0165] The access sleeve 11 is configured to allow tightly sealed isolation of the inlet tank 10, for example by closure of a special valve not shown.

[0166] The apparatus 1, or at least the inlet tank 10 and the access sleeve 11, is disposed inside a laminar flow hood.

[0167] The inlet tank 10 has a preferably cylindrical side wall 10a. At least a portion of the side wall 10a is fabricated from an at least partially transparent material, such as glass, so that an operator can see the level of the coating substance inside the inlet tank 10 without having to open the inlet tank 10. The side wall 10a has a graduated scale adapted to allow the amount of coating substance inside the inlet tank 10 to be measured.

[0168] The inlet tank 10 further comprises a lower wall 10b and an upper wall 10c, preferably made from stainless steel. A side wall 10a extends between the lower wall 10b and the upper wall 10c.

[0169] The inlet tank 10 is configured to gradually release the coating material. The inlet tank 10 is kept at room temperature. The coating material is introduced therein at room temperature and maintained at room temperature.

[0170] The apparatus 1 includes a feed assembly 20 configured to withdraw coating material from the inlet tank 10 .

[0171] The service member 21 is associated with the inlet tank 10 .

[0172] The service member 21 is configured to pressurize the coating material in the inlet tank 10 to cause the coating material to flow into the supply assembly 20 .

[0173] The service member 21 comprises, for example, a pressure pump or a compressed air line connected to a compressor.

[0174] The supply assembly 20 includes a first fluid circuit 22 in fluid communication with the inlet tank 10 for receiving the coating material exiting the inlet tank 10. In particular, the first fluid circuit 22 includes a first end 23 at which the first fluid circuit 22 is connected to the inlet tank 10.

[0175] The supply assembly 20 further comprises a first sterile filter 30a configured to filter the coating material removed from the inlet tank 10. The first sterile filter 30a is configured to remove, preferably completely, biological contaminants from the coating material.

[0176] In a preferred embodiment, the first sterile filter 30a has a mesh size of 0.22 μm (micrometers).

[0177] The first sterile filter 30a is located in the first fluid circuit 22 in fluid communication with the inlet tank 10 through a first conduit having a first conduit branch 31 extending from the inlet tank 10 to a first junction 33 and a second conduit branch 32a extending from the first junction 33 to the first sterile filter 30a.

[0178] The first conduit branch 31 and the second conduit branch 32a are preferably made from stainless steel or from a heat resistant plastic material such as PTFE (polytetrafluoroethylene) or FEP (fluorinated ethylene propylene).

[0179] The service member 21 is configured to provide the coating material with a pressure that is sufficient to cause the coating material to pass through the first sterilizing filter 30a with a predetermined flow rate.

[0180] The supply assembly 20 further comprises a first storage tank 40, shown diagrammatically in FIG. 2, and preferably fabricated from stainless steel.

[0181] The first storage tank 40 is installed downstream of the first sterilizing filter 30a and is fluidly connected to the inlet tank 10 through the first sterilizing filter 30a, so that the first storage tank 40 can temporarily store the coating material removed from the inlet tank 10 and filtered by the first sterilizing filter 30a.

[0182] The first fluid circuit 22 includes a second conduit 41 extending from the first sterile filter 30a to the first storage tank 40 for fluidly connecting the first sterile filter 30a with the first storage tank 40. The first fluid circuit 22 further includes a second end 42 at which the first fluid circuit 22 is connected to the first storage tank 40 and through which the coating substance is introduced into the first storage tank 40.

[0183] The second conduit 41 is preferably made from stainless steel or from a heat resistant plastic material such as PTFE or FEP.

[0184] The pressure exerted on the coating material by the service member 21 allows the coating material to flow from the inlet tank 10 through the first conduit branch 31, the second conduit branch 32a, the first sterilizing filter 30a and the second conduit 41 until it reaches the first storage tank 40.

[0185] A first pressurizing member 44, e.g., a compressed air line in fluid communication with a pressure pump or compressor, interfaces with the first storage tank 40 to pressurize the coating material stored in the first storage tank 40 in a selective and controlled manner. In particular, the first pressurizing member 44 is configured to pressurize the coating material in the first storage tank 40 to a pressure above atmospheric pressure and below 250 kPa (2.5 bar), more preferably below 200 kPa (2 bar).

