Partition for pharmaceutical secondary packaging transport

Abstract

The present invention relates to a special separation layer for transporting secondary packaging of pharmaceutical products, and a transport system for transporting secondary packaging of pharmaceutical products, comprising the special separation layer.

Description

[0001] This invention application is a divisional application of Chinese patent application CN202110023455.5. Technical Field

[0002] The present invention describes a separator for transporting secondary packaging of pharmaceuticals and a transport system for transporting secondary packaging of pharmaceuticals. Background Technology

[0003] In pharmaceutical manufacturing, drugs are dispensed from larger containers into smaller containers (so-called primary drug packaging) for distribution to consumers. Examples of such primary drug packaging include vials, carpules, ampoules, and syringes. This typically involves the production of uncleaned primary drug packaging, which is then received, cleaned, and sterilized by specially designed machines, followed by filling and sealing. To simplify, and particularly enhance, the flexibility of this complex process in the pharmaceutical industry, pre-cleaned, sterile primary drug packaging is now placed in boxes or trays, known as secondary drug packaging. The box contains a nest to hold the primary drug packaging, which is then inserted directly into the tray. Sealing of the box and tray can be achieved using microfiber nonwoven fabric made of high-density polyethylene (HDPE) produced by flash evaporation. The selectively permeable microfiber nonwoven fabric allows for sterilization of the box / tray interior with ethylene oxide or vapor, even when sealed, while simultaneously creating a microbial barrier. Therefore, the sealed box or tray constitutes a sterile barrier system. These ready-to-use packaging systems can be directly opened, filled, and resealed by pharmaceutical companies under controlled aseptic conditions. This type of packaging system... Figure 1 As shown in the image.

[0004] Ready-to-use packaging systems are loosely stacked in transport boxes for delivery to sterilization and pharmaceutical plants. One problem with these systems is that even the smallest variations in the dimensions of nests, boxes, or pallets can disrupt the delicate processes during filling, or compromise sterility due to cracks, breaks, or deformation. Furthermore, individual primary packaging packages may become unusable due to cracks, breaks, or deformation, or even rupture. This damage renders the packaging system unusable, requiring cleaning and causing production interruptions.

[0005] Another potential problem with transporting ready-to-use packaging systems is that the primary packaging of the medication can be shaken back and forth in nests or pallets during transport, thus abrading very small particles. These particles are often a problem because they may be injected into the patient during medication administration, or they may block cannulas, rendering medical devices inoperable. Therefore, it is necessary to exclude packaging systems with high particle contamination.

[0006] Extensive research was conducted on these problems, and the inventors were surprised to find that most of the damage to the packaging system and the formation of particles occurred during transportation from the production site to the point of use, and that these problems could be reduced by special separation layers. Summary of the Invention

[0007] Therefore, the object of the present invention is to provide a separator layer for transporting secondary packaging of pharmaceuticals and a transport system for transporting secondary packaging of pharmaceuticals, which overcomes the above-mentioned problems and better protects the sterile barrier system consisting of the walls and protective film (e.g., microfiber nonwoven fabric) of the secondary packaging and the primary packaging of pharmaceuticals contained therein during transport.

[0008] This objective is achieved by a separator layer for secondary packaging transport of pharmaceuticals, wherein the separator layer comprises a polymer; and wherein the separator layer comprises a folded section and a planar section.

[0009] This objective is also achieved by a transport system for transporting secondary packaging of pharmaceuticals, which includes a transport box comprising the partition layer described herein and two secondary packaging packages of pharmaceuticals.

[0010] During transport, the secondary drug packages rest on or are covered by the planar surface of the separator layer. The planar sections interact with the folded sections located between two secondary drug packages or between the secondary drug package and the wall of the transport container, thus achieving a damping effect that reduces sloshing during transport. This reduces deformation and breakage of the secondary drug packages, nests, and / or primary drug packages. The separator layer further reduces the risk of particle formation. Figure 4 A transportation system according to an embodiment of the present invention is shown.

