cartridge closure method, support structure for supporting cartridge closures, and shipping or packi

专利摘要:
In a method for closing a plurality of medical cartridges (5), a closure nest to support a plurality of closures is used, comprising a flat support plate, having a plurality of receptacles having a plurality of tubular receptacles (61) and retaining structures to reliably house the locks (200). In the method, the plurality of medical cartridges (5) is supported in a corresponding cartridge nesting. the nesting closures are disposed above the cartridge nesting so that the closing nesting receptacles are precisely aligned with the cartridge nesting receptacles the closures (200) are then pushed down out of the nesting receptacles. closures and cartridges (5), while cartridges are supported by cartridge nesting. nesting closures can be fed directly into existing filling and capping machine configurations for sealed pre-filled syringe barrel processing, basically without the need to change the configuration.
公开号:BR112017022251A2
申请号:R112017022251
申请日:2016-04-18
公开日:2019-10-01
发明作者:Narayan Narvekar Anil；Prakash Potdar Pratul
申请人:Schott Kaisha Pvt Ltd；
IPC主号:

专利说明:

METHOD FOR CLOSING CARTRIDGES, SUPPORT STRUCTURE TO SUPPORT CARTRIDGE CLOSING AND TRANSPORT OR PACKAGING CONTAINER [001] This application claims Indian patent application priority no. 1590 / MUM / 2015, “PRE-CORRUGATED AND PRE-STERILIZED CARTRIDGE CONTAINER AND VESSEL ASSEMBLY FOR EXISTING FILLABLE SYRINGE MACHINES”, filed on April 17, 2015, and application for PCT- No PCT / IN2015 / 000394 , “SUPPORT STRUCTURE FOR SUPPORT OF SEALED CARTRIDGES, TRANSPORT OR PACKAGING CONTAINER AND PROCESS FOR PROCESSING THE SAME”, deposited on October 16, 2015, the total content of which is incorporated here for reference.
FIELD OF THE INVENTION [002] The present invention relates, in general, to the processing of a batch of sealed cartridges, particularly pre-crimped cartridges, for use in pharmaceutical, medical or cosmetic applications and relates in particular to a support structure (also called nesting) provided for making closures, such as elastic plugs or plunger brakes, for use in a process for closing or plugging cartridges. Other aspects of the present invention relate to a nesting and tub assembly that accommodates these closures, which can be directly fed into existing filling and capping machine configurations for processing previously filled syringe cylinders. Other aspects of the present invention relate to a buffering process and an integrated filling and buffering process for the processing of sealed pre-filled syringe cylinders.
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BACKGROUND OF THE INVENTION [003] Conventionally pre-sterilized pre-filled syringe cylinders are supplied in vat and nesting sets that are hermetically sealed to pharmaceutical customers, who will then fill drugs into the pre-sterilized syringe cylinders under sterile conditions, using filling and buffering machines. On the market, there are three types of filling and buffering machines available, namely, 1) manual machines, 2) semi-automatic machines and 3) fully automatic machines.
[004] There is a bowl and nesting format available on the market for pre-crimped cartridges, but there are many disadvantages to using this existing bowl and nesting format with new existing filling and buffering machines because this bowl and nesting format requires changing complete configuration of the inlet to the outlet to accommodate different levels of cartridge height in nesting. In addition, a complete replacement of filling conveyors is required to maintain the height between the filling nozzles and the upper level of the cartridge. In addition, the disadvantage of two different exchange parts needs a separate validation study, according to the requirements of GMP guidelines (Good Assembly Practice). If an attempt to fill the commercially available pre-crimped cartridge nesting on the same machine without changing the height setting of the machine, accidents will happen which can cause damage to the filling nozzles or glass cartridges can be broken because the difference height between the fill nozzles and pre-crimped cartridges is very small.
[005] These disadvantages remain, similarly, 1) for manual filling and buffering machines that are operated electrically and pneumatically and where the processes are triggered by an operator, 2) for semi-automatic filling and buffering machines, operated
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3/51 electrically, electronically and pneumatically and where the operator has to remove the outer pouch from the bowl and nesting set and then an upper bowl lid together with an inner sheet, and 3) for automatic filling and buffering machines , which are operated electrically, electronically and pneumatically and where the packages are inserted into the filling and buffering machine one by one, the machine will automatically remove the outer pouch and then remove the top cover from the bowl using a peeling unit automatic, then the inner sheet of the bowl and nesting set will be removed automatically and the machine will automatically remove the nests by means of a vacuum cup and place them on conveyors, which are then moved to the filling station nozzles for the filling process. filling the medicine.
[006] The bowl and nesting sets currently available on the market, require the replacement of filling conveyors to maintain an exact height difference between the filling nozzles and the upper level of the cartridge s. In addition, after replacing the replacement parts filling conveyors, they require separate validation studies according to the requirements of the GMP guidelines. If the commercially available bowl and nesting sets are fed directly into the filling of pre-crimped cartridges in the same machine, without any changes in the filling machines, then the filling nozzles may be damaged or glass cartridges may be broken because the The difference in height between the filling nozzles and the pre-crimped cartridges is very small. All of the above activities will incur higher costs and additional time will also be required to change the parts resulting in production losses. In addition, all fully automatic machines and new separate replacement parts are very expensive.
[007] The above disadvantages are overcome by a support structure to support a plurality of sealed cartridges for use in applications
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4/51 pharmaceutical, medical or cosmetic, by a shipping container or packaging that accommodates this support structure and by a process to process a batch of sealed cartridges using this support structure as disclosed in Indian patent application no. 1590 / MUM / 2015 and PCT application no. PCTIN2015000394 of the applicant, whose total content is incorporated here for reference.
[008] US 2013/0161225 A1 describes a packaging unit for the transportation and processing of syringe bodies, which comprises a tray that can hold a plurality of syringe bodies in a suspended vertical position and a cover that can cover the tray. The cover comprises at least two flanks that can surround the tray. According to one embodiment, openings are provided in the top wall of the cover that allow the circulation of steam or gas during a sterilization process. According to another embodiment, these openings are placed above the openings in the containers and, thus, allow the filling and / or plugging of the containers.
[009] Conventionally, the cartridges are closed by feeding closures, such as elastic plugs or plunger brakes, individually, to a closing machine and closing the cartridges individually, as for example described in US 2014/0069062 A1. This often requires removing the cartridges from a carrier after filling and reinserting the cartridges after closing the carrier, as described, for example, in US 8 978 344 B2.
[010] Closures are normally insulated using vibrating bowls and transported using vibrating rails. The vibrating bowl and gutters contact the stoppers, whose surfaces will eventually be in direct contact with the product inside the container. To solve this problem, it is generally considered necessary to steam sterilize the vibrating bowls and gutters. At the
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However, it is practically impossible to transfer the stopper and trough bowl aseptically from the sterilization autoclave to the processing environment.
[011] US 2012/0248057 A1 describes a method of buffering system for sealing pharmaceutical vials. A plurality of test flasks are arranged in an upright position in a vat, which also accommodates a respective closure set for each flask comprising a pre-assembled elastomeric stopper and a retaining element. Each closure element is placed on the neck of its associated bottle so that a portion of the stopper partially closes the opening of the bottle. Then, a force is applied to each of the closure assemblies to make the retaining elements snap into the flange neck of its associated bottle, so that parts of its associated stopper seal the opening in its associated bottle. This approach makes it easier to seal vials under aseptic conditions.
[012] A process for filling pharmaceutical containers using a similar cover system is disclosed in WO 2015/023924 A2. The process uses nests that are configured to allow multiple closures and containers to be simultaneously aligned concentric and closed simultaneously. The spring loaded retaining structures in the closing nest allow it to particularly retain several closures above the corresponding multiple containers. The retention structures used, however, are still complicated and it is not easy to use this approach in the existing pharmaceutical filler machinery.
SUMMARY OF THE INVENTION [013] According to the present invention, a buffering process or an integrated filling and buffering process is provided for processing sealed pre-filled syringe cylinders using a
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6/51 support structure to retain a plurality of closures. According to another related aspect of the present invention, a support structure is provided for retaining a plurality of closures (nesting for closures), such as elastic plugs or plunger brakes, for use in the process for closure or buffer cartridges . In accordance with another related aspect of the present invention, a transport or packaging container (nesting and tub assembly) is provided which houses at least one nest to close containers configured so that the nesting that accommodates the closures can be fed directly into existing filling and plugging machine configurations for processing sealed pre-filled syringe cylinders.
[014] A support structure for closures according to the present invention, for use in the buffering process or an integrated filling and buffering process is configured to reliably support a plurality of containers, which have a cylindrical shape, consisting of a material resilient and are for use to close cartridges for use in pharmaceutical, medical or cosmetic applications. The support structure for closures comprises a flat support plate that has a plurality of tubular receptacles to accommodate the closures, at least partially, for the simultaneous support of a plurality of closures for the support plate. According to the present invention, the receptacles are formed by circumferential side walls arranged in a regular arrangement on the support plate and protruding from the support plate, in which the receptacles are configured to accommodate the closures at least partially.
[015] The support structure for closures allows a plurality of closures to be releasably maintained in exactly the same two-dimensional arrangement as a support structure for cartridges disclosed in Indian patent no. 1590 / MUM / 2015 and application for PCT- no.
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PCTIN2015000394 of the applicant. This simplifies a process for significantly closing the cartridges, because this process only requires placing the closure support structure above the cartridge support structure in a low pressure environment so that the containers of the closure support structure are aligned with their associated cartridge support frame receptacles, and pushing the closures downward out of the closure support frame containers and into the filling openings at the bottom ends of the cartridges while the cartridges are accommodated in the cartridge receptacles support structure for cartridges.
