EP3615106A1 - Structure for packaging containers for pharmaceutical use - Google Patents

Structure for packaging containers for pharmaceutical use

Info

Publication number
EP3615106A1
EP3615106A1 EP18722736.8A EP18722736A EP3615106A1 EP 3615106 A1 EP3615106 A1 EP 3615106A1 EP 18722736 A EP18722736 A EP 18722736A EP 3615106 A1 EP3615106 A1 EP 3615106A1
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical use
seats
containers
perimeter walls
packing containers
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP18722736.8A
Other languages
German (de)
French (fr)
Inventor
Gianpaolo BERTOLIN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nuova Ompi SRL
Original Assignee
Nuova Ompi SRL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nuova Ompi SRL filed Critical Nuova Ompi SRL
Publication of EP3615106A1 publication Critical patent/EP3615106A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/008—Racks for supporting syringes or needles

Definitions

  • the present invention concerns a structure for packing containers for pharmaceutical use.
  • Structures are known for packing containers for pharmaceutical use comprising a tray, called a "tub", made of plastic material and with a closed bottom, which supports therein a support plane or matrix (called a 'nest ' ) , typically made of plastic material, and having a series of accommodation holes wherein the containers are housed vertically.
  • Some types of primary containers such as, for example, syringes, may be held in place supported on the rim of the accommodation holes by their perimeter flange, while other containers, without protruding parts, need special elements to hold them inside the holes.
  • the tray is sealed by means of a porous filter membrane, such as a paper filter or a Tyvek® type filter.
  • a porous filter membrane such as a paper filter or a Tyvek® type filter.
  • Such structures for packing primary containers are usually closed and sealed in at least one protective wrapper, known as a "steribag”.
  • the packing structure therefore comprises at least two overlapping sterility barriers, the first between the tray and the porous membrane and the second between the sealed tray and the protective wrapper, so as to block any microbiological or particle contamination.
  • the containers are stacked and positioned on pallets before being subjected to a final sterilization cycle.
  • the primary containers are placed in an area of controlled contamination, e.g. sterile, to be subjected to an aseptic filling process.
  • an area of controlled contamination e.g. sterile
  • Such filling step provides for unpacking the packing structures sealed inside their protective wrappings, opening the protective wrappings by a process to reduce contamination (typically through the effect of a laminar flow of ultra-clean air so as to create a barrier to external contaminants), extracting the packing structures from their protective wrapping after biological decontamination of the external surface: then proceeding with positioning each packing structure within the aseptic zone before removing the tray filter.
  • contamination typically through the effect of a laminar flow of ultra-clean air so as to create a barrier to external contaminants
  • FIG. 1 represents a plan view of a structure for packing containers for pharmaceutical use according to the present invention
  • figure 2 represents a sectional view of the structure of figure 1 along the sectional plane II-II indicated in figure 1;
  • figure 3 represents the enlarged detail III shown in figure 1;
  • figure 4 represents the enlarged detail IV shown in figure 1;
  • figure 5 represents a perspective view from the top of the support plane of the structure in figure 1;
  • figure 6 represents a perspective view of an enlarged detail of the support plane in figure 5;
  • FIG. 7 represents a perspective view from the bottom of the support plane 5;
  • figure 8 represents a perspective view of an enlarged detail of the support plane in figure 7;
  • containers for pharmaceutical use is irrelevant, meaning containers of various types, sizes and/or materials such as, for example, syringes, vials, tubular injection vials, bottles and the like.
  • the structure 4 comprises a tray 8 that accommodates and supports a support plane 12 provided with a plurality of seats 16 for accommodating containers for pharmaceutical use 20.
  • the seats 16 have a cylindrical shape with respect to main extension axes X-X, parallel to each other .
  • Said main extension axes are perpendicular to the support plane 12.
  • the seats 16 are delimited by perimeter walls 24 which project from the support plane 12 towards an upper side 28 of the structure 4.
  • the top side 28 is in turn opposite to a bottom 32 of the tray 8, preferably closed.
  • the perimeter walls 24 of the seats 16 are cylindrical with a circular cross-section with respect to a cross-section plane perpendicular to said main extension axes X-X.
  • the perimeter walls 24 of adjacent seats 16 are mechanically connected to each other by a lattice structure 36 comprising a plurality of bridges 40.
  • the lattice structure 36 defines, in the interstices 44 between the perimeter walls 24 of adjacent seats 16, a plurality of through-openings 48 through the support plane 12 in such a way that it becomes pervious to the passage of an air flow that intersects said interstices 44 of the support plane 12.
  • the support plane 12 does not only have holes in the seats 16, as in the solutions of the prior art, but also and above all in the interstices 44 between adjacent seats 16 that, in the known solutions, are on the other hand solid as they constitute reinforcements and stiffenings of the support plane itself .
  • the flow of suitably purified air serves to create a barrier against impurities; it is therefore essential that the support plane 12 is as pervious as possible to this flow not so much at the seats 16, which, when occupied by the containers for pharmaceutical use 20, do not allow the passage of air, but precisely at the interstices that always oppose the passage of air, creating negative turbulence.
  • through-openings 48 allows a good overall perviousness of the support plane 12, regardless of the presence or not of containers for pharmaceutical use 20: due to such perviousness, the air flow may be essentially laminar even after penetrating the support plane 12.
