FIELD OF THE INVENTION

The present invention relates to the technical sector concerning the filling of containers with micro-doses of powder material of a pharmaceutical type. More in particular, the invention relates to a dosing wheel which can form micro-doses of powder material and which subsequently release the micro-doses internally of the containers.

DESCRIPTION OF THE PRIOR ART

EP3755629 describes a dosing wheel for formation of micro-doses of powder material and for the subsequent release thereof internally of empty underlying containers, wherein: it includes a plurality of pistons each comprising a rod and a piston head which is permeable to air and impermeable to powder material; it comprises a discoid body which is rotatable about a horizontal rotation axis and which is provided with an outer edge having a cylindrical shape; the outer edge of the discoid body is provided with a plurality of through-holes which are radial, angularly equidistanced to one another and dimensioned each to receive a piston; the volume defined between: the walls of each through-hole, the piston head of a piston inserted in the through-hole and the external end of the through-hole defines a dosing chamber in which a micro-dose of powder material can be formed; it comprises regulating means of the position of each piston internal of the corresponding through-hole for regulating the dimensions of the dosing chamber and, thus, the entity of the micro-dose of powder material which is to be formed internally thereof; each piston is couplable to, and decouplable from, the discoid body using the regulating means; the discoid body is provided with a plurality of pipes which connect each through-hole to a gas aspiration and gas injection source, so that when gas is aspirated it is possible to form or retain a micro-dose of powder material in the dosing chamber and when gas is injected it is possible to expel the micro-dose of powder material from the dosing chamber.

Also included is a hopper which is arranged superiorly of the dosing wheel, so as to release the powder material into the through-holes for the formation of the micro-dose of powder material. A dosing wheel of this type can generally form micro-doses of powder material comprised between 20mg and 2500mg, more usually between 20mg and 1500mg.

As is known, the directives at present applicable require that each unit (dosing wheel, hopper etc.) entering into contact with powder material of a pharmaceutical type is washed and sterilised periodically and, in any case, at each change of production batch, i.e. when it is necessary to change the type of powder material.

Also generally, for washing and sterilisation it is possible to proceed in two different ways: according to a first mode, the unit is removed from the machine on which it is installed and taken to an autoclave, in order to be washed and sterilised; according to a second mode, the unit is not removed, and the washing and sterilisation take place in loco (this is the CIP-SIP, acronym of Cleaning In Place & Sterilization In Place).

If the unit can be washed and sterilised in loco, it can also be used internally of an isolator, which, as known, can border with an ambient having a class C hygiene rating (in accordance with the GMP (Good Manufacturing Practice) standard; this unit can also be used internally of an isolator if it is demountable into parts that can pass through the RTP ports of the isolator (Rapid Transfer Port). The RTP ports can be of various dimensions: however, the maximum useful material passage diameter is around 250 - 350 mm.

In the case of the dosing wheel as described with reference to EP3755629, the relative discoid body in general is not able to pass through an RTP port, not even one of maximum dimensions. However, even if it were possible for the discoid body to pass through an RTP port of large dimensions, an important consideration would be the high cost of an RTP port of this type; further, one or more RTP ports having large dimensions would also condition, during the design step, the choice of layout of the machine in which the dosing wheel is incorporated.

Also, the discoid body cannot be washed and sterilised in loco (CIP-SIP), mainly because each through-hole has a diameter and a longitudinal extension which are such that, during the washing step, the water might stagnate and, during the sterilisation step, the steam might condensate.

SUMMARY OF THE INVENTION In the light of the above, the aim of the present invention consists in obviating the above-mentioned drawbacks, enabling the discoid body of the dosing wheel to be washed and sterilised in loco (CIP-SIP).

The above-mentioned aim has been obtained with a dosing wheel for formation of micro-doses of powder material of a pharmaceutical type and for the subsequent release thereof, according to claim 1 .

For the washing and sterilisation, the inserts and the pistons can be removed from the discoid body and taken for example to an autoclave, making them pass from an RTP port if the dosing wheel is arranged internally of an isolator.

