Holding structure for simultaneously holding a plurality of containers for substances for pharmaceutical, medical or cosmetic applications, transport structure and transport or packaging container comprising the holding structure
By introducing guide ribs and inclined surfaces into the retaining structure, the problem of large degrees of freedom of movement of the container in the receiving part is solved, enabling precise positioning of the container and high filling density, simplifying the insertion process, and reducing glass contact and wear.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- SCHOTT PHARMA SCHWEIZ AG
- Filing Date
- 2017-10-30
- Publication Date
- 2026-06-02
Smart Images

Figure CN122126539A_ABST
Abstract
Description
[0001] This application is a divisional application of patent application 201780079159.9, filed on October 30, 2017, entitled "A holding structure for simultaneously holding multiple containers of a substance for pharmaceutical, medical or cosmetic applications, a transport structure including the holding structure and a transport container or packaging container".
[0002] This application claims priority to German utility model application No. 20 2016 107 209.3, filed on December 21, 2016, entitled "A retaining structure for simultaneously holding multiple containers of a substance for pharmaceutical, medical or cosmetic applications, a transport structure including the retaining structure and a transport container or packaging container", the contents of which are expressly incorporated herein by reference. Technical Field
[0003] This invention generally relates to the processing of containers for substances used in pharmaceutical, medical or cosmetic applications, and more particularly to a holding structure for simultaneously holding multiple containers for substances used in pharmaceutical, medical or cosmetic applications, as well as a transport structure or transport container or packaging container having such a holding structure and containers held thereon. Background Technology
[0004] Pharmaceutical containers, such as vials, ampoules, or cartridges, are used on a large scale as storage containers for storing medical, pharmaceutical, or cosmetic preparations administered in liquid form, particularly in pre-dose quantities. These are typically cylindrical, made of plastic or glass, and readily available in large quantities at low cost. Lyophilization processes are increasingly used for long-term storage after filling containers as economically as possible under aseptic conditions. For this purpose, the containers must be opened under aseptic conditions at a filling machine (such as in a pharmaceutical company) before further processing.
[0005] CN 103359348A discloses a tray-type retaining structure. The tray has multiple vertical locating pins on its bottom, and a container can be accommodated between the locating pins without contacting each other. The retaining structure is formed from plastic material by injection molding. The vertical locating pins also serve as guides for inserting the container into the receiving portion formed by the locating pins.
[0006] WO 2016 / 135051 A1 discloses another retaining structure designed as a so-called nest, which can be accommodated in a barrel-shaped transport container or packaging container (also called a barrel). A plurality of receiving portions are formed on the bottom surface of the retaining structure, their bottoms connected to each other, and each has a vertical locating pin protruding from the bottom. The container can be accommodated between the locating pins without contacting each other. Here, the vertical locating pins serve as guides for inserting the container into the receiving portions formed by the locating pins.
[0007] Other retention structures are disclosed in the applicant’s public applications EP 2868593A1, EP 2848882A1, WO 2014 / 072019A2 and EP2740537 A1.
[0008] EP 2 448 541 B1 discloses another retaining structure having a tubular receptacle formed by a protruding sidewall perpendicular to the upper side of the retaining structure.
[0009] Inserting the container into the retaining structure from above usually requires very precise pre-positioning of the container relative to the retaining structure, which is complex.
[0010] Because the aforementioned retaining structure is produced using injection molding or deep drawing methods on plastic materials, the geometry of the receiving portion varies to some extent, for example, due to warpage, draft angles, roundness, concentricity, etc. These variations lead to an increased gap between the container and the retaining structure, which allows the container greater freedom of movement within the receiving portion, and also results in more particle generation due to material wear and a reduction in achievable filler density. Subsequent processing of the retaining structure within the tooling is therefore highly complex, making certain geometric variations unavoidable.
[0011] Due to the demolding process during the injection molding of retaining structures, a correspondingly large demolding ramp is required at the retaining structure's groove or receiving portion that shrinks on the core of the mold used for injection molding, wherein the inclination angle of the demolding ramp must be at least about 2°. However, such a large demolding ramp can lead to relatively inaccurate guidance, especially in the case of relatively long and thin containers (such as cartridges), and result in lower filling density.
[0012] DE 297 00 878 U1 discloses a bottle box in which a bottle is housed between cylindrical guide pins having guide ribs on their front edges. A rounded end face is provided at the upper end of the guide pin.
[0013] US 2005 / 0 133 386 A1 discloses a bottle carrier in which the bottle to be held must be suspended from below. Guide ribs and introductory ramps in the sense of this application are not disclosed.
[0014] US 2015 / 0272827 A1 discloses a nesting device for vials. The vial is inverted and received within a nested receiving portion. The receiving portion is formed by a circumferential guide pin, wherein the bottom of the receiving portion is closed. A stepped guide portion is disposed on the guide pin, and the shoulder of the vial rests on the guide pin.
