Patent Publication Number: US-2019177026-A1

Title: Opening assembly for a package

Description:
This invention concerns an opening assembly for a package, particularly for containers, preferably vials, bottles, syringes, carpules and the like, which can be installed in a container handling and filling system. 
     It is known that, in the pharmaceutical industry, products and substances in liquid and/or powder form can be appropriately packaged in special containers, often designed to contain a single dose, in order to facilitate their administration to patients. 
     These containers may be bottles, vials, cartridges (such as, for example carpules, used in syringes, intended to administer local anaesthetics), syringes (such as ready-to-use syringes used for many miscellaneous applications) and similar devices. 
     The known procedures for filling and packaging containers such as bottles, cartridges, syringes and similar devices require the provision of tubs containing suitable nests, within which the individual containers are neatly arranged. 
     The tubs, nests and containers to be filled are manufactured by their suppliers, which generally differ from those taking care of the filling procedure. 
     Therefore, in order to protect the contents of the tub from any risk of contamination by the outside environment, before sending the package to the filling and packaging system, the tub is sealed with a covering film and inserted into a bag. 
     Once the tub has been extracted from the bag, it is necessary to remove the covering film. 
     This procedure is normally carried out in a special environment with a minimal risk of contamination (for example, contamination class A). 
     It should also be noted that such procedure is very delicate and may expose the containers to contamination due to particles that could remain in the air and enter the tub and, therefore, the containers, when the covering film is removed. 
     The main aim of this invention is to resolve the above problems, by providing an opening assembly for a package that eliminates the risk of contamination of the contents of the package during the process of removing the covering film from such package. 
     Within the scope of this aim, one purpose of this invention is to propose a relatively easy-to-use, practical, safe and cost-effective opening assembly for a package. 
     This aim and these purposes are achieved by an opening assembly for a package according to claim  1 . 
    
    
     
       Additional features and advantages of this invention are further detailed in the description of a preferred, but not exclusive, form of execution, of the opening assembly for a package according to the invention, illustrated by way of a non-limiting example, in the accompanying drawings, in which: 
         FIG. 1  shows an axonometric view of the opening assembly, according to this invention, during an intermediate package opening phase; 
         FIG. 2  shows an aerial view of the assembly as shown in  FIG. 1 , according to the invention; 
         FIG. 3  shows a cross-sectional view of the assembly as shown in  FIG. 1 , according to the invention, in a first clamping phase of a package by at least one clamp; 
         FIG. 4  shows an enlarged view of a portion of  FIG. 3 ; 
         FIG. 5  shows a cross-sectional view of the assembly as shown in  FIG. 1 , according to the invention, in a package alignment phase to at least one clamp; 
         FIG. 6  shows an enlarged view of a portion of  FIG. 5 ; 
         FIG. 7  shows a cross-sectional view of the assembly as shown in  FIG. 1 , according to the invention, in a clamping phase with at least one clamp on a portion of a covering film; 
         FIG. 8  shows an enlarged view of a portion of  FIG. 7 ; 
         FIG. 9  shows a cross-sectional view of the assembly as shown in  FIG. 1 , in an intermediate film-removal phase; 
         FIG. 10  shows an enlarged view of a portion of  FIG. 9 ; 
         FIG. 11  shows a cross-sectional view of the assembly as shown in  FIG. 1 , in a final package-opening phase, when the film is completely removed from the tub; 
         FIG. 12  shows an enlarged view of a portion of  FIG. 11 ; 
         FIG. 13  shows a cross-sectional view of a different embodiment of the assembly of  FIG. 1 , in an intermediate film-removal phase. 
     
    
    