  • the lattice structure 36 comprises linear bridges 40,42 that mechanically connect the perimeter walls 24 of two adjacent seats 16 to each other.
  • the lattice structure 36 comprises Y-shaped bridges 52 that mechanically connect the perimeter walls 24 of three adjacent seats 16 arranged to form a triangle.
  • the lattice structure 36 is shaped in such a way as to provide a Y-shaped bridge 52 at each interstice 44 delimited by three adjacent seats 16 arranged to form a triangle.
  • said Y-shaped bridges 52 have sides 56 of equal length and angularly equally spaced from each other at 120°.
  • said Y-shaped bridges 52 have sides 56 each oriented so as to intersect at least one axis of symmetry W-W of one of the three seats 16.
  • the seats 16 are arranged according to a quincunx pattern.
  • the lattice structure 36 comprises a plurality of Y-shaped bridges 52 having respective branches 56 all oriented parallel to three main directions PI, P2, P3, angularly equally spaced at 120°.
  • directions parallel to said main directions P1,P2,P3 intersect the axes of symmetry W-W of all the seats 16 of the lattice structure 36.
  • the lattice structure 36 has seats 16 arranged according to a repetitive scheme, defined by the three main directions PI, P2, P3 that define the spatial positions of the seats on the support plane.
  • the positions of the seats 16 are defined by their respective axes of symmetry W-W.
  • the lattice structure 36 has a remarkable mechanical strength.
  • the interstices 44 between three adjacent seats 16 arranged in a triangle have three lobes 46 equal and equally spaced with respect to a central axis ⁇ 0' of the respective Y-shaped bridge.
  • Central axis ⁇ 0' means the axis identified by the intersection of the branches 56 of the Y-shaped bridge 40, 52.
  • bridges 40,52 extend axially in a direction parallel to the main extension axes X-X from a centerline M of the perimeter walls 24 to the support plane 12.
  • the centerline M is to be understood in relation to the overall height of the perimeter walls, parallel to the main extension axes X-X, from the support plane 12 to the upper side 28.
  • the perimeter walls 24 of the seats 16 comprise a plurality of external ribs 60, opposite to an inner containment volume 64 of associable containers for pharmaceutical use 20.
  • said external ribs 60 extend near the upper side 28 in order to realize abutments and guides 68 for positioning and aligning perimeter collars or flanges 72 of associable containers for pharmaceutical use 20.
  • the external ribs 60 are cantilevered with respect to the perimeter walls 24 and do not touch the external ribs of adjacent seats 16 so as to allow the perviousness of the air flows.
  • At least one through-opening 48 through the support plane 12, said at least one through-opening comprising two holes 76 partially separated by opposite external ribs 60 protruding from the perimeter walls 24 of their respective seats 16.
  • said external ribs 60 extend parallel from the upper side 28 of the lattice structure 36, so as to realize abutments and guides 68 for positioning and aligning collars 72 of containers for pharmaceutical use 20 on the support plane 12 in order to realize an anchoring of the perimeter walls 24 to the support plane 12 and a stiffening of the latter.
  • the seats 16 on the respective perimeter walls 24 comprise internal ribs 80 (figures 6, 8), which project internally to the inner containment volume 64 of associable containers for pharmaceutical use 20, so as to partially reduce the lumen of the seats 16 themselves and guide the insertion and positioning of containers 20.
  • the internal ribs 80 guide the insertion of a tubular body 82 of the containers for pharmaceutical use 20.
  • the lattice structure 36 is dimensioned in such a way that the interstices 44 between the perimeter walls 24 of three adjacent seats 16, arranged in a triangle, define collectively a through or pervious area 84 not less than 3 mm2.
  • This through or pervious area 84 constitutes the collective air passage lumen through these interstices 44, regardless of whether or not containers for pharmaceutical use 20 are present in the relative seats 16.
  • the through area 84 does not depend only on the geometric shape of the lattice structure 36 but also on the presence and/or positioning of collars 72 of the containers for pharmaceutical use 20.
  • the through or pervious area 84 may be reduced by the positioning of collars 72 of the containers for pharmaceutical use 20.
  • the presence of internal ribs 80 in addition to ensuring the alignment of the containers according to the main vertical extension axes, i.e. perpendicular to the support plane 12, greatly limits the variability of the through-area 84, due to the positioning of the containers for pharmaceutical use, always ensuring an adequate through-area 84.
  • the present invention overcomes the disadvantages of the prior art .
  • the structure for packing containers for pharmaceutical use is highly pervious to the passage of the flows of pure air for decontamination that may be essentially laminar so as to limit the penetration of polluting particles in the containers for pharmaceutical use .
  • a high perviousness of the interstices defined between adjacent seats is guaranteed not only by the geometric configuration of the lattice structure, but also by the correct positioning of the containers for pharmaceutical use within their respective seats. In this way, the collars of containers for pharmaceutical use do not significantly obscure the through or pervious areas.
  • the structure has a mechanical stiffness and/or a geometric shape sufficient to guarantee a reduced elastic flexion of the structure and therefore the correct alignment of the containers within their respective seats, even under conditions of maximum load (i.e. maximum filling) of the structure.
  • This improved stiffness is obtained by means of the lattice structure, suitably shaped to guarantee both strength and perviousness to air.
  • the structure is also light as a whole as it is highly pervious due to the presence of holes and openings: the reinforcement shelf normally used in the solutions of the prior art to confer mechanical strength to the structure is therefore eliminated.