[0015] WO 2016 / 166765 A1 discloses a retaining structure according to the preamble of claim 1, comprising a plurality of hollow cylindrical receiving portions wherein guide ribs are provided for guiding and positioning the container. Furthermore, an introduction ramp is provided at the upper end of the guide rib, the ramp being inclined relative to the guide rib, thereby guiding the container radially inward when inserted from above. It does not disclose that the guide ribs are inclined relative to the central axis of the container.
[0016] US 2015 / 272827 A1 discloses another retaining structure including a hollow cylindrical receiving portion. However, there are no guide ribs inside the receiving portion, and no bevels are introduced on such guide ribs. Summary of the Invention
[0017] One object of the present invention is to provide an improved holding structure for simultaneously holding multiple containers of substances for pharmaceutical, medical, or cosmetic applications, said holding structure being easily and economically manufactured and allowing containers to be easily and reliably inserted into the receiving portion of the holding structure. Other aspects of the invention relate to transport structures or transport containers or packaging containers including such holding structures, as well as aseptic packaging structures.
[0018] These problems are addressed by the retaining structure according to claim 1, the transport structure according to claims 18 and 26, the transport container or packaging container according to claim 27, and the aseptic packaging structure according to claim 29. Further advantageous embodiments are the subject of the dependent claims.
[0019] According to the present invention, a retaining structure is provided for simultaneously retaining multiple containers, particularly multiple vials or cartridges, of substances for pharmaceutical, medical, or cosmetic applications. The retaining structure has multiple receiving portions for at least partially or completely receiving the containers therein, such that the upper or lower end of the container may or may not protrude axially from the receiving portion. Each receiving portion has an upper opening for inserting the container into the receiving portion and a lower end having a retaining portion, wherein the retaining portion restricts axial movement of the container within the receiving portion, i.e., keeps the container axially fixed within the receiving portion. Furthermore, a guide portion is provided for guiding the container when it is inserted into the receiving portion.
[0020] According to the present invention, the guide portion is formed as a guide rib extending along the longitudinal direction of the receiving portion, wherein an introduction slope inclined relative to the guide rib is formed at the upper end of the guide rib.
[0021] When viewed laterally along the longitudinal direction of the receiving section, the guide ribs are relatively narrow. According to the invention, this allows containers to be held in a relatively tight fit by the guide ribs of the receiving section, yet they can easily slide into the receiving section. Simultaneously, the introduction ramp at the upper end of the guide ribs effectively supports the insertion of the container into the receiving section. The introduction ramp acts as a trapping funnel, trapping the ends of the container as it is inserted vertically above the holding structure and guiding them in the direction toward the guide ribs. Therefore, according to the invention, the container must be pre-positioned relatively imprecisely relative to the receiving section, which reduces the workload of handling the container, but the containers can still be reliably inserted into the receiving section. For inserting the container into the receiving section, a rough pre-positioning of the container perpendicular to the receiving section is sufficient. The container is then lowered perpendicularly into the receiving section, so that, if the guide ribs and introduction ramp are properly designed, the container can even simply fall due to the trapping effect described above, and then be guided into the receiving section.
[0022] Typically, the ramp can begin directly from the top of the receiving section to reduce the effective diameter of the receiving section to the diameter between the guide ribs. However, in general, the ramp can also begin only at a certain distance from the top of the receiving section, thereby maximizing the opening width at the top of the receiving section to effectively capture the container when it is inserted into the receiving section.
[0023] Typically, the introduced slope can also be concave, but it is preferred to be a flat inclined surface at the upper end of the guide rib, which is then incorporated into the guide rib by changing its inclination angle.
[0024] If the guide rib protrudes radially inward from only a relatively small extent, such as less than 1 mm, from the sidewall or a portion of the sidewall of the receiving part, it may be sufficient. According to the invention, this allows for maintaining a very high fill density of the structure. Preferably, the guide rib, or at least its leading edge, is designed as a flat, sloping surface.
[0025] According to the invention, the inclination angle of the guide rib relative to the central axis of the receiving portion is, in principle, negligible, or, to facilitate demolding of the structure from the injection mold during the injection molding process, the inclination angle of the guide rib relative to the central axis of the receiving portion is less than 1 degree. The very small or even negligible demolding ramps on the surface of the guide rib associated with container guidance result in precise positioning and guidance of the container within the receiving portion, thereby leading to precisely adjustable restrictions on the degrees of freedom of movement of the container within the receiving portion, or a significant reduction in the tilt of the container contained within the receiving portion. This restriction on the degrees of freedom of movement of the container within the receiving portion reduces the movement and impact velocity of the container relative to the holding structure, thereby reducing the force when the container collides with the sidewall or a portion of the sidewall of the receiving portion during transport. These reduced normal forces and friction paths result in lower friction and less material wear (particle formation) when the container is contained within the receiving portion, and this is also true when it is inserted into the receiving portion. Furthermore, according to the invention, the very precise guidance of the container also enables very precise removal of the container from the receiving portion, for example, by lifting the container using a pre-positioned clamp. Such guide ribs also allow for precise adaptation and adjustment of geometric deviations (such as warpage, roundness, concentricity, etc. caused by injection molding methods used to prepare structures that retain their integrity).