At this point the discoid body can advantageously be washed and sterilised in loco, as the shape thereof does not require a plurality of through-holes, as occurs in the prior art, having dimensions such as to be able to form stagnant puddles of water or steam condensation. In fact, the through-holes are equivalent to channels for the inserts, which inserts can be extracted and taken outside the ambient (example: the isolator) in which the dosing wheel is located, in order to be washed and sterilised apart.

BRIEF DESCRIPTION OF THE DRAWINGS

Specific embodiments of the invention will be described in the following part of the present description, according to what is set down in the claims and with the aid of the accompanying tables of drawings, in which:

- figure 1 shows a frontal perspective view of a dosing wheel for formation of micro-doses of powder material of a pharmaceutical type and for the subsequent release thereof, object of the present invention, from which a relative nonius has been removed in order better to illustrate some characteristics which otherwise would not be visible;

- - figure 1A illustrates detail K of figure 1 ;

- figure 1 B is a tranversal sectional view taken along a radius of the portion of dosing wheel illustrated in figure 1A;

- figure 2 shows a rear perspective view of the dosing wheel of figure 1 ;

- figure 3 shows a perspective view of an embodiment of a dosing machine for formation of micro-doses of powder material of a pharmaceutical type and for the subsequent release thereof internally of the containers, also an object of the present invention, in which the dosing wheel of figures 1 , 2 is integrated;

- figure 4 is the same perspective view of figure 3 but sectioned according to a vertical section plane;

- figure 5 is a lateral view of the machine of figure 3, from which the relative nonius has been removed;

- figure 6 is a frontal view of the machine of figure 3, from which the relative nonius and some pistons have been removed;

- figure 7 is a view of section VII-VII of figure 6;

- figure 7A is an enlarged view of detail K1 of figure 7;

- figure 7B is a perspective view of the same enlarged detail of figure 7A;

- figure 8 is a view of section VIII-VIII of figure 5;

- figure 8A is a larger-scale view of detail K2 of figure 8;

- figure 8B is a lateral view of an insert identical to the one shown in figure 8A;

- figure 8C is a view from above of the insert of figure 8B;

- figure 9 is a perspective view of a part of the machine of figure 1 ;

- figure 10 is a frontal view of the part of the machine illustrated in figure 9;

- figure 11 is the view of the machine of figure 3 but in a configuration which follows the actuation of a first step of a method for preparing for washing and sterilising of the machine, also object of the present invention;

- figure 12 is the same view of figure 11 but sectioned according to a vertical section plane;

- figure 13 is the view of the machine of figure 3 but in a configuration which follows the actuation of a second step of the method for preparing for washing and sterilising of the machine;

- figure 14 is the same view of figure 13 but sectioned according to a vertical section plane;.

DESCRIPTION OF PREFERRED EMBODIMENTS With reference to the appended tables of drawings, reference numeral (1) denotes in its entirety a dosing wheel for formation of micro-doses of powder material of a pharmaceutical type (illustrated only in figure 7) and for the subsequent release thereof, wherein: it comprises a discoid body (2) which is rotatable about a rotation axis (clearly visible in figures 5, 7 and denoted by (A1)) and which is provided with an outer edge (21) having a cylindrical shape; the outer edge (21) of the discoid body (2) is provided with a first plurality of through-holes (11) which are distributed along the outer edge (21); it comprises a plurality of pistons (3) each comprising a rod (35) and a piston head (36) which is permeable to air and impermeable to powder material; each piston (3) of the plurality of pistons (3) is couplable to, and decouplable from, the discoid body (2); it comprises a plurality of inserts (4); each through-hole (11) of the first plurality of through-holes (11) is dimensioned so as to allow insertion of an insert (4) of the plurality of inserts (4); each insert (4) of the plurality of inserts (4): is couplable to, and decouplable from (figures 11 , 12, 14), the discoid body (2); comprises an insert head (45) the top (450) of which forms a cylindrical portion of the cylinder (figures 1 , 2, 8A) and is dimensioned so as to close a through-hole (11) of the first plurality of through- holes (11); is crossed by a main conduit (115) which is dimensioned to slidably receive the piston head (36) and a first rod portion (350) of a piston (3) of the plurality of pistons (3); the discoid body (2) and the inserts (4) of the plurality of inserts (4) are dimensioned in such a way that when an insert (4) of the plurality of inserts (4) is coupled to the discoid body (2), then: the relative insert head (45) is inserted in a corresponding through-hole (11) of the first plurality of through-holes (11) in such a way that the top (450) of the insert head (45) connects (figures 7A, 7B, 8A) to the outer edge (21) and closes the through-hole (11) of the first plurality of through-holes (11); the main conduit (115) opens towards the outside of the discoid body (2) so as to receive powder material internally thereof; the volume defined between: the walls of the main conduit (115) of each insert (4) of the plurality of inserts (4); the piston head (36) of a piston (3) of the plurality of pistons (3) which is inserted in the main conduit (115); and the external end (500) of the main conduit (115) defines a dosing chamber (6) in which a micro-dose of powder material can be formed (figures 7A, 7B, 8A, 8B); each insert (4) comprises one or more gas conduits and/or channels (55, 56) in fluid communication with the relative main conduit (115) and connectable to a gas aspiration and gas injection source (neither illustrated), so that when gas is aspirated it is possible to form or retain a micro-dose of powder material in the dosing chamber (6) and when gas is injected it is possible to expel the micro-dose of powder material from the dosing chamber (6).