[0011] In this application, unless otherwise stated, all singular terms should also include plural terms, and all plural terms should also include singular terms. For example, all limitations and preferred embodiments of primary / secondary pharmaceutical packaging should also apply particularly to multiple, such as two or more, primary / secondary pharmaceutical packaging. Furthermore, unless otherwise stated, all limitations and preferred embodiments of separator layers should also apply to transport systems, and vice versa. Unless otherwise stated, preferred embodiments of the transport systems described herein also apply to all transport systems described herein.

[0012] Minor modifications may be made to the separation layer and the transport system without departing from the scope of the invention.

[0013] Separator

[0014] The separator according to the invention is a separator for transporting secondary packaging of pharmaceuticals, wherein the separator comprises a polymer; and wherein the separator comprises an erhebung portion and a planar section.

[0015] The separator layer for transporting secondary packaging of pharmaceuticals comprises polymers, preferably thermoplastics, more preferably polyolefins, more preferably polypropylene and / or polyethylene, with the separator layer preferably being made of polypropylene. Using polypropylene and / or polyethylene has many advantages. This material is robust, lightweight, hygienic, free of harmful substances, chemical-resistant, recyclable, and the separator layer can be selectively reused. Furthermore, the incineration of this material produces only CO2 and water. The separator layer is preferably made of corrugated sheet, more preferably of polypropylene corrugated sheet. They are particularly flexible, and the corrugated structure further increases the damping effect. The separator layer is preferably formed in one piece, for example, from a polymer corrugated sheet, preferably from a polypropylene corrugated sheet. Separators with fibrous surfaces (e.g., paper) are unsuitable because they can cause excessive particle abrasion.

[0016] There are no particular limitations on the length, width, and thickness of the separator. The length of the separator is preferably 500 mm to 2000 mm, more preferably 750 mm to 1500 mm, more preferably 800 mm to 1200 mm, and / or, more preferably, the width of the separator is 100 mm to 400 mm, more preferably 150 mm to 300 mm, more preferably 200 mm to 250 mm, and / or, more preferably, the thickness of the separator is not less than 0.5 mm, more preferably not less than 1.0 mm, further preferably not less than 2.0 mm, more preferably not less than 3.0 mm, more preferably not less than 3.5 mm, more preferably not less than 4.0 mm, and / or, more preferably not greater than 10.0 mm, more preferably not greater than 5.0 mm, more preferably not greater than 4.0 mm, more preferably not greater than 3.0 mm, more preferably not greater than 2.0 mm. The inventors have surprisingly discovered that, with sufficiently large elastic forces, the damping effect of the separator is particularly effective when the thickness is not less than 1.0 mm, preferably not less than 2.0 mm. However, it was found that when the thickness of the separator layer is greater than 4.0 mm, preferably 3.5 mm, the polymer (e.g., a corrugated sheet made of polymer) becomes more difficult to bend, thus hindering production. Therefore, the thickness of the separator layer is preferably not less than 1.0 mm and not more than 4.0 mm, and preferably not less than 2.0 mm and not more than 3.5 mm.

[0017] When the separator is made in one piece, its manufacturing is particularly simple, which also ensures that the folded sections will not detach from the planar sections during transportation. Separators made of a single material, where the folded sections and planar sections are formed by folding, further simplify the operation, avoiding the complex construction of individual components or continuous insertion. Furthermore, the folded sections of the separator will not slip out of place during transportation, thus ensuring damping even under violent movement. To achieve the same effect, it is preferable to securely connect the folded sections to the planar sections. Another advantage is that because the damping effects of the individual folded sections are coupled together, connecting multiple folded sections through one or more planar sections improves the damping effect.

[0018] To mitigate the problems described above, the separator includes a folded section and a flat section. The flat section should be understood herein as the section on which the secondary pharmaceutical package is placed or covers the package during transport. The flat section essentially does not include the folded section relative to a plane. This section can be sheet-like or a single area, for example, a square cut off below the center of the secondary pharmaceutical package to reduce weight. Small notches may also be provided at the edges to facilitate removal from the shipping container.