[0026] According to the present invention, the very precise positioning and guidance of the container within the containment section can increase the filling density, especially in the case of long, thin, or slender containers, because with the increased restriction on the degrees of freedom of movement, glass-to-glass contact of the container becomes less likely. Therefore, a narrower range of specifications can be selected.
[0027] The necessary guide length can also be reduced by significantly decreasing the degrees of freedom of movement of the container within the receiving section. This is particularly applicable to small-sized containers, such as long, thin, or elongated containers like cartridges or syringe barrels, because typically only these containers can be inserted into the lower half of the receiving section. Due to the very precise positioning and guidance of the container according to the invention, it is still reliably ensured that there is no glass-to-glass contact. Therefore, materials can also be saved according to the invention.
[0028] According to another embodiment, an inclined surface is introduced that is tilted relative to the guide rib, with an inclination angle between 5° and 15°, more preferably between 10° and 15°, and even more preferably between 12.5° and 14.5°. On the one hand, this allows for efficient capture of the container during insertion into a plane perpendicular to the retaining structure; on the other hand, it enables reliable insertion into the receiving portion formed by the guide rib below. The transition zone of the guide rib may be angled or curved.
[0029] According to another embodiment, the inclination angle of the introducing ramp relative to the central axis of the receiving portion is greater than the inclination angle of the guide rib relative to the central axis of the receiving portion. Since the inclination angle of the guide rib relative to the central axis of the receiving portion can be negligible or at least very small, particularly only within the range of about one degree, the inclination angle of the guide rib substantially corresponds to the inclination angle of the introducing ramp.
[0030] According to another embodiment, the inclination angle of the guide rib relative to the central axis of the receiving portion is between 0° and 2°, more preferably between 0° and 1.5°, and even more preferably between 0.5° and 1.0°. Therefore, the container can be supported in the receiving portion with a relatively tight fit, wherein the container preferably rests only along a linear region on the flat or convex front side of the guide rib.
[0031] According to another embodiment, the guide ribs protrude radially inward into the receiving portion and are distributed at angular intervals with each other, preferably at equal angular distances, particularly at 90° or 45° angular distances. It may be sufficient if the guide ribs protrude radially inward into the receiving portion to a minimum extent (e.g., the maximum distance is about 1 mm).
[0032] According to another embodiment, the guide ribs of the corresponding receiving portion form a circle, or are distributed along a circle, the diameter of which is smaller than the diameter of the receiving portion formed by the sidewalls, locating pins, separating webs, etc., wherein the diameter of the circle located at the bottom end of the guide ribs corresponds to the outer diameter of the container end. At least in the bottom region of the receiving portion, the container is then held tightly between the guide ribs. In particular, the cylindrical sidewalls of the container directly abut against the guide ribs at the bottom end of the receiving portion. Therefore, the container can be supported in this region with substantially no radial clearance.
[0033] According to another embodiment, the receiving portions are arranged in multiple rows and columns, wherein the receiving portions of the retaining structure, i.e., those not directly located on the edges of the retaining structure, are formed by axially extending positioning posts, with multiple guide ribs disposed on the sidewalls of the positioning posts. These positioning posts essentially represent the only lateral boundary of the receiving portions, i.e., they are arranged in the middle of four adjacent receiving portions. Here, the actual lateral support of the container is provided by the guide ribs.
[0034] According to another embodiment, the guide ribs of the radially opposite positioning posts of the corresponding receiving portions are aligned, such that the guide ribs on the sidewalls of the positioning posts are offset from each other by 90°. This means that the container is supported laterally by only four guide ribs, thereby minimizing friction, for example, when the container is inserted into the receiving portion.
[0035] According to another embodiment, the guide ribs and associated introduction ramps have a relatively small extension in the circumferential direction of the receiving portion, i.e., designed as relatively narrow ribs. For example, the circumferential extension of the receiving portion can be in the range of a few degrees, such as in the range of 1° to about 15°, more preferably in the range of 1° to 8°, and even more preferably in the range of 1° to 2° or 3°.
[0036] According to another embodiment, the guide ribs can, of course, have a certain extension in the circumferential direction of the receiving portion; that is, they are not simply designed as linear, very narrow ribs. This is because it leads to a reduction in surface pressure when the container is received, resulting in a smaller local number of particles due to material wear at the guide ribs, which is less important for the optical detection system. In other words, the reduction in surface pressure results in a smaller mechanical load on the surface (i.e., the softer plastic surface that holds the structure in place).
[0037] In order to manufacture a guide structure consisting of closely fitted ribs, the guide ribs that hold the structure can be further processed after its production, especially by injection molding of plastic materials, and optimally adapted to the geometry of the container to be contained.
[0038] According to another embodiment, the positioning posts are connected to each other by separate webs aligned along rows and columns. The separate webs primarily serve to reinforce the retaining structure, thereby enabling the positioning posts to be positioned with greater precision. The separate webs can also be used to prevent direct glass-to-glass contact between containers within the housing. Additional ribs may be provided on the side surfaces of the separate webs, extending longitudinally along the housing and also serving as additional lateral supports for the containers within the housing.