Therefore both the pistons (3) of the plurality of pistons (3) and the inserts (4) of the plurality of inserts (4) can be removed from the discoid body (2) and be taken to another site (for example: into an autoclave, not illustrated) in order to be washed and sterilised.

The dosing wheel (1) can generally form micro-doses of powder material comprised between 20mg and 2500mg, preferably between 20mg and 1500mg.

The discoid body (2) can comprise, on the relative rear side (figure 2) a perforated disc (23) which is provided with a plurality of through-holes (13) which are functionally interposed between the one or more gas conduits and/or channels (55, 56) and the gas aspiration and gas injection source.

The dosing wheel (1) is preferably arranged in such a way that the discoid body (2) is rotatable about a horizontal rotation axis (A1).

The through-holes (11) of the first plurality of through-holes (11) are preferably uniformly distributed along the outer edge (21) of the discoid body (2), i.e. are reciprocally equidistanced.

The main conduit (115) of each insert (4) of the plurality of inserts (4) is preferably dimensioned to slidably, and sealingly against powder material, receive the piston head (36) of a piston (3) of the plurality of pistons (3).

According to an aspect of the invention: each insert (4) of the plurality of inserts (4) comprises an insert bottom (46) which is opposite the relative insert head (45); the discoid body (2) comprises an annular support (25) (figures 1 , 1A, 6, 11) which: is interposed between the outer edge (21) and the centre (26) of the discoid body (2); is concentric to the outer edge (21); and comprises a second plurality of through-holes (12) which are distributed along the annular support (25); the through-holes (12) of the second plurality of through-holes (12) are arranged and dimensioned so as to each receive the insert bottom (46) of an insert (4) of the plurality of inserts (4) once the insert (4) has been inserted through a through- hole (11) of the first plurality of through-holes (11) and has reached a position in which the top (450) of the corresponding insert head (45) connects to the outer edge (21) and closes the through-hole (11) of the first plurality of through-holes (11) (figure 8A).

Advantageously, the fact that each insert (4) of the plurality of inserts (4) is inserted with the relative insert head (45) in a through-hole (11) of the first plurality of through-holes (11) and with the relative insert bottom (46) in a through-hole (12) of the second plurality of through-holes (12) enables a certain orientation (for example radial) of the insert (4).

The annular support (25) preferably has a circular shape.

Each insert (4) of the plurality of inserts (4) preferably comprises an undercut (47) (figure 1 B) for receiving an anti-rotation pin (48) (figures 1A, 1 B), while the discoid body (2) comprises a plurality of anti-rotation pins (48) which are inserted each in the undercut (47) of an insert (4) of the plurality of inserts (4), in order to prevent the rotation of the insert (4) with respect to the axis thereof.