Abstract

A structure (4) for packing containers for pharmaceutical use (20 comprising a tray (8) accommodating and supporting a support plane (12) fitted with a plurality of seats (16) for accommodating containers for pharmaceutical use (20), the seats (16) having a cylindrical shape with respect to the main extension axes (X-X), parallel to each other. The seats (16) are delimited by perimeter walls (24) which project from the support plane (12) towards an upper side (28) of the structure (4). Advantageously, the perimeter walls (24) of adjacent seats (16) are mechanically connected to each other by a lattice structure (36) comprising a plurality of bridges (40). The lattice structure (36) defines, in the interstices (44) between the perimeter walls (24) of adjacent seats (16), a plurality of through-openings (48) through the support plane (12) so that it is pervious to the passage of an air flow that intersects said interstices (44) of the support plane (12).

Description

DESCRIPTION
"Structure for packaging containers for pharmaceutical use"
SCOPE
[0001] The present invention concerns a structure for packing containers for pharmaceutical use.
STATE OF THE ART
[0002] As is well known, primary containers for pharmaceutical use such as, for example, vials, bottles, tubular injection vials and syringes must be kept in a controlled environment that is isolated from the outside, as well as kept clean and sterile, until they are used or employed in treatment processes, in particular, filling and closure.
[0003] Structures are known for packing containers for pharmaceutical use comprising a tray, called a "tub", made of plastic material and with a closed bottom, which supports therein a support plane or matrix (called a 'nest ' ) , typically made of plastic material, and having a series of accommodation holes wherein the containers are housed vertically.
[0004] Some types of primary containers, such as, for example, syringes, may be held in place supported on the rim of the accommodation holes by their perimeter flange, while other containers, without protruding parts, need special elements to hold them inside the holes.
[0005] The tray is sealed by means of a porous filter membrane, such as a paper filter or a Tyvek® type filter.
[0006] Such structures for packing primary containers are usually closed and sealed in at least one protective wrapper, known as a "steribag".
[0007] The packing structure therefore comprises at least two overlapping sterility barriers, the first between the tray and the porous membrane and the second between the sealed tray and the protective wrapper, so as to block any microbiological or particle contamination.
[0008] Such sealed packing structures, inside their protective wrapping, are in turn placed in containers of a size and weight suitable for handling during packing and unpacking operations.
[0009] Generally, the containers are stacked and positioned on pallets before being subjected to a final sterilization cycle.
[0010] At the time of use, the primary containers are placed in an area of controlled contamination, e.g. sterile, to be subjected to an aseptic filling process.
[0011] Such filling step provides for unpacking the packing structures sealed inside their protective wrappings, opening the protective wrappings by a process to reduce contamination (typically through the effect of a laminar flow of ultra-clean air so as to create a barrier to external contaminants), extracting the packing structures from their protective wrapping after biological decontamination of the external surface: then proceeding with positioning each packing structure within the aseptic zone before removing the tray filter.
[0012] As can be seen from the above, the handling of packing structures and the filling of containers for pharmaceutical use entails a plurality of technical problems that need to be resolved.
[0013] In effect, on the one hand there are sterility problems, whereby the packing structures are subjected to air flows, preferably laminar, to prevent polluting particles from reaching the containers.
[0014] The effectiveness of such air flows is not however absolute and the presence of obstacles to the air flow causes the onset of turbulence that may affect the barrier effect of the air. In effect, pharmaceutical containers typically comprise, as seen, support planes that, on the one hand, accommodate the containers and, on the other, have a plurality of walls that constitute obstacles to the passage of the air itself. Such walls are, however, necessary to ensure the required mechanical strength to adequately support the containers for pharmaceutical use. In effect, under the weight of the containers and the contents thereof, the support planes tend to flex downwards. Because of such flexion, the containers lose their mutual parallelism with respect to a vertical direction, perpendicular to the support plane.