[0039] Typically, the receiving part can also be hexagonal by properly arranging the positioning posts in a hexagonal pattern.
[0040] According to another embodiment, the positioning post is a hollow cylinder, which further increases the rigidity of the positioning post and helps to save material. The upper edge of the positioning post is preferably rounded, so that when inserted from above the retaining structure, the container can be captured and guided into the receiving part even more effectively.
[0041] According to another embodiment, the outer receiving portion of the retaining structure (i.e., the receiving portion directly disposed at the edge of the retaining structure) is formed by sidewalls that are at least partially circularly curved and extend perpendicular to the upper side of the retaining structure or parallel to the central axis of the receiving portion. The sidewalls match the cylindrical sidewalls of the container, thereby minimizing the distance between the receiving portion and the edge of the retaining structure. Here, the upper edge of the sidewall may be circular, which further supports the vertical insertion of the container into the receiving portion from above the retaining structure.
[0042] According to another embodiment, the retaining portion at the bottom of the receiving part is designed as radially inwardly projecting retaining protrusions so that the end of the container can be directly supported on these retaining protrusions. The retaining protrusions are designed to be sufficiently rigid to withstand standard axial forces. If further processing of the container is envisioned when it is housed within the receiving part of the retaining structure, the rigidity of these retaining protrusions can be quite high. Therefore, relatively high axial forces can also be applied to the container housed within the receiving part, for example, when a stopper is placed through the filling opening of the cartridge, while the cartridge is supported on the retaining protrusions at the opposite end of the filling opening.
[0043] Here, the retaining protrusions can each surround the opening at the bottom of the receiving portion, so that when the container is received in the receiving portion of the retaining structure, the end of the container can, in principle, at least partially enter from below the receiving portion, for example, for further processing or handling.
[0044] According to another embodiment, the container is typically cylindrical, particularly in the form of a cartridge. These containers have a constricted neck at the upper end and an adjacent shoulder that is incorporated into the cylindrical sidewall of the container. The opening width of the aforementioned opening matches the outer diameter of the upper end of the container, such that the upper end of the container extends through these openings, and the shoulder of the container rests directly on a retaining protrusion to restrict axial movement of the container within the receiving portion. This design is particularly suitable for holding the cartridge inverted within a retainer of a retaining structure. Here, the cartridge's injection port can be closed with a stopper and sealed with a cap or closure, for example, by a crimped metal cap, which still allows access to the diaphragm in the stopper (pre-crimped cartridge). The opening width of the aforementioned opening at the bottom end of the receiving portion can be determined such that the front end of the cartridge with the stopper and crimped metal cap can extend fully through the opening, thus allowing the cartridge to rest on the retaining protrusion only in the shoulder region. For this purpose, the opening is preferably circular, or corresponds to the profile of the cartridge at its front end.
[0045] According to another embodiment, the upper side of the retaining structure is flat at least along its edges, and the bottom ends of the receiving portions are connected to each other by webs that share a common plane. This results in high stiffness of the retaining structure and lower requirements for space and materials. In summary, the retaining structure can be designed for so-called nesting in the concept of nested drum packaging, where multiple containers are received.
[0046] According to another embodiment, the length of the receiving portion matches the length of the container, such that the upper or lower end of the container protrudes from the receiving portion, allowing free access from above the holding structure. When the container is received in the receiving portion and held by the holding structure, this can be used for further processing or handling of the container. For example, when material is filled into the container held on the holding structure through a filling opening, the container can be temporarily held in a holder, such as in a processing station of a pharmaceutical filling company. Alternatively, when the container is held by the holding structure, a stopper can be pushed into the end of the container to close it. Alternatively, the end protruding from the holder can be used to clamp the container and remove it from the holder.
[0047] According to a further particularly preferred embodiment, the retaining structure is integrally molded from a plastic material through injection molding. The aforementioned inclined guide ribs and / or introduced ramps effectively support the demolding of the retaining structure from the injection mold.
[0048] According to another aspect of the invention, a transport structure for containers is provided, the transport structure comprising a combination of the aforementioned retaining structure and a plurality of containers for pharmaceutical, medical, or cosmetic applications held thereon, wherein the containers are at least partially housed in a receiving portion of the retaining structure and axially fixed to the retaining structure as described above. For this purpose, the retaining structure can be specifically designed as a so-called nested arrangement for holding vials, cartridges, or similar pharmaceutical containers.
[0049] According to another possible alternative embodiment, the retaining structure is designed as a receiving member, wherein a plurality of receptacles are formed in a regularly arranged truncated conical receptacle, thereby orienting the container so that its upper end faces the bottom of the receptacle and is received within the receptacles of the receiving member, while preventing direct contact between adjacent containers. The receiving member can serve as a retaining tray (so-called a pallet) for the container and can also be directly sealed, for example by sealing foil, for aseptic transport and storage of the container.
