Patent Description:
As is well known, injection medical devices are widely used in the medical field. They generally comprises a glass cylinder having an inner surface coated with a coating layer and a sealing plunger in sliding engagement within the glass cylinder to deliver a drug to a patient by an injection.

Such medical injection devices include syringes, cartridges but also auto-injectors or automatic injectors used for the subcutaneous and/or intravenous administration of drugs.

In this type of device, both to obtain the desired sliding properties of the plunger inside the cylinder of the injection medical device, e.g. the cylinder of a syringe, preventing abrasion of the cylinder surface of the syringe, and to provide a layer of protection between the drug and the cylinder, the inner surface of the syringe cylinder is typically coated with a lubricating coating substance, which is typically silicone oilbased.

To apply the coating substance, apparatuses are used which essentially consist of an inlet tank which can be filled with the coating substance, a delivery nozzle connected to the inlet tank and configured to deliver the coating substance nebulising it by the supply of compressed air, and a pump which is operationally interposed between the inlet tank and the delivery nozzle and configured to pump the coating substance towards the delivery nozzle.

The coating substance delivered on the injection medical device must necessarily be sterile, that is free of biological contaminants. Typically, a pre-sterilised coating substance is introduced into the inlet tank. The coating substance is thus sterilised on-site before it is introduced into the inlet tank, or it is purchased already pre-sterilised.

The Applicant has noted that sterilising the coating substance before introducing it into the inlet tank causes a burden on the operators. Furthermore, handling the coating substance for its sterilisation before introducing it into the inlet tank causes a risk of contact of the coating substance with biological contaminants, with consequent contamination of the coating substance.

The Applicant has also found that purchasing a pre-sterilised coating substance leads to increased costs and contamination risks of the coating substance in the time which passes between the supply of supplying the coating substance and its introduction into the inlet tank.

The Applicant has therefore felt the need to adopt precautions in handling the coating substance before and during the introduction thereof into the inlet tank.

The Applicant has realised that if an unsterilised coating substance is introduced in the inlet tank and the coating substance is sterilised while it is being supplied from the inlet tank to the delivery nozzle, both the supply of an unsterilised coating substance and the sterilisation of the coating substance prior to introduction into the inlet tank could be avoided. Furthermore, all the precautions which must be adopted to eliminate the risk of contamination of the coating substance during its introduction into the inlet tank could be avoided.

<CIT> discloses an apparatus for coating medical devices at the point of care with a polymer and/or therapeutic agent comprising an environmentally controlled device coating chamber in which the device may be delivered by the manufacturer as the device packaging, or the device may be placed into the chamber at the point of care. The environmentally controlled chamber can provide a sterile enclosure in which the polymer and/or a therapeutic agent can be applied to an uncoated or previously coated device and converted to another form (such as a liquid to a film or gel) if desired, under controlled and reproducible conditions.

<CIT> discloses a method for coating a medical implant, wherein the implant is submersed in an aqueous solution of magnesium, calcium and phosphate ions through which a gaseous weak acid is passed, the solution is degassed, and the coating is allowed to precipitate onto the implant. A medical implant coated in said method and a device for use in said method are also disclosed.

<CIT> discloses a process (and an apparatus carrying out said process) using an aqueous coating material. The process comprises a step in which at least part of the aqueous coating material and/or of an aqueous coating added to the aqueous coating is pasteurized continuously in a circulation loop of a tank containing the material or in a line carrying the material to a sprayhead.

<CIT> relates to the technical field of dental medical spray guns and discloses a one piece assembly-free aseptic three-purpose spray gun head structure comprising an air chamber cover provided with a water spraying pipe, an air spraying pipe and a mist spraying pipe connected with a spraying gun. The end of the air chamber cover is integrally connected with an air pipe assembly. The air pipe assembly can be prevented from being infected with bacteria in the installation process of the air chamber cover, and the sterile effect in the oral surgery is improved.

The present invention therefore relates, in a first aspect thereof, to an apparatus for coating an injection medical device, comprising:.

characterised in that said delivery nozzle is configured to deliver said coating substance to an injection medical device and in that said supply assembly comprises at least one sterilisation filter configured to filter the coating substance withdrawn from said inlet tank.

According to the invention, the inlet tank is filled with an unsterilised coating substance. The filling of the inlet tank is thus simplified and speeded up, as it is not necessary to adopt precautions to avoid contaminating the coating substance with biological contaminants.

The/each sterilisation filter filters the coating substance while it is supplied by the inlet tank to the delivery nozzle, removing the biological contaminants therefrom. Therefore, the filtering of the coating substance occurs automatically and does not require any additional operations by the operator, apart from the introduction of the coating substance into the inlet tank. Furthermore, the positioning of the sterilisation filter(s) in the supply assembly ensures that the coating substance does not come into contact with the external environment after sterilisation, eliminating any risk of contamination with biological contaminants.

In a second aspect thereof, the present invention relates to a method for coating an injection medical device, comprising:.

Throughout the present description and the appended claims, the term "sterilisation filter" is used to indicate a filter having a mesh size fine enough to intercept and capture at least <NUM>% of the bacteria present in the coating substance, preferably substantially <NUM>%.

The expression "fluid communication", referred to two or more components, is used to indicate that such components are hydraulically connected so that a fluid can pass from one component to the other, possibly after opening any valves interposed between the components.

The term "thermally insulating material" is used to indicate a material having a thermal conductivity equal to or less than <MAT>.

In at least one of the aforementioned aspects, the present invention may comprise one or more of the following features, taken individually or possibly combined with each other.

Preferably, the entire apparatus of the invention, or at least the part of the apparatus that is upstream of the sterilisation filter(s), is arranged within a laminar flow hood, so as to fall within the environmental class suitable for the production of sterile components (class <NUM> of ISO <NUM>-<NUM> standard).

Preferably, the inlet tank is maintained at room temperature. Preferably, the coating substance is fed into the inlet tank at room temperature.

Preferably, the coating substance is kept at room temperature in the inlet tank.

Preferably, a service member is provided which is configured to pressurise the coating substance in the inlet tank.

Preferably, the service member is configured to provide the coating substance which is in the inlet tank with a pressure that is sufficient to move the coating substance from the inlet tank towards the sterilisation filter(s).

More preferably, the service member is configured to move the coating substance from the inlet tank through the sterilisation filter(s). Preferably, said coating substance has a viscosity greater than <NUM> cSt (<NUM> cSt = <NUM><NUM>/s).

More preferably, said coating substance has a viscosity less than <NUM> cSt.

In particularly preferred embodiments, said viscosity is comprised between <NUM> cSt and <NUM> cSt, more preferably between <NUM> cSt and <NUM> cSt, e.g. about <NUM> cSt.

The Applicant has found that by delivering a coating substance whose viscosity is one order of magnitude greater than the typically adopted viscosity of about <NUM> cSt on the injection medical device, the coating obtained in the injection medical device maintains its lubricating properties more effectively over time and the possibility of the coating substance to release particles into the injection medical device, thus altering the properties of the medical product to be injected by the injection medical device, is reduced.

