Holder device for holding a plurality of vials to be moved in a processing line

Abstract

The invention relates to a holder device for holding (10) a plurality of vials (50) to be moved in a processing line. The holder device (10) comprises a plate (20) having a plurality of housing seats (30) for receiving vials (50) and a plurality of rigid spacer elements (40) arranged within the housing seats (30) and configured to maintain the vials (50) in a suspended position relative to a substantially horizontal operating surface (100) of the process line. Each housing seat (30) comprises an open base (32) for facing the operating surface (100).

Description

[0001] manual

[0002] The present invention relates to a device for holding a plurality of vials to be moved in a processing line.

[0003] The retainer device meets the definition of a "nest" of standard ISO 21882:2019.

[0004] The invention also relates to an ordered vial assembly comprising the above-mentioned holder device and a plurality of vials held by the holder device.

[0005] The present invention also relates to a container for containing the above-mentioned ordered vial assembly.

[0006] Preferably, the vial to which this specification and the appended claims relate is a vial made of glass or thermoplastic material for pharmaceutical use.

[0007] According to ISO 21882:2019, a nest is used to safely move a plurality of vials along a processing line and generally comprises a plate made of a plastic material on which a plurality of seats for accommodating the vials are formed. The housing seats are shaped to hold the various vials in a stable manner, thereby avoiding possible mutual collisions during movement of the nest.

[0008] Typically, several process steps are initiated in the above-mentioned processing lines, such as sterilization of empty vials, filling of vials and storage of the filled vials.

[0009] In many cases, a freeze drying step is also performed in the processing line, which involves first freezing the liquid product contained in the vial, then reducing the pressure and introducing heat to allow the frozen water in the product within the vial to sublime.

[0010] Pharmaceutical companies often perform a freeze drying step because it allows the quality of the product inside the vial to remain unchanged and therefore the shelf life of the product is increased. Freeze drying also makes it easier to move the vials through the processing line after they have been filled.

[0011] The freeze-drying step presents some critical issues.

[0012] The first critical issue involves the need to provide uniform heat transfer from the heated surface of the freeze-drying chamber into the vial.

[0013] The second key issue relates to the fact that freeze drying takes a long time, up to 300 hours to complete one cycle.

[0014] A further key issue relates to the fact that pharmaceutical products are often freeze-dried in large batches, which can result in the quality of the freeze-dried product varying depending on the location of the vials in the freeze-drying chamber.

[0015] Therefore, thought has been given to how to perform a rapid freeze-drying step so as to produce a uniform freeze-dried product regardless of the position of the vials in the freeze-drying chamber.

[0016] It is known from the publication "From Batch to Continuous: Freeze Drying of Suspended Vials for Pharmaceuticals in Unit Doses - Luigi C. Capozzi, Bernhardt L. Trout and Roberto Pisano - Industrial & Engineering Chemistry Research 2019 58 (4), 1635-1649 - DOI: 10.1021 / acs.iecr.8b02886" that the freeze drying step is carried out on vials kept suspended from a heated surface of a freeze drying chamber. This enables a uniform transfer of heat from the heated surface to all vials provided in the freeze drying chamber and the processing time is 3-4 times shorter than when the vials are placed on the heated surface.

[0017] It is known from the publication "Investigation of freezing phenomena in vials using an infrared camera - Harguindehen M, Stratta L, Fissor D, Pisano R, Pharm. 2021 Oct 12;13(10):1664. doi:10.3390 / pharm.13101664. PMID:34683957; PMCID:PMC8539506" that in the case of suspended vials, heat is transferred uniformly from the heating surface to the interior of the vial mainly by natural convection through the base and side surfaces of the vial.

[0018] WO 2016075647 A1 describes a freeze-drying method in which the vials contained in the holder device do not come into contact with the heating surface. In particular, in WO 2016075647 Figure 1 In variant 3 of , spacers made of thermally insulating material are used. These spacers are placed between the heating surface and the holder device, preferably under the base of some housing seats arranged at the edge of the holder device or between pairs of adjacent housing seats. Figure 1 In variant 4 of the invention, the holder device keeps the vials suspended relative to the heating surface by holding the vials at corresponding necks.

[0019] The Applicant believes that the solution of variant 3 has some disadvantages.