[0050] Here, the receiving portion is preferably matched to the length of the container, so that the container is completely contained within the receiving portion, i.e., its ends do not protrude from the receiving portion.
[0051] According to another embodiment, a support member is also provided to cover the bottom of the container housed in the receiving member, wherein the support member is formed of a base plate having a flat support surface facing the receiving portion.
[0052] Such receiving components can be integrally molded, particularly by thermoforming plastic material, especially by deep drawing sheet plastic material. Here, the receiving component can be formed by deep drawing a thin foil or sheet of foil material with a thickness of up to 2.0 mm, preferably up to 1.25 mm, and even more preferably up to 1.0 mm.
[0053] Here, the support member can also be integrally formed by thermoforming the plastic material, particularly by deep drawing a sheet of plastic material. In particular, the support member can be formed by deep drawing a thin foil or sheet of foil, the material thickness of which is up to 2.0 mm, preferably up to 1.25 mm, and even more preferably up to 1.0 mm.
[0054] According to another aspect of the invention, a transport structure for containers is provided. The transport structure comprises a combination of a retaining structure as described above and a plurality of containers for pharmaceutical, medical, or cosmetic applications held thereon, wherein the containers are housed within the retaining portion and axially fixed to the retaining structure.
[0055] According to another aspect of the invention, a transport container or packaging container for a plurality of containers of a substance for pharmaceutical, medical or cosmetic applications is provided, the transport container or packaging container being box-shaped, wherein a so-called nested retaining structure, as described above, together with the containers held thereon, is housed within the box-shaped transport container or packaging container for retaining the plurality of containers within the transport container or packaging container.
[0056] In particular, transport containers or packaging containers can be sealed or sealed with a breathable plastic film, especially with a plastic film formed of a breathable woven fabric of plastic fibers, particularly with Tyveck® film, so that sterilization of the container can be achieved by the flow of gas through the breathable plastic film.
[0057] For aseptic transport and storage, an aseptic packaging structure may be further provided, comprising at least one transport structure as described above or at least one transport container or packaging container as described above and a container contained therein, wherein at least one transport structure or at least one transport container or packaging container is contained within at least one aseptic outer packaging bag and aseptically packaged to protect against environmental influences. Here, at least one aseptic outer packaging bag may include a breathable portion, which is particularly formed of a woven fabric of plastic fibers (e.g., polypropylene fibers (PP)). Attached Figure Description
[0058] In the following description, the invention will be illustrated by way of example with reference to the accompanying drawings, from which other features, advantages, and problems to be solved will become apparent. In the drawings: Figure 1 The retaining structure according to the first embodiment of the present invention is shown in perspective view; Figure 2 As shown in the plan view Figure 1 The retaining structure shown; Figure 3 It shows Figure 2 A partial cross-sectional view along AA; Figure 4a It shows that according to Figure 3 The illustration shows a partial detail, in which the cartridge case is inverted and contained within the receiving part; Figure 4b This illustrates the process of vertically inserting the cartridge into the relevant receiving part from above, according to... Figure 3 Illustrations of local details; Figure 5a It shows that according to Figure 3 The illustration shows a partial detail, in which the container holds an upright vial; Figure 5b This illustrates how the vial is vertically inserted into the relevant receiving section from above, according to... Figure 3 Illustrations of local details; Figure 6 The perspective view shows the following based on Figure 1 The structure is preserved; Figure 7 The side view shows the results according to Figure 1 The structure is preserved; Figure 8a The retaining structure according to a second embodiment of the present invention is shown in a plan view; Figure 8b It shows Figure 8a A partial cross-section along AA; and Figure 8c It shows Figure 8a A partial cross-sectional view along BB.
[0059] In the accompanying drawings, the same reference numerals denote identical or substantially equivalent elements or groups of elements. Detailed Implementation
[0060] Figure 1 and 2 A retaining structure 1 according to a first embodiment of the invention is shown in perspective and bottom views. The retaining structure 1 includes a plurality of receiving portions 5 arranged in rows and columns perpendicular to their extension and for receiving medicine containers, particularly vials or cartridges. The receiving portions 5 are separated from each other by vertical positioning posts 20. These posts are connected to each other by plate-shaped separating webs 15 and to partially circularly curved sidewalls 10. Outer receiving portions 5b are provided along the edges of the retaining structure 1, separated from each other by the sidewalls 10 and the separating webs 15. The remaining inner receiving portions 5a are separated from each other only by the separating webs 15.
[0061] The entry opening 9 in the upper 2 is set to be offset from each other on the two opposite sides of the retaining structure 1 for clamping the retaining structure 1.
[0062] The receiving portion 5 extends vertically to the upper side 2 and is axially defined at its bottom end by a bottom web 12. The bottom web 12 is connected to the bottom end of the side wall 10 and the positioning post 20, and together they span a plane (see...). Figure 6 The bottom web 12 surrounds the circular opening 13 at the bottom end of the receiving part and is connected to each other. The upper end 21 of the positioning post 20 is flush with the upper side 2. The edge 6 of the upper side 2 and the upper end 21 of the positioning post 20 have rounded edges or bevels 7.