Each anti-rotation pin (48) is preferably arranged at a through-hole (12) of the second plurality of through-holes (12), while the undercut (47) is arranged at the insert bottom (46) of each insert (4) of the plurality of inserts (4).

The through-holes (12) of the second plurality of through-holes (12) are preferably uniformly distributed along the outer edge (21), i.e. they are mutually equidistanced.

The axis of each through-hole (11) of the first plurality of through-holes (11) is preferably radial and coincides with the axis of an opposite through-hole (12) of the second plurality of through-holes (12).

According to another aspect of the invention: the discoid body (2) comprises a plurality of endrun stops (15) (which in the illustrated embodiment are integrated, in particular, in the perforated disc (23), see figures 1 B, 7A, 7B) which are arranged each to abut an insert (4) of the plurality of inserts (4) once the insert (4) has been inserted via a through-hole (11) of the first plurality of through-holes (11) and has reached a position in which the top (450) of the corresponding insert head (45) connects to the outer edge (21) and closes the through-hole (11).

Each endrun stop (15) of the plurality of endrun stops (15) is preferably located at a bottom of a through-hole (12) of the second plurality of through-holes (12), in order to abut an insert bottom (46) of an insert (4) of the plurality of inserts (4).

According to another aspect of the invention, the dosing wheel (1) comprises blocking means (75,76) for removably blocking each insert (4) of the plurality of inserts (4) to the discoid body (2) once the insert (4) has been inserted via a through-hole (11) of the first plurality of through-holes (11) and has reached a position in which the top (450) of the corresponding insert head (45) connects to the outer edge (21) and closes the through-hole (11).

The dosing wheel (1) can comprise a peripheral crown (20) which comprises an inner edge (22); the outer edge (21) is an integral part of the peripheral crown (20) and is opposite the inner edge (22).

The blocking means (75,76) preferably comprise a plurality of ring nuts (75) which are dimensioned so as each to be crossed by an insert bottom (46) of an insert (4) of the plurality of inserts (4) when the insert (4) is inserted via a through-hole (11) of the first plurality of through-holes (11); the blocking means (75,76) further comprise a threading (76) made on each insert (4) of the plurality of inserts (4), between the insert head (45) and the insert bottom (46), in a position that enables a ring nut (75) of the plurality of ring nuts (75) to screw onto the threading (76) up to abutting against the inner edge (22) of the discoid body (2), with a consequent removable blocking of the insert (4) to the discoid body (2), once the insert (4) has been inserted via a through-hole (11) of the first plurality of through-holes (11) and has reached a position in which the top (450) of the corresponding insert head (45) connects to the outer edge (21) and closes the through-hole (11). The discoid body (2) preferably comprises a plurality of connecting walls (27) which connect the outer edge (21) with the annular support (25), and which each have a first end which is arranged between two through-holes (11) of the first plurality of through-holes (11) and a second end, opposite the first end, which is arranged between two through-holes (12) of the second plurality of through-holes (12); the dimensions of the walls (27) of each pair of adjacent connecting walls (27) of the plurality of connecting walls (27) are such that a chamber for containing an insert (4) of the plurality of inserts (4) is defined.

The chamber can further be dimensioned so as to make available a free space which is usable by an operator for removably coupling the insert (4) to the discoid body (2).

The one or more gas conduits and/or channels (55, 56) preferably comprise: a gas channel (55) (figures 1 B, 7A, 8A, 8B) which is annular and which extends perpendicularly to the axis of the insert (4), along a lateral surface portion thereof; and a plurality of gas conduits (56) (figures 1 B, 7A, 7B, 8B, 8C) which connect the gas channel (55) with the main conduit (115).

Each main conduit (115) of each insert (4) of the plurality of inserts (4) is preferably concentric to the axis of the insert (4).

The gas channel (55) is preferably circular.

The gas conduits (56) are preferably angularly equidistanced from one another.

The gas conduits (56) preferably have a radial extension.