[0186] A first pressure reducing member 45, such as a vacuum pump, is in communication with the first storage tank 40 to reduce the pressure of the coating material stored in the first storage tank 40 in a selective and controlled manner.

[0187] In particular, the first pressure reducing member 45 is configured to reduce the pressure of the coating substance in the first storage tank 40 to a pressure below atmospheric pressure, preferably comprised between 5 kPa (50 mbar) and 40 kPa (400 mbar), more preferably comprised between 10 kPa (100 mbar) and 30 kPa (300 mbar), for example about 20 kPa (200 mbar).

[0188] The first storage tank 40 includes a first fill level detector 46 configured to detect the fill level of the first storage tank 40. The first fill level detector 46 may include, for example, a load cell configured to measure the pressure of the coating material in the first storage tank 40.

[0189] The first heating element 47 is in communication with the first storage tank 40 to selectively and controlledly heat the first storage tank 40 and the coating material contained therein. The first pressurizing element 47 is removably mounted to the first storage tank 40, preferably external to the first storage tank 40.

[0190] In a preferred embodiment, the first heating element 47 is integrated into a first thermal jacket 48 that is at least partially made from insulating material and is located on the exterior of the first storage tank 40. The first heating element 47 may comprise, for example, an electrical resistor or a heating conduit (coil) through which a heated fluid is circulated.

[0191] The first thermal jacket 48 is configured to insulate the first storage tank 40 from dissipating heat provided by the first heating element 47. The first storage tank 40 can be removed from the first thermal jacket 48, for example, to perform maintenance or cleaning operations.

[0192] A first temperature sensor 49a is associated with the first thermal jacket 48 and, therefore, the first storage tank 40 to monitor the temperature of the first thermal jacket 48 and, therefore, the first storage tank 40 and the coating material contained in the first storage tank 40. Preferably, the first temperature sensor 49a comprises a temperature sensor located inside the first thermal jacket 48 to verify that the temperature of the coating material contained in the first storage tank 40 has reached 120°C.

[0193] The delivery assembly 20 further comprises a second sterile filter 30b and a second storage tank 50 located downstream of the second sterile filter 30b. The second sterile filter 30b and the second storage tank 50 are shown schematically in Figure 3 and are similar to the first sterile filter 30a and the first storage tank 40, respectively.

[0194] The second sterilizing filter 30 b is configured to filter the coating material removed from the inlet tank 10 and delivered to the second storage tank 50 .

[0195] Like the first sterile filter 30a, the second sterile filter 30b is also preferably configured to completely exclude biological contaminants from the coating material and has a mesh size of 0.22 μm.

[0196] The second sterile filter 30b is located in the first fluid circuit 22 in fluid communication with the inlet tank 10 through a third conduit having a first conduit branch 31 extending from the inlet tank 10 to a first junction 33 and a third conduit branch 32b extending from the first junction 33 to the second sterile filter 30b.

[0197] The third conduit branch 32b is also preferably fabricated from stainless steel or from a heat resistant plastic material such as PTFE or FEP.

[0198] The service member 21 is configured to provide the coating material with a pressure that is sufficient to cause the coating material to pass through the second sterilizing filter 30b having a predetermined flow rate.

[0199] The second storage tank 50 is placed in fluid communication with the inlet tank 10 through the second sterile filter 30b. The second storage tank 50 is configured to temporarily store the coating material that is removed from the inlet tank 10 and filtered by the second sterile filter 30b.

[0200] In a preferred embodiment, the second storage tank 50 is fabricated from stainless steel.

[0201] The first fluid circuit 22 includes a fourth conduit 51 extending from the second sterile filter 30b to the second storage tank 50 for fluidly connecting the second sterile filter 30b with the second storage tank 50.

[0202] The second fluid circuit 22 further comprises a third end 52 at which the first fluid circuit 22 is connected to the second storage tank 50, and through which the coating material is introduced into the second storage tank 50.

[0203] The fourth conduit 51 is preferably made from stainless steel or from a heat resistant plastic material such as PTFE or FEP.

[0204] The coating material can be conveyed from the inlet tank 10 to the second storage tank 50. Pressure exerted on the coating material by the service member 21 allows the coating material to flow from the inlet tank 10 through the first conduit branch 31, the third conduit branch 32b, the second sterilizing filter 30b and the fourth conduit 51 until it reaches the second storage tank 50.

