A transport chute and track

Abstract

Described is a conveying chute (1000, 1000') which comprises, on a relative load-bearing frame (1003), a first track (1001, 1001') and a second track (1002, 1002') for sliding elements to be conveyed (T). The elements (T) to be conveyed extend along a movement direction (S) defining a predetermined trajectory to be travelled along. the first track (1001, 1001') and the second track (1002, 1002') can be spaced apart from each other in a dynamic manner, between a position of minimum reciprocal distance (Dmin) and a position of maximum reciprocal distance (Dmax). In the position of minimum reciprocal distance (Dmin) the first track (1001, 1001') and the second track (1002, 1002') are simultaneously in contact with at least two end portions of each element to be conveyed (T) and in the position of maximum reciprocal distance (Dmax) at least one of the end portions is not in contact with the first track (1001, 1001') or the second track (1002, 1002').

Description

[0001] A transport chute and track DESCRIPTION

[0002] Technical field

[0003] This invention relates to a conveying chute and track, in particular for conveying sterile elements.

[0004] The invention also relates to a system for filling and closing sterile elements for parenteral drugs, wherein the chute and / or the track connect two containers which can be sterilised with saturated process vapour for the sterile elements.

[0005] Background Art

[0006] The process of filling and finishing containers such as bottles, vials, syringes and carpules, known as “fill-finish”, is crucial in the production of drugs, especially for injectable ones. The main challenge is to maintain the sterility of the product during this delicate phase. Unlike terminal sterilisation, where the drug is treated in closed containers, the “aseptic fill-finish” involves the risk of losing sterility, since the drug is dispensed in open containers. For this reason, in order to ensure sterility, it is essential that the filling and finishing are carried out in specially designed environments to prevent contamination.

[0007] The national and international pharmaceutical guidelines establish strict requirements for the qualification and production of machinery used in this process. The production in an aseptic environment requires particular care, and the regulations require monitoring methods to ensure sterility and prevent particle and microbiological contamination during the filling and finishing of the containers.

[0008] The aseptic filling and finishing, known as “fill-finish”, currently occurs inside systems with redistricted access barriers (RABS) or isolators. These apparatuses create a confined environment for the filling and sealing of the containers, often integrating with automatic filling machines. The legislation imposes strict particle and microbiological requirements in these areas, with strict limits for non-viable particles both at rest and during the cycle and requiring a total absence of microbiological contamination.

[0009] The filling machines integrated into RABS or isolators must handle both parts in direct and indirect contact, adopting special measures to prevent contamination of the sterile product. The isolators can be closed or opened, with a mouse-hole for the extraction, designed to minimise the risk of contamination while performing fill-finish processes inside them. They incorporate ventilation chambers with HEPA filtration (high efficiency particulate air system) and HVAC systems (heating, ventilation and air conditioning) to maintain controlled environmental conditions.

[0010] The isolators, which can be likened to small “white rooms”, are constructed with materials certified for aseptic areas, such as stainless steels or plastic, and are subject to a rigorous qualification. The air inside isolators is filtered to reduce the amount and size of the dispersed particulate, and decontamination systems, often based on vaporised hydrogen peroxide, are used before production to reduce microbiological charge. The meticulous design allows for effective cleaning and sanitising.

[0011] The current aseptic filling and finishing process, although advanced, has some critical aspects. The main technique used for reducing the microbiological charge is the hydrogen peroxide or vaporised hydrogen (VPHP or VHP) generator, which is considered essential for achieving the aseptic condition. However, this method is defined as “decontamination” and not “sterilisation” and shows significant limitations with respect to systems such as steam sterilisation, ionizing radiation, or chemical sterilisation with ethylene oxide (ETO).

[0012] The VHP develops a surface action, having a low penetration strongly depends on the previous surface cleaning process and is difficult to control; in fact, even light films of accumulated residual substances can adversely affect the effectiveness of the process. In addition, VHP residues may compromise the pharmaceutical specialty; therefore, adequate removal of any residues from the indirect contact areas must also be ensured. This limitation makes VHP unsuitable for sterilising the parts in direct contact with pharmaceutical products and is commonly only accepted for the indirect contact surfaces in the filling and closing machines. As a result, these parts must be disassembled and steam sterilised separately, resulting in high production times and additional costs.

[0013] The transfer of sterilised parts inside the isolator, normally at a lower sterility level, involves the risk of losing the sterility during contact with air or handling. Complicated and risky methods, such as the use of “Rapid Transfer Port” (RTP) or the transfer and assembly by means of the isolator gloves, are used to maintain sterility, but are subject to residual contact risks, procedural errors and violations of the “first air” criterion in the aseptic area.