[0019] The term "bend" should be understood herein to refer to a bend that protrudes outward from the plane of a planar segment. The height of the bend can be freely chosen. Surprisingly, particularly good damping characteristics are observed in the following ranges: when the bend extends from the plane between 10 mm and 200 mm, preferably between 20 mm and 100 mm, more preferably between 30 mm and 80 mm, more preferably between 40 mm and 70 mm, and / or preferably, the length measured from one planar segment to another is between 10 mm and 150 mm, preferably between 15 mm and 100 mm, more preferably between 20 mm and 80 mm, more preferably between 25 mm and 50 mm.

[0020] The partition layer preferably includes a folded section and two planar sections, wherein the folded section is arranged between the two planar sections; or the partition layer includes two folded sections and one planar section, wherein the planar section is arranged between the two folded sections; more preferably, the partition layer consists of n planar sections and n+1 folded sections, wherein each planar section is arranged between two folded sections, and n is equal to 2 to 7, preferably equal to 3 to 5, and more preferably equal to 3.

[0021] In an alternative embodiment, the partition layer consists of n+1 planar segments and n folded sections, wherein each folded section is arranged between two planar segments, and n is equal to 2 to 7, preferably equal to 3 to 5, and more preferably equal to 3.

[0022] The folded portion can have any desired shape. One or more folded portions can extend upward and / or downward relative to a plane spanned by one or more planar segments. Particularly good elastic properties can be obtained when the cross-section of the folded portion is substantially triangular, trapezoidal, hemispherical, circular, or rectangular, preferably triangular, trapezoidal, or hemispherical, and more preferably triangular. These shapes are also particularly easy to manufacture. For example, a folded portion with a substantially triangular cross-section can be produced by folding a planar layer three times and forming these creases. In one embodiment of the separator layer, the separator layer is formed from a single piece as described above, and the cross-section of the folded portion is substantially triangular, trapezoidal, hemispherical, circular, or rectangular, preferably triangular, trapezoidal, or hemispherical, and more preferably triangular. This embodiment is particularly preferred because such a separator layer exhibits very good damping characteristics and is very simple and inexpensive to manufacture.

[0023] Other preferred embodiments of the separator layer satisfy one or more of the following features:

[0024] i) Weight is 100g / m 2 Up to 2000g / m 2 Optimal 200g / m 2 Up to 1000g / m 2 More preferably 300g / m 2 Up to 700g / m 2 More preferably 300g / m 2 Up to 400g / m 2 ;

[0025] ii) The melting point, as measured by differential scanning calorimetry (DSC), is between 100°C and 250°C, preferably between 130°C and 180°C, more preferably between 160°C and 170°C; and / or,

[0026] iii) The partition layer consists of corrugated plates, preferably double-walled plates.

[0027] The separator layer is more preferably characterized by features i+ii; i+iii; ii+iii; or i+ii+iii.

[0028] Other preferred embodiments of the separator layer satisfy one or more of the following features:

[0029] i) During sterilization, preferably in a heat sterilization process at, for example, up to 60°C, or in a chemical sterilization process using, for example, ethylene oxide, or in a sterilization process using radiation, for example, gamma rays, the separator layer remains dimensionally stable.

[0030] ii) The separator layer has an axial elastic force of 1N to 50N in the longitudinal direction, preferably 1.5N to 40N, more preferably 2N to 35N, and even more preferably 20N to 30N; and / or

[0031] iii) The normal elastic force of the separator layer in the longitudinal direction is 0.2N to 5N, preferably 0.3N to 4N, more preferably 0.4N to 3N, and even more preferably 0.5N to 2N.

[0032] The separator layer is more preferably characterized by features i+ii; i+iii; ii+iii; or i+ii+iii.

[0033] Transportation system

[0034] The transport system according to the invention is a transport system for transporting secondary packages of pharmaceuticals, comprising a transport container including a separating layer as described herein and two secondary packages of pharmaceuticals. The secondary packages of pharmaceuticals typically comprise a nest and multiple primary packages of pharmaceuticals.