[0205] In an embodiment not shown, the device 1 comprises a single sterile filter instead of the two sterile filters 30a, 30b. Such a single sterile filter may be disposed in the first conduit branch 31, and a first junction 33 may be installed between said single sterile filter and the first storage tank 40 and the second storage tank 50. Alternatively, said single sterile filter may be installed at the first junction 33. In both cases, the second conduit branch 32a and the second conduit 41 define a single conduit.

[0206] Through the first junction 33, the coating material can alternatively and in a controlled manner be directed from the inlet tank 10 to the first storage tank 40 through the first conduit branch 31, the second conduit branch 32a, the first sterilizing filter 30a and the second conduit 41, or from the inlet tank 10 to the second storage tank 50 through the first conduit branch 31, the third conduit branch 32b, the second sterilizing filter 30b and the fourth conduit 51.

[0207] As shown in FIG. 1, the first fluid circuit 22 includes an inlet valve 43, for example located at the junction 33, configured to isolate either the first storage tank 40 or the second storage tank 50 from the first fluid circuit 22 in a controlled manner.

[0208] The inlet valve 43 is controlled to selectively direct the coating material from the inlet tank 10 to either the first storage tank 40 or the second storage tank 50 .

[0209] Preferably, the inlet valve 43 is a three-way valve.

[0210] Alternatively, a first inlet valve, for example located at the second end 42, and a second inlet valve, for example located at the third end 52, may be provided to isolate the first storage tank 40 or the second storage tank 50, respectively, from the first fluid circuit 22 in a controlled manner.

[0211] A second pressurizing member 54, such as a compressed air line in fluid communication with a pressure pump or compressor, interfaces with the second storage tank 50 to selectively and controlledly pressurize the coating material stored in the second storage tank 50. The second pressurizing member 54 is configured to pressurize the coating material in the second storage tank 50 to a pressure above atmospheric pressure and below 250 kPa (2.5 bar), more preferably below 200 kPa (2 bar).

[0212] A second pressure reducing member 55, e.g., a vacuum pump, is associated with the second storage tank 50 to selectively and controlledly reduce the pressure of the coating material stored in the second storage tank 50. The second pressure reducing member 55 is configured to reduce the pressure of the coating material in the second storage tank 50 to a pressure below atmospheric pressure, preferably comprised between 5 kPa (50 mbar) and 40 kPa (400 mbar), even more preferably between 10 kPa (100 mbar) and 30 kPa (300 mbar), e.g., about 20 kPa (200 mbar).

[0213] The second storage tank 50 includes a second fill level detector 56 configured to detect the fill level of the second storage tank 50. The second fill level detector 56 may include, for example, a load cell configured to measure the pressure of the coating material in the second storage tank 50.

[0214] The second heating element 57 is in communication with the second storage tank 50 to heat the coating material contained therein in a controlled manner. The second pressurizing element 57 is removably mounted to the second storage tank 50, preferably external to the second storage tank 50.

[0215] In a preferred embodiment, the second heating element 57 is integrated into a second thermal jacket 58 that is at least partially made from insulating material and is located on the exterior of the second storage tank 50. The second heating element 57 may comprise, for example, an electrical resistor or a heating conduit (coil) through which a heated fluid is circulated.

[0216] The second thermal jacket 58 is configured to insulate the second storage tank 50 from dissipating heat provided by the second heating element 57. The second storage tank 50 can be removed from the second thermal jacket 58, for example, to perform maintenance or cleaning operations.

[0217] A second temperature sensor 59a is associated with the second thermal jacket 58 and, therefore, the second storage tank 50 to monitor the temperature of the second thermal jacket 58 and, therefore, the second storage tank 50 and the coating material contained therein. Preferably, the second temperature sensor 59a comprises a temperature sensor located inside the second thermal jacket 59a to verify that the temperature of the coating material contained in the second storage tank 50 has reached 120°C.

[0218] The supply assembly 20 further comprises a second fluid circuit 60 in fluid communication with the first storage tank 40 and the second storage tank 50 .

[0219] The second fluid circuit 60 has a first end 61 connected to the first storage tank 40 and a second end 62 connected to the second storage tank 50 .