[016] As the support structure according to the present invention can be easily accommodated and stored or transported in a transport container (vat), the present invention allows the use of the existing vat and nesting format widely used in the market with machines filling and buffering systems as well as new ones. In addition, the support structure according to the present invention can be used to efficiently store and supply a plurality of closures in a predetermined geometric arrangement under sterile conditions, using the tub and nest format widely used in the market.
[017] The receptacles can accommodate the closures totally or only partially, depending on the circumstances of the further processing of the closures and cartridges. The support plate is preferably made of a plastic material, for example, by plastic injection molding and offers sufficient strength, stiffness and mechanical stability, although these requirements are generally easy to fulfill, as the closures to be accommodated are light and only small forces are generally exerted on the support plate during further processing.
[018] The closures can be accommodated in the receptacles only
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8/51 by friction. As the closures are made of an elastic and resilient material, inserting the closures into the receptacles may involve imposing a slight elastic deformation of the closures, so that the closures rest resiliently against the circumferential side walls of the receptacles. Since the closures are lightweight, reliable accommodation of the closures generally requires only a small degree of deformation of the closures, which corresponds to small forces required only to insert or remove the closures inside and outside the receptacles. Since cartridge closures, such as plunger brakes, generally have several annular protuberances on their outer circumference, this slight elastic deformation would generally only occur in the region of these annular bulges. Thus, the side walls of the receptacles are preferably straight side walls that define cylindrical receptacles that are not tapered.
[019] In order to more reliably accommodate the closures in the receptacles, according to another modality, the receptacles comprise retention structures that fit reliably with the closures for retaining the closures in the receptacles. Preferably, the retaining structures engage with the closures in a form-fitting manner. This form-fitting coupling can be applied to the upper and lower ends of the closures, or in any other suitable positions, such as the bottom ends and in central portions of the containers, which can be concave bent, for example, in the case of piston brakes. To this end, the retaining structure can project slightly into the receptacles to retain the closures.
[020] According to another embodiment, protuberances are formed on the inner sides of the circumferential side walls of the receptacles, which can be easily achieved by integrally forming the protuberances with the lateral walls of the receptacles, for example, by molding by
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9/51 plastic injection.
[021] According to another modality, the protrusions can be configured to fit the outer contour of the closures. If, for example, the outer contour of the closures is wavy, the protrusions can be at least partially waved in correspondence with the outer contour of the closures.
[022] According to another embodiment, the protrusions can be formed at equal angular distances along the inner sides of the circumferential side walls of the receptacles, for example, as small, dot-like protuberances. According to an alternative embodiment, however, the protrusions can also be formed as circumferential protuberances on the inner sides of the circumferential side walls of the receptacles.
[023] According to another embodiment, the receptacles may comprise upper retaining structures formed at or near an upper end of the receptacles and bottom retaining structures formed at the lower end of the receptacles, wherein the distance between the respective retaining structures upper and lower retention can be equal to the axial length of the closures so that the closures are reliably fixed in both axial directions in the receptacles. The closures can even rest on these retaining structures, thus allowing substantially frictionless housing of the closures in the receptacles and the removal of the closures out of the receptacles with only small forces. According to another embodiment, however, this distance may also be shorter, for example, if one of the retaining structures fits with some portions of the closures in a shape-fit manner.
[024] According to a particularly preferred embodiment, the upper retaining structures can be formed as protuberances
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10/51 convexly curves protruding from the inner sides of the circumferential side walls of the receptacles, which allows the insertion of the closures in the receptacles with small forces and only a slight elastic deformation whereas the bottom retaining structures can be formed as protuberances hook-shaped protruding from the inner sides of the circumferential side walls of the receptacles, which allows the closures to be pushed out of the receptacles at the same time, because the time when the holding forces are overcome by a pushing force a buffering machine can be precisely adjusted, for example, by means of the geometric shape of the bottom retaining structures, their material and strength.
[025] According to a particularly preferred embodiment, the bottom retaining structures can be chamfered on an upper and / or lower side of it. While the chamfer on the top facilitates pushing the closures out of the receptacles during a buffering process, the chamfer on the bottom side can be useful if the receptacles are supported directly on the lower ends of the cartridges during the buffering process, because the chamfers in the lower sides can then lodge in these lower ends and peak forces or tension can thus be avoided, particularly if the bottom retaining structures are made of a resilient plastic material.
[026] According to another related aspect of the present invention, a shipping or packaging container is provided to accommodate a plurality of closures for closing cartridges for use in pharmaceutical, medical or cosmetic applications, wherein the shipping or packaging container it is box-shaped and comprises: a bottom that is closed or sealed by a seal, vertical lower side walls that essentially and perpendicularly extend from said bottom, a circumferential support step that extends horizontally from the
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11/51 said side walls, upper side walls extending upwards from said support step, and a circumferential flange formed at upper ends of the upper side walls. According to the present invention, at least one support structure for closures, as disclosed in the present patent application is accommodated in the transport or packaging container, wherein the plurality of closures are accommodated in the receptacles of at least one structure of support for closings.
[027] The transport or packaging container for closures allows the storage and transport of a plurality of closures in exactly the same format as the existing format of tub and nesting widely used in the market so that it can be used easily with filling machines and buffering, as well as new ones, without the need to change its entire configuration.
[028] According to another embodiment, the edge of the lowest flat support plate of the closing support structure can be supported directly on the circumferential support step or in the transport or packaging container.
[029] According to another embodiment, a plurality of support structures for closures can be accommodated together within the transport or packaging container stacked on top of each other. For this purpose, spacers can be provided on the undersides of the support plates. However, this is generally not necessary because, in general, the lower ends of the receptacles of an upper closing nest can rest directly on the lower surface of another closing nest, because the outer diameter of the receptacles is greater than the inner diameter of the receptacles, so that the receptacles of the upper closing nest cannot enter the receptacles of another closing nest. To this end, it can be
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12/51 advantageous if the upper ends of the closures are arranged at a certain minimum distance from the upper ends of the receptacles.
[030] According to another modality, the transport or packaging container is closed or sealed by a protective sheet against the environment, the protective sheet being connected to the circumferential flange. The protective sheet may be impermeable to gas, implementing completely sterile conditions during the storage and transportation of the closures.
[031] According to a particularly preferred embodiment, the protective sheet may be a gas-permeable plastic film that allows sterilization of the interior of the transport or packaging container through the protective film by a flow of a sterilizing gas, such as ethylene oxide. In particular, the protective sheet can be made of a weft of synthetic fibers such as polypropylene (PP) fibers or a Tyvek® protective film for this purpose.
[032] According to another related aspect of the present invention, a method is provided for closing a plurality of cartridges for use in pharmaceutical, medical or cosmetic applications, said cartridges having an upper end and a lower end opposite the upper end, a cylindrical body of a first outer diameter with a filling opening at the lower end and a shoulder portion at the upper end with a secondary opening which is sealed by a seal, a predetermined axial length being defined between the upper end and the lower end, said method comprising: providing a support structure for closures as described in the present application, accommodating a plurality of closures in the receptacles in a regular arrangement; providing a support structure for cartridges as disclosed in Indian patent application no. 1590 / MUM / 2015 and PCT application
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13/51 no. PCTIN2015000394 of the applicant, accommodating a plurality of cartridges in the same regular arrangement as in the support structure for closings; discarding the closure support structure above the cartridge support structure in a low pressure environment so that the closure support frame receptacles are aligned with the cartridge support structure receptacles; and pushing the locks simultaneously downwardly out of the receptacles of the closure support structure and into the filling openings at the lower ends of the cartridges while the cartridges are accommodated in the receptacles of the cartridge support structure.
[033] The nesting that accommodates the closures can be fed directly into the existing filling and plugging machine configurations for processing sealed pre-filled syringe cylinders. The method according to the present invention can be easily implemented for cartridges of different lengths, because this only requires an adjustment of the distance between the support structure for closings and the support structure for cartridges, which can be performed by a simple vertical adjustment of any support structure, which does not alter the exact alignment of the receptacles of both support structures.
[034] According to another embodiment, the support structure for cartridges is maintained by a frame that supports the lower part, whereas the support structure for closures is made by an upper support frame, in which the support frame lower and upper support frame are arranged with a fixed spacing and aligned with each other by alignment devices. For this purpose, one of the support frames can be provided with alignment devices, such as protrusions, rods or the like, which cooperate with corresponding alignment devices, such as holes or recesses, provided in the other support frame. Thus, an accurate and reliable alignment of all
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14/51 the support structure receptacles can be realized with ease.
[035] According to another embodiment, the upper support frame may be arranged at such a distance from the lower support frame that the bottom ends of the upper support frame receptacles or the bottom ends of the support structure receptacles for closures held by the upper support frame are in direct contact with the lower ends of the cartridges accommodated in the receptacles of the cartridge support structure, so that the closures are guided directly into the open lower ends of the cartridges if they are pushed downward outward of the support structure receptacles for closings.
[036] In this method, the support structures for closures and / or the support structures for cartridges can be supplied in sterile conditions, for example, for a pharmaceutical filler, in transport and packaging containers, as described in more detail below .
[037] Naturally, the method according to the present invention may involve additional processing steps, particularly a step of filling the plurality of cartridges with a pharmaceutical, medical or cosmetic product, which can be carried out in any appropriate sequence, particularly in row or simultaneously for all cartridges supported by a support structure.
[038] According to another embodiment, this step of filling the plurality of cartridges with the pharmaceutical, medical or cosmetic product can be carried out while the support structure for cartridges is maintained in the same lower support frame used during buffering.