Preferably, the inlet tank comprises at least one transparent wall portion through which the level of the coating substance inside the inlet tank can be checked, without the need to open the inlet tank.

Preferably, said at least one sterilisation filter has a mesh size less than <NUM>.

Preferably, said at least one sterilisation filter has a mesh size greater than <NUM>.

In particularly preferred embodiments, the mesh size of said at least one sterilisation filter is comprised between <NUM> and <NUM>, more preferably between <NUM> and <NUM>, e.g. about <NUM>.

Preferably, the supply assembly comprises a supply pump interposed between, and in fluid communication with, said at least one sterilisation filter and said delivery nozzle, the supply pump being configured to pump said coating substance towards said delivery nozzle.

Preferably, the supply pump is a pump of the volumetric type.

Preferably, the supply assembly comprises a plurality of heating elements configured to heat said coating substance withdrawn from said inlet tank prior to being delivered by said delivery nozzle. Indeed, the Applicant has found that when heated the coating substance flows more easily through the various conduits and the various components of the apparatus of the present invention, especially when, as in the preferred embodiments of the invention, a high-viscosity coating substance is used.

Preferably, said supply assembly comprises a first storage tank interposed between, and in fluid communication with, a first sterilisation filter and said delivery nozzle, wherein said first storage tank is configured to receive and temporarily store the coating substance withdrawn from said inlet tank and intended to be supplied to the delivery nozzle.

Preferably, said first storage tank can be configured in a filling condition in which said first storage tank receives and stores the coating substance withdrawn from the inlet tank.

The possibility to store the already sterilised coating substance in the first storage tank allows the coating substance to be supplied to the delivery nozzle while operations are being carried out on the inlet tank (e.g. cleaning or filling operations) or on the first sterilisation filter (e.g. cleaning or replacement operations).

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

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

Preferably, said first storage tank can be configured in a depressurisation condition in which the coating substance stored in the first storage tank is maintained at a pressure less than the atmospheric pressure.

Preferably, such pressure is comprised between <NUM> mbar and <NUM> mbar, more preferably between <NUM> mbar and <NUM> mbar, e.g. about <NUM> mbar.

Depressurising the coating substance in the first storage tank for a certain period of time allows to remove any bubbles formed following the passage of the coating substance through the first sterilisation filter. Such an expedient is particularly useful when the coating substance has a particularly high viscosity, a circumstance which makes the formation of bubbles more likely.

Preferably, when said first storage tank is in the depressurisation condition it is tightly sealed off with respect to the other components of the apparatus of the invention.

Preferably, said first storage tank can be configured in a heating condition in which the coating substance stored in the first storage tank is heated up to a temperature of <NUM> or higher, preferably <NUM>.

Heating the coating substance in the first storage tank improves the rheological properties of the coating substance, especially if the coating substance has a high viscosity, and facilitates its supply to the delivery nozzle. The improved rheological properties of the coating substance allow to deliver it from the delivery nozzle more uniformly and precisely, thereby obtaining a uniform and thin layer of coating substance on the medical device.

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

The first heating element can be any element configured to release thermal energy and placed in a heat exchange relationship with the coating substance stored in the first storage tank.

Preferably, said at least one first heating element is arranged inside a first insulating jacket made at least partially of a thermally insulating material and placed outside the first storage tank.

Said first heating element may comprise, for example, one or more electrical resistors or one or more conduits formed in, or associated with, the first insulating jacket and in which heating fluid circulates.

In alternative embodiments, the first heating element is a heating coil (e.g. an electrical resistor or a conduit in which a suitable heating fluid circulates) placed inside the first storage tank.

Preferably, the first storage tank is removable from the first insulating jacket.

In this way it is possible to easily perform maintenance or cleaning operations on the first storage tank.

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

Preferably, said first storage tank can be configured in a supply condition in which the coating substance stored in the first storage tank is withdrawn from the first storage tank to be supplied to the delivery nozzle.

Preferably, in the aforementioned supply condition, the coating substance stored in the first storage tank is brought to a pressure greater than the atmospheric pressure.

Preferably, such pressure is less than <NUM> bar, more preferably less than <NUM> bar.

In this way the exit of the coating substance from the first storage tank is facilitated and the risk of cavitation of the supply pump is reduced.

Preferably, said first storage tank is selectively configurable in the filling condition or in the supply condition.

Preferably, said first storage tank is selectively configurable in the filling condition or in the depressurisation condition or in the heating condition or in the supply condition.

Preferably, said supply assembly comprises a second storage tank interposed between, and in fluid communication with, a second sterilisation filter and said delivery nozzle, wherein said second storage tank is configured to receive and temporarily store the coating substance withdrawn from said inlet tank and intended to be supplied to the delivery nozzle.

Preferably, said second storage tank can be configured in a filling condition in which said second storage tank receives and stores the coating substance withdrawn from the inlet tank.

The possibility to store the already sterilised coating substance in the second storage tank allows to supply the coating substance from the inlet tank to the second storage tank while the first storage tank is in an unsuitable condition to receive the coating substance, e.g. in a depressurisation, heating or supply condition. Furthermore, it is possible to supply the coating substance to the delivery nozzle from the second storage tank while the first storage tank is filled with further coating substance, or during a possible replacement of the first storage tank, or while operations are performed on the inlet tank (e.g. cleaning or filling operations) or on the first sterilisation filter (e.g. cleaning or replacement operations).

The provision of two storage tanks therefore allows one of such storage tanks to be filled with coating substance coming from the inlet tank, or cleaning or replacement operations to be carried out on such a storage tank, or on the respective sterilisation filter if a respective sterilisation filter is provided upstream of each storage tank, while the other previously filled storage tank supplies the coating substance to the delivery nozzle and vice versa, thus achieving a substantially continuous supply of coating substance to the delivery nozzle.

In some embodiments, the supply assembly comprises a single sterilisation filter arranged downstream of the inlet tank and upstream of the two storage tanks.

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

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

Preferably, said second storage tank can be configured in a depressurisation condition in which the coating substance stored in the second storage tank is maintained at a pressure less than the atmospheric pressure.

Preferably, such pressure is comprised between <NUM> mbar and <NUM> mbar, more preferably comprised between <NUM> mbar and <NUM> mbar, e.g. about <NUM> mbar.

The depressurisation of the coating substance in the second storage tank allows the removal of bubbles formed following the passage of the coating substance through the second sterilisation filter or through the single sterilisation filter which might be provided upstream of the two storage tanks.

Preferably, when said second storage tank is in the depressurisation condition it is tightly sealed off with respect to the other components of the apparatus of the invention.

Preferably, said second storage tank can be configured in a heating condition in which the coating substance stored in the second storage tank is heated up to a temperature of <NUM> or higher, preferably <NUM>.