[0035] The term "primary pharmaceutical packaging" (also known as a container) herein includes all primary pharmaceutical packaging capable of receiving pharmaceutical formulations. Preferred primary pharmaceutical packaging includes vials, ampoules, syringes, syringe bodies, cartridges, and carbomer vials; more preferably, vials, syringes, or carbomer vials are preferred.

[0036] The term "nest" in this document refers to an article used to hold primary pharmaceutical packaging. Therefore, all primary pharmaceutical packaging in the packaging system comes into direct contact with the nest. The nest preferably comprises 10 to 200 primary pharmaceutical packages, more preferably 16 to 160, and even more preferably 40 to 100. The length and width of the nest are freely selectable. The length and width of the nest are preferably between 10 cm and 50 cm, more preferably between 15 cm and 30 cm, and the thickness of the nest is preferably between 0.4 mm and 2.0 mm, more preferably 0.8 mm to 1.5 mm, and even more preferably 0.8 mm to 1.2 mm. The nest preferably comprises polypropylene or polyethylene, more preferably polypropylene, and even more preferably the nest is made of polypropylene.

[0037] The term "secondary packaging of pharmaceuticals" should be understood here as referring to an article in which a nest containing a primary pharmaceutical package can be inserted as close as possible to provide further protection. Preferably, the primary pharmaceutical package does not directly contact the secondary pharmaceutical package, but is held in place solely by the nest inserted within it. The shape of the secondary pharmaceutical package is flexible. Preferred shapes include cylindrical, cubic, and trapezoidal prisms (also called slotted shapes). The secondary pharmaceutical package has an opening side through which the nest and the primary pharmaceutical package within it can be removed. This opening can be sealed during transport, for example, with a cap or a removable protective film, preferably comprising polyethylene, more preferably a permeable microfiber nonwoven fabric made of polyethylene. The removable protective film particularly protects the contents of the secondary pharmaceutical package, ensuring a sterile environment inside the secondary pharmaceutical package during transport. For easier handling, the secondary pharmaceutical package preferably has a circumferential edge. This edge can be very thin, making it highly susceptible to deformation and breakage. The difference between a tray and a box is the presence or absence of a nest. If there is no nest, the primary packaging of the medicine is located inside the box. Even if some of the parameters and effects described in this article apply to the box, they also apply to the tray, and vice versa.

[0038] In a preferred embodiment, the secondary pharmaceutical package is trough-shaped, more preferably having an edge along the top surface that extends along the plane of the top surface. The secondary pharmaceutical package is sealed on the top surface by a removable protective film, more preferably comprising polyethylene, and even more preferably composed of a permeable microfiber nonwoven fabric made of polyethylene. The secondary pharmaceutical package includes nests for the primary pharmaceutical package; wherein the nests preferably comprise 10 to 200, more preferably 20 to 160, and even more preferably 40 to 100 primary pharmaceutical packages.

[0039] In ready-to-use packaging systems, the secondary packaging of the pharmaceutical product is preferably surrounded by a sealed bag. This ensures a sterile environment and also protects the secondary packaging from contamination. Since ready-to-use packaging systems are designed for use at the filling site without prior sterilization, it is preferable to first sterilize the secondary packaging and its contents, for example, with gamma rays or ethylene oxide, before surrounding it with a bag; or to first seal the bag and then sterilize it, for example, with gamma rays. Preferably, the secondary packaging comprises polypropylene or polyethylene, more preferably polypropylene, and even more preferably, the nest and the secondary packaging are made of polypropylene. The more bags surrounding the secondary packaging, the better the protection, while also allowing for staged unpacking, thus simplifying the loading into a sterile environment.

[0040] The transport system preferably includes 4 to 6 compartments and / or, more preferably, 9 to 21 sub-packages of pharmaceuticals, and more preferably 12 to 16 sub-packages of pharmaceuticals.