[0015] This deformation must be avoided or controlled with extreme precision, since the packing structures must be handled automatically using mechanical arms that could interfere with some of said containers, if they are misplaced/misorientated within the respective seats of the support plane.
[0016] As may be deduced from the above, the need for mechanical stiffness, in order to always guarantee the correct positioning/alignment of the containers for pharmaceutical use, leads to an increase in the thickness and extension of the reinforcement walls, which oppose the smooth passage of the laminar air flow to counteract the contamination of the containers. In addition, these reinforcements end up further weighing down the support plane and increasing the flexion under its own weight.
[0017] Therefore, the requirements of biological and/or particle decontamination and containment of the deformation of the packing structures are antithetic to each other.
PRESENTATION OF THE INVENTION
[0018] The solutions of the prior art guarantee the mechanical strength of the support plane, and therefore the correct handling thereof by means of automation but at the expense of the effectiveness of the decontamination air flow that meets significant obstacles when it strikes the support plane, generating troublesome and harmful turbulence that reduces its effectiveness as an anti-contaminant.
[0019] The need is therefore perceived to resolve the drawbacks and limitations cited with reference to the known art .
[0020] Therefore, the need is perceived to provide a structure for packing containers for pharmaceutical use which allows effective biological and/or particle decontamination and, at the same time, a correct handling of the structure in a fast and automated manner.
[0021] Such requirement is met by a structure for packing containers for pharmaceutical use in accordance with claim 1.
DESCRIPTION OF THE FIGURES
[0022] Further features and advantages of the present invention will become more comprehensible from the following description of its preferred and non-limiting embodiments, wherein:
[0023] - figure 1 represents a plan view of a structure for packing containers for pharmaceutical use according to the present invention;
[0024] - figure 2 represents a sectional view of the structure of figure 1 along the sectional plane II-II indicated in figure 1;
[0025] - figure 3 represents the enlarged detail III shown in figure 1;
[0026] - figure 4 represents the enlarged detail IV shown in figure 1;
[0027] - figure 5 represents a perspective view from the top of the support plane of the structure in figure 1;
[0028] - figure 6 represents a perspective view of an enlarged detail of the support plane in figure 5;
[0029] - figure 7 represents a perspective view from the bottom of the support plane 5;
[0030] - figure 8 represents a perspective view of an enlarged detail of the support plane in figure 7;
[0031] The elements or parts of elements in common between the embodiments described hereinafter will be indicated at the same numerical references.
DETAILED DESCRIPTION
[0032] With reference to the aforementioned figures, an overall view of a structure for packing containers for pharmaceutical use is collectively indicated at 4.
[0033] It should be noted that, for the purposes of the scope of protection of the present invention, the specific type of containers for pharmaceutical use is irrelevant, meaning containers of various types, sizes and/or materials such as, for example, syringes, vials, tubular injection vials, bottles and the like.
[0034] The structure 4 comprises a tray 8 that accommodates and supports a support plane 12 provided with a plurality of seats 16 for accommodating containers for pharmaceutical use 20.
[0035] Typically, the seats 16 have a cylindrical shape with respect to main extension axes X-X, parallel to each other .
[0036] Said main extension axes are perpendicular to the support plane 12.
[0037] The seats 16 are delimited by perimeter walls 24 which project from the support plane 12 towards an upper side 28 of the structure 4.
[0038] The top side 28 is in turn opposite to a bottom 32 of the tray 8, preferably closed.
[0039] Preferably, the perimeter walls 24 of the seats 16 are cylindrical with a circular cross-section with respect to a cross-section plane perpendicular to said main extension axes X-X.
[0040] Advantageously, the perimeter walls 24 of adjacent seats 16 are mechanically connected to each other by a lattice structure 36 comprising a plurality of bridges 40.