Heating the coating substance in the second storage tank improves the rheological properties of the coating substance, as described above with reference to the first storage tank.

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

The second heating element may be any element configured to release thermal energy and placed in a heat exchange relationship with the coating substance stored in the second storage tank.

Preferably, said at least one second heating element is arranged inside a second insulating jacket made at least partially of a thermally insulating material and placed outside the second storage tank.

Said second heating element may comprise, for example, one or more electrical resistors or one or more conduits formed in, or associated with, the second insulating jacket and in which heating fluid circulates.

In alternative embodiments, the second heating element is a heating coil (e.g. an electrical resistor or a conduit in which a suitable heating fluid circulates) placed inside the second storage tank.

Preferably, the second storage tank is removable from the second insulating jacket, so that maintenance or cleaning operations can be performed, for example.

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

Preferably, said second storage tank can be configured in a supply condition in which the coating substance stored in the second storage tank is withdrawn from the second storage tank to be supplied to the delivery nozzle.

The coating substance, properly filtered, degassed and heated, can thus be supplied to the delivery nozzle from the second storage tank while the first storage tank is in the filling, depressurisation or heating condition.

Preferably, in the aforementioned supply condition, the coating substance stored in the second storage tank is brought to a pressure greater than the atmospheric pressure.

Preferably, such pressure is less than <NUM> bar, more preferably less than <NUM> bar, so as to facilitate the exit of the coating substance from the second storage tank and reduce the risk of cavitation of the supply pump.

Preferably, said second storage tank is selectively configurable in the filling condition or in the supply condition.

Preferably, said second storage tank is selectively configurable in the filling condition or in the depressurisation condition or in the heating condition or in the supply condition.

Preferably, a control unit is operatively connected to said first storage tank and second storage tank.

Preferably, the control unit is configured to set in said first storage tank said supply condition when said second storage tank is in the filling condition.

Preferably, the control unit is configured to set in said first storage tank said supply condition when said second storage tank is in the depressurisation condition.

Preferably, the control unit is configured to set in said first storage tank said supply condition when said second storage tank is in the heating condition.

Preferably, the control unit is configured to set in said second storage tank said supply condition when said first storage tank is in the filling condition.

Preferably, the control unit is configured to set in said second storage tank said supply condition when said first storage tank is in the depressurisation condition.

Preferably, the control unit is configured to set in said second storage tank said supply condition when said first storage tank is in the heating condition.

Preferably, the control unit is configured to control the first heating element based on signals received from the first temperature sensor.

Preferably, the control unit is configured to control the second heating element based on signals received from the second temperature sensor.

Preferably, the control unit is configured to switch from the heating condition to the supply condition of the first storage tank based on signals received from the first temperature sensor.

Preferably, the control unit is configured to switch from the heating condition to the supply condition of the second storage tank based on signals received from the second temperature sensor.

Preferably, the control unit is configured to switch from the filling condition to the depressurisation condition of the first storage tank based on signals received from the first fill level detector.

Preferably, the control unit is configured to switch from the filling condition to the depressurisation condition of the second storage tank based on signals received from the second fill level detector.

Preferably, the control unit is configured to switch from the supply condition to the filling condition of the first storage tank based on signals received from the first fill level detector.

Preferably, the control unit is configured to switch from the supply condition to the filling condition of the second storage tank based on signals received from the second fill level detector.

Preferably, said supply assembly comprises a first fluid circuit having a first end coupled to said inlet tank, a second end coupled to said first storage tank and a third end coupled to said second storage tank.

Preferably, said supply assembly comprises a second fluid circuit having a first end coupled to said first storage tank, a second end coupled to said second storage tank and a third end coupled to said delivery nozzle.

Preferably, said first fluid circuit comprises a first conduit that connects said inlet tank to said first sterilisation filter, a second conduit that connects said first sterilisation filter to said first storage tank, a third conduit that connects said inlet tank to said second sterilisation filter, and a fourth conduit that connects said second sterilisation filter to said second storage tank.

Preferably, the first conduit and the third conduit can be entirely separate from each other or share a common conduit branch.

Preferably, the supply pump belongs to the second fluid circuit.

Preferably, a first conduit of the second fluid circuit connects said first storage tank to said supply pump.

Preferably, a second conduit of the second fluid circuit connects said second storage tank to said supply pump.

Preferably, a third conduit of the second fluid circuit connects said supply pump to said delivery nozzle.

Preferably, said supply assembly comprises at least one insulation jacket removably placed around at least part of said second fluid circuit.

The possibility of removing the insulation jacket from the part of the second fluid circuit on which it is placed allows an easy disassembly of such a part of circuit, such disassembly being necessary to be able to perform periodic cleaning operations on this part of circuit. Such periodic cleaning is particularly necessary when the coating substance used is high-viscosity silicone.

Preferably, said supply assembly includes at least one third heating element configured to heat at least part of said second fluid circuit.

The third heating element allows to keep the coating substance in the second fluid circuit at a temperature such as to optimise the rheological properties of the coating substance, promoting the flow thereof in the second fluid circuit and an uniform spraying from the delivery nozzle.

Preferably, said at least one third heating element is arranged inside said at least one insulation jacket.

Preferably, said at least one third heating element comprises an electrical resistor.

Preferably, said supply assembly comprises at least one temperature sensor associated with said insulation jacket.

Preferably, said temperature sensor is integrated in said at least one insulation jacket.

Preferably, the control unit is configured to control said at least one third heating element based on signals received by the respective temperature sensor.

In particularly preferred embodiments, a first insulation jacket is provided on the first conduit of the second fluid circuit.

Preferably, a second insulation jacket is provided on the second conduit of the second fluid circuit.

Preferably, a third insulation jacket is provided on the third conduit of the second fluid circuit.

Thus, all the conduits that connect the first storage tank and the second storage tank to the supply pump and the latter to the delivery nozzle can be disassembled and possibly replaced or reassembled after being cleaned thanks to the provision on each of such conduits of a respective removable insulation jacket.

Preferably, the first conduit and the second conduit of the second fluid circuit have equal length.

Preferably, the first conduit and the second conduit of the second fluid circuit have equal fluid passage sections.

Preferably, the first conduit and the second conduit of the second fluid circuit have a constant fluid passage section along them.

In this way, the properties of the coating substance which is supplied to the delivery nozzle from the first storage tank or the second storage tank do not change.

Preferably, when said coating substance is fed into said inlet tank, the inlet tank is at atmospheric pressure.

Preferably, withdrawing said coating substance from said inlet tank comprises pressurising said inlet tank.

Preferably, filtering said coating substance after it has been withdrawn from said inlet tank comprises passing said coating substance through the sterilisation filter due to the pressurisation of the inlet tank.

Preferably, the coating substance withdrawn from the inlet tank is heated when it is supplied to the delivery nozzle while maintaining the inlet tank at room temperature.

Preferably, the coating substance withdrawn from the inlet tank is filtered while maintaining it at room temperature, and then heated.