[039] The above-mentioned aspects of the present invention are thus closely related to a support structure for supporting a plurality of sealed cartridges for use in pharmaceutical applications,
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15/51 medical or cosmetic, as disclosed in Indian patent application no. 1590 / MUM / 2015 and PCT application no. Applicant's PCTIN2015000394, said cartridges having an upper end and a lower end opposite the upper end, a cylindrical body of a first outer diameter with a filling opening at the lower end, and a shoulder portion at the upper end with a secondary opening. which is sealed by a seal, a predetermined axial length being defined between the upper end and the lower end. The support structure comprises a flat support plate and a plurality of tubular receptacles formed on the flat support plate in a regular arrangement and extending downwardly from the underside of the flat support plate to accommodate the sealed cartridges, in that the retaining protuberances are formed at the lower ends of the inwardly protruding receptacles and the axial length of the receptacles is less than the axial length of the sealed cartridges.
[040] According to the present invention, the retaining protrusions are coupled with the projection portions of the sealed cartridges in such a way that the projection portions of the sealed cartridges are supported on the receptacle retention protuberances and that the lower ends of the cartridges Seals protrude from the upper ends of the receptacles on an upper side of the flat support plate when the sealed cartridges are housed upside down in the receptacles.
[041] Since the cartridge seals at their upper ends, which are susceptible to damage after the application of excessive forces, do not rest on a support surface, the cartridges, once filled, can be capped (closed at the lower ends) with rubber caps, plungers or similar sealing members) without damaging the seals at the upper ends. At the same time, the filling openings, which extend beyond the upper frames of the receptacles, are freely accessible for processing.
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16/51 [042] According to another embodiment, the receptacles are cylindrical in shape and a plurality of ribs are formed in equidistant angular spacing on the inner circumferential side walls of the receptacles, preferably in their diametrically opposite positions, in which the ribs protrude radially inward from the inner circumferential side walls of the receptacles to center the sealed cartridges within the receptacles. Thus, a reliable centralization of the cartridges, storage without agitation inside the receptacles and a smooth and agitation-free insertion and removal of the receptacles can be performed. In addition, the forces exerted, for example, after plugging, can be distributed more efficiently without deformation of the receptacles, thus ensuring more accurate centralization and positioning of the cartridges within the receptacles.
[043] According to another embodiment, the retaining protuberances are formed as ring segments that project radially inward at the lower ends of the receptacles and with an angular equidistant spacing, preferably in diametrically opposite positions, thus allowing a more uniform distribution forces, in particular by buffering.
[044] According to another embodiment, an outer diameter of the sealed cartridges at their upper sealed ends is greater than the outer diameter at their shoulder portions, but less than the first outer diameter. In addition, the thickness of the retaining protrusions in the axial direction may be less than the axial length of the sealed upper ends so that the sealed upper ends of the sealed cartridges extend through openings formed by the retaining protuberances at the lower ends of the receptacles. The sealed upper ends of the cartridges do not rest on any support surface, but remain free in space, thus reducing the risk of mechanical damage through plugging and steps of
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17/51 related processing.
[045] According to another embodiment, the support plate is formed of a plastic material and the side walls of the receptacles and the retaining protrusions are formed unitarily with the support plate, in which the retention protuberances are configured to support axial forces exerted on sealed cartridges up to 1000 N, preferably up to 750 N and more preferably up to 500 N.
[046] According to another modality, the front ends of the retaining protrusions are wedge-shaped, in correspondence with the outer contour of the raised parts of the sealed cartridges, thus allowing a more reliable and precise deformation of the parts rebound and even less deformation of the retaining protrusions through buffering or related processing steps.
[047] According to another modality, the virtual connecting lines between the centers of the adjacent receptacles respectively form a hexagon with another receptacle arranged in the center of the respective hexagon, in which the receptacles extend beyond the upper surface of the plate. the support and the stiffening ribs projecting upwards from the upper surface of the support plate are formed on the upper surface of the support plate in order to connect the circumferential side walls of the receptacles, to harden the support plate. Thus, a very efficient stiffness of the support plate can be achieved.
[048] In accordance with another aspect of the present invention, a shipping or packaging container (tub) is provided to accommodate a plurality of sealed cartridges for use in pharmaceutical, medical or cosmetic applications, wherein the shipping container or The packaging is box-shaped and comprises a bottom, which is closed or sealed by a seal, lower vertical side walls that extend essentially
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18/51 perpendicularly from said bottom, a circumferential support step that extends horizontally from said side walls, upper side walls that extend upwards from said support step and a circumferential flange formed at the ends upper side walls. A support structure (nesting), as described in more detail below, is accommodated in the transport or packaging container and supports a plurality of sealed cartridges in its receptacles. Nesting rests directly on the support step of the tank. Thus, regardless of whether the cartridges are processed while being accommodated only in the nesting or in a vat and in the nesting set, it can be ensured that the lower ends of all cartridges are at the same height level. Thus, a precise distance between the lower ends of all cartridges and the lower ends of filling nozzles or the like can be reliably ensured, thereby preventing breakage or damage during cartridge processing.
[049] According to another embodiment, the transport or packaging container further comprises a flexible lid sealed on the circumferential flange of the transport or packaging container to seal the transport or packaging container, preferably to seal the volume tightly. inside the transport or packaging container against the environment.
[050] In accordance with another aspect of the present invention there is provided a process for processing a batch of sealed cartridges for use in pharmaceutical, medical or cosmetic applications, comprising the steps of: a) providing a support structure, as described in more detail below; b) arrangement of sealed cartridges upside down in the receptacles and with their lower ends protruding from the upper ends of the receptacles in a
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19/51 upper side of the flat support plate so that the portions of the seals of the sealed cartridges are supported on the retaining protrusions of the receptacles and the lower ends of the sealed cartridges are arranged at the same height level; c) feeding the support structure with the sealed cartridges to a processing station; and d) processing the sealed cartridges at their lower ends in the processing station while being supported by the support structure.
[051] According to another embodiment, step d) comprises one or more of the following procedures: filling the sealed cartridges through the filling openings at the lower ends; buffering of the sealed cartridges at their lower ends using rubber stoppers; pre-gas and post-gas.
[052] According to another modality, the process also includes: arrangement of the support structure of a support table of the frame type; feeding the support structure together with the sealed cartridges to the processing station, while being supported by the frame-type support table; and arrangement of the support structure with the sealed cartridges inside a transport container or carton-shaped container, after said step d), which comprises a lower part, lower vertical side walls, extending essentially and perpendicularly from of said bottom, a circumferential support step that extends horizontally from said upper side walls extending upwards from said support step and a circumferential flange formed at upper ends of the side walls so that the edge of the flat support plate of the support structure is supported on the circumferential support step of the transport and packaging container, the lower ends of the sealed cartridges not protruding beyond the circumferential flange of the transport and packaging container, and the upper ends of the sealed cartridges
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20/51 are arranged away from the bottom of the transport or packaging container.
[053] According to another modality, the process also comprises: the arrangement of the support structure with the sealed cartridges inside a transport container or box-shaped packaging, comprising a lower part, lower vertical side walls that extend essentially perpendicularly from said bottom, a circumferential support step that extends horizontally from said side walls, upper side walls that extend upwards from said support step and a circumferential flange formed at upper ends of the side walls so that the edge of the flat support plate of the support structure is supported on the circumferential support step, the lower ends of the sealed cartridges do not protrude beyond the circumferential flange of the transport or packaging container and the upper ends of the sealed cartridges are away from the fu of the shipping container or packaging; wherein step c) further comprises: the arrangement of the transport or packaging container, on a support table of the frame type so that the support step of the transport or packaging container is supported on an upper side of the support table shaped and that the lower ends of the sealed cartridges are arranged at the same height level; and feeding the frame-type support table together with the transport or packaging container, the support structure and the sealed cartridges for the processing station.
[054] According to another embodiment, the transport or packaging container is sealed with a flexible lid.
[055] According to another method of the process, sealed cartridges are pre-crimped cartridges.
GLOBAL VIEW OF THE DRAWINGS
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21/51 [056] Hereinafter, the present invention will be disclosed by way of example and with reference to the drawings, in which:
figure 1 is a top perspective view of a cartridge support structure for use in a method according to the present invention;
figure 2 is a top view of the support structure of figure 1;
figure 3 is a bottom view of the support structure of figure 1;
figure 4 is a perspective view from the bottom of the support structure of figure 1;
Figure 5 is a schematic cross-section of the support structure of Figure 1 without cartridges.
Figure 6a is an enlarged partial view of Figure 5, showing how the cartridges are supported inside the containers of the support structure according to the present invention;
Figure 6b is a sectional view of a displayed cartridge in Figure 6, Figure 7 is an exploded view showing a transport container or package with the support structure of Figure 1 (vat and nesting together to cartridges) with cartridges inserted into the receptacles of the support structure and with a sealed cartridge, at an upper end of it, Figure 8 is a partial, enlarged view of the cartridge and nesting assembly for Figure 7;
Figure 9 shows the cartridge housing and nesting assembly of Figure 7 with the cartridge holder structure inserted and a sealing cap sealed to an upper edge of the shipping container and
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22/51 packaging;
Figure 10 is a schematic top view of a processing station for processing sealed cartridges using the cartridge support structure in a filling process;
Figure 11 is a schematic cross-sectional view of the bowl and nesting assembly in a filling station used in a process according to the present invention, the Figures. 12a - 12c show details of a support structure for cartridge closures according to a first embodiment of the present invention;
figures 12d - 12e show the housing of closures in the receptacles of a support structure for closures for cartridges according to another embodiment of the present invention;
the figures. 13a - 13d show a shipping or packaging container in conjunction with the support structure of figure 12a (bowl and nesting set for closings) to accommodate a plurality of cartridge closures, at various stages of supplying the shipping or packaging container for closings.
the figures. 14a - 14h show a configuration for simultaneously closing (buffering) a plurality of cartridges using a nesting for closures and a nesting for cartridges with their receptacles in alignment in several stages;
Figure 14g shows this configuration in an exploded perspective view; and Figure 15 shows a method according to the present invention for simultaneously closing (buffering) a plurality of cartridges
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23/51 in a schematic sectional side view.