[0020] Firstly, the spacers may collapse, deform and / or move relative to the heating surface and / or the holder device, for example even simply due to the forces applied to close the vials, thus negatively affecting the freeze drying step. If even only one spacer is defective or damaged or moves, the vials may no longer all be at the same distance from the heating surface, and the freeze dried product within the vials of the same production batch may not be homogeneous.

[0021] In order to limit the negative effects of possible failure, deformation and / or displacement of the spacers, it is necessary to increase the number of spacers used, which has a significant impact on costs.

[0022] The use of spacers is also expensive since they must usually be manufactured by moulding and therefore a certain amount of moulding material must be purchased.

[0023] The applicant has also noted that the use of insulating materials to make the spacer may adversely affect the transfer of heat from the heating surface to the interior of the vial.

[0024] Furthermore, in industrial processes that require a high degree of automation and large production batches, the use of spacers is not a practical and easy to implement solution.

[0025] Furthermore, the base of the housing is closed. This does not allow for optimal heat exchange between the heating surface and the vials, thus negatively affecting the outcome of the freeze-drying step.

[0026] According to the Applicant, on the other hand, the solution of variant 4 described above has the disadvantage that during the closing step of the vials, the vials may be damaged or broken at the respective necks, since this closing step involves the application of high pressures on the vials.

[0027] The technical problem underlying the present invention is to provide a holder device for holding a plurality of vials to be moved in a processing line, which holder device does not have the above-discussed disadvantages.

[0028] Thus, the present invention relates in a first aspect to a holder device for holding a plurality of vials to be moved in a processing line, the holder device comprising a plate having a plurality of housing seats for accommodating the vials and a plurality of rigid spacing elements arranged in the housing seats and configured to maintain the vials in a suspended position relative to a substantially horizontal operating surface of the processing line, wherein the housing seats each comprise an open base intended to face the operating surface.

[0029] In the present description and the appended claims, the term "suspended position" is used to indicate a position such that there is a gap between the vial and the operating surface of the processing line on which the holder device is placed, so that heat is exchanged by natural convection between the operating surface and the vial (rather than by conduction).

[0030] Providing a housing with a corresponding open base facing the operating surface of the processing line and a spacing element in the housing makes it possible to achieve ideal conditions for performing a freeze-drying step suitable for ensuring the desired quality and uniformity of the freeze-dried product in the various vials of the same production batch. In this way, in fact, each vial is supported in a suspended position relative to the above-mentioned operating surface independently of the other vials, and the heat from the operating surface can pass through the open base of the housing directly to the vial.

[0031] The spacer elements can be made in one piece with the plate, achieving clear advantages in terms of production costs and industrial processability compared to solutions involving spacers arranged outside the housing and made in a separate piece from the plate (such as variant 3 of WO 2016075647A1).

[0032] The base of the housing also allows stable support of the vial during its closing step, eliminating the risks of breakage and / or damage typical in those solutions in which the vial is gripped at the corresponding neck, such as in variant 4 of WO 2016075647A1.

[0033] In a second aspect of the invention, the invention relates to an ordered vial assembly comprising a holder device according to the first aspect of the invention and a plurality of vials having corresponding seat surfaces resting on spacing elements of corresponding housings.

[0034] This assembly allows all vials from a production batch to be processed simultaneously on the processing line.

[0035] In a third aspect of the invention, the invention relates to a container for containing an ordered assembly of vials according to the second aspect of the invention, wherein each of said vials contains a freeze-dried product.

[0036] The container allows production batches of vials to move simultaneously along the processing line.

[0037] The following describes preferred features of the present invention. Each of these features may be provided individually or in combination with other preferred features.

[0038] Preferably, the base defines a first support plane for supporting the holder arrangement on the operating surface.

[0039] Preferably, at least one of the spacing elements defines a second support plane within the housing for supporting a vial.

[0040] Preferably, the second supporting plane is parallel to the first supporting plane and is spaced apart from the first supporting plane by a predetermined distance.

[0041] In a preferred embodiment, the base has a predetermined thickness and the predetermined distance is greater than three times, preferably equal to four times, the predetermined thickness. This distance ensures that the vial is suspended relative to the operating surface at a height that the applicant considers optimal for an efficient freeze drying step.