[0220] 2 and 3, a first inlet valve 64 may be disposed, for example, at the first end 61 and configured to isolate the first storage tank 40 from the second fluid circuit 60 in a controlled manner. Similarly, a second outlet valve 65 may be disposed, for example, at the second end 62 and configured to isolate the second storage tank 50 from the second fluid circuit 60 in a controlled manner.

[0221] 1, the supply assembly 20 also includes a supply pump 70 in fluid communication with the first storage tank 40 and the second storage tank 50. The supply pump 70 is disposed in the second fluid circuit 60 and is preferably a positive displacement pump.

[0222] In a preferred embodiment, the feed pumps 70 include respective heating elements 70a configured to heat the coating material within the pumps. For example, the heating elements 70a may include one or more electrical resistors applied to or integrated into the housing of the feed pumps 70.

[0223] The second fluid circuit 60 comprises a first conduit 71 connecting the first storage tank 40 to the feed pump 70 and a second conduit 72 connecting the second storage tank 50 to the suction head of the feed pump 70 .

[0224] The first conduit 71 and the second conduit 72 are preferably made from stainless steel or from a heat resistant plastic material such as PTFE or FEP.

[0225] The first conduit 71 and the second conduit 72 meet at a second junction 73 located between the first storage tank 40, the second storage tank 50, and the feed pump 70. The first conduit 71 and the second conduit 72 may have a common section between the second junction 73 and the feed pump 70, as shown in FIG.

[0226] Preferably, the first conduit 71 and the second conduit 72 have equal lengths and fluid passage cross-sections. Furthermore, the first conduit 71 and the second conduit 72 have a constant fluid passage cross-section along them.

[0227] Coating material can be supplied to the supply pump 70 in a selective and controlled manner from the first storage tank 40 through a first conduit 71 or from the second storage tank 50 through a second conduit 72 .

[0228] The first outlet valve 64 and the second outlet valve 65 can be controlled to allow the coating material to be supplied alternately from the first storage tank 40 or from the second storage tank 50 .

[0229] The apparatus 1 includes at least one delivery nozzle 80 configured to deliver the coating substance and in fluid communication with the supply assembly 20 .

[0230] The second fluid circuit 60 comprises a third conduit 81 extending from the feed pump 70, particularly from the delivery head of the feed pump 70, to the delivery nozzle 80 for fluidly connecting the feed pump 70 with the delivery nozzle 80. The second fluid circuit 60 further comprises a third end 82 at which the second fluid circuit 60 is connected to the delivery nozzle 80 and through which the coating substance is supplied to the delivery nozzle 80.

[0231] The third conduit 81 is preferably made from stainless steel or from a heat resistant plastic material such as PTFE or FEP.

[0232] A plurality of third heating elements 90 are in communication with the second fluid circuit 60 to heat the coating material flowing therethrough. One of the third heating elements 90 is shown schematically in FIG.

[0233] In a preferred embodiment, the third heating elements are integrated into respective thermal jackets 91 made from insulating material and removably attached to respective portions of the second fluid circuit 60 .

[0234] The third heating element 90 may comprise, for example, an electrical resistor or a heating conduit through which a heating fluid is circulated.

[0235] As shown in FIG. 4, each thermal jacket 91 further comprises a temperature sensor 92 configured to measure the temperature of the portion of the second fluid circuit 60 in which the respective third heating element 90 operates.

[0236] In the embodiment shown in FIG. 1 , a first thermal jacket 91a of the plurality of thermal jackets 91 and an associated heating element 90 are applied to a section of the first conduit 71 extending from the first end 61 to the second junction 73, a second thermal jacket 91b of the plurality of thermal jackets 91 and an associated third heating element 90 are applied to a section of the second conduit 72 extending from the second end 62 to the second junction 73, a third thermal jacket 91d of the plurality of thermal jackets 91 and an associated third heating element 90 are applied to a common section of the first conduit 71 and the second conduit 72 extending from the second junction 73 to the supply pump 70, and a fourth thermal jacket 91c of the plurality of thermal jackets 91 and an associated third heating element 90 are applied to a third conduit 81 extending from the supply pump 70 to the delivery nozzle 80.

[0237] In its preferred embodiment, the device 1 comprises a plurality of delivery nozzles 80 and a corresponding plurality of third conduits 81, each comprising a respective fourth thermal jacket 91c and a respective third heating element 90.