     With specific reference to these figures,  1  globally indicates an opening assembly for a package A, particularly for containers such as: vials, bottles, syringes, carpules and the like. 
     This assembly  1  can be installed in a container handling and filling system. 
     The package A comprises a tub B, with a covering film D, containing a nest bearing the containers in an orderly manner. 
     According to the invention, the opening assembly  1  comprises at least one clamp  2  located upstream of an opening  3  placed on a separation wall  4  between a first sterile environment F and second sterile environment E, located upstream and downstream said opening  3  respectively. 
     Where upstream and downstream refer to the moving direction of the tub B. 
     It should also be noted that a “clamp”  2  refers to any clamping device. 
     Whilst the package A passes through the opening  3 , passing from the first sterile environment F to second sterile environment E, the clamp  2  clamps an edge of the covering film C, consequently removing the covering film. 
     Removing the covering film C, by clamping it and raising it by means of the clamp  2 , within the first environment D, before the package A completely passes through the opening  3 , prevents particles that could be released during this removal procedure from entering the second environment E, where the package A have no covering film C and is, therefore, exposed to the risk of contamination. 
     According to a useful feature, the first environment D can have a lower contamination class that the second environment E. 
     It should be noted that each contamination class corresponds to a maximum allowed number of particles present in the environment. 
     It is essential to minimise the entry, generation and retention of airborne particles within the environments, in order to enable contamination-susceptible activities to be carried out. 
     According to an undeniably easy-to-use and practical solution, the clamp  2  can be moved in a direction substantially perpendicular to the direction of movement of the package A, by the action of a respective actuator. 
     In the figures, the package moves horizontally and the clamp vertically. 
     Specifically, the clamp  2  can be moved between a first clamping configuration to the package A, to a second raised configuration. 
     It should be noted that, in the raised configuration, the clamp  2  is raised from the package A by a distance from the bottom of the opening which is equal to at least the length of the covering film C, when the covering film C has been removed from the package A and the package A fully entered in the second environment E. By removing the covering film C by clamping it and raising it using the clamp  2 , the package A is conveyed from the first environment D to the second environment E. 
     It is also possible that the assembly  1  may comprise an abutment bar  5  for the covering film C, this bar  5  is arranged so as to face and be closed to the separation wall  4 , at the upstream of the opening  3 , in the vicinity of a top portion (the covering film) of the package A. 
     The presence of the bar  5  therefore prevents the raising of the package A during the removal of the covering film C by the clamp  2 . 
     The assembly  1  may also comprise a handling device  6  provided with coupling elements  7  for the package A. 
     This handling device  6  is designed to move the package A through the opening  3  from the first environment D to the second environment E. 
     According to a different embodiments, showed in  FIG. 13 , the clamp  2  can be fixed at a distance form a bottom side of the opening  3  and the handling device  6 , as a consequence of the clamping of the clamp  2  on the covering film C, draws a sloping downwards trajectory towards the opening  3 , in order to distance the package A from the clamp  2  and therefore remove the covering film C. 
     It is also possible that the handling device  6  may have securing elements  8  to secure the package A, in order to prevent it from rising during the removal of the covering film C. 
     It should also be noted that the handling device  6  may be a high-precision anthropomorphic robot. 
     According to a preferred embodiment, the coupling elements  7  are movable within the space, with at least 6 degrees of freedom of movement, according to the three cartesian axes and also have three degrees of freedom of rotation. 
     In order to ensure that the handling device  6  performs the appropriate alignments of the package A in order to enable the clamp  2  to remove the covering film C, the assembly  1 , according to the invention, comprises a programmable control and management unit for the controlled movement of at least one component, chosen from the handling device  6  and the clamp  2 . 
     The assembly  1  may comprise at least two opposite containment shoulders  9  arranged to guide the package A whilst the package A moves through the opening  3 . 
     The pressure within the second environment E may be higher than the pressure within the first environment D, such different pressures causing a constant flow of gas through the opening  3  from the second environment E to the first environment D, such flow investing the package A whilst it passes through the opening ( 3 ). 
     By removing the covering film C, by clamping it and raising using the clamp  2 , within the first environment D, before the package A completely passes through the opening  3 , prevents particles that could be released during this removal procedure from entering the package A. 
     In fact, these particles, possible produced during this removal procedure, are driven by the flow that invest the package A towards the first environment D and therefore towards a portion of the package A which is still covered by the covering film C. 
     If the package A comprises a protection sheet between the covering film C and the contents, the protection sheet can be removed in the second environment E, as its removal does not cause any particle formation. 
     Advantageously, this invention resolves the above problems, by proposing an opening assembly  1  for a package A that eliminates the risk of contamination of the contents of the package A during the removal of the covering film C from the package A. 
     The invention, thus conceived, is subject to numerous changes and variations, all falling within the scope of protection of the invention; also, all details can be replaced by other technically equivalent elements. 
     In the illustrated examples, individual features, shown in relation to specific examples, can, in reality, be interchanged with other different features, existing in other examples of implementation. 
     In practice, the materials used, as well as the dimensions, can be of any kind, according to the needs and status of the technique.