According to a further aspect of the invention: the dosing wheel (1) comprises regulating means (85, 86, 9) for regulating the position of each piston (3) of the plurality of pistons (3) internally of the main conduit (115) of an insert (4) of the plurality of inserts (4), so as consequently to regulate the entity of the micro-dose of powder material; the regulating means (85, 86, 9) comprise: a plurality of tracks (85) (figures 1A, 1 B, 7A, 11 , 12) which are made in the discoid body (2); and a plurality of cursors (86) which are movable along the tracks (85) of the plurality of tracks (85); each rod (35) of a piston (3) of the plurality of pistons (3) is couplable to, and decouplable from, a cursor (86) of the plurality of cursors (86), so that the movement of the cursor (86) in the track (85) of the plurality of tracks (85) determines the movement of the piston head (36) of a piston (3) of the plurality of pistons (3) along the main conduit (115) of an insert (4) of the plurality of inserts (4).

The tracks (85) of the plurality of tracks (85) are preferably arranged between the annular support (25) and the centre (26) of the discoid body (2).

Each rod (35) of a piston (3) of the plurality of pistons (3) is preferably constrained to a cursor (86) of the plurality of pistons (3) at the relative free end (figures 1 , 1A).

The regulating means (85, 86, 9) can comprise a nonius (9) (figures 3, 4) for manually regulating the position of the cursors (86) of the plurality of cursors (86) along the corresponding tracks (85) of the plurality of tracks (85).

Alternatively to the use of a nonius (9), a brushless motor can be used to regulate the position of the cursors (86) of the plurality of cursors (86) along the corresponding tracks (85) of the plurality of tracks (85) (a variant not illustrated).

Also an object of the invention is a dosing machine (10) for formation of microdoses of powder material of a pharmaceutical type and for the subsequent release thereof internally of underlying containers, (not illustrated) wherein: it comprises a frame; it comprises a mixing unit (100) (figures 7, 4, 8, 12, 14) for mixing powder material of a pharmaceutical type, which comprises: an upper mouth (101) from which a powder material or washing and sterilising fluids can be supplied (not illustrated); a mixing element (103) for mixing the powder material; and a lower mouth (102) (figures 8, 14) from which the mixing element (103) (figure 14) can partially project; it comprises a hub (110) solidly constrained to a drive shaft (120); it comprises a dosing wheel (1) according to any one of the preceding claims, which is arranged beneath the mixing unit (100) and which is fixed to the hub (110); it comprises a shaving unit (130) which comprises shavers, for example a first shaver (131) and a second shaver (132) (figure 8), and which is arranged beneath the mixing unit (100) and the dosing wheel (1); the mixing unit (100), the shaving unit (130) and the dosing wheel (1) are dimensioned and mutually arranged to define a mixing chamber (150) (figures 4, 7) in which the powder material mixing and the filling of the dosing chambers (6) takes place as the dosing wheel (1) rotates with respect to the axis thereof (see figure 8); it comprises a distributor ring (140) which is functionally interposed between the gas aspiration and gas injection source (as mentioned, not illustrated), on one side, and the one or more gas conduits and/or channels (55, 56) of each insert (4), on the other side, so that the aspiration of gas and the injection of gas take place when each insert (4) of the plurality of inserts (4) assumes predetermined angular positions during the rotation of the dosing wheel (1 ).

The distributor ring (140) is solidly constrained to the frame during the normal use of the dosing wheel (1), i.e. during the formation of micro-doses of powder material and for the subsequent release thereof internally of the containers.

The mixing element (103) can comprise four angularly equidistanced blades (by ninety degrees), activated in rotation in phase relation with the dosing wheel (1): the embodiment illustrated in the figures relates to a mixing element (103) having four blades, though the various sections views reveal only two blades.

There follows a description of the functioning of the dosing machine (10) for formation of micro-doses of powder material of a pharmaceutical type and for the subsequent release thereof internally of underlying containers.

The dosing wheel (1) can be step-activated: as the dosing wheel (1) illustrated in the drawings comprises ten dosing chambers (6), it can perform an angular step of thirtysix degrees.

A plurality of empty containers are supplied below the dosing wheel (1) in step motion (as mentioned, not illustrated), each to be filled with a micro-dose of powder material.

The mixing unit (100) receives, via the upper mouth (101), powder material of a pharmaceutical type; this powder material can be supplied by an upper hopper, not illustrated.