[0042] Preferably, each housing seat comprises a tubular wall extending from the base along a substantially vertical longitudinal axis.

[0043] Preferably, each housing seat comprises at least three spacing elements projecting radially from said tubular wall towards the interior of said housing seat.

[0044] Preferably, the at least three spacer elements are circumferentially equidistantly spaced from each other.

[0045] In some preferred embodiments, there are four spacer elements and they are angularly offset by 90°.

[0046] In a particularly preferred embodiment, there are six spacer elements and they are angularly offset by 60°.

[0047] In the present specification and the appended claims, the term "axial" and the corresponding term "axially" are used to refer to the longitudinal direction of the housing of the retainer device, the term "radial" and the corresponding term "radially" are used to refer to any direction perpendicular to the above-mentioned longitudinal direction, and the term "circumferential" and the corresponding term "circumferentially" are used to refer to any circumferential direction around the above-mentioned longitudinal direction.

[0048] The provision of at least three circumferentially equidistantly spaced spacing elements ensures an optimal and stable support of the vial in the corresponding housing seat.

[0049] In a preferred embodiment, the spacing element is formed as a single piece with the tubular wall and thus with the plate. In this way, the retainer device can be manufactured by moulding the plastic material without providing a separate element relative to the plate.

[0050] In an alternative embodiment, the spacing element is made as a separate part from the housing and can be (possibly removably) received in a corresponding housing.

[0051] In this case, preferably, each of the spacer elements comprises an annular body and a plurality of appendages extending from the annular body, the appendages being configured to support a vial.

[0052] More preferably, the annular body comprises at least one anti-rotation element configured to prevent the annular body from freely rotating about the longitudinal axis of the housing after the spacing element is arranged in the housing.

[0053] In all the embodiments discussed above, preferably, the base is defined by at least three support elements which radially project from the tubular wall towards the interior of the housing seat and are circumferentially equidistantly spaced from each other.

[0054] In some embodiments, there are four support elements and they are angularly offset by 90°.

[0055] In a particularly preferred embodiment, there are six support elements and they are angularly offset by 60°.

[0056] In a preferred embodiment, each spacing element is arranged above a corresponding supporting element. In this case, the latter acts as a reinforcement element for both the corresponding spacing element and the plate of the holder device.

[0057] Preferably, the support element is formed in one piece with the tubular wall, which has significant advantages in terms of ease of production and cost.

[0058] Preferably, the spacing element has an axial extension that is greater than the axial extension of the support element.The axial extension of the spacing element is also selected depending on the axial extension of the support element in order to place the vial seat at a predetermined distance from the operating surface.

[0059] Preferably, the spacer element has a circumferential extension that is smaller than the circumferential extension of the support element. In this way, the contact area between the vial and the spacer element is reduced, so that a heat exchange between the operating surface and the vial is facilitated during the freeze-drying step.

[0060] Preferably, the spacing element has a smaller radial extension than the supporting element.This ensures a stable support of the vial in the housing while ensuring the desired heat exchange between the operating surface and the vial.

[0061] Preferably, each housing seat comprises at least three longitudinal ribs projecting radially from said tubular wall towards the interior of the housing seat. These longitudinal ribs contribute to stiffening the plate of the retainer device.

[0062] Preferably, all longitudinal ribs have the same shape and size and are circumferentially equidistantly spaced from one another in order to achieve a precise and centered positioning of the vial within the housing.

[0063] Preferably, each of said at least three spacing elements is an extension of a corresponding longitudinal rib.This allows a better distribution of the vertical loads exerted on the holder device and the vial (when closed).

[0064] Preferably, each housing seat comprises longitudinal ribs, which protrude radially from the tubular wall towards the outside of the housing seat and are connected to the tubular wall of the adjacent housing seat. These longitudinal ribs provide rigidity to the tubular wall of the housing seat and allow for better distribution of vertical loads applied when, for example, the bottle is closed.

[0065] Preferably, each longitudinal rib is arranged at a corresponding longitudinal rib.

[0066] Preferably, the housing seat extends on the opposite side relative to the plate.

[0067] Preferably, the tubular walls of some pairs of adjacent housing seats include corresponding lateral through holes facing each other on the opposite side of the corresponding base relative to the plate. These lateral through holes allow positioning on the plate of additional devices (such as vial closure devices) used in certain processing steps combined with the holder device.