[057] Throughout the drawings, the same reference numbers designate the same or substantially identical components or groups of components.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [058] A support structure (in the following nesting for cartridges or nesting of cartridges), in the sense of the present invention and as disclosed in Indian patent application no. 1590 / MUM / 2015 and application for PCT- no. The Depositor's PCTIN2015000394 is used to simultaneously support a plurality of sealed cartridges for use in pharmaceutical, medical or cosmetic applications. Such cartridges, including pen cartridges, bypass cartridges and dental cartridges, are a packaging solution commonly used for drug delivery systems, for example, insulin delivery, pen systems, pump systems, auto injectors and injectors. needle-free. For special requirements, such as bypass and chemically reinforced cartridges, custom designs are available on the market. Commercially available cartridges can be made of glass material, particularly Fiolax® glass from SCHOTT AG, and offer fixed volumes for drug delivery of, for example, 1.0 ml, 1.5 ml and 3.0 ml. Different volumes generally correspond to different axial lengths of the cartridges.
[059] An example for such a cartridge realized as a syringe cylinder is shown in Figure 6b and comprises a lower end with a filling opening 53, an upper end 52 opposite the lower end and a cylindrical body 50 of a first outer diameter, which is generally identical to the diameter of the filling opening 53 at the lower end of the syringe barrel. The cylindrical body 50 merges with a tapered shoulder portion 51 at the upper end of a reduced diameter, which is followed by an enlarged bottom ring 52 with an opening
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24/51 secondary 54 used for drug administration. After filling the cylindrical body 50, the filling opening 53 is closed by means of an elastomeric closure provided with or without a fluoropolymer barrier coating, such as a thick rubber or plastic plug, which then acts as a plunger when the content is pressed out for drug administration. The secondary opening 54 is sealed by a seal, generally with a septum rubber plug (rubber punch) provided with or without a fluorinated polymer barrier coating or with a combined seal. To protect the septum and fix the plug, an outer closure (crimped lid) often made from aluminum foil and / or plastic and aluminum composite material, is used, which is usually folded over the wide bottom rim. 52 to thus securely seal the cartridge and thus form a pre-crimped cartridge in the direction of the present application. In the cross-sectional view of Figure 6b, a pre-crimped cartridge, including a seal 55 of the type mentioned above, is shown on the right and left side of the drawing, while the central cartridge is shown in a cross section and without this seal . As can be concluded from Figure 6b, a predetermined axial length is defined between the upper and lower ends of the cartridge. Particularly, cartridges, in the sense of the present invention, do not have hand rests on their lower extremities like conventional syringe bodies, and if they had this finger support, that finger support would not be supported directly on a plate of support or on the members thereof, as described in more detail in the following, when these cartridges were accommodated in a nest.
[060] Referring to the figures of. 1 to 4, a cartridge support structure (in the next cartridge nesting or cartridge nesting) comprises a flat support plate 10 having a plurality of tubular receptacles 11, arranged in a regular arrangement,
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25/51 which, at least, extend downwards from the bottom side of the flat support plate 11 (see the bottom view of Figure 4), and preferably also project upwards from the top side of the plate of support, as shown in the top perspective view of Figure 1. Thus, the tubular receptacles 11 are formed by circumferential side walls 12,14 that project from the upper and lower sides of the support plate 10, respectively. Preferably, these side walls 12, 14 are cylindrical in shape to accommodate the cartridges, although other shapes, such as polygonal shapes, are also possible. These receptacles 11 are arranged in a regular two-dimensional arrangement, with an equidistant spacing. As shown in the top view of Figure 2, the virtual connecting lines between the directly adjacent receptacle centers 11, respectively, can form a hexagon with another receptacle 11 disposed in a center of the respective hexagon. According to other modalities, the receptacles can also be arranged with an equidistant spacing along two mutually orthogonal directions.
[061] The inside diameter of the receptacles is slightly larger than the outside diameter of the cartridges to be accommodated To allow accurate centering of the cartridges, a plurality of ribs 13 are formed on the inner circumferential surfaces of the side walls 12, 14 that project radially inland. These ribs 13 are formed with an angular equidistant spacing on the inner surfaces of the side walls 12, 14, preferably in diametrically opposite positions, so that the total number of these ribs 13 can be, for example, four or eight.
[062] The upper ends of these ribs 13 preferably do not extend to the upper rim of the side walls 12. In order to allow smooth insertion of the cartridges into the receptacles 11, the upper ends of the ribs 13 are preferably angled radially to inside, to guide the cartridges when
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26/51 insertion. Together, the ribs 13 comprise an inner volume of a diameter, which is essentially equal to the outer diameter of the cartridges, thus allowing essentially free oscillation of the cartridges and a smooth and oscillating axial movement of the cartridges upon insertion or removal out of the receptacles 11. The ribs 13 allow precise centering of the cartridges in predetermined positions, so that automated processing systems can wait for the cartridges in predetermined positions, precisely after they are transferred to a processing station, which significantly reduces the effort required for automation.
[063] As shown in Figure 6a, the axial length of the receptacles 11 is less than the axial length of the cartridges to be accommodated, so that in use the lower ends with the filling openings 53 extend beyond the upper rim of the upper side walls 12 of the receptacles so that the filling openings 53 are freely accessible for processing, for example to perform a filling operation, as shown in Figure 11.
[064] As shown in Figures 4 to 6, retaining protuberances 15 are formed at the lower ends of the receptacles 11 projecting radially inward. These retaining protrusions 15 are coupled with the projection portions 51 of the cartridges, such that the projection portions 51 are directly supported on the retention protuberances 15 of the receptacles 11 when the cartridges are accommodated upside down in the receptacles 11, as shown in Figure 6. In addition, the axial length of the receptacles is matched with that of the cartridges so that the lower ends of the cartridges protrude from the upper ends of the receptacles 11, as shown in Figure 6.
[065] As shown in Figures 3 and 4, the retaining protuberances 15 are formed as ring segments that project radially inward
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27/51 at the lower ends of the receptacles 11 and with an equidistant angular spacing, preferably in diametrically opposite positions. As shown in Figure 3, the intervals 16 of essentially rectangular profile are formed between the adjacent of the retaining protuberances
15. These gaps 16 preferably extend to the inner surface of the side walls 14 of the receptacles 11. The aforementioned axial ribs 13 can extend downwardly to the retaining protuberances 15, but for accurate centering of the cartridges this is not essential.
[066] For a smooth, more stable and accurate cartridge support, the front ends of the retaining protuberances 15 can be angled or wedge-shaped in correspondence with the outer contour of the shoulder parts 51 of the cartridges to be accommodated.
[067] As shown in Figure 6b, the outside diameter of the sealed or pre-crimped cartridges 5 at their sealed upper ends is greater than the outside diameter at their shoulder portions 51, but less than the (first) outside diameter of the cylindrical body 50. In addition, the thickness of the retaining protuberances 15 in the axial direction is less than the axial length of the sealed upper ends of the sealed cartridges 5 so that the sealed upper ends of the sealed cartridges extend through central openings 17 (shown in Figure 5) formed by the retaining protuberances 15 at the bottom ends of the receptacles 11.
[068] The support plate 10 of a nesting 1 according to the present invention is preferably formed of a plastic material and the side walls 12, 14 of the receptacles 11 and the retaining protuberances 15 are thus formed unitarily with the support plate 10. To allow the filling openings 53 to be plugged with rubber plugs or syringe plungers, while the cartridges are accommodated in the
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28/51 receptacles 11 of nesting 1, the retaining protuberances 15 are preferably configured to support typical axial forces exerted on the sealed cartridges by buffering up to 500 N, preferably up to 750 N and more preferably up to 1,000 N, which can be easily ensured by an appropriate choice of plastic material and material strength of the support plate 10 and all its members.
[069] As shown in Figures 2 and 4, for the hardening of the support plate 10, reinforcement ribs 26, 28 can be provided on the top and bottom side, respectively, of the support plate 10, which connects the upper side walls 12 and lower side walls 14 of the receptacles. In the arrangement of the receptacles 11 shown in Figure 2, these reinforcement ribs 26 thus form hexagons that interconnect the directly adjacent receptacles and triangles that connect the exteriors of these receptacles with another receptacle 11 disposed in the center of a respective hexagon. As shown in Figure 4, these reinforcement ribs 28 can interconnect the side walls 14 of the exteriors of the receptacles 11. In addition, the central reinforcement 28 can also be provided near the center of the support plate 10, to interconnect the centrals of these receptacles 11 In a preferred embodiment, this nesting 1 will be made of a plastic material with plastic injection molding techniques. Despite the aforementioned hardening measures, the support plate 10 can still be flexible to some extent, if necessary.
[070] For the transport, storage and packaging of a nest 1 as described above, together with the cartridges housed within it, a shipping container or packaging 3 (hereinafter also called the cartridge tank) is used as shown schematically in Figure 7. According to Figure 7, the transport or packaging container 3 is essentially box-shaped or tub-shaped and has a base 30, a circumferential side wall 31 that projects essentially in its vertical direction, a step of
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29/51 support 32 essentially rectangular projecting from it, an upper circumferential side wall 33 and an upper rim 34 which is formed as a flange. The corners 35 of the shipping container or packaging 3 are suitably formed rounded, particularly near the support step 32. Preferably, the upper side wall 33 is formed inclined at a small angle of inclination with respect to a vertical to the base 30, a in order to facilitate the insertion of nesting 1. This transport container or packaging 3 is preferably formed from a plastic material, in particular by plastic injection molding, and is preferably formed from a transparent plastic in order to allow a visual inspection of the nesting 1 accommodated in the shipping container or packaging 3 and the cartridges 5 supported by it.