[0041] In particular, the lattice structure 36 defines, in the interstices 44 between the perimeter walls 24 of adjacent seats 16, a plurality of through-openings 48 through the support plane 12 in such a way that it becomes pervious to the passage of an air flow that intersects said interstices 44 of the support plane 12.
[0042] Between the perimeter walls 24 of two adjacent seats 16 there is at least one through-opening 48 through the support plane 12.
[0043] In other words, holes are made in the interstices 44 between adjacent seats 16 in order to allow the passage of an air flow; therefore, the support plane 12 does not only have holes in the seats 16, as in the solutions of the prior art, but also and above all in the interstices 44 between adjacent seats 16 that, in the known solutions, are on the other hand solid as they constitute reinforcements and stiffenings of the support plane itself .
[0044] The flow of suitably purified air, as seen, serves to create a barrier against impurities; it is therefore essential that the support plane 12 is as pervious as possible to this flow not so much at the seats 16, which, when occupied by the containers for pharmaceutical use 20, do not allow the passage of air, but precisely at the interstices that always oppose the passage of air, creating negative turbulence.
[0045] The presence of through-openings 48, on the other hand, allows a good overall perviousness of the support plane 12, regardless of the presence or not of containers for pharmaceutical use 20: due to such perviousness, the air flow may be essentially laminar even after penetrating the support plane 12.
[0046] The anti-contamination effectiveness of such laminar-type flow is certainly improved compared to the effect obtainable with the structures of the prior art.
[0047] According to an embodiment of the present invention, the lattice structure 36 comprises linear bridges 40,42 that mechanically connect the perimeter walls 24 of two adjacent seats 16 to each other.
[0048] According to a further embodiment, the lattice structure 36 comprises Y-shaped bridges 52 that mechanically connect the perimeter walls 24 of three adjacent seats 16 arranged to form a triangle.
[0049] Preferably, the lattice structure 36 is shaped in such a way as to provide a Y-shaped bridge 52 at each interstice 44 delimited by three adjacent seats 16 arranged to form a triangle.
[0050] Preferably, but not necessarily, said Y-shaped bridges 52 have sides 56 of equal length and angularly equally spaced from each other at 120°.
[0051] According to a preferred embodiment, said Y-shaped bridges 52 have sides 56 each oriented so as to intersect at least one axis of symmetry W-W of one of the three seats 16.
[0052] According to one embodiment, the seats 16 are arranged according to a quincunx pattern.
[0053] Preferably, the lattice structure 36 comprises a plurality of Y-shaped bridges 52 having respective branches 56 all oriented parallel to three main directions PI, P2, P3, angularly equally spaced at 120°.
[0054] Preferably, directions parallel to said main directions P1,P2,P3 intersect the axes of symmetry W-W of all the seats 16 of the lattice structure 36.
[0055] In other words, the lattice structure 36 has seats 16 arranged according to a repetitive scheme, defined by the three main directions PI, P2, P3 that define the spatial positions of the seats on the support plane. The positions of the seats 16 are defined by their respective axes of symmetry W-W.
[0056] In this way the lattice structure 36 has a remarkable mechanical strength.
[0057] Preferably, the interstices 44 between three adjacent seats 16 arranged in a triangle have three lobes 46 equal and equally spaced with respect to a central axis Λ0' of the respective Y-shaped bridge.
[0058] "Central axis Λ0' " means the axis identified by the intersection of the branches 56 of the Y-shaped bridge 40, 52.
[0059] The symmetry and/or repetition of the interstitial geometry between the various seats 16 facilitates the passage of a laminar air flow between the through- openings 48 between the seats 16.
[0060] According to one possible embodiment, bridges 40,52 extend axially in a direction parallel to the main extension axes X-X from a centerline M of the perimeter walls 24 to the support plane 12. The centerline M is to be understood in relation to the overall height of the perimeter walls, parallel to the main extension axes X-X, from the support plane 12 to the upper side 28.
[0061] According to one possible embodiment, the perimeter walls 24 of the seats 16 comprise a plurality of external ribs 60, opposite to an inner containment volume 64 of associable containers for pharmaceutical use 20.
[0062] For example, said external ribs 60 extend near the upper side 28 in order to realize abutments and guides 68 for positioning and aligning perimeter collars or flanges 72 of associable containers for pharmaceutical use 20.