[0068] Preferably, the spacing element is made of an at least partially thermally conductive or non-insulating material, so that heat exchange between the operating surface and the vial during the freeze-drying step is facilitated or not hindered.

[0069] Further features and advantages of the present invention will become apparent from the following detailed description of preferred embodiments of the present invention, which are made with reference to the accompanying drawings and are provided for indicative and non-limiting purposes. In these drawings:

[0070] Figure 1 is a perspective schematic diagram of a first embodiment of a retainer device according to the present invention, viewed from above;

[0071] Figure 2 yes Figure 1 A three-dimensional schematic diagram of a retainer device viewed from below;

[0072] Figure 3 yes Figure 1 An enlarged schematic plan view of a portion of a retainer device;

[0073] Figure 4 yes Figure 3 An enlarged perspective schematic diagram of a detail of the portion;

[0074] Figure 5 yes Figure 1 An enlarged perspective schematic diagram of another portion of the retainer device;

[0075] Figure 6 yes Figure 1 An enlarged perspective schematic diagram of a portion of a holder device and a cross-section of a vial held by the holder device;

[0076] Figure 7 is an enlarged perspective schematic view of a portion of a second embodiment of a holder device of the present invention and a cross section of a vial held by said holder device;

[0077] Figure 8 yes Figure 7 An enlarged perspective schematic diagram of a cross section of a component of a retainer device;

[0078] Fig. 9 is a schematic perspective view of a container of a holder device according to the present invention.

[0079] Figures 1 to 6 A first embodiment of a holder device 10 according to the invention is shown in FIG.

[0080] The retainer device 10 comprises a square plate 20. Figure 1 and Figure 2 In the non-limiting example of , the plate 20 is substantially rectangular and has four rounded vertices 21 .

[0081] The plate 20 includes a plurality of vials 50 ( Figure 6 ) of multiple shell seats 30.

[0082] Each vial 50 has a substantially cylindrical shape and includes a substantially circular closed base surface 52 and a neck 54 on a side opposite to the base surface 52 , the neck being provided with a through hole 56 to allow the vial 50 to be filled with a predetermined amount of medicine.

[0083] The vial 50 is made of glass or thermoplastic material.

[0084] When the vials 50 of a production batch have been arranged in the housing seats 30 of the holder device 10, an ordered assembly 150 of the vials 50 is obtained, which allows all the vials 50 of the production batch to be processed simultaneously, such as for example for a freeze drying step of the drugs provided in the vials 50. The vials 50 can be filled before or after they are placed in the respective housing seats 30.

[0085] The vials 50 are moved along a processing line (not shown) and optionally by placing the holder device 10 in a Fig. 9 The present invention relates to a method for storing the cellulose matrix in a container 200 as shown in FIG.

[0086] exist Fig. 9In the non-limiting example of , the container 200 has a substantially parallelepiped or truncated pyramid shape and comprises four side walls 202. An abutment surface 204 is formed on the inner wall of the side wall 202, on which the plate 20 of the holder device 10 is to be supported.

[0087] In this way, a production batch of vials 50 is gathered in a so-called "nest and tub" configuration, where the holder device 10 is the "nest" and the container 200 is the "tub".

[0088] The processing steps to which the vial 50 accommodated in the housing seat 30 may be subjected may be, for example, sterilization, filling, freeze drying, closing, etc., or manual and / or automatic inspection operations, etc.

[0089] In the plate 20, the housing seats 30 are arranged relative to each other according to a predetermined geometric configuration.

[0090] exist Figures 1 to 6 In a non-limiting example, the housing seats 30 are arranged in a hexagonal configuration, ie, wherein each housing seat 30 except for the housing seats 30 located at the edge of the board 20 is surrounded by six housing seats 30 .

[0091] Each housing seat 30 comprises, at its lower end 31 a , a base 32 having a through opening 33 and, at its upper end 31 b , a through opening configured to allow the insertion and removal of a vial 50 .

[0092] The base 32 has a predetermined thickness W ( Figure 6 ).

[0093] The base 32 is intended to rest on a substantially horizontal operating surface 100 of a processing line, such as a heated surface of a temperature-controlled shelf of a freeze-drying chamber.