Preferably, the coating substance withdrawn from the inlet tank and intended to be supplied to the delivery nozzle is selectively introduced into the first storage tank or the second storage tank.

Preferably, the selective feeding of the coating substance into the first storage tank or the second storage tank occurs due to the pressurisation of the inlet tank.

Preferably, the coating substance stored in the first storage tank is kept at a value less than <NUM> bar, more preferably less than <NUM> bar, when said coating substance is supplied to the delivery nozzle from the first storage tank.

Preferably, the pressure of the coating substance stored in the first storage tank is maintained at a value greater than the atmospheric pressure when said coating substance is supplied to the delivery nozzle from the first storage tank.

Preferably, the pressure of the coating substance stored in the second storage tank is kept at a value less than <NUM> bar, more preferably less than <NUM> bar, when said coating substance is supplied to the delivery nozzle from the second storage tank.

Preferably, the pressure of the coating substance stored in the second storage tank is maintained at a value greater than the atmospheric pressure when said coating substance is supplied to the delivery nozzle from the second storage tank.

Preferably, supplying the coating substance to the delivery nozzle comprises supplying the coating substance to the delivery nozzle selectively from the first storage tank or from the second storage tank.

Preferably, before supplying the coating substance to the delivery nozzle from said first storage tank, a depressurisation condition is created in said first storage tank.

Preferably, creating a depressurisation condition in said first storage tank comprises bringing the pressure of the coating substance in the first storage tank to a value less than the atmospheric pressure, preferably comprised between <NUM> mbar and <NUM> mbar, even more preferably comprised between <NUM> mbar and <NUM> mbar, e.g. about <NUM> mbar.

Preferably, the depressurisation condition in said first storage tank is maintained for a time comprised between <NUM> and <NUM> minutes.

Preferably, a single depressurisation cycle is carried out in said first storage tank, in which case the pressurisation condition is maintained for a minimum time of <NUM> minutes.

Alternatively, several depressurisation cycles (e.g. <NUM>-<NUM> cycles) can be carried out in said first storage tank, in which case in each of said depressurisation cycles the pressurisation condition is maintained for about <NUM> minutes.

Preferably, before creating said depressurisation condition in said first storage tank, said first storage tank is tightly sealed off from the inlet tank and from the delivery nozzle.

Preferably, before supplying the coating substance to the delivery nozzle from said second storage tank, a depressurisation condition is created in said second storage tank.

Preferably, creating a depressurisation condition in said second storage tank comprises bringing the pressure of the coating substance in the second storage tank to a value less than the atmospheric pressure, preferably comprised between <NUM> mbar and <NUM> mbar, even more preferably comprised between <NUM> mbar and <NUM> mbar, e.g. about <NUM> mbar.

Preferably, the depressurisation condition in said second storage tank is maintained for a time comprised between <NUM> and <NUM> minutes.

Preferably, a single depressurisation cycle is carried out in said second storage tank, in which case the pressurisation condition is maintained for a minimum of <NUM> minutes.

Alternatively, several depressurisation cycles (e.g. <NUM>-<NUM> cycles) can be carried out in said second storage tank, in which case in each of said depressurisation cycles the pressurisation condition is maintained for about <NUM> minutes.

Preferably, before creating said depressurisation condition in said second storage tank, said second storage tank is tightly sealed off from the inlet tank and from the delivery nozzle.

Preferably, said first storage tank is heated before supplying the coating substance to the delivery nozzle from the first storage tank.

Preferably, the coating substance stored in the first storage tank is heated to a temperature of <NUM> or higher, more preferably <NUM>, before supplying the coating substance to the delivery nozzle from the first storage tank.

Preferably, said second storage tank is heated before supplying the coating substance to the delivery nozzle from the second storage tank.

Preferably, the coating substance stored in the second storage tank is heated to a temperature of <NUM> or higher, more preferably <NUM>, before supplying the coating substance to the delivery nozzle from the second storage tank.

Preferably, said first storage tank is heated after having created in said first storage tank said depressurisation condition.

Preferably, said second storage tank is heated after having created in said second storage tank said depressurisation condition.

Preferably, supplying said coating substance to the delivery nozzle from said first storage tank comprises pressurising said first storage tank after having created said depressurisation condition in said first storage tank.

Preferably, supplying said coating substance to the delivery nozzle from said second storage tank comprises pressurising said second storage tank after having created said depressurisation condition in said second storage tank.

The features and advantages of the present invention will result from the following detailed description of some examples embodiments thereof, provided by way of non-limiting example only, such a description being conducted referring to the appended drawings, in which:.

An apparatus for coating an injection medical device, which is the subject matter of the present invention, is schematically shown in <FIG> and is indicated by numerical reference <NUM>.

The apparatus <NUM> comprises an inlet tank <NUM> that can be filled with a coating substance by an operator.

The inlet tank <NUM> comprises an access sleeve <NUM> through which the coating substance can be fed.

The access sleeve <NUM> is configured to allow a tight sealed insulation of the inlet tank <NUM> by, for example, the closure of a special valve, not shown.

The apparatus <NUM>, or at least the inlet tank <NUM> and the access sleeve <NUM>, is/are arranged inside a laminar flow hood.

The inlet tank <NUM> comprises a side wall 10a, preferably cylindrical. At least part of the side wall 10a is made of at least partially transparent material, for example glass, so that the operator can check the level of the coating substance inside the inlet tank <NUM> without having to open it. The side wall 10a has a graduated scale adapted to allow the amount of coating substance inside the inlet tank <NUM> to be measured.

The inlet tank <NUM> further comprises a lower wall 10b and an upper wall 10c, preferably made of stainless steel. The side wall 10a extends between the lower wall 10b and the upper wall 10c.

The inlet tank <NUM> is configured to gradually release the coating substance. The inlet tank <NUM> is kept at room temperature. The coating substance is fed therein at room temperature and is maintained at room temperature.

The apparatus <NUM> comprises a supply assembly <NUM> configured to withdraw the coating substance from the inlet tank <NUM>.

A service member <NUM> is associated with inlet tank <NUM>.

The service member <NUM> is configured to pressurise the coating substance in the inlet tank <NUM> so as to make it flow out into the supply assembly <NUM>.

The service member <NUM> comprises, for example, a pressure pump or a compressed air line connected to a compressor.

The supply assembly <NUM> comprises a first fluid circuit <NUM> in fluid communication with the inlet tank <NUM> to receive the coating substance flowing out therefrom. In particular, the first fluid circuit <NUM> comprises a first end <NUM> at which the first fluid circuit <NUM> is connected to the inlet tank <NUM>.

The supply assembly <NUM> further comprises a first sterilisation filter 30a configured to filter the coating substance withdrawn from the inlet tank <NUM>. The first sterilisation filter 30a is configured to remove biological contaminants from the coating substance, preferably in their entirety.

In the preferred embodiment, the first sterilisation filter 30a has a mesh size of <NUM> (micrometre).