[071] In this way, nesting 1 can be accurately positioned in the shipping container or packaging 3 and thus the plurality of cartridges 5 can be positioned and maintained in a regular matrix and in precisely defined positions in a shipping container or package 3 with standardized dimensions. In particular, it can be ensured in this way that all the upper ends of the cartridges are positioned in a defined plane, together and parallel to the base 30 and that all the bottom or lower ends of the cartridges are positioned in a defined plane, together and parallel to the upper rim 34 of the shipping container or packaging 3. As shown in Figure 9, the lower ends of the cartridges do not extend beyond the upper rim 34 of the shipping container or packaging 3, but are spaced apart from the rim higher 34.
[072] As shown in Figure 9, a packaging unit (also called bowl and nesting set) formed by the transport or packaging container (bowl) 3 and the nesting 1 with the cartridges 5 accommodated in it is closed or sealed, at least , on the upper side by means of a protective sheet or packaging sheet 6 glued to the top edge
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30/51 similar to flange 34 of bowl 3. In this way, it is guaranteed that the inside of the bowl 3 is hermetically sealed from the environment, from the manufacturing unit until the moment when access must be obtained inside the bowl 3 for processing additionally of the cartridges 5. The protective sheet 6 can in particular be a gas-permeable plastic film, in particular, a web of synthetic fibers such as polypropylene (PP) fibers or a Tyvek® protective film, which allows sterilization of the cartridges housed in it through the film 6.
[073] As will become evident to a person skilled in the art, the underside of the transport or packaging container (bowl) 3 can also be formed open, for example, in the shape of bowl 3 shown in Figure 9, that is, from so that the bottom side of the bowl is also provided with a flange-shaped bottom ring in the manner of the upper ring 34 so that the lower parts of the cartridges 5 can be freely accessible for processing steps also from the side of under the bowl3, if necessary.
[074] As shown in Figures 1 and 2, to allow easy insertion of nesting 1 in a bowl 3 and removal of the latter, access openings 22 are formed on two longitudinal sides of the support plate 10, through which the arms grips or the like can grab the nest 22. As shown in Figure 1, the access openings 22 are partially surrounded by vertical side walls 23 to prevent a collision of the gripping arms or the like with the cartridges accommodated. As shown in Figure 1, the access openings 22 are displaced in relation to each other, for example, by a line, which further facilitates an unambiguous positioning of nesting 1 in the bowl 3.
[075] A packaging unit as shown in Figure 9 that accommodates pre-fillable, pre-sterilized syringe cartridges or cylinders can be stored under sterile and economical conditions and then supplied to pharmaceutical customers for further processing. In particular,
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31/51 pharmaceutical customers will then fill medicines or other liquids into the pre-sterilized nested syringes through the filling openings using conventional filling and capping machines, which can be any of the following three types of filling and capping machines : 1) manual machines, 2) semi-automatic machines and 3) fully automatic machines.
[076] An example of this filling operation is shown in Figure 11 in a schematic cross-sectional view. At the time of distribution in sterile conditions, the packaging unit will be sealed by a cover or protective film, as described above (not shown), while nesting 1 will be supported on the support step 32 of the bowl 3. At the moment of distribution under sterile conditions, the packaging unit can be additional packages in at least one sterile plastic bag. The cartridges 5, which are sealed by seals 55, for example, pre-crimped, at their upper ends will be accommodated upside down in the nesting receptacles 1 so that their filling openings 53 face the upper end of the bowl 3 and the cover or protective film (not shown). The level of height of the lower ends of the cartridges 5 is thus precisely defined in relation to the level of the support plate 10, which is essentially equal to the level of the support step 32 of bowl 3, because the support plate 10 rests directly on the support step 32.
[077] The exemplary filling process shown in Figure 11, considers that the support plate 10 rests directly on a rectangular support frame 40 after removing the bowl 3. The interior free width of the support frame 40, however, also allows direct support on the outside of support step 32 on the support frame. In any case, the height level of the lower ends of the cartridges 5 is precisely defined in relation to the level of the support frame 40.
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32/51 [078] For the filling process, the retaining frame 40 is transferred at a precisely defined height level to a filling station comprising a line of filling injectors 41 supported by a support arm 42 used to inject a liquid, for example, a medicine, through the filling openings 53 for the cartridges 5 supported by nesting 1. In addition, the height level of the lower extremities of filling injectors 41 is precisely defined so that it will be A well-defined non-zero clearance Δζ is ensured between the lower ends of the cartridges 5 and the lower ends of filling injectors 41. Normally, the width Δζ of this opening will be precisely adjusted before executing the process and will be part of the general settings of a station processing. The Δζ width of this gap will be adjusted according to general safety standards, namely in accordance with the requirements of GMP guidelines (Good Manufacturing Practice).
[079] For a given length of the cartridges 5 to be supported in a nest 1, the height level of the lower ends of the cartridges 5 will be precisely defined by the axial lengths of the nesting receptacles 11 and, therefore, the level of height of the retaining protuberances 15. Thus, if different types of cartridges 5 with different axial lengths are to be processed by one and the same processing station, according to the present invention, no change in the general configurations of the processing station is necessary . Instead, only a different type of nesting 1 with receptacles 11 of different axial length needs to be used to ensure that the different type of cartridge 5 will also be fed into the processing station, at the same height level as the lower ends. of cartridges 5 of a different type.
[080] As the different nesting type 1 required for the different cartridge type 5 together with the sealed cartridges 5 accommodated therein can be inserted into the packaging unit in the same way
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33/51 and while the entire packaging unit can be sealed and transported under sterile conditions to pharmaceutical customers, according to the present invention, it can be ensured that also the different type of cartridge can be processed under the same definitions and conditions without the need to adjust the general settings of the processing station. In addition, no additional hygiene permits are required for this purpose. Thus, according to the present invention different types of cartridges involving different axial lengths can be processed in the same way and under the same general conditions and definitions. Thus, the present invention allows cost-effective processing of pre-sterilized sealed cartridges.
[081] As will become apparent to the person skilled in the art, the above principle of replacing a type of nesting with a different type for compensating for different axial lengths of batches of different types of cartridges also works to compensate for the different outside diameters of lots of different types of cartridges. More specifically, if a first batch of cartridges having a first outer diameter and a second batch of cartridges having a second outer diameter different from the first outer diameter have to be processed by the same processing station, according to the invention only a first type of nesting used for the first batch of cartridges and that have containers with a diameter corresponding to the first outer diameter has to be replaced by a second type of nesting to be used for the second batch of cartridges and that have containers of a diameter that corresponds to the second outside diameter.
[082] As will become apparent to the person skilled in the art, when studying the above, the aforementioned principle can also be applied if access to the upper ends of the cartridges is necessary, because also the height level of the upper ends of all the cartridges accommodated by a nesting is precisely defined in relation to the level
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34/51 the height of the support frame 40. This applies even if the bowl 3 has to be supplied to the pharmaceutical customer with an open bottom sealed by a cover or protective film.
[083] Figure 12a shows a support structure for closings (in the next nesting for closings or nesting of closures) in a bottom perspective view, which comprises a flat support plate 60 that has a plurality of tubular receptacles 61 arranged in a regular arrangement, which at least extend downwards from the bottom side of the flat support plate 60, and preferably also project upwards from the top side of the support plate 60, as shown in the sectional view Figures 12d and 12e for another embodiment. Thus, the tubular receptacles 61 are formed by the circumferential side walls 62, 63 projecting from the upper and lower sides of the support plate 60, respectively. Preferably, these side walls 62, 63 are cylindrical in shape to accommodate the closures 200, although other shapes, such as elliptical shapes, are also possible. These receptacles 61 are arranged in the same regular two-dimensional arrangement as for the cartridge support structure defined above with equidistant spacing.
[084] Figure 12c shows the insertion of a plurality of closures 200, such as elastic plugs or plunger brakes, into closure nesting receptacles 61. For this purpose, closures 200 are inserted from above or below into the receptacles 61 to a desired extent, preferably until they are fully housed in the receptacles and the upper ends of the closures 200 are a short distance to the upper ends of the upper side walls 63, as defined by the interior retaining structures of receptacles 61, as shown in Figure 12e.
[085] To reliably retain closures 200 in receptacles 61,
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35/51 particularly to prevent locks 200 simply sliding out of receptacles 61 during handling nesting closures, which may include reversing the orientation of nesting closures receptacles 61 comprise retaining structures 66, 67 for releasably engaging with locks 200 to retain the locks on the containers. More specifically, the retaining structures 66, 67 are formed on the inner sides of the circumferential side walls 62, 63 of the receptacles 61 and configured to cooperate with the closures in a shape-adjustable manner.
[086] As shown in Figure 12e, the retaining structures comprise protrusions 66, 67 formed on the inner sides of the circumferential side walls 62, 63 of the receptacles. The protrusions 66, 67 can be formed as circumferential protrusions on the inner sides of the circumferential side walls 62, 63 of the receptacles 61. Preferably, the protrusions 66, 67 are formed at equal angular distances along the interior sides of the circumferential side walls 62 , 63 of receptacles 61.
[087] At least one of the protrusions can be configured to correspond to the outer contour of the closing devices 200 to be accommodated. As shown in Figure 12e, the closures 200 may have a wavy outer contour that has several circumferential concave recesses 202 or protuberances 201 and the protuberances may be formed to at least partially mate this outer contour.