This powder material accumulates in the mixing chamber (150), where it is mixed and the aspirated internally of the dosing chambers (6) of the dosing wheel (1) for formation of the micro-doses of powder material.

According to the angular position in which each dosing chamber (6) is located, the following steps can take place (see figure 8). The formation of the micro-dose of powder material in the first dosing chamber (6) occurs in a first angular position (201) and a second angular position (202): the powder material in arrival from the mixing chamber (150) is aspirated with negative pressure internally of the dosing chamber (6). In a third angular position (203), in a fourth angular position (204), in a fifth angular position (205) and in a sixth angular position (206) the retention (162) of the micro-dose of powder material takes place: the powder material is therefore retained internally of the dosing chamber (6), for example with a lower negative pressure (in absolute value) than that which is obtained during the formation of the micro-dose in the dosing chamber (6). The expulsion of the microdose of powder material internally of an underlying empty container takes place in a seventh angular position (207): the powder material is therefore expelled with positive pressure from the dosing chamber (6). The blowout of any residues of powder material to outside the dosing chamber (6) takes place in an eighth angular position (208) and in a ninth angular position (209), so as to clean the dosing chamber (6): therefore, the residues of powder material are expelled with positive pressure from the dosing chamber (6). In a tenth angular position (210) no operation takes place.

The dosing machine preferably comprises accessories as follow for carrying out a wash and sterilisation in loco of a part thereof: an insulating wall (160) which is fixed to the frame so as to be solidly constrained thereto, which has a wall through-hole (161) through which the drive shaft (120) passes and which is arranged along the axis of the drive shaft (120) to insulate the hub (110), the distributor ring (140) and the dosing wheel (1); a seal (162) which is fixed at the wall through-hole (161) so as to stop washing and sterilising fluids coming from the upper mouth (101 ) of the mixing unit (100); a part of container (163) which is provided with a drain (164) of washing and sterilising fluids, which comprises a connecting mouth (165) which is sealingly connectable (162) with the lower mouth (102) of the mixing unit (100), when the shaving unit (130) has been removed, and which is removably fixable to the insulating wall (160) so as to form therewith a sealed container (162), so that the washing and sterilising fluids coming from the upper mouth (101) of the mixing unit (100) are expelled via the drain (164).

The insulating wall (160) and the seal (162) can therefore be fixed respectively to the frame and to the wall through-hole (161) once only, preferably before the first startup of the dosing machine.

Also object of the present invention is a method for preparing for washing and sterilising in loco of a part of the dosing machine (10) described in the foregoing, comprising following steps: removing the shaving unit (130); axially moving the distributor ring (140) and the discoid body (2) away from one another; removing the pistons (3) of the plurality of pistons (3) from the discoid body (2) and the inserts (4) of the plurality of inserts (4) from the discoid body (2); fixing the part of container (163) to the insulating wall (160) and connecting the connecting mouth (165) to the lower mouth (102) of the mixing unit (100).

The seal (162) is preferably mounted between the insulating wall (160) and the hub (110) (figures 4, 12, 14).

The shaving unit (130), the pistons (3) of the plurality of pistons (3) and the inserts (4) of the plurality of inserts (4) have dimensions that are such as to be able to pass through a standard RTP port, if the dosing machine is arranged in an isolator, so as to be portable to another site (for example in an autoclave) for washing and sterilisation.

The dosing machine (10) can comprise: elastic means (not illustrated), for example springs, interposed between the insulating wall (160) and the distributor ring (140), so as to press the distributor ring (140) against the perforated disc (23) of the discoid body (2); and at least two screws (166) which each comprise a screw thread (167) and a screw head (168), which engage in the insulating wall (160), which are arranged so that with the relative screw head (168) they abut the distributor ring (140) or an additional ring (169) solidly constrained thereto, as illustrated in figures 9, 10, and which are designed in such a way that by screwing the screws (166) into the insulating wall (160) the distributor ring (140) is moved away axially from the discoid body (2).

It is understood that the above has been described by way of non-limiting example and that any technical-functional variants are considered to fall within the protective scope of the present technical solution, as claimed in the following.