[0238] Each delivery nozzle 80 is configured to spray a coating substance onto a respective injection medical device.

[0239] Each delivery nozzle 80 may be provided with a respective heating element 85 configured to heat the coating material being delivered. For example, such a heating element may be an electrical resistor applied to or integrated into the delivery nozzle 80.

[0240] Each delivery nozzle 80 is configured to spray the coating material by supplying pressurized gas from a suitable delivery gas, such as compressed air, source 100. Source 100 is configured to deliver gas at a pressure comprised between 5 psi (34 kPa (0.34 bar)) and 150 psi (1.034 MPa (10.34 bar)), preferably about 30 psi (207 kPa (2.07 bar)).

[0241] The source 100 communicates with each delivery nozzle 80 by a respective conduit 101 .

[0242] The apparatus 1 comprises a movable support frame configured to support a plurality of injection medical devices, in particular the cylinders of respective syringes.

[0243] The delivery nozzles 80 and syringe cylinder support frame are movable relative to one another to insert / remove each delivery nozzle 80 in its respective cylinder.

[0244] In a preferred embodiment, relative movement between the dispensing nozzle 80 and the syringe cylinder support frame is achieved by moving the latter relative to the dispensing nozzle 80, which is fixed.

[0245] The first storage tank 40 can be set to a fill state in which it receives and stores the coating material removed from the inlet tank 10. In the fill state, the inlet valve 43 is open to the second conduit branch 32a and closed to the third conduit branch 32b.

[0246] The first storage tank 40 may also be set to a reduced pressure state in which the coating material present therein is depressurized to remove any air bubbles. In the reduced pressure state, the inlet valve 43 is closed towards the second conduit branch 32a, the first outlet valve 64 is closed, and the first pressure reducing member 45 is activated.

[0247] The first storage tank 40 can also be set to a heating state in which the coating material present therein is heated, in which the inlet valve 43 is closed to the second conduit branch 32a, the first outlet valve 64 is closed, and the first heating element 47 is activated.

[0248] The first storage tank 40 can also be set to a feed state in which the coating material present therein is removed and fed to the delivery nozzle 80. In the feed state, the inlet valve 43 is closed towards the second conduit branch 32a, the first outlet valve 64 is open and the first pressurizing element 44 is activated.

[0249] Similarly, the second storage tank 50 can be set to a fill state in which it receives and stores the coating material removed from the inlet tank 10. In the fill state, the inlet valve 43 is open to the third conduit branch 32b and closed to the first conduit branch 32a.

[0250] The second storage tank 50 may also be set to a reduced pressure state in which the coating material stored therein is reduced in pressure to remove any air bubbles. In the reduced pressure state, the inlet valve 43 is closed towards the third conduit branch 32b, the second outlet valve 65 is closed, and the second pressure reducing member 55 is activated.

[0251] The second storage tank 50 can also be set to a heating state in which the coating material stored therein is heated, in which the inlet valve 43 is closed to the third conduit branch 32b, the second outlet valve 65 is closed, and the second heating element 57 is activated.

[0252] The second storage tank 50 may also be set to a supply state in which the coating material stored therein is removed and supplied to the delivery nozzle 80. In the supply state, the inlet valve 43 is closed towards the third conduit branch 32b, the second outlet valve 65 is open, and the second pressurizing member 54 is activated.

[0253] The apparatus 1 further comprises a control unit 5 operatively connected to at least the inlet valve 43, the first outlet valve 64, the second outlet valve 65, the first pressurizing member 44, the first pressure reducing member 45, the first heating element 47, the second pressurizing member 54, the second pressure reducing member 55 and the second heating element 57.

[0254] The control unit 5 is configured to alternately set the first storage tank 40 and the second storage tank 50 to a supply state, and after an initial transient state, to alternately maintain the first storage tank 40 or the second storage tank 50 in said supply state.

[0255] When one of the first storage tank 40 and the second storage tank 50 is in a supply state, the control unit 5 sets the other of the first storage tank 40 and the second storage tank 50 to a filling state, then a depressurized state, and then a heating state. In particular, the control unit 5 is configured to maintain the depressurized state for a time comprised between 5 and 30 minutes.