[0063] Longitudinal grooves 11 are formed in the sidewalls 10 of the receiving section to save material and enable optical inspection of the containers contained in the receiving section. The separating web 10 is mainly used to further reinforce the retaining structure 1 and the positioning post 20, but it also prevents direct contact between containers contained in adjacent receiving sections 5.
[0064] Guide ribs 18 and 25 are provided on all sidewalls 10 and positioning posts 20. The guide ribs project radially inward into the receiving portion 5, so that the sidewalls of the container do not contact the sidewalls 10 and positioning posts 20, but instead rest directly against the guide ribs 18 and 25, and are guided by the guide ribs 18 and 25 during insertion into the receiving portion 5. The guide ribs 18 and 25 extend substantially along their longitudinal direction over the entire length of the receiving portion 5. Figure 1 As shown, guide ribs 18 and 25 begin slightly from the upper side 2 of the retaining structure 1 and extend downwards to the bottom of the receiving portion 6. The figure shows that guide ribs 18 and 25 have no longitudinal interruption, but interruptions are generally possible. The upper ends of guide ribs 18 and 25 have introductory ramps 19 and 26, which are inclined at an acute angle relative to the guide ribs 18 and 25. In the illustrated embodiment, guide ribs 18 and 25 are designed as flat introductory ramps. The upper ends of introductory ramps 19 and 26 merge into the sidewall 10 or the positioning post 20.
[0065] Figure 3 It shows Figure 2 A partial cross-sectional view along AA shows that the positioning post 20 is hollow and cylindrical, with the retaining protrusion 22 protruding vertically radially from the bottom end of the positioning post 20 into the receiving portion 5. According to... Figure 3 The guide rib 25 is inclined at a 0.5° angle relative to the central axis of the receiving portion 5. This inclination angle can be negligible, but it is very small in any case, preferably a maximum of 2°. When the retaining structure is manufactured by injection molding, the guide ribs 18 and 25 can serve as demolding ramps to aid in demolding from the injection mold. Figure 3 As shown, the inclined surface 26 is inclined at an angle of 14° relative to the guide rib 25. This also applies to the corresponding inclination angle of the inclined surface 19 relative to the guide rib 18 on the side wall 10 of the receiving part 5.
[0066] For radial support of the container in the receiving section, a plurality of guide ribs 18, 25 are arranged in each receiving section 5. The guide ribs 18, 25 are spaced apart from each other, preferably spaced apart at equal angular distances on the side wall 10, and spaced apart at equal angular distances on the outside of the positioning post 20.
[0067] Figure 4a and 4b The diagram shows two stages of inserting the cartridge 50 into the receiving portion 5 of the retaining structure from a vertical position, namely, the case of full insertion. Figure 4a ) and the case when starting vertical insertion ( Figure 4b The cartridge 50 is a hollow cylinder with cylindrical sidewalls 52 that converge at an inclined shoulder 54 to form a constriction 55. This constriction 55 has an outer diameter smaller than that of the cylindrical sidewalls 52, and a widened edge 56 with a nozzle 58 is formed at the front end of the constriction 55. This can be sealed with a stopper (not shown). The stopper can be secured by a crimped metal cap at the front end of the cartridge 50 (so-called pre-pressed cartridge). At its rear end, the cartridge 50 is open, having a filling opening 57 through which liquid substances can be filled.
[0068] When the cartridge 50 is inserted vertically into the receiving portion 5 from above, the tip with the injection port 58 first enters the area between the upper end of the positioning post 20 and the side wall (not shown). The tip of the cartridge 50 is guided into the receiving portion 5 by the introduction ramps 26 (and 19) provided in this area. As the cartridge 50 continues to approach, the transition area between the shoulder 54 and the cylindrical side wall 52 contacts the introduction ramps 26 (and 19), thereby further guiding the tip of the cartridge 50 into the receiving portion 5. As the cartridge 50 continues to approach, the transition area between the shoulder 54 and the cylindrical side wall 52 continues to be guided by the introduction ramps 26 (and 19) until the transition area between the shoulder 54 and the cylindrical side wall 52 slides along the guide ribs 25 (and 18) until the shoulder 54 is finally directly supported on the retaining protrusion 22. In this case (see Figure 4a At least the front end of the cylindrical sidewall 52 rests directly on the bottom end of the guide ribs 25 (and 18) and is therefore centered on the receiving portion 5, and is supported at a distance from the sidewall 10 and the positioning post 20. In this case, the front end of the cartridge, including the constricted neck 55 and the widened upper edge 56, extends through the opening 23 between the retaining protrusions 22, and the cartridge may include a metal cap (not shown) pressed thereon. The metal cap does not contact the retaining protrusions 22, so even if a large axial force is applied to the cartridge 50, such as when the plunger is inserted into the filling opening 57, no force is applied to these protrusions, and the plug can securely close the filling opening 13 of the cartridge 50 while keeping the cartridge 50 in a position such as Figure 4aThe cartridge 50 is inverted and supported in the receiving portion 5 in the position shown. In this position, the rear end of the cartridge 50 protrudes from the receiving portion 5.