[0014] The situation becomes particularly critical for large components, such as vibrating cups and hoppers, which are sterilised in autoclaves, but because of the size they cannot be handled with gloves with the doors closed, thereby compromising the sterile safety. In conclusion, the current system represents a mitigated risk but not completely safe from the point of view of sterility.

[0015] Italian patent application No. 102023000024198, filed in the name of the same Applicant, describes a double-container system, both of which can be sterilised by superheated steam, which - by means of an automatic and autonomous process for sterilising the process instruments - greatly limits or eliminates the need for intervention by the operator during normal operation of the system, without a supporting autoclave or gloves, since there are no preparation operations in an aseptic condition.

[0016] Moreover, the above-mentioned system can be cleaned automatically, like conventional systems, such as freeze-dried devices, and guarantees an absolute safety of the sterility of the machine and all its parts inside the process chambers, making the filling and finishing step of the bottles, syringes and carpules extremely efficient, so much so that it is possible to achieve production speeds equal to the conventional filling systems.

[0017] According to the prior art, the caps are conveyed by falling from guides formed with the assembly of rigid pieces, which can be mounted and removed, and then placed in an autoclave, also engaging personnel and requiring lengthy times which slow down the production efficiency of the system.

[0018] Moreover, when the caps or the covers which are conveyed by these guides become jammed, which occurs more frequently than one might think, the production is forced to stop whilst waiting for the operator to wear sterile gloves and restore the correct operation.

[0019] The operator must therefore stop the production cycle before intervening manually to free the blocked part, but if the jamming is serious, as sometimes occurs, the entire guide must be freed.

[0020] Summary of the Invention

[0021] The aim of the invention is to overcome the above-mentioned drawbacks, allowing continuous feeding of the sterile elements, without the risk of obstructions and blockages.

[0022] In the context of the above-mentioned purpose, another aim of the invention is to render manual intervention by the operator unnecessary in order to resolve any blockages.

[0023] Another aim of the track according to the invention is to guarantee a perfect and certain sterility of the machine and all its parts.

[0024] This purpose, as well as these and other aims, which are described in more detail below, are achieved by a conveying chute according to the invention, comprising the technical features described in one or more of the appended claims. The dependent claims correspond to possible different embodiments of the invention.

[0025] In particular, according to a first aspect, this invention relates to a conveying chute which comprises, on a relative load-bearing frame, a first and a second sliding track for elements to be conveyed. The tracks extend along a direction of movement defining a predetermined trajectory to be travelled along for the elements to be conveyed. The first track and the second track can be spaced apart from each other in a dynamic manner, between a position of minimum reciprocal distance and a position of maximum reciprocal distance. In the minimum distance position the contact of two end portions of each element to be conveyed is ensured with both the above- mentioned tracks, whilst in the maximum distance position at the most only one end portion of the elements to be conveyed is in contact with one of the two tracks and, therefore, in this maximum distance position, the elements fall to the ground.

[0026] Advantageously, suitable actuators which can be operated remotely allow at least one between the first and the second track to be movable relative to the other, in such a way as to allow the operators to intervene remotely, without stopping the production cycle and avoiding harmful contamination. Preferably, each movable actuator can translate between a rest point and a working point, respectively corresponding to the minimum and maximum reciprocal distance between the first and the second track.

[0027] Advantageously, there is a contact cage for containing above the elements to be conveyed along the predetermined trajectory to be travelled along, so as to prevent a jolt from causing the escape from the front trajectory.

[0028] Another aspect of the invention relates to a conveying track for sterile elements which comprises at least two chutes, according to the invention, coupled to each other.

[0029] Lastly, the Applicant requests protection for a system for filling and closing sterile elements for parenteral drugs, which comprises at least two containers which can be sterilised by saturated steam, wherein a first container is used for filling bottles, syringes and carpules, designed to be filled and finished inside the relative process chamber, and a second container is used for distributing caps and covers for bottles, syringes and carpules, designed to be distributed to the first container. According to the system, the conveying chute or track, according to the invention, can convey the sterile elements from the second container to the first container.

[0030] Detailed description

[0031] Further features and advantages of the invention are more apparent in the detailed description below, with reference to a preferred, non-limiting embodiment of the conveying chute, illustrated by way of example and without limiting the scope of the invention, with the aid of the accompanying drawings, in which:

[0032] Figure 1 is a front perspective view of a track 86 with a double chute (1000, 1000’);

[0033] Figure 2 is a rear perspective view of the track 86 of Figure 1 ;

[0034] Figure 3 is a side view of the track 86 of Figure 1 ;

[0035] Figure 4 is a plan view from below of the track 86 of Figure 1 ;

[0036] Figures 5A and 5B show the cross-section V-V of Figure 4, wherein the tracks 1001 and 1002 and 1001 ’ and 1002’ are, respectively, in a position of minimum and maximum reciprocal distance;

[0037] Figure 6 is a perspective view of a system 100 for filling and closing sterile elements for parenteral drugs, with two containers 1 and 101 which can be sterilised by saturated steam connected by the track 86.