[0094] The base 32 of the housing 30 defines a support plane P1 ( Figure 6 ).

[0095] In the present specification and the appended claims, the terms "below", "lower" and "downwardly", "above", "upper" and "upwardly" relating to the retainer device 10 or parts thereof are used with reference to the position that the retainer device 10 assumes when it rests on the operating surface 100.

[0096] Each housing 30 also includes a tubular wall 34, Figures 1 to 6 In a non-limiting example, the tubular wall is substantially cylindrical.

[0097] The tubular wall 34 extends along a substantially vertical longitudinal axis Y above the base 32 .

[0098] The vials 50 are arranged in the corresponding housing seats 30 so that their axes substantially coincide with the longitudinal axis Y.

[0099] like Figure 1 and Figure 2 As shown, the housing seat 30 extends on opposite sides relative to the plate 20. In this way, the lower portion 34a of the tubular wall 34 is placed below the plate 20 (i.e., on the side of the base 32) and the upper portion 34b of the tubular wall 34 is placed above the plate 20 (i.e., on the side of the upper end 31b).

[0100] like Figure 1 and Figure 5 As shown, the upper parts 34b of the tubular walls 34 of some pairs of adjacent housing seats 30 include mutually facing side through openings 35. These side through openings 35 extend to the upper end 31b of the housing seat 30.

[0101] exist Figures 1 to 6 In the non-limiting example of , the base 32 is defined by six support elements 32 a which project radially from the tubular wall 34 towards the interior of the housing seat 30 and are circumferentially equidistant from one another (ie angularly offset by 60° around the longitudinal axis Y).

[0102] like Figures 3 to 6 As shown in FIG. 1 , the longitudinal ribs 36 extend outwardly from the corresponding tubular wall 34 to the tubular wall 34 of the adjacent housing seat 30 in a substantially radial direction so as to connect the two housing seats 30 .

[0103] A plurality of longitudinal ribs 38 extend inside each housing seat 30 and project radially from the tubular wall 34. Figures 4 to 6 In the non-limiting example of , there are six longitudinal ribs 38 , which are identical in shape and size, circumferentially equidistant from one another, located above the support element 32 a and each located at a corresponding longitudinal rib 36 .

[0104] A plurality of rigid spacing elements 40 are provided within each housing seat 30 .

[0105] exist Figures 1 to 6 In a non-limiting example, each housing seat 30 comprises six spacing elements 40 which protrude radially from the tubular wall 34 towards the interior of the housing seat 30 and are circumferentially equidistantly spaced from one another (ie arranged angularly offset by 60° around the longitudinal axis Y).

[0106] The spacer element 40 defines a support plane P2 ( Figure 6 ).

[0107] The support plane P2 is parallel to the support plane P1 and is spaced apart from the first support plane by a predetermined distance D.

[0108] The distance D is preferably greater than three times the predetermined thickness W of the base 32 , for example, four times the predetermined thickness W.

[0109] exist Figure 4 and Figure 6 In the non-limiting example of , each spacing element 40 is arranged above the corresponding support element 32a, and the longitudinal ribs 38 are arranged above the spacing elements 40. In this way, each spacing element 40 can be made in one piece with the corresponding support element 32a and the corresponding longitudinal rib 38 and define an extension or continuation of the latter.

[0110] exist Figures 1 to 6 In the non-limiting example of , the spacing elements 40 , the support elements 32 a , the longitudinal ribs 38 and the longitudinal ribs 36 are formed in one piece with the tubular wall 34 and therefore with the plate 20 .

[0111] exist Figure 3 and Figure 4 In the non-limiting example of , the circumferential extension of the spacing element 40 is smaller than the circumferential extension of the corresponding support element 32a.

[0112] Furthermore, the axial extension of the spacing element 40 is greater than the axial extension of the corresponding support element 32a. This axial extension is for example comprised between 0.1 mm and 12 mm, preferably between 0.1 mm and 10 mm, extreme values ​​included.

[0113] For example, the thickness (or axial extension) W of the base 32 is comprised between 0.1 mm and 4 mm, including extreme values.

[0114] Preferably, the axial extension of the spacing element 40 is substantially equal to three times the thickness W of the base 32 .

[0115] Furthermore, the spacing elements 40 have a smaller radial extension than the radial extension of the corresponding support elements 32 a .