[0069] therefore, Figure 5a and 5b The diagram shows two stages of inserting the vial 51 vertically into the receiving portion 5 of the retaining structure from above, namely, the case of full insertion. Figure 4a ) and the situation at the start of insertion ( Figure 4b The diagram shows the vial 51 inserted upright. Typically, as... Figure 4a and 4b As shown, the vial 51 can also be inserted upside down. During the insertion process described above, the guidance of the vial 51 is accomplished through the interaction between the transition area between the vial bottom 53 and the cylindrical sidewall 52 and the introduction ramps 26 (and 19) and guide ribs 25 (and 18). In the fully inserted state, the bottom 53 of the vial 51 is supported on the retaining protrusion 22, thus the vial 51 is fixed in the receiving portion 5 in the axial direction.
[0070] like Figure 6 As shown, reinforcing ribs 8 are provided on the back of the retaining structure 1 for further reinforcement. The cup-shaped design of the receiving part 5 is clearly visible.
[0071] As described above, the retaining structure 1 can be used for storing and transporting pharmaceutical containers such as vials or cartridges. For operation, the retaining structure 1 can be gripped and guided through the access opening 9 using a clamp or similar device. As described above, while the pharmaceutical container is held by the retaining structure 1, it can be further processed or treated. For aseptic transport, this retaining structure can be used as a so-called nested storage within a barrel-shaped transport container or packaging container, for example, as disclosed in the applicant's EP 2 868 593 A1, the contents of which are disclosed and incorporated herein by reference for the purposes of disclosure. The transport container or packaging container can be closed or sealed with a breathable plastic film, particularly with a plastic film formed from a breathable woven fabric of plastic fibers, especially with Tyveck® film.
[0072] This retaining structure can be molded as a single piece, especially through injection molding of plastic material. Introducing bevels and guide ribs facilitates demolding of the retaining structure.
[0073] However, as Figures 8a to 8c As shown, the retaining structure according to the invention is also substantially applicable to so-called tray schemes, particularly for small bottles.
[0074] according to Figures 8a to 8cThe retaining structure 1 is designed as a receiving member, wherein most of the receiving portions can be integrally molded and arranged regularly to form truncated conical receiving portions 5. The receiving portions 5 are closed by circumferential sidewalls 10. Vials 51 (as an example of a pharmaceutical container) are oriented with their upper ends facing the bottom 14 of the receiving portion 5 and are received within the receiving portion 5 of the receiving member 1, thereby preventing direct contact between adjacent vials 51. The vials 51 are fully received within the receiving portions 5 such that they do not protrude beyond the edge of the retaining structure 1. The length of the receiving portion 5 is preferably matched to the vials 51 such that the bottom of the vials 51 is flush with the edge of the retaining structure 1. The aforementioned introduced bevels and guide ribs are formed on the inner side of the sidewalls 10.
[0075] To form a transport structure, a support member can be placed on and connected to the receiving member to cover the bottom of the vial contained in the receiving member. Preferably, the support member is formed of a base plate having a flat support surface facing the receiving portion, and the bottom of the vial 51 is directly supported on the support member.
[0076] Such receiving and / or supporting components for retaining the structure can be integrally formed by thermoforming plastic material, particularly by deep drawing sheet-like plastic material, preferably by deep drawing a film or film sheet, the film or film sheet having a material thickness of up to 2.0 mm, more preferably up to 1.25 mm, or even more preferably up to 1.0 mm.
[0077] For this type of pallet system, the receiving component can generally also be manufactured by injection molding of plastic material, thereby introducing bevels and guide ribs to assist in the demolding of the receiving component in the manner described above.
[0078] If non-sterile transport of the drug container is sufficient, it can be formed into a non-sterile closed transport structure by connecting the receiving member to the supporting member. If sterile transport of the drug container is required, the open side of the receiving member can also be sealed with a sealing film, for example, by bonding along the flange-like edge of the receiving member, and additional welding points can be used if necessary, to form a sterile transport structure.
[0079] For aseptic transport, this transport structure may be housed together with other similar transport structures in at least one aseptic outer packaging bag and aseptically packaged to protect it from environmental influences. The at least one aseptic outer packaging bag may have a breathable portion, or may even be formed entirely of it, the breathable portion being particularly formed of a woven fabric of plastic fibers (e.g., polypropylene fibers (PP)).