The first sterilisation filter 30a is placed in the first fluid circuit <NUM>, in fluid communication with the inlet tank <NUM> through a first conduit having a first conduit branch <NUM> extended from the inlet tank <NUM> to a first junction <NUM> and a second conduit branch 32a extended from the first junction <NUM> to the first sterilisation filter 30a.

The first conduit branch <NUM> and the second conduit branch 32a are preferably made of stainless steel or of a temperature-resistant plastic material, e.g. PTFE (polytetrafluoroethylene) or FEP (fluorinated ethylene propylene).

The service member <NUM> is configured to provide the coating substance with a pressure that is sufficient to make it pass through the first sterilisation filter 30a with a predetermined flow rate.

The supply assembly <NUM> further comprises a first storage tank <NUM>, schematically shown in <FIG> and preferably made of stainless steel.

The first storage tank <NUM> is placed downstream of the first sterilisation filter 30a and in fluid communication with the inlet tank <NUM> through the first sterilisation filter 30a, so that it can temporarily store the coating substance withdrawn from the inlet tank <NUM> and filtered by the first sterilisation filter 30a.

The first fluid circuit <NUM> comprises a second conduit <NUM> extended from the first sterilisation filter 30a to the first storage tank <NUM> to put the first sterilisation filter 30a in fluid communication with the first storage tank <NUM>. The first fluid circuit <NUM> further comprises a second end <NUM> at which the first fluid circuit <NUM> is connected to the first storage tank <NUM> and through which the coating substance is fed into the first storage tank <NUM>.

The second conduit <NUM> is preferably made of stainless steel or of a temperature-resistant plastic material, e.g. PTFE or FEP.

The pressure provided to the coating substance by the service member <NUM> allows the coating substance to flow from the inlet tank <NUM> through the first conduit branch <NUM>, the second conduit branch 32a, the first sterilisation filter 30a and the second conduit <NUM> until it reaches the first storage tank <NUM>.

A first pressurisation member <NUM>, for example a pressure pump or a compressed air line in communication with a compressor, is associated with the first storage tank <NUM> to pressurise the coating substance stored in the first storage tank <NUM> in a selective and controlled manner. In particular, the first pressurisation member <NUM> is configured to pressurise the coating substance in the first storage tank <NUM> to a pressure greater than the atmospheric pressure and less than <NUM> bar, preferably less than <NUM> bar.

A first depressurisation member <NUM>, e.g. a vacuum pump, is associated with the first storage tank <NUM> to depressurise the coating substance stored in the first storage tank <NUM> in a selective and controlled manner.

In particular, the first depressurisation member <NUM> is configured to depressurise the coating substance in the first storage tank <NUM> to bring it to a pressure less than the atmospheric pressure, preferably comprised between <NUM> mbar and <NUM> mbar, more preferably comprised between <NUM> mbar and <NUM> mbar, e.g. about <NUM> mbar.

The first storage tank <NUM> comprises a first fill level detector <NUM> configured to detect the fill level of the first storage tank <NUM>. The first fill level detector <NUM> may comprise, for example, a load cell configured to measure the pressure of the coating substance in the first storage tank <NUM>.

A first heating element <NUM> is associated with the first storage tank <NUM> to heat the first storage tank <NUM> and the coating substance contained therein in a selective and controlled manner. The first heating element <NUM> is removably mounted on the first storage tank <NUM>, preferably outside the first storage tank <NUM>.

In the preferred embodiment, the first heating element <NUM> is integrated in a first insulating jacket <NUM>, which is made at least partially of a thermally insulating material and is placed outside the first storage tank <NUM>. The first heating element <NUM> may comprise, for example, electrical resistors or heating conduits (coils) in which a heating fluid circulates.

The first insulating jacket <NUM> is configured to thermally insulate the first storage tank <NUM> so as not to dissipate the heat provided by the first heating element <NUM>. The first storage tank <NUM> can be removed from the first insulating jacket <NUM>, e.g. to carry out maintenance or cleaning operations.

A first temperature sensor 49a is associated with the first insulating jacket <NUM>, and thus with the first storage tank <NUM>, to monitor the temperature of the first insulating jacket <NUM>, and thus of the first storage tank <NUM> and of the coating substance contained in the first storage tank <NUM>. Preferably, the first temperature sensor 49a comprises a temperature sensor placed inside the first insulating jacket <NUM> to check that the temperature of the coating substance contained in the first storage tank <NUM> reaches <NUM>.

The supply assembly <NUM> further comprises a second sterilisation filter 30b and a second storage tank <NUM> placed downstream of the second sterilisation filter 30b. The second sterilisation filter 30b and the second storage tank <NUM> are schematically shown in <FIG> and are analogous to the first sterilisation filter 30a and the first storage tank <NUM>, respectively.

The second sterilisation filter 30b is configured to filter the coating substance withdrawn from the inlet tank <NUM> and supplied to the second storage tank <NUM>.

Like the first sterilisation filter 30a, the second sterilisation filter 30b is also configured to eliminate biological contaminants from the coating substance, preferably in their entirety, and has a mesh size of <NUM>.

The second sterilisation filter 30b is placed in the first fluid circuit <NUM>, in fluid communication with the inlet tank <NUM> through a third conduit comprising the first conduit branch <NUM> extended from the inlet tank <NUM> to the first junction <NUM> and a third conduit branch 32b extended from the first junction <NUM> to the second sterilisation filter 30b.

The third conduit branch 32b is also preferably made of stainless steel or of a temperature-resistant plastic material, e.g. PTFE or FEP.

The service member <NUM> is configured to provide the coating substance with a pressure that is sufficient to make it pass through the second sterilisation filter 30b with a predetermined flow rate.

The second storage tank <NUM> is placed in fluid communication with the inlet tank <NUM> through the second sterilisation filter 30b. The second storage tank <NUM> is configured to temporarily store the coating substance withdrawn from the inlet tank <NUM> and filtered by the second sterilisation filter 30b.

In the preferred embodiment, the second storage tank <NUM> is made of stainless steel.

The first fluid circuit <NUM> comprises a fourth conduit <NUM> extended from the second sterilisation filter 30b to the second storage tank <NUM> to put the second sterilisation filter 30b in fluid communication with the second storage tank <NUM>.

The second fluid circuit <NUM> further comprises a third end <NUM> at which the first fluid circuit <NUM> is connected to the second storage tank <NUM> and through which the coating substance is fed into the second storage tank <NUM>.

The fourth conduit <NUM> is preferably made of stainless steel or of a temperature-resistant plastic material, e.g. PTFE or FEP.

The coating substance can be brought from the inlet tank <NUM> to the second storage tank <NUM>. The pressure provided to the coating substance by the service member <NUM> allows the coating substance to flow from the inlet tank <NUM> through the first conduit branch <NUM>, the third conduit branch 32b, the second sterilisation filter 30b and the fourth conduit <NUM> until it reaches the second storage tank <NUM>.