[088] As shown in Figure 12e, receptacles 61 comprise upper retaining structures 66 formed at an upper end of receptacles 61 and lower retaining structures 67 formed at a lower end of receptacles 61, wherein the distance between respective upper structures and retention bottom is basically equal to the axial length of the locking devices 200 so that the
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36/51 closures 200 can be held loosely, that is, even with radial and / or axial clearance, between the two support structures 66, 67, or at least with less friction.
[089] As shown in Figure 12e, the upper retaining structures 66 are formed as convexly curved protrusions on the inner sides of the upper circumferential side walls 63 of receptacles 61, while the lower retaining structures 67 are formed as protrusions. hook protruding from the inner sides of the lower circumferential side walls 62 of the receptacles 61.
[090] According to Figure 12e, the lower retaining structures 67 can be chamfered on an upper side, to support the lower side of the same locks 200 and to reduce the forces necessary to push the locks 200 down. According to Figure 12e, the lower retaining structures 67 can also be chamfered on the underside in the same way that the containers can rest directly and without stress induction on the lower ends of the cartridges during buffering, as shown in Figure 15 and described below in more detail.
[091] For the transport, storage and packaging of a nest 2 as described above, together with the closures accommodated therein, a transport container or packaging 3a (hereinafter also called the closure tub used as shown schematically in Figure 13a). According to Figure 13a, the transport or packaging container 3a has basically the same configuration as described above with reference to Figure 7 and is essentially box-shaped or vat-shaped and has a base 30a, a circumferential side wall 31a projecting essentially in the vertical direction thereof, a support step 32a projecting essentially rectangular therefrom, an upper circumferential side wall 33a and an upper rim 34a which is formed
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37/51 as a flange. The corners 35a of the transport or packaging container 3a are suitably rounded, particularly near the support step 32a. Preferably, the upper side wall 33a is formed inclined at a small angle of inclination with respect to a vertical one for the base 30a, in order to facilitate the insertion of nesting 2. Such a transport container or packaging 3a is preferably formed from a plastic material, particularly by plastic injection molding, and is preferably formed of a transparent plastic, in order to allow a visual inspection of the nesting 2 accommodated in the transport container or packaging 3a of the closures housed therein, and is preferably formed transparent plastic in order to allow a visual inspection of the nesting 2 accommodated in the transport or packaging container 3a and of the closures accommodated therein. The rounded corners 64 of the support plate 60 correspond to the internal rounded corners 36a of the bowl 3a, at least if arranged at the lower end of the upper side walls 33a.
[092] As shown in Figure 13A, a plurality of nets 2 for closures can be accommodated within the same transport container or package 3a stacked on top of each other. In the stacked configuration, the lower ends of the side walls of an upper part of two adjacent support plates 60 can rest directly on the upper surface of the lower part of the two adjacent support plates 60. Since the outer diameter of the receptacles 61 ( see Figure 12e) is larger than the inner diameter of the receptacles 61, the side walls 64 will not penetrate the upper ends 65 of the receptacles 61. Thus, the adjacent spacers between support plates are not required, which contributes to the optimization packing density.
[093] Figure 13b shows a bowl and nesting set 4a with all the nests inserted in the bowl 31a to close containers. For the sake of clarity, the closings are omitted in the figures. 13a and 13b.
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38/51 [094] Figure 13c shows another sealing phase of the bowl and nesting assembly 4a of Figure 13b, by sealing the upper end of the bowl 3a with a protective sheet 6, which can be connected to the circumferential flange 34a and may be impermeable to gas. Preferably, however, the protective sheet 6 is a gas-permeable plastic film, in particular, a web of synthetic fibers such as polypropylene (PP) fibers or a Tyvek® protective film, which allows for sterilization of the interior from the transport container or packaging 4a by a flow of a sterilization gas through the protective sheet 6.
[095] Figure 13d shows the sterile bowl and nest assembly 4a of Figure 13c sealed against the environment. In this condition, the closures can be stored and transported under sterile conditions. For this purpose, the bowl and nesting set 4a can additionally be packed in at least one gas-impermeable plastic bag.
[096] Referring to the Figures. 14a to 14g, a general cartridge closure (buffering) configuration according to the present invention will be described.
[097] To support and align a support plate 10 of a cartridge nesting in a predetermined position and orientation, a frame that supports the lower part 80 is used, which comprises a central opening 84, whose contour corresponds exactly to the outside counter of the nesting cartridges. More specifically, as shown in Figure 1, the cartridge nesting receptacles 11 are aligned in rows along a first direction, but are not aligned in rows in a second direction perpendicular to the first direction thereof. Instead, in the second direction each second container 11 is moved, for example by a half distance between two adjacent containers 11 in the first direction. The side walls 12 of the receptacles 11 thus define a wavy outline along the second
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39/51 direction, that is, in Figure 1 along the left edge and the right edge of the support plate 10. The two opposite edges of the central opening 84 at the bottom that holds the frame 80 correspond exactly to this undulating pattern, so that the cartridge nesting 1 can only be inserted in a given orientation that is unambiguously defined by the wavy pattern formed by the cartridge nesting receptacles 11. By means of the lower support frame 80, the lower ends of the cartridges 5 are positioned in a precisely defined height level in relation to the machine support frame 70, which can be part of a processing machine for processing the containers and can be supplied in a clean room or under sterile conditions, for example to a company pharmaceutical or filling material.
[098] As shown in Figure 14a, several spacer rods 72 are arranged on the machine holding frame 70 to precisely define the position and orientation of the lower part that holds the frame 80. For this purpose, the alignment tips can be provided at the front ends of the spacer rods 72 which engage with the alignment holes 81 formed in the lower support frame 80.
[099] Figure 14b shows how the cartridge nesting is accommodated and positioned in the lower support opening 80.
[100] As shown in Figures 14a and 14c, several spacer rods 82 are arranged on the upper side of the lower support frame 80 to precisely define the position and orientation of an upper support frame 90 used for positioning and aligning a nest of closings above and in relation to nesting cartridges underneath. Alignment tips 83 are provided at the front ends of spacer rods 82 that engage with alignment holes 91 formed in the upper support frame 90a [101] Figure 14d shows how the upper support frame 90
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40/51 is positioned and aligned on the lower support frame 80. A plurality of openings or receptacles 92 formed as through holes are formed on the upper retaining frame 90, in exactly the same geometric arrangement as the cartridge nesting containers underneath.
[102] Figure 14e shows how the support plate 60 of a locking nest is placed over the upper retaining frame 90. For reasons of clarity, the closures are omitted in the Figures. 14a - 14g. As shown in Figure 14e, the closing nest support plate 60 is placed over the upper retaining frame 90, such that the side walls of the containers on the lower side of the support plate 60 enter the openings or containers 92 of the frame upper retainer 90 and are finally fully accommodated therein. Again, this can only be done in a single orientation and positioning that is unequivocally defined by the pattern formed by the openings or receptacles 92 of the upper retaining frame 90.
[103] Thus, in the state of Figure 14f all receptacles 61 of the support plate 60 of the nesting closures are precisely aligned with all the containers formed by the side walls 14 of the nesting cartridges and, thus, with all the cartridges supported by the nesting of cartridges. Figure 14g shows this example configuration in an exploded perspective.
[104] Figure 15 shows the configuration of Figure 14f, in a schematic sectional view. This configuration can be carried out in a buffering machine or in a combined filling and buffering machine, in which case the lower support frame 80 could be identical to the support frame 40 shown in Figure 11 and the set of configurations will be arranged under conditions of reduced pressure or vacuum, at least, during the buffering process.
[105] As shown in Figure 15, the lower ends of the walls
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41/51 lateral 62 of the closing nesting containers are precisely held at the same level by hook-shaped protuberances 94 formed at the lower ends of the cylindrical side walls 93 of the containers of the upper retaining structure 90. More specifically, the lower ends of the walls sides 62 of the rest nesting containers on the upper sides of the hook-shaped protuberances 94. As the upper retaining structure 90, which is preferably made of a stable sheet of metal, has a high mechanical stability and rigidity and will not flex during the buffering process, the top alignment of the closures 200 with the cartridges 5 below will be maintained throughout all phases of the buffering process.
[106] As shown in Figure 15, the lower ends of the cylindrical side walls 93 of the containers of the upper retaining structure 90 are chamfered inwardly so that they can snug into the open lower ends of the cartridges 5, if necessary. These lower ends can be coated with a resin or plastic to reduce tension in this region. During the buffering process, there is preferably a very narrow gap between the lower ends of the cartridges 5 and the lower ends of the cylindrical side walls 93 of the containers of the upper retaining structure 90.
[107] As shown in Figure 15, the inside diameter of the locking nest receptacles corresponds to the inside diameter of the cartridges
5. To close the lower ends of the cartridges 5, the closures 200 are pushed downwards out of the closing nesting receptacles into the filling openings at the lower ends of the cartridges 5, while the cartridges are accommodated in the receptacles of the cartridge nesting. The locks are pushed downward by means of a plurality of adjustable push rods 121 of the buffering machine 120. This buffering process can be carried out in line mode, but it can also be carried out simultaneously
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42/51 for all 200 closures and 5 cartridges held by the nests. To this end, both the cartridge nesting support plate 10 and the buffer nesting retaining plate 60 are sufficiently rigid to ensure the precise alignment of the top closures 200 and cartridges 5 at all stages of the buffering process.