[0041] In a preferred embodiment, one or more of the following features are satisfied:

[0042] i) The partition layer includes a folded section and two planar sections, wherein the folded section is arranged between the two planar sections;

[0043] ii) The separator layer is arranged such that the planar section of the separator layer and the bottom surface of the secondary drug packaging are in contact with each other, and the folded portion of the separator layer protrudes inward between the two secondary drug packaging packages; and / or, iii) the folded portion of the separator layer is sized such that the secondary drug packaging packages do not contact each other.

[0044] The transportation system more preferably has features i+ii; i+iii; ii+iii; or i+ii+iii.

[0045] Preferably, one or more planar segments of the separator layer contact the bottom surface of the first secondary pharmaceutical package and the top surface of the second secondary pharmaceutical package. This achieves a compact layered structure, and the secondary pharmaceutical packages have very low degrees of freedom of movement, thus further reducing particle abrasion.

[0046] In a preferred embodiment, one or more of the following features are satisfied:

[0047] i) The secondary packaging of the medicine is trough-shaped, preferably having an edge along the top surface that extends along the plane of the top surface;

[0048] ii) Sealing the secondary pharmaceutical package on the top surface with a removable protective film, preferably comprising polyethylene, more preferably comprising a permeable microfiber nonwoven fabric made of polyethylene; and / or

[0049] iii) The secondary packaging of the pharmaceutical product includes nests for the primary packaging of the pharmaceutical product; wherein the nests preferably include 10 to 200 primary packaging units of the pharmaceutical product.

[0050] The transportation system more preferably has features i+ii; i+iii; ii+iii; or i+ii+iii.

[0051] In a preferred embodiment, one or more of the following features are satisfied:

[0052] i) The secondary packaging of the medicine is surrounded by a sealed bag, preferably two sealed bags;

[0053] ii) The interior of the secondary packaging of the drug is sterile; and / or

[0054] iii) The secondary packaging of the medicine has been sterilized using gamma rays, steam or ethylene oxide.

[0055] The transportation system more preferably has features i+ii; i+iii; ii+iii; or i+ii+iii.

[0056] In a preferred embodiment, one or more of the following features are satisfied:

[0057] i) The transport container is substantially (≥95% by weight, preferably ≥99% by weight) made of the same material as the separator layer;

[0058] ii) The ratio of the width of the partition layer to the internal width of the shipping container is equal to 0.8 to 1.5, preferably 0.9 to 1.3, more preferably 1.0 to 1.1; and / or

[0059] iii) The ratio of the length of the partition layer to the internal length of the transport box is equal to 1.1 to 2.0, preferably 1.2 to 1.9, and more preferably 1.3 to 1.7.

[0060] The transportation system more preferably has features i+ii; i+iii; ii+iii; or i+ii+iii.

[0061] A particular challenge for transportation systems is long-distance transport, which can generate significant stress. If only minimal damage occurs even under high stress, this results in less damage during production. Therefore, it is preferable that, in an impact test according to "Inclined Impact Test ASTM D880-92 (2015)" at an impact velocity of 2.14 m / s (see detailed description below), the damage to secondary packaging, nests, and primary packaging of the pharmaceutical product does not exceed 50%, preferably not more than 40%, more preferably not more than 30%, more preferably not more than 20%, more preferably not more than 10%, and even more preferably not more than 5%. In particular, when the damage does not exceed 10%, preferably not more than 5%, the production loss rate is within expectations.

[0062] If the primary packaging of a pharmaceutical product is filled with an injectable solution, very low particulate contamination must be ensured. If, after running transport simulation procedures ASTM D4169-16, DC12 (excluding procedures I and F), safety level I (details below), the external particulate matter on the primary packaging (i.e., each individual primary packaging of the pharmaceutical product) is particularly low, then the packaging is particularly suitable for injectable solutions (measurement methods are below).