[0063] The external ribs 60 are cantilevered with respect to the perimeter walls 24 and do not touch the external ribs of adjacent seats 16 so as to allow the perviousness of the air flows.
[0064] Preferably, between two adjacent seats 16 there is at least one through-opening 48 through the support plane 12, said at least one through-opening comprising two holes 76 partially separated by opposite external ribs 60 protruding from the perimeter walls 24 of their respective seats 16.
[0065] Preferably, said external ribs 60 extend parallel from the upper side 28 of the lattice structure 36, so as to realize abutments and guides 68 for positioning and aligning collars 72 of containers for pharmaceutical use 20 on the support plane 12 in order to realize an anchoring of the perimeter walls 24 to the support plane 12 and a stiffening of the latter.
[0066] Moreover, such external ribs 60, when not obscured to the air flow by the collars 72 of the containers for pharmaceutical use 20, realize a sort of guidance and channeling of the laminar air flows sent to avoid the contamination of the structure 4.
[0067] According to one possible embodiment, the seats 16 on the respective perimeter walls 24 comprise internal ribs 80 (figures 6, 8), which project internally to the inner containment volume 64 of associable containers for pharmaceutical use 20, so as to partially reduce the lumen of the seats 16 themselves and guide the insertion and positioning of containers 20.
[0068] In other words, the internal ribs 80 guide the insertion of a tubular body 82 of the containers for pharmaceutical use 20.
[0069] Preferably, the lattice structure 36 is dimensioned in such a way that the interstices 44 between the perimeter walls 24 of three adjacent seats 16, arranged in a triangle, define collectively a through or pervious area 84 not less than 3 mm2.
[0070] This through or pervious area 84 constitutes the collective air passage lumen through these interstices 44, regardless of whether or not containers for pharmaceutical use 20 are present in the relative seats 16.
[0071] The through area 84 does not depend only on the geometric shape of the lattice structure 36 but also on the presence and/or positioning of collars 72 of the containers for pharmaceutical use 20.
[0072] In effect, such collars 72, which constitute a barrier to air, may be handled in relation to the clearance that the tubular body 82 of the container for pharmaceutical use 20 has within the inner containment volume 64 of the seats 16.
[0073] Therefore the through or pervious area 84 may be reduced by the positioning of collars 72 of the containers for pharmaceutical use 20.
[0074] In this regard, the presence of internal ribs 80, in addition to ensuring the alignment of the containers according to the main vertical extension axes, i.e. perpendicular to the support plane 12, greatly limits the variability of the through-area 84, due to the positioning of the containers for pharmaceutical use, always ensuring an adequate through-area 84.
[0075] As may be appreciated from the foregoing, the present invention overcomes the disadvantages of the prior art .
[0076] In effect, the structure for packing containers for pharmaceutical use is highly pervious to the passage of the flows of pure air for decontamination that may be essentially laminar so as to limit the penetration of polluting particles in the containers for pharmaceutical use .
[0077] A high perviousness of the interstices defined between adjacent seats is guaranteed not only by the geometric configuration of the lattice structure, but also by the correct positioning of the containers for pharmaceutical use within their respective seats. In this way, the collars of containers for pharmaceutical use do not significantly obscure the through or pervious areas. [0078] At the same time, the structure has a mechanical stiffness and/or a geometric shape sufficient to guarantee a reduced elastic flexion of the structure and therefore the correct alignment of the containers within their respective seats, even under conditions of maximum load (i.e. maximum filling) of the structure.
[0079] This improved stiffness is obtained by means of the lattice structure, suitably shaped to guarantee both strength and perviousness to air.
[0080] Finally, the structure is also light as a whole as it is highly pervious due to the presence of holes and openings: the reinforcement shelf normally used in the solutions of the prior art to confer mechanical strength to the structure is therefore eliminated.
[0081] A person skilled in the art, in the object of satisfying contingent and specific requirements, may make numerous modifications and variations to the structures described above, all of which are within the scope of the invention as defined by the following claims.