[0116] This radial extension, calculated at the support plane P2 , has a value chosen as a function of the diameter of the seat surface 52 of the vial 50 , the maximum value being equal to the inner radius of the housing 30 .

[0117] The diameter of the base surface 52 of the vial 50 is greater than the diameter defined by the radially inner end of the spacer element 40 .

[0118] The holder device 10 described above may be made by moulding a plastic material, preferably a partially thermally conductive and non-insulating plastic material, such as polypropylene.

[0119] Figure 7 and Figure 8A second embodiment of a retainer device 10 according to the invention is shown. Figures 1 to 6 Identical or similar parts and components of the retainer device 10 are given the same reference numerals, and for their description reference is made to the above discussion.

[0120] Figure 7 and Figure 8 The retainer device 10 and Figures 1 to 6 The holder device 10 of WO 2013 / 051334 PCT / EP2013 / 02634 differs only in the spacing element 140, which in this case is produced as a separate piece from the plate 20. The spacing element 140 is inserted into the corresponding housing seat 30 and can optionally be removed from the housing seat 30.

[0121] Figure 7 and Figure 8 Each of the spacer elements 140 includes an annular body 141 and six appendages 142 extending axially above the annular body 141. Figure 8 , the spacing element 140 is divided into two halves, so that two entire attachments 142 divided into two halves and two opposing attachments 142 are shown.

[0122] The appendages 142 are circumferentially equidistant from one another, i.e., they are angularly offset by 60° about the longitudinal axis Y and have the same Figures 1 to 6 The construction of the spacer element 40 is similarly constructed.

[0123] See also Figure 7 The spacer element 140 is inserted into the housing seat 30 from the upper end 31 b until the annular body 141 rests on the support element 32 a. The appendix 142 protrudes radially from the tubular wall 34 towards the interior of the housing seat 30 .

[0124] Each attachment 142 is arranged above a corresponding supporting element 32a.

[0125] and Figures 1 to 6 Similar to the spacing element 40, the circumferential extension of each appendage 142 is preferably smaller than the circumferential extension of the support element 32a, the axial extension of each appendage 142 is preferably larger than the axial extension of the support element 32a, and the radial extension of each appendage 142 is preferably smaller than the radial extension of the support element 32a.

[0126] Figure 7 and Figure 8 The spacing element 140 further comprises at least one anti-rotation element 144 extending axially below the annular body 141. The anti-rotation element 144 abuts against one of the support elements 32a (or against a specially provided contrast element), thereby preventing the spacing element 140 from rotating freely about the longitudinal axis Y.

[0127] The anti-rotation element 144 has an axial extension which is less than or equal to the axial extension of the support element 32a.

[0128] The applicant has verified through experimental tests and finite element simulations (FEM) that the holder device 10 of the invention ensures the integrity of the vial during the closing process, which usually occurs after the freeze-drying step, despite the fact that the mechanical strength of the vial is reduced by the freeze-drying step itself.

[0129] The Applicant has also verified that the provision of spacing elements 40, 140 in the holder device 10 of the invention does not affect the strength of the holder device 10 in the different steps of the processing line.

[0130] Specifically, Applicants performed finite element simulations (FEM) by applying vertical compressive stresses similar to those applied during closure of vials, including vials arranged in the holder device 10 of the present invention and vials arranged in conventional nests without the spacing elements 40 , 140 .

[0131] Through experimental testing, it was determined that a vial resting on a surface and subjected to vertical compression broke at 1100 N, corresponding to a breaking load of 230 MPa, and the force applied to the vial closed with the cap of the internally sealed vial was 5 N, while the force applied to the vial closed with the cap of the externally sealed vial was 100 N.

[0132] The most onerous case of a cap that seals the vial externally is considered. Such a cap is connected to vials arranged in the holder device 10 of the present invention and vials arranged in conventional nests.

[0133] The stress applied to the vial arranged in the conventional nest was 34 MPa, whereas the force applied to the vial arranged in the holder device 10 of the present invention was 92 MPa, and thus well below the breaking load of 230 MPa.

[0134] The stresses induced in the retainer device 10 of the present invention were also measured to verify that deformation of the plastic material (typically polypropylene) did not result in damage (ie permanent deformation).