[0063] If the primary packaging of a pharmaceutical product is filled with an injectable solution, very low particulate contamination must be ensured. The packaging is particularly suitable for injectable solutions if, after running the transport simulation procedure ASTM D4169-16, DC12 (excluding procedure I), safety level I (details below), there are exceptionally few particles on the exterior of the primary packaging (i.e., each individual primary packaging of the pharmaceutical product) (measurement methods are below).

[0064] In a preferred embodiment, the secondary pharmaceutical packaging thus comprises 10 to 200, preferably 25 to 200 primary pharmaceutical packages, wherein, after running the transport simulation programs ASTM D4169-16, DC12 (excluding programs I and F), and safety level I, there are particles with a size of 15 μm to 25 μm, preferably 10 μm to 50 μm, more preferably 10 μm to 100 μm, more preferably 1 μm to 100 μm, more preferably zero, on the outside of each primary pharmaceutical package (i.e., each individual primary pharmaceutical package). These particularly preferred values, represented by the above parameters, can be achieved by the special separation layer and / or the special transport system described herein. When these parameters are met, the primary pharmaceutical packaging is particularly suitable for storing injectable solutions.

[0065] In a preferred embodiment, the secondary pharmaceutical packaging thus comprises 10 to 200, preferably 25 to 200 primary pharmaceutical packages, wherein, after running the transport simulation program ASTM D4169-16, DC12 (excluding programs I and F), safety level I, there are particles with a size of 15 μm to 25 μm, preferably 10 μm to 25 μm, preferably 10 μm to 25 μm, preferably 10 μm to 50 μm, preferably 10 μm to 100 μm, more preferably 10 μm to 100 μm, more preferably not less than 10 μm, more preferably not less than 1 μm, on the outside of the primary pharmaceutical package (i.e., each individual primary pharmaceutical package), in quantities not exceeding 6000, preferably not exceeding 5000, more preferably not exceeding 2500, more preferably not exceeding 1000, more preferably not less than 10 μm, more preferably not less than 1 μm. These particularly preferred values, represented by the parameters described above, can be achieved through the special separation layer and / or the special transport system described herein. When these parameters are met, the primary packaging for pharmaceuticals is particularly suitable for storing injectable solutions.

[0066] In a preferred embodiment, the secondary pharmaceutical packaging thus comprises 10 to 200, preferably 25 to 200 primary pharmaceutical packages, wherein, after running the transport simulation program ASTM D4169-16, DC12 (excluding program I), safety level I, there are particles with a size of 15 μm to 25 μm, preferably 10 μm to 25 μm, preferably 10 μm to 25 μm, preferably 10 μm to 50 μm, preferably 10 μm to 100 μm, more preferably 10 μm to 100 μm, more preferably not less than 10 μm, more preferably not less than 1 μm, on the outside of the primary pharmaceutical package (i.e., each individual primary pharmaceutical package). These particularly preferred values, represented by the parameters described above, can be achieved through the special separation layers and / or the special transport systems described herein. When these parameters are met, the primary packaging for pharmaceuticals is particularly suitable for storing injectable solutions.

[0067] In a preferred embodiment, the secondary pharmaceutical packaging thus comprises 10 to 200, preferably 25 to 200 primary pharmaceutical packages, wherein, after running the transport simulation program ASTM D4169-1, DC12 (excluding programs I and F), safety level I, there are, on the outside of each primary pharmaceutical package (i.e., each individual primary pharmaceutical package), particles with a size of 15 μm to 25 μm, preferably 10 μm to 50 μm, preferably 10 μm to 100 μm, more preferably 1 μm to 100 μm, more preferably zero, in quantities preferably no more than 450, more preferably no more than 400, more preferably no more than 350, more preferably no more than 300, more preferably no more than 250, more preferably no more than 100, more preferably no more than 50, and more preferably zero. These particularly preferred values, represented by the above parameters, can be achieved by the special separation layer and / or the special transport system described herein. When these parameters are met, the primary pharmaceutical packaging is particularly suitable for storing injectable solutions.