Claims

Claims
1. Structure (4) for packing containers for pharmaceutical use (20) comprising:
- a tray (8) housing and supporting a support plane (12) fitted with a plurality of seats (16) for housing containers for pharmaceutical use (20), the seats (16) having a cylindrical shape with respect to the main extension axes (X-X) , parallel to each other,
- the seats (16) being delimited by perimeter walls (24) which project from the support plane (12) towards an upper side (28) of the structure (4),
characterized in that
- the perimeter walls (24) of adjacent seats (16) are mechanically connected to each other by a lattice structure (36) comprising a plurality of bridges (40),
- said lattice structure (36) identifying, in the interstices (44) between the perimeter walls (24) of adjacent seats (16), a plurality of through-openings (48) through the support plane (12) so that it is pervious to the passage of a flow of air that intersects said interstices (44) of the support plane (12) .
2. Structure (4) for the packing containers for pharmaceutical use (20) according to claim 1, wherein the lattice structure (36) comprises linear bridges (40,42) which mechanically connect the perimeter walls (24) of two adjacent seats (16) to each other.
3. Structure (4) for the packing containers for pharmaceutical use (20) according to claim 1 or 2, wherein said lattice structure (36) comprises Y-shaped bridges (40,52) which mechanically connect the perimeter walls (24) of three adjacent seats (16) arranged to form a triangle.
4. Structure (4) for the packing containers for pharmaceutical use (20) according to claim 3, wherein the lattice structure (36) is shaped so as to present a Y- shaped bridge (40,52) at each interstice (44) delimited by three adjacent seats (16) arranged to form a triangle.
5. Structure (4) for the packing containers for pharmaceutical use (20) according to claim 3 or 4, wherein said Y-shaped bridges (40,52) have sides (56) of equal length and angularly equally spaced from each other at 120°.
6. Structure (4) for the packing containers for pharmaceutical use (20) according to claim 3, 4 or 5, wherein said Y-shaped bridges (40,52) have sides (56) each oriented to intersect an axis of symmetry (W-W) of one of the three seats (16) .
7. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the preceding claims, wherein the seats (16) inside the lattice structure (36) are arranged in a quincunx.
8. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the claims from 3 to 7, where the lattice structure (36) comprises a plurality of Y-shaped bridges (40,52) having respective branches (56) all oriented in parallel to three main directions (PI, P2, P3) , angularly equally spaced by 120° .
9. Structure (4) for the packing containers for pharmaceutical use (20) according to claim 8, wherein parallel directions to said main directions (PI, P2, P3) intersect axes of symmetry (W-W) of all the seats (16) of the lattice structure (36) .
10. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the claims from 3 to 9, wherein the interstices (44) located between three adjacent seats (16) arranged in a triangle, have three lobes equal and evenly-spaced from each other with respect to a central axis of the respective Y-shaped bridge (40, 52) .
11. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the preceding claims, wherein between the perimeter walls (24) of two adjacent seats (16) there is at least one through-opening (48) across the support plane (12) .
12. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the preceding claims wherein said bridges (40,42,52) extend axially, parallel to the main extension axes (X-X) , from a centerline (M) of the perimeter walls (24) towards the support plane (12) .
13. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the preceding claims, wherein the perimeter walls (24) of the seats (16) comprise a plurality of external ribs (60), opposite an inner containment volume (64) of associable containers for pharmaceutical use (20), said external ribs (60) extending next to the upper side (28) so as to form abutments and guides (68) for the positioning and alignment of collars (72) of associable containers for pharmaceutical use (20) .
14. Structure (4) for the packing containers for pharmaceutical use (20) according to claim 13, wherein said external ribs (60) are cantilevered with respect to the perimeter walls (24) and do not touch the external ribs (60) of adjacent seats (16) so as to make the air flows striking the lattice structure (36) pervious.
15. Structure (4) for the packing containers for pharmaceutical use (20) according to claim 13 or 14, wherein between two adjacent seats (16) there is at least one through-opening (48) through the support plane (12), said at least one through-opening (48) comprising two holes (76) partly separated by opposite external ribs (60) projecting from the perimeter walls (24) of the respective seats (16) .
16. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the claims from 13 to 15, wherein said external ribs (60) extend parallel from the upper side (28) of the structure (4), so as to realize abutments and guides (68) for positioning and aligning collars (72) of containers (20), as far as the support plane (12) so as to realize an anchoring of the perimeter walls (24) to the support plane (12) and a stiffening of the latter.
17. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the preceding claims wherein the perimeter walls (24) of the seats (16) are cylindrical with a circular cross-section with respect to a cross-section plane perpendicular to said main extension axes (X-X)
18. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the preceding claims, wherein the seats (16) on the respective perimeter walls (24) comprise internal ribs (80) which project inside a containment volume (64) of associable containers for pharmaceutical use (20) so as to partially reduce the lumen of said seats (16) and guide the insertion and positioning of the containers for pharmaceutical use (20) .
19. Structure (4) for the packing containers for pharmaceutical use (20) according to any of the preceding claims, wherein the lattice structure (36) is dimensioned so that the interstices (44) between the perimeter walls (24) of three adjacent seats (16) arranged in a triangle define a through or pervious area of not less than 3 mmA2.
EP18722736.8A 2017-04-28 2018-04-24 Structure for packaging containers for pharmaceutical use Withdrawn EP3615106A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102017000046565A IT201700046565A1 (en) 2017-04-28 2017-04-28 Structure for packaging containers for pharmaceutical use
PCT/IB2018/052844 WO2018198028A1 (en) 2017-04-28 2018-04-24 Structure for packaging containers for pharmaceutical use