[0256] To coat the injection medical device with a coating material, the coating material is introduced into the inlet tank 10. Preferably, the coating material comprises a silicone-based oil. Preferably, the injected coating material is introduced into the inlet tank 10 at a volume of 110 cm. 2 / s(11000cSt)~140cm 2 / s (14000 cSt), and even more preferably 120 cm 2 / s(12000cSt)~130cm 2 / s (13000cSt), for example, about 125cm 2 / s (12500cSt), 100cm 2 / s (10000 cSt). Preferably, the coating material has not been pre-sterilized. Preferably, the coating material and inlet tank are at room temperature.

[0257] The coating material is then removed from the inlet tank 10 by the service member 21, which pressurizes the coating material in the inlet tank 10. The coating material thus drains from the inlet tank 10 and flows into the first conduit branch 31 and through the first junction 33 and the inlet valve 43 into the second conduit branch 32a. In such a case, the inlet valve 43 is open towards the second conduit branch 32a and closed towards the third conduit branch 32b.

[0258] The coating material is then filtered through a first sterile filter 30 a and discharged through a second conduit 41 into a first storage tank 40 .

[0259] In this manner, the coating material is stored in the first storage tank 40 .

[0260] The second conduit branch 32 a is then closed by the inlet valve 43 to isolate the coating material stored in the first storage tank 40 .

[0261] The coating substance stored in the first storage tank 40 is then depressurized. Such depressurization is carried out by a first depressurization member 45. The pressure of the coating substance in the first storage tank 40 is brought to a value below atmospheric pressure, preferably comprised between 5 kPa (50 mbar) and 40 kPa (400 mbar), even more preferably comprised between 10 kPa (100 mbar) and 30 kPa (300 mbar), for example about 20 kPa (200 mbar), for a time comprised between 5 and 30 minutes in order to remove any air bubbles.

[0262] After depressurizing the coating material stored in the first storage tank 40, such coating material is heated by the first heating element 47. In particular, the coating material is heated until it reaches a temperature of 100° C. or above, more preferably 120° C. Alternatively, the coating material can be heated before or during depressurization in the first storage tank 40.

[0263] After the coating substance has been placed in the first storage tank 40, the inlet valve 43 closes the second conduit branch 32a and opens the third conduit branch 32b, allowing the coating substance to be dispensed from the inlet tank 10 into the second storage tank 50 through the second sterilizing filter 30b.

[0264] The coating material is therefore stored in a second storage tank 50 .

[0265] The third conduit branch 32 b is then closed by the inlet valve 43 to isolate the coating material stored in the second storage tank 50 .

[0266] The coating substance stored in the second storage tank 50 is then depressurized. Such depressurization is carried out by a second depressurization member 55. The pressure of the coating substance in the second storage tank 50 is brought to a value below atmospheric pressure, preferably comprised between 5 kPa (50 mbar) and 40 kPa (400 mbar), even more preferably comprised between 10 kPa (100 mbar) and 30 kPa (300 mbar), for example about 20 kPa (200 mbar), for a time comprised between 5 and 30 minutes in order to remove any air bubbles.

[0267] After depressurizing the coating material stored in the second storage tank 50, such coating material is heated by the second heating element 57. In particular, the coating material is heated until it reaches a temperature of 100° C. or above, more preferably 120° C. Alternatively, the coating material can be heated before or during depressurization in the second storage tank 50.

[0268] The coating material is then supplied from the first storage tank 40 to the delivery nozzle 80 by operating the supply pump 70, opening the first outlet valve 64 while keeping the second outlet valve 65 closed, and pressurizing the coating material in the first storage tank 40 by the first pressurizing member 44. The pressure of the coating material in the first storage tank 40 is raised to a value above atmospheric pressure and below 250 kPa (2.5 bar), more preferably below 200 kPa (2 bar).

[0269] The coating material therefore flows from the first storage tank 40 through the first conduit 71 , the feed pump 70 and the third conduit 81 until it reaches the delivery nozzle 80 .

[0270] While the coating material is being fed from the first storage tank 40 to the delivery nozzle 80 , the coating material is further heated, particularly by the third heating element 90 .

[0271] While coating material is being supplied from the first storage tank 40 to the delivery nozzle 80, further coating material coming from the inlet tank 10 is introduced, stored, depressurized and heated in the second storage tank 50 as described above.