In an embodiment not shown, apparatus <NUM> comprises a single sterilisation filter in place of the aforesaid two sterilisation filters 30a, 30b. Such a single sterilisation filter may be arranged in the first conduit branch <NUM> and the first junction <NUM> be placed between the aforementioned single sterilisation filter, the first storage tank <NUM> and the second storage tank <NUM>. Alternatively, the aforementioned single sterilisation filter may be placed at the first junction <NUM>. In both cases, the second conduit branch 32a and the second conduit <NUM> define a single conduit.

Through the first junction <NUM>, the coating substance can be directed alternatively and in a controlled manner from the inlet tank <NUM> to the first storage tank <NUM>, through the first conduit branch <NUM>, the second conduit branch 32a, the first sterilisation filter 30a and the second conduit <NUM>, or from the inlet tank <NUM> to the second storage tank <NUM>, through the first conduit branch <NUM>, the third conduit branch 32b, the second sterilisation filter 30b and the fourth conduit <NUM>.

As shown in <FIG>, the first fluid circuit <NUM> comprises an inlet valve <NUM>, placed for example at the junction <NUM> and configured to isolate in a controlled manner either the first storage tank <NUM> or the second storage tank <NUM> from the first fluid circuit <NUM>.

The inlet valve <NUM> is controlled to selectively direct the coating substance from inlet tank <NUM> to the first storage tank <NUM> or the second storage tank <NUM>.

Preferably, the inlet valve <NUM> is a three-way valve.

Alternatively, a first inlet valve placed for example at the second end <NUM> and a second inlet valve placed for example at the third end <NUM> may be provided to isolate in a controlled manner the first storage tank <NUM> or the second storage tank <NUM>, respectively, from the first fluid circuit <NUM>.

A second pressurisation member <NUM>, for example a pressure pump or a compressed air line in communication with a compressor, is associated with the second storage tank <NUM> to pressurise the coating substance stored in the second storage tank <NUM> in a selective and controlled manner. The second pressurisation member <NUM> is configured to pressurise the coating substance in the second storage tank <NUM> to a pressure greater than the atmospheric pressure and less than <NUM> bar, preferably less than <NUM> bar.

A second depressurisation member <NUM>, e.g. a vacuum pump, is associated with the second storage tank <NUM> to depressurise the coating substance stored in the second storage tank <NUM> in a selective and controlled manner. The second depressurisation member <NUM> is configured to depressurise the coating substance in the second storage tank <NUM> to bring it to a pressure less than the atmospheric pressure, preferably comprised between <NUM> mbar and <NUM> mbar, even more preferably comprised between <NUM> mbar and <NUM> mbar, e.g. about <NUM> mbar.

The second storage tank <NUM> comprises a second fill level detector <NUM> configured to detect the fill level of the second storage tank <NUM>. The second fill level detector <NUM> may comprise, for example, a load cell configured to measure the pressure of the coating substance in the second storage tank <NUM>.

A second heating element <NUM> is associated with the second storage tank <NUM> to heat the coating substance contained therein in a controlled manner. The second heating element <NUM> is removably mounted on the second storage tank <NUM>, preferably outside the second storage tank <NUM>.

In the preferred embodiment, the second heating element <NUM> is integrated in a second insulating jacket <NUM>, which is made at least partially of a thermally insulating material and is placed outside the second storage tank <NUM>. The second heating element <NUM> may comprise, for example, electrical resistors or heating conduits (coils) in which a heating fluid circulates.

The second insulating jacket <NUM> is configured to thermally insulate the second storage tank <NUM> so as not to dissipate the heat provided by the second heating element <NUM>. The second storage tank <NUM> can be removed from the second insulating jacket <NUM>, for example to perform maintenance or cleaning operations.

A second temperature sensor 59a is associated with the second insulating jacket <NUM>, and thus the second storage tank <NUM>, to measure the temperature of the second insulating jacket <NUM>, and thus of the second storage tank <NUM> and of the coating substance contained therein. Preferably, the second temperature sensor 59a comprises a temperature sensor placed inside the second insulating jacket <NUM> to check that the temperature of the coating substance contained in the second storage tank <NUM> reaches <NUM>.

The supply assembly <NUM> further comprises a second fluid circuit <NUM> in fluid communication with the first storage tank <NUM> and with the second storage tank <NUM>.

The second fluid circuit <NUM> comprises a first end <NUM> connected to the first storage tank <NUM> and a second end <NUM> connected to the second storage tank <NUM>.

As shown in <FIG>, a first outlet valve <NUM> is arranged for example at the first end <NUM> and is configured to isolate the first storage tank <NUM> from the second fluid circuit <NUM> in a controlled manner. Similarly, a second outlet valve <NUM> is arranged for example at the second end <NUM> and is configured to isolate the second storage tank <NUM> from the second fluid circuit <NUM> in a controlled manner.

As shown in <FIG>, the supply assembly <NUM> also comprises a supply pump <NUM> in fluid communication with the first storage tank <NUM> and with the second storage tank <NUM>. The supply pump <NUM> is arranged in the second fluid circuit <NUM> and is, preferably, a volumetric pump.

In a preferred embodiment, the supply pump <NUM> comprises a respective heating element 70a configured to heat the coating substance within the pump. For example, the heating element 70a may comprise one or more electrical resistors applied on or integrated in a casing of the supply pump <NUM>.

The second fluid circuit <NUM> comprises a first conduit <NUM> that connects the first storage tank <NUM> to the supply pump <NUM> and a second conduit <NUM> that connects the second storage tank <NUM> to a suction head of the supply pump <NUM>.

The first conduit <NUM> and the second conduit <NUM> are preferably made of stainless steel or of a temperature-resistant plastic material, e.g. PTFE or FEP.

The first conduit <NUM> and the second conduit <NUM> converge in a second junction <NUM> placed between the first storage tank <NUM>, the second storage tank <NUM> and the supply pump <NUM>. The first conduit <NUM> and the second conduit <NUM> may comprise a common section between the second junction <NUM> and the supply pump <NUM>, as shown in <FIG>.

Preferably, the first conduit <NUM> and the second conduit <NUM> have equal length and fluid passage section. Furthermore, the first conduit <NUM> and the second conduit <NUM> have constant fluid passage sections along them.

The coating substance may be supplied to the supply pump <NUM> selectively and in a controlled manner from the first storage tank <NUM> through the first conduit <NUM> or from the second storage tank <NUM> through the second conduit <NUM>.

The first outlet valve <NUM> and the second outlet valve <NUM> may be controlled to allow the coating substance to be supplied alternately from the first storage tank <NUM> or from the second storage tank <NUM>.

The apparatus <NUM> comprises at least one delivery nozzle <NUM> configured to deliver the coating substance and placed in fluid communication with supply assembly <NUM>.