[0080] List of reference numerals 1. Maintain structure 2 upper side 2a Bottom 3. Top edge 4. Round the corner area 5. Reception area 5a Content Department 5b External Reception Section 6. Top edge 7. Round off the edge area 8 Reinforcing ribs 9. Enter the opening 10 Sidewalls 11 slots 12. Bottom web 13 Opening 14 Bottom 15. Separate the web. 16 ribs 18 guide ribs 19. The inclined surface for introducing guide rib 18 20 positioning pins 21. Upper end of locating pin 20 22. Maintain protrusion 23 cavities 24 Upper edge region 25 guide ribs 26. The inclined surface for introducing guide rib 25 27. Round off the edge area 50 cartridges / containers 51 vials / containers 52 Sidewall 53 Bottom 54 Shoulders 55. Neck retraction 56 Top edge 57 Fill the opening 58 Injector nozzle
Claims
1. A holding structure for simultaneously holding multiple containers (50, 51) of a substance for pharmaceutical, medical, or cosmetic applications, comprising multiple receiving portions (5) for receiving at least partially the containers therein, wherein Each of the receiving portions has an upper opening for inserting the container into the receiving portion and a bottom end having retaining portions (12, 22) for restricting axial movement of the container within the receiving portion; and A guide portion is provided to guide the container when it is inserted into the receiving portion; in, The guide portion is formed as guide ribs (18, 25) extending along the longitudinal direction of the receiving portion, and An introductory inclined surface (19, 26) inclined relative to the guide ribs (18, 25) is formed at the upper end of the guide ribs (18, 25), wherein... The guide ribs (18, 25) are inclined at an angle relative to the central axis of the receiving portion, and The tilt angle is greater than 0° and less than or equal to 2°. The internal storage portion (5a) of the retaining structure is formed by an axially extending positioning post (20), on which a plurality of guide ribs (18, 25) are provided on the sidewall of the positioning post, and The positioning posts are connected to each other by partition webs (15) aligned along rows and columns.
2. The retaining structure according to claim 1, wherein the tilt angle is greater than 0° and less than or equal to 1.5°.
3. The retaining structure according to claim 2, wherein the tilt angle is greater than 0.5° and less than or equal to 1.0°.
4. The retaining structure according to claim 1, wherein the introducing inclined surface (19, 26) is inclined relative to the guide rib (18, 25) at an angle between 5° and 15°.
5. The retaining structure according to claim 4, wherein the introducing inclined surfaces (19, 26) are inclined relative to the guide ribs (18, 25) at an angle between 10° and 15°.
6. The retaining structure according to claim 5, wherein the introducing inclined surfaces (19, 26) are inclined relative to the guide ribs (18, 25) at an angle between 12.5° and 14.5°.
7. The retaining structure according to claim 1, wherein the guide ribs (18, 25) protrude radially inward into the receiving portion (5) and are distributed at angular intervals to each other.
8. The retaining structure according to claim 1, wherein the guide ribs (18, 25) of the corresponding receiving portion form a circle with a diameter smaller than that of the receiving portion (5), wherein the diameter of the circle located at the bottom end of the guide ribs (18, 25) corresponds to the outer diameter of the container.
9. The retaining structure according to claim 1, wherein the guide ribs (18, 25) of the radially opposite positioning posts (20) of the corresponding receiving portions are aligned, and wherein the guide ribs (18, 25) are arranged at 90° angular intervals relative to each other on the sidewalls of the positioning posts.
10. The retaining structure according to claim 1, wherein the positioning post is a hollow cylinder and wherein the upper edge (27) of the positioning post is circular.
11. The retaining structure according to claim 1, wherein the outer receiving portion (5b) of the retaining structure is formed by a sidewall (10), the sidewall (10) being at least partially circularly curved, and the upper edge (6) of the sidewall being circular.
12. The retaining structure according to claim 1, wherein the retaining portion is formed as a radially inwardly projecting retaining protrusion (12, 22) surrounding a corresponding opening (13) at the bottom end of the receiving portion (5).
13. The retaining structure according to claim 1, wherein the upper side (2) of the retaining structure is flat at least along the edge of the retaining structure, and the bottom ends of the receiving portions are connected to each other by webs (12) that coexist across the plane.
14. The retaining structure according to claim 13, wherein the retaining structure is configured to receive nested containers (50, 51) therein.
15. The retaining structure according to claim 1, wherein the length of the receiving portion matches the length of the container (50, 51) such that the upper or lower end of the container (1) protrudes from the receiving portion and can be freely contacted from above the retaining structure.
16. The retaining structure according to claim 1, wherein the retaining structure (1) is integrally formed from plastic material by injection molding.
17. A transport structure comprising a combination of a retaining structure according to any one of the preceding claims and a plurality of containers (50, 51) for a substance held thereon for pharmaceutical, medical or cosmetic applications, wherein the containers are at least partially contained in the receiving portion (5) and axially fixed to the retaining structure (1).
18. The retaining structure according to claim 1, wherein the retaining structure is formed as a receiving member, wherein the plurality of receiving portions (5) are integrally formed as regularly arranged truncated conical receiving portions, thereby orienting the container so that its upper end faces the bottom of the receiving portion, and the container can be received in the receiving portion of the receiving member while preventing direct contact between adjacent containers, and the receiving portion is matched to the length of the container so that the container is completely received in the receiving portion. The retaining structure further includes a support member for covering the bottom of the container housed in the receiving member, the support member being formed of a base plate having a flat support surface facing the receiving portion.
19. The retaining structure of claim 18, wherein the receiving member is integrally formed by deep drawing a sheet-shaped plastic material.