[0272] When the coating material in the first storage tank 40 drops below or falls below a predetermined minimum level, the supply of coating material from the first storage tank 40 to the delivery nozzle 80 is interrupted, in particular by closing the first outlet valve 64. Coating material is then supplied from the second storage tank 50 to the delivery nozzle 80, whereby the supply of coating material to the delivery nozzle 80 is not interrupted.

[0273] To supply the coating material from the second storage tank 50 to the delivery nozzle 80, the second outlet valve 64 is opened while keeping the first outlet valve 65 closed, and the coating material is pressurized in the second storage tank 50, in particular by the second pressurizing member 54. The pressure of the coating material in the second storage tank 50 is raised to a pressure above atmospheric pressure and below 250 kPa (2.5 bar), more preferably below 200 kPa (2 bar).

[0274] The coating material therefore flows from the second storage tank 50 through the second conduit 72 , the feed pump 70 and the third conduit 81 until it reaches the delivery nozzle 80 .

[0275] While the coating material is being fed from the second storage tank 50 to the delivery nozzle 80 , the coating material is further heated, particularly by the third heating element 90 .

[0276] While coating material is being supplied from the second storage tank 50 to the delivery nozzle 80, additional coating material from the inlet tank 10 is introduced, stored, depressurized and heated in the first storage tank 40 as described above.

[0277] When the coating material in the second storage tank 50 drops below or falls below a predetermined minimum level, the supply of coating material from the second storage tank 50 to the delivery nozzle 80 is interrupted, particularly by closing the second outlet valve 65. The cycle is then restarted by supplying coating material from the first storage tank 40 to the delivery nozzle 80.

[0278] The coating material supplied to the delivery nozzle 80 is atomized at the delivery nozzle 80 by supplying pressurized gas from a source 100 .

[0279] The sprayed coating material is then delivered from the delivery nozzle 80 to the injection medical device to obtain an average thickness at the injection medical device, as measured by optical reflectometry, comprised between 100 and 200 nm, with a standard deviation of thickness of 50 nm or less, preferably 40 nm or less, more preferably 30 nm or less, and even more preferably 20 nm or less.

[0280] Naturally, in order to meet specific and uncertain requirements, those skilled in the art can make numerous modifications and variations to the invention described above, all of which nevertheless fall within the scope of protection defined by the following claims.

Claims

1. Apparatus (1) for coating injectable medical devices, - Inlet tank (10) that may be filled with a coating material - Dispensing nozzle (80) - A supply assembly (20) inserted between the inlet tank (10) and the discharge nozzle (80), in fluid communication with them, and configured to extract the coating material from the inlet tank (10) and supply it to the discharge nozzle (80). Equipped with, The apparatus (1) is characterized in that the delivery nozzle (80) is configured to deliver the coating material to an injection medical device, and the supply assembly (20) comprises at least one sterile filter (30a, 30b) configured to filter the coating material taken out from the inlet tank (10).

2. The supply assembly (20) comprises a first storage tank (40) inserted between the first sterilization filter (30a) and the discharge nozzle (80) and in fluid communication with them, wherein the first storage tank (40) is configured to receive and temporarily store the coating material, which is intended to be withdrawn from the inlet tank (10) and supplied to the discharge nozzle (80). The first storage tank (40) is - The first storage tank (40) receives and stores the coating substance taken out from the inlet tank (10), in a filled state. - The coating material stored in the first storage tank (40) is taken out of the first storage tank (40) and supplied to the discharge nozzle (80), supply state. The apparatus (1) according to claim 1, which can be selectively set to the following.

3. The supply assembly (20) comprises a second storage tank (50) inserted between the second sterilization filter (30b) and the discharge nozzle (80) and in fluid communication with them, wherein the second storage tank (50) is configured to receive and temporarily store the coating material, which is intended to be withdrawn from the inlet tank (10) and supplied to the discharge nozzle (80). The second storage tank (50) is - The second storage tank (50) receives and stores the coating material taken out from the inlet tank (10), in a filled state. - The coating material stored in the second storage tank (50) is taken out of the second storage tank (50) and supplied to the discharge nozzle (80), supply state. The apparatus (1) according to claim 2, which can be selectively set to the following.