The second fluid circuit <NUM> comprises a third conduit <NUM> extended from the supply pump <NUM>, in particular from a delivery head of the supply pump <NUM>, to the delivery nozzle <NUM> to put the supply pump <NUM> in fluid communication with the delivery nozzle <NUM>. The second fluid circuit <NUM> further comprises a third end <NUM> at which the second fluid circuit <NUM> is connected to the delivery nozzle <NUM> and through which the coating substance is supplied to the delivery nozzle <NUM>.

The third conduit <NUM> is preferably made of stainless steel or of a temperature-resistant plastic material, e.g. PTFE or FEP.

A plurality of third heating elements <NUM> are associated with the second fluid circuit <NUM> to heat the coating substance flowing therein. One of the third heating elements <NUM> is schematically shown in <FIG>.

In the preferred embodiment, the third heating elements are integrated in respective insulation jackets <NUM> made of a thermally insulating material and removably fitted on respective portions of the second fluid circuit <NUM>.

The third heating elements <NUM> may comprise, for example, electrical resistors or heating conduits in which heating fluid circulates.

As shown in <FIG>, each insulation jacket <NUM> further comprises a temperature sensor <NUM> configured to measure the temperature of the portion of the second fluid circuit <NUM> on which the respective third heating element <NUM> acts.

In the embodiment shown in <FIG>, a first insulation jacket 91a of the plurality of insulation jackets <NUM> and the relative heating element <NUM> are applied on a section of the first conduit <NUM> extended from the first end <NUM> to the second junction <NUM>, a second insulation jacket 91b of the plurality of insulation jackets <NUM> and the relative third heating element <NUM> are applied on a section of the second conduit <NUM> extended from the second end <NUM> to the second junction <NUM>, a third insulation jacket 91d of the plurality of insulation jackets <NUM> and the relative third heating element <NUM> are applied on the common section of the first conduit <NUM> and the second conduit <NUM> extended from the second junction <NUM> to the supply pump <NUM>, and a fourth insulation jacket 91c of the plurality of insulation jackets <NUM> and the relative third heating element <NUM> are applied on the third conduit <NUM> extended from the supply pump <NUM> to the delivery nozzle <NUM>.

In preferred embodiments thereof, the apparatus <NUM> comprises a plurality of delivery nozzles <NUM> and a corresponding plurality of third conduits <NUM>, each comprising a respective fourth insulation jacket 91c and a respective third heating element <NUM>.

Each delivery nozzle <NUM> is configured to spray the coating substance onto a respective injection medical device.

Each delivery nozzle <NUM> can be provided with a respective heating element <NUM> configured to heat the delivered coating substance. For example, such a heating element can be an electrical resistor applied to the delivery nozzle <NUM> or incorporated in the delivery nozzle <NUM>.

Each delivery nozzle <NUM> is configured to nebulise the coating substance by supplying pressurised gas coming from a source <NUM> of a suitable delivery gas, e.g. compressed air. The source <NUM> is configured to deliver gas at a pressure comprised between <NUM> psi (<NUM> bar) and <NUM> psi (<NUM> bar), more preferably, about <NUM> psi (<NUM> bar).

The source <NUM> is associated with each delivery nozzle <NUM> by a respective conduit <NUM>.

The apparatus <NUM> comprises a movable support frame configured to support a plurality of injection medical devices, in particular cylinders of respective syringes.

The delivery nozzles <NUM> and the syringe cylinder support frame are movable with respect to each other to insert/remove each delivery nozzle <NUM> in a respective cylinder.

In a preferred embodiment, the relative movement between the delivery nozzles <NUM> and the cylinder support frame is carried out by moving the latter with respect to the delivery nozzles <NUM>, which are fixed.

The first storage tank <NUM> can be configured in a filling condition in which it receives and stores the coating substance withdrawn from the inlet tank <NUM>. In the filling condition the inlet valve <NUM> is open towards the second conduit branch 32a and closed towards the third conduit branch 32b.

The first storage tank <NUM> can also be configured in a depressurisation condition in which the coating substance that is present therein is depressurised to remove any bubbles. In the depressurisation condition the inlet valve <NUM> is closed towards the second conduit branch 32a, the first outlet valve <NUM> is closed and the first depressurisation member <NUM> is activated.

The first storage tank <NUM> can also be configured in a heating condition in which the coating substance that is present therein is heated. In the heating condition the inlet valve <NUM> is closed towards the second conduit branch 32a, the first outlet valve <NUM> is closed and the first heating element <NUM> is activated.

The first storage tank <NUM> can also be configured in a supply condition in which the coating substance that is present therein is withdrawn to be supplied to the delivery nozzle <NUM>. In the supply condition the inlet valve <NUM> is closed towards the second conduit branch 32a, the first outlet valve <NUM> is open and the first pressurisation element <NUM> is activated.

Similarly, the second storage tank <NUM> can be configured in a filling condition in which it receives and stores the coating substance withdrawn from the inlet tank <NUM>. In the filling condition the inlet valve <NUM> is open towards the third conduit branch 32b and closed towards the first conduit branch 32a.

The second storage tank <NUM> can also be configured in a depressurisation condition in which the coating substance stored therein is depressurised to remove any bubbles. In the depressurisation condition the inlet valve <NUM> is closed towards the third conduit branch 32b, the second outlet valve <NUM> is closed and the second depressurisation member <NUM> is activated.

The second storage tank <NUM> can also be configured in a heating condition in which the coating substance stored therein is heated. In the heating condition the inlet valve <NUM> is closed towards the third conduit branch 32b, the second outlet valve <NUM> is closed and the second heating element <NUM> is activated.

The second storage tank <NUM> can also be configured in a supply condition in which the coating substance stored therein is withdrawn to be supplied to the delivery nozzle <NUM>. In the supply condition the inlet valve <NUM> is closed towards the third conduit branch 32b, the second outlet valve <NUM> is open and the second pressurisation member <NUM> is activated.

The apparatus <NUM> further comprises a control unit <NUM> operatively connected to at least the inlet valve <NUM>, the first outlet valve <NUM>, the second outlet valve <NUM>, the first pressurisation member <NUM>, the first depressurisation member <NUM>, the first heating element <NUM>, the second pressurisation member <NUM>, the second depressurisation member <NUM> and the second heating element <NUM>.

The control unit <NUM> is configured to alternately set the first storage tank <NUM> and the second storage tank <NUM> to the supply condition and to alternately maintain, after an initial transient, the first storage tank <NUM> or the second storage tank <NUM> in the aforementioned supply condition.

When one between the first storage tank <NUM> and the second storage tank <NUM> is in the supply condition, the control unit <NUM> configures the other between the first storage tank <NUM> and the second storage tank <NUM> in the filling condition, then in the depressurisation condition, then in the heating condition. In particular, the control unit <NUM> is configured to maintain the depressurisation condition for a time comprised between <NUM> and <NUM> minutes.