[0038] The above-mentioned drawings show a preferred embodiment of a conveying chute, in particular for conveying sterile elements, according to the invention, which is denoted in its entirety with the numerals 1000 and 1000’; an embodiment of a conveying track is also illustrated, in particular for conveying sterile elements, according to the invention, which is denoted in its entirety with the numeral 86.

[0039] In Figures 1 to 6, the track 86 is formed by two chutes 1000 and 1000’ which have in common a relative track 1001 and 100T, attached to the loadbearing frame 1003 of the track and the chutes themselves.

[0040] The sliding tracks 1001 , 100T, 1002 and 1002’ for the elements to be conveyed, that is to say, sterile caps T intended for closing sterile bottles, as well as the frame 1003, extend sinuously along a direction of movement S of the caps T, thus defining a trajectory which the caps T must travel along (for example between two containers 1 and 101 ).

[0041] The tracks 1002 and 1002’ can be spaced from the corresponding tracks 1001 and 100T by a series of respective actuators 1010 and 1010’ which are actuated remotely.

[0042] With reference to Figures 5A and 5B, the actuators are pneumatic pistons 1010 (1010’) which are dynamically movable between a position of minimum reciprocal distance Dmin of the tracks 1001 (1001 ’) and 1002 (1002’), as shown in Figure 5A, and a position of maximum reciprocal distance Dmax, Figure 5B.

[0043] In the position of minimum distance from each other the first 1001 (1001 ’) and the second track 1002 (1002’) are both in contact with two end portions of the caps T, whilst in the position of maximum distance from each other the contact between one of the end portions ceases with the first 1001 ,

[0044] 1001 ’ or the second track 1002.

[0045] The pistons 1010 and 1010’ are mounted transversely to the direction of movement S and each of them comprises a relative cylinder 1014 associated with the second track 1002 (1002’) on which a relative rod 1015 acts.

[0046] All the rods 1015 are movable along a feed direction Y substantially perpendicular to the direction of movement S between a rest point, wherein the two tracks 1001 and 1002 and 100T and 1002’ are at the minimum mutual distance Dmin and a working point, wherein the two tracks 1001 and

[0047] 1002 and 100T and 1002’ are at the maximum mutual distance Dmax.

[0048] In other words, the rest point corresponds to the minimum stroke value C of the respective rod 1015 of the cylinder 1014, and the working point corresponds to the maximum stroke value C of the rod 1015.

[0049] Each rod 1015 has a first end 1015a fixed to the first track 1001 (1001 ’) by a screw 1016 and a second end which has a head 101 1 for slidably engaging inside the cylinder 1014, for a maximum amplitude equal to the maximum stroke value C.

[0050] There is also, on each chute 1000 (100T), located on the median between the two tracks 1001 and 100T (1002 and 1002’), a contact cage 1004 (1004’), associated - by screws 1034 (1034’) - with the rib 1003a of the load-bearing frame 1003, for upper containment of the caps T on the predetermined trajectory to be travelled along (Figures 1 and 2).

[0051] For the protection of the pistons 1010 and 1010’, bellows 1020 and 1020’ are advantageously mounted, for example to always keep all the surfaces exposed to the sterilising or sanitising agent without ever carrying a portion in non-sterile recesses.

[0052] Moreover, a support 1003b of the load-bearing frame 1003 guarantees the resting on the ground of the track 86 (Figures 1 and 2).

[0053] As shown in Figure 6, the system 100 for filling and closing sterile elements for parenteral drugs comprises two containers 1 and 101 which can be sterilised by saturated steam.

[0054] The first container 1 is used for filling bottles F to be filled and finished inside the relative process chamber 2.

[0055] The second container 101 is used for distributing caps T designed to be distributed to the first container 1 .

[0056] In this case, the track 86, comprising the chutes 1000 and 1000', conveys the sterile caps T from the second container 101 to the first container 1 .

[0057] In use, two rows of sterilised caps T, coming out from the container 101 , travel - thanks to the gravity - along the trajectory drawn by the tracks 1001 - 1002 and 100T-1002’, constrained also by the cages 1004 and 1004’, towards the other container 1 , located lower down.

[0058] When a jamming occurs, the operator operates a remote command which moves the actuators 1010 and 1010’ from the rest point, corresponding to the position of minimum reciprocal distance between the tracks 1001 -1002 and 1001 ’-1002’, to the working point, with the tracks 1001 -1002 and 1001 ’- 1002’ going to the maximum reciprocal distance, allowing the falling of the caps T.