Publications (1)

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EP3615106A1 true EP3615106A1 (en) 2020-03-04

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Application Number Title Priority Date Filing Date
EP18722736.8A Withdrawn EP3615106A1 (en) 2017-04-28 2018-04-24 Structure for packaging containers for pharmaceutical use

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EP (1) EP3615106A1 (en)
IT (1) IT201700046565A1 (en)
WO (1) WO2018198028A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11505389B2 (en) 2020-01-10 2022-11-22 Schott Schweiz Ag Separating layer for the transport of pharmaceutical secondary packagings

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT201900011982A1 (en) 2019-07-17 2021-01-17 Nuova Ompi Srl STRUCTURE FOR THE PACKAGING OF PRIMARY CONTAINERS FOR PHARMACEUTICAL USE

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9630745B2 (en) * 2010-09-17 2017-04-25 Flexiways Sprl Packaging for the storage, protection and transport of syringes
DE102011104300A1 (en) * 2011-03-18 2012-09-20 Schott Schweiz Ag Support plate and transport and / or storage device for pharmaceutical containers
WO2016111698A1 (en) * 2015-01-09 2016-07-14 West Pharmaceutical Services, Inc. Covers for drug container piston arrays or piston nests and packages for cover and piston nest assemblies

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11505389B2 (en) 2020-01-10 2022-11-22 Schott Schweiz Ag Separating layer for the transport of pharmaceutical secondary packagings
US11897681B2 (en) 2020-01-10 2024-02-13 Schott Pharma Schweiz Ag Separating layer for the transport of pharmaceutical secondary packagings

Also Published As

Publication number Publication date
WO2018198028A1 (en) 2018-11-01
IT201700046565A1 (en) 2018-10-28

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