[0135] It is known from the data sheets for polypropylene that this material remains within the linear deformation range when the deformation is less than 10%.

[0136] The results obtained by simulation with the conventional nest and the holder device 10 of the present invention are all below the 10% threshold. A maximum value of 5% was measured for the conventional nest and a maximum value of 7% was measured for the holder device 10 of the present invention. This proves that in the holder device 10 of the present invention, no permanent deformation occurs during closing of the vial.

[0137] Obviously, in order to meet specific and accidental requirements, a person skilled in the art may make several changes and modifications to the invention described above, all of which are included in the scope of protection defined by the appended claims.

[0138] For example, in Figures 1 to 6 In a not shown variant of the first embodiment of the holder device 10 , the support element 32 a can be omitted. In this case, the base 32 of the housing seat 30 is defined by the spacing element 40 .

[0139] exist Figures 1 to 6 In a further, not shown, variant of the first embodiment of the retainer device 10, the spacer elements 40 can be connected to each other circumferentially to form a Figure 7 and Figure 8 The spacer element 140 is similar to a single annular structure.

Claims

1. A holder device (10) for holding a plurality of vials (50) to be moved in a processing line, the holder device comprising: A plate (20) having a plurality of housing seats (30) for accommodating the vials (50) and a plurality of rigid spacing elements (40; 140) arranged in the housing seats (30) and configured to hold the vials (50) in a suspended position relative to a substantially horizontal operating surface (100) of the processing line, wherein each of the housing seats (30) includes an open base (32) for facing the operating surface (100).

2. The holder device (10) according to claim 1, wherein: The base (32) defines a first support plane (P1) for supporting the holder device (10) on the operating surface (100), and wherein at least one of the spacer elements (40; 140) defines a second support plane (P2) for supporting a vial (50) within the housing (30), the second support plane (P2) being parallel to the first support plane (P1) and spaced apart from the first support plane (P1) by a predetermined distance (D).

3. The holder device (10) according to claim 2, wherein: The base (32) has a predetermined thickness (W), and the predetermined distance (D) is greater than three times the predetermined thickness (W).

4. The holder device (10) according to claim 2 or 3, wherein: Each housing seat (30) comprises a tubular wall (34) extending from the base (32) along a substantially vertical longitudinal axis (Y), and at least three spacing elements (40) projecting radially from the tubular wall (34) toward the interior of the housing seat (30) and being circumferentially equidistantly spaced from one another.

5. The holder device (10) according to claim 4, wherein: The spacing element (40) is formed in one piece with the tubular wall (34).

6. The holder device (10) according to claim 4 or 5, wherein: The base (32) is defined by at least three support elements (32a) which radially protrude from the tubular wall (34) toward the interior of the housing seat (30) and are circumferentially equidistantly spaced from each other, wherein each spacing element (40) is arranged above a corresponding support element (32a).

7. The holder device (10) according to claim 6, wherein: The circumferential extension of the spacer element (40) is smaller than the circumferential extension of the support element (32a), the axial extension of the spacer element (40) is larger than the axial extension of the support element (32a), and the radial extension of the spacer element (40) is smaller than the radial extension of the support element (32a).

8. The holder device (10) according to any one of claims 4 to 7, wherein: The housing seats (30) extend on opposite sides relative to the plate (20), and wherein the tubular walls (34) of some pairs of adjacent housing seats (30) include corresponding lateral through-openings (35) facing each other on opposite sides relative to the corresponding base (32) of the plate (30).

9. The holder device (10) according to any one of claims 4 to 8, wherein: Each housing seat (30) comprises at least three longitudinal ribs (38) radially projecting from the tubular wall (34) toward the interior of the housing seat (30), and each of the at least three spacing elements (40) is an extension of the corresponding longitudinal rib (38).

10. The holder device (10) according to any one of the preceding claims, wherein The spacing element (40; 140) is made of an at least partially thermally conductive or non-insulating material.

11. An ordered assembly (150) of vials (50) comprising a holder device (10) according to any of the preceding claims and a plurality of vials (50) having respective base surfaces (52) resting on the spacing elements (40; 140) of respective housing seats (30).

12. A container (200) for containing an ordered assembly (150) of vials (50) according to claim 11, wherein: Each of said vials (50) contains a freeze-dried product.

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