[0059] The tracks 1001 -1002 and 1001 ’-1002’, which are now free, are restored in the position of minimum distance from each other, that is to say, of normal use, again by means of a remote control which returns the actuators 1010 and 1010’ to the initial rest point and the caps T can continue their sliding path from the container 101 to the container 1 . From the above description it may be seen how the invention achieves the preset purpose and aims and in particular the fact that a conveying track is made in which there is a continuous feeding of the elements to be conveyed, without the risk that obstructions and blockages can slow down the process. In particular, having conceived remotely controlled actuators for opening the sliding tracks of the elements to be conveyed allows the operator to not have to intervene directly in the sterile environment to resolve any blockages, as well as avoiding the use of sterile gloves which are not always convenient to use.

[0060] Another advantage of the above-mentioned track is due to the fact that it guarantees the perfect and certain sterility of the machine and all its parts and constitutes a conveying which is simple to make and easy to use.

[0061] The invention described can be modified and adapted in several ways without thereby departing from the scope of the inventive concept.

[0062] Moreover, all the details of the invention may be substituted by other technically equivalent elements.

[0063] In practice, the materials used, as well as the dimensions, may be of any type, depending on requirements, provided that they are consistent with their production purposes.

Claims

CLAIMS1 ) A conveying chute (1000, 1000’) comprising, on a relative load-bearing frame (1003), a first (1001 , 1001 ’) and a second sliding track (1002, 1002') for elements to be conveyed (T), extending along a direction of movement (S) and defining a predetermined trajectory to be travelled along for the elements to be conveyed (T); the first track (1001 , 1001 ’) and the second track (1002, 1002’) which can be spaced apart from each other in a dynamic manner, between a position of minimum reciprocal distance (Dmin) and a position of maximum reciprocal distance (Dmax); wherein in the position of minimum reciprocal distance (Dmin) the first track (1001 , 1001 ’) and the second track (1002, 1002’) are simultaneously in contact with at least two end portions of each element to be conveyed (T) and in the position of maximum reciprocal distance (Dmax) at least one of the end portions is not in contact with the first track (1001 , 1001 ’) or the second track (1002, 1002’).2) The chute (1000, 1000’) according to claim 1 , wherein at least one between the first track (1001 , 1001 ’) and the second track (1002, 1002’) is movable relative to the other by means of actuators (1010, 1010’).3) The chute (1000, 1000’) according to claim 2, wherein the actuators (1010, 1010’) can be operated by remote control.4) The chute (1000, 1000’) according to claim 2 or 3, wherein each actuator (1010, 101 O’) is a piston (1010, 101 O’) mounted transversely to the direction of movement (S) and comprising a relative cylinder (1014) associated with the second track (1002, 1002’) on which a relative rod (1015) acts; all said rods (1015) are movable along a feed direction (Y) substantially perpendicular to the direction of movement (S) between a rest point and a working point; the rest point, wherein the first track (1001 , 1001 ’) and the second track (1002, 1002’) are at the minimum reciprocal distance (Dmin), corresponds to the minimum value of the stroke (C) of the respective rod (1015) of thecylinder (1014), and the working point, wherein the first track (1001 , 1001 ’) and the second track (1002, 1002’) are at the maximum reciprocal distance (Dmax), corresponds to the maximum value of the stroke (C) of the rod (1015).5) The chute (1000, 1000’) according to claim 4, wherein each rod (1015) has a first end (1015a) fixed to the first track (1001 , 100T) and a second end having a head (101 1 ) engaging in a sliding fashion inside the cylinder (1014) for a maximum amplitude equal to the maximum value of the stroke (C).6) The chute (1000, 1000’) according to any one of claims 1 to 5, comprising a contact cage (1004) for the upper containment of the elements to be conveyed (T) on the predetermined trajectory to be travelled along.7) The chute (1000) according to any one of claims 1 to 6, is designed to be coupled in parallel to at least one other conveying chute (1000’).8) A conveying track (86) for elements to be conveyed (T) comprising at least two chutes (1000, 1000’) according to any one of claims 1 to 7, coupled to each other and having one of their respective tracks (1001 , 100T) in common, attached to the load-bearing frame (1003).9) A system (100) for filling and closing sterile elements (F, T) for parenteral drugs, comprising at least two containers (1 , 101 ) which can be sterilised by saturated steam; wherein a first container (1 ) is used for filling bottles (F), syringes and carpules, designed to be filled and finished inside the relative process chamber (2), and a second container (101 ) is used for distributing caps (T) and covers for bottles (F), syringes and carpules, designed to be distributed to the first container (1 ); characterised in that it comprises a conveying chute (1000, 1000’) according to one or more of claims 1 to 7, or a track (86) according to claim 8, for elements to be conveyed (T) from the second container (101 ) to the first container (1 ).

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