4. The supply assembly (20) - At least one first heating element (47) configured to heat the coating material stored in the first storage tank (40) - At least one second heating element (57) configured to heat the coating material stored in the second storage tank (50) The apparatus (1) according to claim 3, which is dependent on claim 2, comprising:

5. - The at least one first heating element (47) is installed outside the first storage tank (40), and one or more electrical resistors are arranged inside the first insulation jacket (48) through which the heating fluid circulates. - The at least one second heating element (57) is installed outside the second storage tank (50), and one or more electrical resistors are arranged inside the second insulation jacket (58) through which the heating fluid circulates. The apparatus (1) according to claim 4.

6. The apparatus (1) according to claim 5, wherein the first storage tank (40) is removable from the first insulation jacket (48), and the second storage tank (50) is removable from the second insulation jacket (58).

7. A control unit (5) is operably connected to the first storage tank (40) and the second storage tank (50), wherein the control unit (5) - When the second storage tank (50) is in the filled state, the first storage tank (40) is set to the supply state, and - When the first storage tank (40) is in the filled state, set the second storage tank (50) to the supply state. The apparatus (1) according to claim 3, as it is dependent on claim 2, configured in such a way.

8. The supply assembly (20) - A first fluid circuit (22) having a first end (23) connected to the inlet tank (10), a second end (42) connected to the first storage tank (40), and a third end (52) connected to the second storage tank (50). - A second fluid circuit (60) having a first end (61) connected to the first storage tank (40), a second end (62) connected to the second storage tank (50), and a third end (82) connected to the discharge nozzle (80). The apparatus (1) according to claim 3, which is dependent on claim 2, comprising:

9. The apparatus (1) according to claim 8, wherein the supply assembly (20) comprises at least one thermal insulation jacket (91) that is removably installed around at least a portion of the second fluid circuit (60).

10. The apparatus (1) according to claim 9, wherein the supply assembly (20) comprises at least one third heating element (90) disposed inside the at least one heat-insulating jacket (91).

11. A method for coating injectable medical devices, - Introducing the coating substance into the inlet tank (10) - To remove the coating substance from the inlet tank (10) - After the coating material is removed from the inlet tank (10), the coating material is filtered. - After the coating material has been filtered, the coating material is supplied to the discharge nozzle (80). - Spray the coating substance onto the discharge nozzle (80) The method includes, - A method comprising: spraying the coating material and then delivering the coating material to an injection medical device by the delivery nozzle (80); and after the coating material is removed from the inlet tank (10), filtering the coating material is performed by at least one sterile filter (30a, 30b).

12. The method according to claim 11, comprising heating the coating material taken out from the inlet tank (10) when it is supplied to the discharge nozzle (80) while maintaining the inlet tank (10) at room temperature.

13. This includes selectively introducing the coating material, which is intended to be taken out of the inlet tank (10) and supplied to the discharge nozzle (80), into a first storage tank (40) or a second storage tank (50), The method according to claim 11 or 12, wherein supplying the coating material to the discharge nozzle (80) includes selectively supplying the coating material to the discharge nozzle (80) from the first storage tank (40) or the second storage tank (50).

14. The method according to claim 13, comprising heating the first storage tank (40) or the second storage tank (50) before supplying the coating material to the discharge nozzle (80) from the first storage tank (40) or the second storage tank (50).

15. The process includes creating a reduced pressure in the first storage tank (40) or the second storage tank (50) before supplying the coating material to the discharge nozzle (80) from the first storage tank (40) or the second storage tank (50), The first storage tank (40) or the second storage tank (50) is heated after the reduced pressure state is created in the first storage tank (40) or the second storage tank (50). The method according to claim 13, wherein supplying the coating material from the first storage tank (40) or the second storage tank (50) to the discharge nozzle (80) includes pressurizing the first storage tank (40) or the second storage tank (50) after creating the reduced pressure state in the first storage tank (40) or the second storage tank (50).

16. The method includes creating a reduced pressure in the first storage tank (40) or the second storage tank (50) before supplying the coating material to the discharge nozzle (80) from the first storage tank (40) or the second storage tank (50), The first storage tank (40) or the second storage tank (50) is heated after the reduced pressure state is created in the first storage tank (40) or the second storage tank (50). The method according to claim 14, wherein supplying the coating material from the first storage tank (40) or the second storage tank (50) to the discharge nozzle (80) includes pressurizing the first storage tank (40) or the second storage tank (50) after creating the reduced pressure state in the first storage tank (40) or the second storage tank (50).

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