To coat an injection medical device with the coating substance, the coating substance is fed into the inlet tank <NUM>. Preferably, the coating substance comprises a silicone-based oil. Preferably, the injected coating substance has a viscosity greater than <NUM> cSt, comprised between <NUM> cSt and <NUM> cSt, even more preferably comprised between <NUM> cSt and <NUM> cSt, e.g. about <NUM> cSt. Preferably, the coating substance is not pre-sterilised. Preferably, the coating substance and the inlet tank are at room temperature.

Subsequently, the coating substance is withdrawn from the inlet tank <NUM> pressurising the coating substance in the inlet tank <NUM> by the service member <NUM>. The coating substance thus exits from the inlet tank <NUM> and flows into the first conduit branch <NUM> and, through the first junction <NUM> and the inlet valve <NUM>, into the second conduit branch 32a. In such a case, the inlet valve <NUM> is open towards the second conduit branch 32a and closed towards the third conduit branch 32b.

Next, the coating substance is filtered by the first sterilisation filter 30a and fed into the first storage tank <NUM> through the second conduit <NUM>.

In this way, the coating substance is stored in the first storage tank <NUM>.

Subsequently, the second conduit branch 32a is closed by the inlet valve <NUM> to isolate the coating substance stored in the first storage tank <NUM>.

Next, the coating substance stored in the first storage tank <NUM> is depressurised. Such depressurisation is performed by the first depressurisation member <NUM>. The pressure of the coating substance in the first storage tank <NUM> is brought to a value less than the atmospheric pressure, preferably comprised between <NUM> mbar and <NUM> mbar, even more preferably comprised between <NUM> mbar and <NUM> mbar, e.g. about <NUM> mbar, for a time comprised between <NUM> and <NUM> minutes, in order to remove any bubbles.

After having depressurised the coating substance stored in the first storage tank <NUM>, such coating substance is heated by the first heating element <NUM>. In particular, the coating substance is heated until reaching a temperature of <NUM> or higher, preferably <NUM>. Alternatively, the coating substance may be heated before or during the depressurisation in the first storage tank <NUM>.

After having entered the coating substance into the first storage tank <NUM>, the inlet valve <NUM> closes the second conduit branch 32a and opens the third conduit branch 32b. Thereby, the coating substance may be fed from the inlet tank <NUM> to the second storage tank <NUM> through the second sterilisation filter 30b.

The coating substance is thus stored in the second storage tank <NUM>.

Next, the third conduit branch 32b is closed by the inlet valve <NUM> to isolate the coating substance stored in the second storage tank <NUM>.

Next, the coating substance stored in the second storage tank <NUM> is depressurised. Such depressurisation is performed by the second depressurisation member <NUM>. The pressure of the coating substance in the second storage tank <NUM> is brought to a value less than the atmospheric pressure, preferably comprised between <NUM> mbar and <NUM> mbar, even more preferably comprised between <NUM> mbar and <NUM> mbar, e.g. about <NUM> mbar, for a time comprised between <NUM> and <NUM> minutes, in order to remove any bubbles.

After having depressurised the coating substance stored in the second storage tank <NUM>, such coating substance is heated by the second heating element <NUM>. In particular, the coating substance is heated until reaching a temperature of <NUM> or higher, preferably <NUM>. Alternatively, the coating substance may be heated before or during the depressurisation in the second storage tank <NUM>.

Subsequently, the coating substance is supplied to the delivery nozzle <NUM> from the first storage tank <NUM> by operating the supply pump <NUM>, opening the first outlet valve <NUM> while keeping the second outlet valve <NUM> closed and pressurising the coating substance in the first storage tank <NUM> by the first pressurisation member <NUM>. The pressure of the coating substance in the first storage tank <NUM> is raised to a value greater than the atmospheric pressure and less than <NUM> bar, preferably less than <NUM> bar.

The coating substance thus flows out of the first storage tank <NUM>, through the first conduit <NUM>, the supply pump <NUM> and the third conduit <NUM> until it reaches the delivery nozzle <NUM>.

While the coating substance is supplied to the delivery nozzle <NUM> from the first storage tank <NUM> the coating substance is further heated, in particular by the third heating elements <NUM>.

While the coating substance is supplied to the delivery nozzle <NUM> from the first storage tank <NUM>, further coating substance coming from the inlet tank <NUM> is fed, stored, depressurised and heated in the second storage tank <NUM>, in accordance with the above.

When the coating substance in the first storage tank <NUM> is over or below a predetermined minimum level, the supply of coating substance to the delivery nozzle <NUM> from the first storage tank <NUM> is interrupted, in particular by closing the first outlet valve <NUM>. Next, the coating substance is supplied to the delivery nozzle <NUM> from the second storage tank <NUM>. Thereby, there is no interruption in the supply of coating substance to the delivery nozzle <NUM>.

In order to supply the coating substance to the delivery nozzle <NUM> from the second storage tank <NUM>, the second outlet valve <NUM> is opened while keeping the first outlet valve <NUM> closed, the coating substance is pressurised in the second storage tank <NUM>, in particular by the second pressurisation member <NUM>. The pressure of the coating substance in the second storage tank <NUM> is raised to a value greater than the atmospheric pressure and less than <NUM> bar, preferably less than <NUM> bar.

The coating substance thus flows out of the second storage tank <NUM>, through the second conduit <NUM>, the supply pump <NUM> and the third conduit <NUM> until it reaches the delivery nozzle <NUM>.

While the coating substance is supplied to the delivery nozzle <NUM> from the second storage tank <NUM> the coating substance is further heated, in particular by the third heating elements <NUM>.

While the coating substance is supplied to the delivery nozzle <NUM> from the second storage tank <NUM>, further coating substance from the inlet tank <NUM> is fed, stored, depressurised and heated in the first storage tank <NUM>, in accordance with the above.

When the coating substance in the second storage tank <NUM> is over or below a predetermined minimum level, the supply of coating substance to the delivery nozzle <NUM> from the second storage tank <NUM> is interrupted, in particular by closing the second outlet valve <NUM>. Subsequently, the cycle is restarted by supplying the coating substance to the delivery nozzle <NUM> from the first storage tank <NUM>.

The coating substance supplied to the delivery nozzle <NUM> is nebulised in the delivery nozzle <NUM> by supplying pressurised gas from the source <NUM>.

Claim 1:
Apparatus (<NUM>) for coating an injection medical device, comprising:
- an inlet tank (<NUM>) that can be filled with a coating substance;
- a delivery nozzle (<NUM>);
- a supply assembly (<NUM>) interposed between, and in fluid communication with, said inlet tank (<NUM>) and said delivery nozzle (<NUM>), said supply assembly (<NUM>) being configured to withdraw the coating substance from said inlet tank (<NUM>) and to supply it to said delivery nozzle (<NUM>);
characterised in that said delivery nozzle (<NUM>) is configured to deliver said coating substance to an injection medical device and in that said supply assembly (<NUM>) comprises at least one sterilisation filter (30a, 30b) configured to filter the coating substance withdrawn from said inlet tank (<NUM>).