[108] Figure 10 shows in a schematic top view, an example of a processing apparatus or station for carrying out a process according to the present invention, as described above, under sterile conditions. The processing apparatus 100 has a sterile inner volume 101 with a feed inlet section on the left side and a feed outlet section on its right side. For processing, the sterile packaging units as described above are fed, through the feed section, into the sterile inner volume 101. During this feeding step, the protective covers or sheets of the packaging units are removed so that the bowl and nesting sets accommodate the pre-sterilized cartridges and pre-sterilized closures are finally arranged close to the feeding position indicated by reference number 102. For processing, the bowl and nesting sets are transported by a conveyor 106 along from the direction of the arrow shown in Figure 10, until finally reaching the feed exit position indicated by reference number 103. To transport the nests, the nests are accommodated by support frames 40 or similar holding tables or vats, respectively , which accommodate a nesting are accommodated by frames retention s 40 or similar retaining tables. In any case, the lower ends of the cartridges are fed to the processing stations 101 at precisely defined height levels.
[109] The feed inlet and outlet sections for cartridge nests and closure nests can be in different positions and in particular can be arranged at different height levels.
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43/51 [110] As an example of a process step, Figure 10 shows the filling and buffering of the cartridges accommodated by nesting in the support frames 40. For filling and buffering, the nesting or tubing and cartridge nesting sets and for closures they are first transported to the waiting position 104 and then to the filling and plugging station 110, where the filling and plugging process is normally carried out in line mode, but can also be carried out simultaneously for all cartridges and closures . After filling and buffering, the nests that hold the filled and buffered cartridges or the bowl and nesting sets, accommodating the filled and buffered cartridges, are finally transported to the feed exit position indicated by reference number 103.
[111] When buffering the cartridges, when generally large axial forces will be exerted from above for the cartridges, the symmetrical arrangement of the retaining protuberances 15 (see Figure 2) together with the axial ribs 13 ensures a symmetrical distribution of such forces with only minor deformation of the general shape of the receptacles 11 and the retaining protuberances 15 so that both the precise centering and the levels of the cartridges will be maintained.
[112] In addition to filling the sealed cartridges through the filling openings at the lower ends and / or plugging the sealed cartridges at their lower ends using rubber stoppers, the previous procedure can also be carried out by pre-gasifying or post-gasifying the cartridges. As can be concluded from the figures. 2 and 4, the intervals formed between the axial ribs 13 of the receptacles, together with the intervals 16 between the retaining protuberances 15 of the receptacles and the access openings 22 further support gas flow suitable for pre-gasification or post-gasification of the cartridges when the nesting is accommodated in a vat, because a sterilization gas can
Petition 870180164692, of 12/18/2018, p. 57/65
44/51 flow essentially unimpeded from the upper side of the nesting to the lower side of the nesting, if accommodated in a vat.
[113] It will be appreciated that, according to the present invention, sealed cartridge cylinders, in particular pre-crimped, are entirely in a known manner and do not require modification, compared to conventional sealed cartridge cylinders. Likewise, the vat is as currently used in a known pre-filled syringe handling system and it is only the nesting that has been modified in such a way that it will be interchangeable for a conventional nesting and a syringe nesting can be pre-filled in terms of level height of sealed cylinders in the tub, as well as on the filling machine table or retaining frame. In addition, as sealed cartridges allow you to use the same table height setting as the pre-filled syringe filling machine, the downward positioning of the receptacles ensures that the sealed cylinders are kept at the same level as previously syringes floods in a conventional nest.
[114] Thus, the cartridge support structure according to the present invention can also be used for a manual, semi-automatic or fully automatic filling and buffering process, as summarized below:
1) Manual filling and capping machine for pre-filled syringes:
[115] Usually, this manual filling and capping machine, as the name suggests, is used for filling and capping pre-filled syringes with a non-automated process. According to the present invention, the customer can pre-fill the medicine in other types of medical devices, that is, in cartridges having a different axial length, while using the same machine.
Petition 870180164692, of 12/18/2018, p. 58/65
45/51 filling and buffering because the nesting and tub assembly according to the present invention allows to perform the same steps of the processing steps on the same machine, without any change in parts of the filling machine and any change in the adjustment of the machine.
[116] Thus, maintaining different parts of changes and different configurations and also the requirement for separate validation studies can be avoided, which will otherwise add to the costs and will also require additional time to change the parts resulting in loss of production.
[117] In the case of a buffering machine only, the top plate needs to be changed to match the design of the nesting, if necessary, without changing the height of the fixing device.
2) Semi-automatic filling and capping machine for pre-filled syringes:
[118] Usually this semi-automatic filling and capping machine, as the name suggests, is also used for filling and capping previously filled syringes. According to the present invention, the customer can fill the medicine in other types of medical devices, for example, in cartridges, having a different axial length, using the same filling and buffering machine as the nesting and tubing set according to the present invention allows to carry out the same processing steps on the same machine, without any change in the parts of the filling machine and any change in the adjustment of the machine, in particular, without any change in the height of the filling table. The same advantages result, as described above for manual filling and buffering machines.
3) Fully automatic filling and buffering machine for
Petition 870180164692, of 12/18/2018, p. 59/65
46/51 pre-filled syringes:
[119] The nested vat for particularly pre-cured sealed cartridges, pre-sterilized according to the present invention can be inserted directly into the existing fully automatic filling and capping machine of previously filled syringes without any change in the machine configuration and without adjustment or change in the height of the filling table and only by replacing a part, that is, resting carrier plate to match the nesting, if necessary.
[120] There are the following additional advantages of nesting the invention for cartridges:
1) The design of the cartridge nesting is developed in such a way that the upper level of the cartridges in the vat and nesting is kept exactly at the same top height as that of the syringe that can be previously filled in a conventional vat and nesting format.
2) Ribs are provided over the top and / or bottom of the nesting surface to keep the nesting surface in a horizontal position without bending or flexing downwards towards the bowl.
3) The retaining protrusions and each socket have a flower-like profile (shown in figures 3 and 4) to support the sealed cartridges in the shoulder portions. The flower profile is designed in such a way that it can support the cartridge stably throughout its processing, especially during the buffering operation where maximum forces are applied over the nesting flower profile [121] The type profile bottom flower can sustain up to 1000 N of strength.
[122] Although specific embodiments of the invention have been described in detail, it will be appreciated by those skilled in the art that various modifications and alternatives to these details could be developed in the light of
Petition 870180164692, of 12/18/2018, p. 60/65
47/51 of the global teachings of the description. Accordingly, the particular provisions described are intended to be illustrative only and not to limit the scope of the invention which will be given the full scope of the appended claims and any and all of their equivalents.
LIST OF REFERENCE NUMBERS cartridge support structure (also called cartridge nesting) support structure for cartridge plugs (also called buffer nesting) transport container or cartridge packaging (also called vat)
3rd transport container or packing for buffers (also called vat) vat and nesting set (for cartridges)
4th bowl and nesting set (for plugs) cartridge protective film (flat) cartridge nesting plate 1 receptacle side wall of receptacle 11 on top side axial rib side wall of receptacle 11 on bottom side
Petition 870180164692, of 12/18/2018, p. 61/65
48/51 retention protrusion space between retention protrusions 15 central opening rounded corner extension access opening side wall of access opening 22 guide rib guide rib reinforcement rib on the upper side reinforcement rib on the underside reinforcement rib on bottom side bottom (from bowl for cartridges) bottom (from bowl to plugs) bottom side wall (from bowl to cartridges) bottom side wall (from bowl to plugs) support step (from bowl to cartridges) support step (from bowl to top side wall (from bowl for cartridges) top side wall (from bowl for plugs)
Petition 870180164692, of 12/18/2018, p. 62/65
49/51 top flange (from bowl for cartridges) top flange (from bowl to plugs) rounded corner (from bowl to cartridges) rounded corner (from bowl to plugs) inner rounded corner (from bowl to plugs) support frame fill injector support arm for filling the injector set 41 support arm for buffering devices cylindrical body shoulder portion enlarged upper rim filling opening bottom opening seal buffering nesting support plate 2 receptacle side wall of receptacle 61 upper wall extension side 62 rounded corner
Petition 870180164692, of 12/18/2018, p. 63/65
50/51 upper end of the receptacle 61 upper fixing structure lower retaining frame machine support frame opening spacer stem alignment hole spacer stem aligning tip spacer stem 82 opening of central support frame 80 support frame upper alignment hole receptacle cylindrical side wall bottom protrusion processing apparatus sterile interior volume bowl and nesting sets feeding bowl and nesting sets
Petition 870180164692, of 12/18/2018, p. 64/65
51/51
104 nesting set in standby position
105 nesting set at the filling station
106 conveyor
110 filling and buffering processing station
111 downstream processing station
120 buffering machine
121 push rod
200 buffer
201 bulge
202 recess

权利要求:
Claims (21)
[1]
1. Method for closing a plurality of pre-crimped cartridges (5) for use in pharmaceutical, medical or cosmetic applications, said pre-crimped cartridges (5) having an upper end and a bottom end opposite the upper end, a body cylindrical (50) with a filling opening (53) at the lower end, and a shoulder portion (51) at the upper end, which is followed by an enlarged upper rim (52) with a secondary opening (54) for the delivery of medicines, in which the secondary opening (54) is sealed by a seal (55) and an external closure is crimped over the enlarged upper rim (52) to guarantee the seal in the pre-crimped cartridge (5), the method characterized by fact of understanding:
providing a support structure (2) for closing containers (200) having a plurality of tubular receptacles (61) arranged in a regular arrangement, wherein the receptacles (61) removably accommodate a plurality of closures (200) , at least partially, and comprise retaining structures (66, 67) for releasably engaging with the locks (200) to retain the locks in the receptacles;
providing a support structure (1) for the cartridges (5) having a plurality of tubular receptacles (11) arranged in the same regular arrangement, which are formed by circumferential side walls (14) projecting downwards from one side bottom of a support plate (10) of the support structure (1) for cartridges (5) and which accommodate a plurality of pre-crimped cartridges (5), in which the protrusions of
Petition 870180164692, of 12/18/2018, p. 6/65
[2]
2/9 retention (15) are formed at the lower ends of the receptacles (11) projecting inwards and the pre-crimped cartridges are accommodated upside down in the receptacles so that the shoulder portions (51) of the pre-cartridges crimps (5) are supported on the retaining protrusions (15) of the receptacles (11) and the sealed upper ends of the pre-crimped cartridges extend through central openings (17) formed by the retention protrusions (15) at the ends of bottom of the receptacles;
arrangement of the support structure (2) for closures above the support structure (1) for cartridges in an environment with reduced pressure, so that the receptacles (61) of the support structure (2) for closures are aligned with the receptacles ( 11) the support structure (1) for cartridges; and push the locks (200) down out of the receptacles (61) of the support structure (2) for closings and into the filling openings (53) at the lower ends of the pre-crimped cartridges (5), while the cartridges pre-crimped are accommodated in the receptacles (11) of the support structure (1) for cartridges.
2. Method according to claim 1, characterized in that the support structure (1) for cartridges is supported by a frame that supports the lower part (80);
the support structure (2) for closures is supported by an upper support frame (90) above the lower support frame (80); and the lower support frame (80) and the upper support frame (90) are arranged at a fixed spacing and aligned with each other by alignment devices (82, 83).
Petition 870180164692, of 12/18/2018, p. 7/65
[3]
3/9
Method according to claim 2, characterized in that the upper support frame (90) is arranged at such a distance from the lower support frame (80) that the bottom ends of the receptacles (92) of the support frame upper (90) or bottom ends of the receptacles (61) of the support structure (2) to close containers held by the upper support frame (90) are in direct contact with or a short distance to the lower ends of the pre-cartridges -crimped (5) accommodated in the receptacles (11) of the support structure (1) for cartridges.
[4]
4. Method according to any of the preceding claims, characterized in that the step of supplying the support structure (2) for closures still comprises:
supply of a transport or packaging container (3a) that houses a plurality of support structures (2) for closure (200) that are sterile sealed against the environment by a protective film (6) connected on a circumferential flange (34a) the transport or packaging container (3a);
removing the protective film (6) from the circumferential flange (34a) to open, thus, the transport or packaging container (3a); and removing one of the support structures (2) for sealing out of the transport or packaging container (3a).
[5]
5. Method according to claim 4, characterized in that the transport or packaging container (3a) that houses the plurality of support structures (2) for closures (200) is box-shaped
Petition 870180164692, of 12/18/2018, p. 8/65 and understand:
a bottom (30a), which is closed or sealed by a seal, lower vertical side walls (31a), which essentially and perpendicularly extend from said bottom;
a circumferential support step (32a) that extends horizontally from said side walls;
upper side walls (33a) extending upwards from said support step (32a) and the circumferential flange (34a) formed at the upper ends of the upper side walls in which the bottom support structure (2) for closures is supported in the circumferential support step (32); and the plurality of support structures (2) for closures are accommodated inside the transport or packaging container (3a) stacked one above the other.
[6]
6. Method according to any of the preceding claims, characterized in that the step of supplying the support structure (1) for cartridges still comprises:
supply of a transport container or packaging (3) accommodating the support structure (1) for cartridges, which is sterile, sealed against the environment by a protective film (6) connected to a circumferential flange (34) of the transport container or packaging (3);
removing the protective film (6) from the circumferential flange (34) of the transport or packaging container (3) to thereby open the transport or packaging container (3) that accommodates the support structure (1) for cartridges; and
Petition 870180164692, of 12/18/2018, p. 9/65
5/9 removal of the support structure (1) for cartridges out of the shipping container or packaging (3).
[7]
Method according to claim 6, characterized in that the transport or packaging container (3) to accommodate the support structure (1) for cartridges is box-shaped and comprises:
a bottom (30), which is closed or sealed by a seal, lower vertical side walls (31) which essentially and perpendicularly extend from said lower part, a circumferential supporting step (32) which extends horizontally from said side walls, upper side walls (33) extending upwards from said support step (32), and a circumferential flange (34) formed at the upper ends of the upper side walls, where the support structure (1) for cartridges is supported on the circumferential support step (32), the lower ends (53) of the pre-crimped cartridges (5) are arranged at the same height level, but do not protrude beyond the circumferential flange (34) of the transport or packaging container (3) to accommodate the cartridge support structure (1) and the upper ends (54) of the pre-crimped cartridges (5) are arranged away from the bottom (30) of the container shipping or packaging (3) to accommodate the support structure (1) for cartridges.
[8]
8. Method, according to any of the preceding claims,
Petition 870180164692, of 12/18/2018, p. 10/65
6/9 characterized by the fact that it further comprises a step of filling a plurality of pre-crimped cartridges (5) with a pharmaceutical, medical or cosmetic product.
[9]
9. Method according to claim 8, characterized in that the step of filling the plurality of pre-crimped cartridges (5) with the pharmaceutical, medical or cosmetic product comprises:
filling the plurality of pre-crimped cartridges (5) with the pharmaceutical, medical or cosmetic product simultaneously while the pre-crimped cartridges (5) are supported by the support structure (1) for cartridges.
[10]
10. Method according to claim 9, characterized in that the step of filling the plurality of pre-crimped cartridges (5) with the pharmaceutical, medical or cosmetic product is carried out while the support structure (1) for cartridges is maintained in a lower support frame (80).
[11]
11. Support structure for removably supporting a plurality of closures (200) for closing cartridges (5) for use in pharmaceutical, medical or cosmetic applications, said closures (200) having a cylindrical shape consisting of a resilient material said support structure (2) comprising a flat support plate (60) having a plurality of tubular receptacles (61) to fully accommodate the closures (200), to simultaneously support a plurality of closures (200) on the plate support (60), characterized by the fact that the receptacles (61) are formed by circumferential side walls (62, 63) arranged in a regular arrangement on the support plate (60) and protruding from the support plate (60) ,
Petition 870180164692, of 12/18/2018, p. 11/65
7/9 the receptacles (61) are configured to accommodate the closures (200) completely, and the receptacles (61) comprise upper retaining structures (66) formed at or near an upper end of the receptacles and lower retaining structures ( 67) formed at a lower end of the receptacles for releasably engaging with the closures (200) to retain the closures in the receptacles, in which the upper retaining structures (66) are formed as convexly curved protuberances projecting from the inner sides from the circumferential side walls (62.63) of the receptacles, the lower retaining structures (67) are formed as hook-shaped protuberances projecting from the inner sides of the circumferential side walls (62.63) of the receptacles, and the structures lower retaining clips (67) are chamfered on an upper or lower side of them.
[12]
Support structure according to claim 11, characterized in that the retaining structures (66, 67) are formed on the inner sides of the circumferential side walls (62, 63) of the receptacles.
[13]
Support structure according to claim 12, characterized in that the retaining structures (66, 67) comprise protuberances formed on the inner sides of the circumferential side walls (62, 63) of the receptacles.
[14]
14. Support structure, according to claim 13, characterized by the fact that the protrusions are configured to correspond to the outer contour of the closures (200).
[15]
15. Support structure, according to any of the
Petition 870180164692, of 12/18/2018, p. 12/65
8/9 claims 13 or 14, characterized in that the protrusions (66, 67) are formed, at equal angular distances along the inner sides of the circumferential side walls (62, 63) of the receptacles.
[16]
Support structure according to either of claims 13 or 14, characterized in that the protuberances (66, 67) are formed as circumferential protuberances (66, 67) on the inner sides of the circumferential side walls (62, 63 ) of the receptacles.
[17]
Support structure according to any one of claims 11 to 16, characterized in that the distance between the respective upper and lower retaining structures is less than or equal to the axial length of the closing devices (200).
[18]
18. Transport or packaging container (3a) to accommodate a plurality of closures (200) for closing cartridges (5) for use in pharmaceutical, medical or cosmetic applications, characterized by the fact that the transport or packaging container (3a) be boxed and understand:
a bottom (30a), which is closed or sealed by a seal, lower vertical side walls (31a) which extend essentially and perpendicularly from said lower part, a circumferential support step (32a) which extends horizontally from said walls side, upper side walls (33a) extending upwards from said support step (32a), and a circumferential flange (34a) formed at the upper ends
Petition 870180164692, of 12/18/2018, p. 13/65
9/9 of the upper side walls; and a plurality of support structures (2) for closures, as claimed in any of claims 11 to 17, being accommodated in the transport or packaging container (4a); wherein the plurality of closures (200) is accommodated in the receptacles (61) of a respective support structure (2) for closures; and the plurality of support structures (2) for closures are housed within the transport or packaging container (3a) stacked on top of each other.
[19]
19. Transport or packaging container according to claim 18, characterized in that the edge of the flat support plate at the lower end (60) of the plurality of support structures (2) for closures housed in the transport container or The packaging (3a) is supported on the circumferential support step (32a) or in the transport or packaging container (3a).
[20]
20. Transport or packaging container according to either of claims 18 or 19, characterized in that the transport or packaging container (3a) is closed or sealed by a protective film (6) against the environment, protective film (6) being connected to the circumferential flange (34a).
[21]
21. Transport or packaging container according to claim 20, characterized in that the protective film (6) is a gas-permeable plastic film, in particular, a web of synthetic fibers such as polypropylene fibers (PP ) or a Tyvek® protective film, which allows sterilization of the interior of the transport container or packaging (4a) through the protective film.

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法律状态:
2020-05-19| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-10-05| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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IN1590MU2015|2015-04-17|

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PCT/IN2015/000394|WO2016166765A1|2015-04-17|2015-10-16|Supporting structure for sealed cartridges, transport or packaging container and process|

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PCT/IN2016/000099|WO2016166769A1|2015-04-17|2016-04-18|Method for closing cartridges, supporting structure for supporting cartridge closures and transport or packaging container|

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