[0068] In a preferred embodiment, the secondary pharmaceutical packaging thus comprises 10 to 200, preferably 25 to 200 primary pharmaceutical packages, wherein, after running the transport simulation program ASTM D4169-16, DC12 (excluding programs I and F), safety level I, there are particles with a size of 15 μm to 25 μm, preferably 10 μm to 25 μm, preferably 10 μm to 25 μm, preferably 10 μm to 50 μm, preferably 10 μm to 100 μm, more preferably 10 μm to 100 μm, more preferably not less than 10 μm, more preferably not less than 1 μm, on the outside of the primary pharmaceutical package (i.e., each individual primary pharmaceutical package), in quantities not exceeding 6000, preferably not exceeding 5000, more preferably not exceeding 2500, more preferably not exceeding 1000, more preferably not less than 10 μm, more preferably not less than 1 μm. These particularly preferred values, represented by the parameters described above, can be achieved through the special separation layer and / or the special transport system described herein. When these parameters are met, the primary packaging for pharmaceuticals is particularly suitable for storing injectable solutions.

[0069] In a preferred embodiment, the secondary pharmaceutical packaging thus comprises 10 to 200, preferably 25 to 200 primary pharmaceutical packages, wherein, after running the transport simulation program ASTM D4169-16, DC12 (excluding program I), safety level I, the primary pharmaceutical package (i.e., each individual primary pharmaceutical package) contains no more than 6000, preferably no more than 5000, more preferably no more than 2500, more preferably no more than 1000, more preferably no more than 600, more preferably no more than 450, more preferably no more than 400, more preferably no more than 350, more preferably no more than 300, more preferably no more than 250, more preferably no more than 100, more preferably no more than 50, more preferably no more than 25, more preferably no more than 10, more preferably zero particles with a size of 15μm to 25μm, preferably 10μm to 25μm, preferably 10μm to 50μm, more preferably 10μm to 100μm, more preferably not less than 10μm, more preferably not less than 1μm. These particularly preferred values, represented by the parameters described above, can be achieved through the special separation layers and / or the special transport systems described herein. When these parameters are met, the primary packaging for pharmaceuticals is particularly suitable for storing injectable solutions.

[0070] The transportation system according to the present invention is a transportation system for transporting secondary packaging (6) of pharmaceuticals, preferably the transportation system according to any of the foregoing embodiments, comprising a transport container (11) including:

[0071] i) Optionally, according to any of the foregoing embodiments, there are preferably 2 to 10 partition layers (7), more preferably 4 to 6 partition layers (7); and

[0072] ii) Two drug sub-packages (6), preferably 9 to 21 drug sub-packages (6), more preferably 12 to 16 drug sub-packages (6);

[0073] The secondary packaging of the pharmaceutical product includes 10 to 200 primary packaging units, preferably 25 to 200 primary packaging units. After running the transport simulation program ASTM D4169-16, DC12 (excluding programs I and F), and safety level I, there are particles with a size of 15μm to 25μm, preferably 10μm to 25μm, preferably 10μm to 25μm, preferably 10μm to 50μm, preferably 10μm to 100μm, preferably 10μm to 100μm, preferably not less than 10μm, and more preferably not less than 1μm on the outside of each primary packaging unit (i.e., each individual primary packaging unit). This makes primary packaging for pharmaceuticals in the transport system particularly suitable for storing injectable solutions (see above).

[0074] A transport system for transporting secondary packaging (6) of pharmaceuticals, preferably the transport system according to any of the foregoing embodiments, includes a transport container (11) comprising:

[0075] i) Optionally, according to any of the preceding claims, there are preferably 2 to 10 partition layers (7), more preferably 4 to 6 partition layers (7); and

[0076] ii) Two drug sub-packages (6), preferably 9 to 21 drug sub-packages (6), more preferably 12 to 16 drug sub-packages (6);

[0077] The secondary packaging of the pharmaceutical product includes 10 to 200 primary packaging units, preferably 25 to 200 primary packaging units. After running the transport simulation program ASTM D4169-16, DC12 (excluding programs I and F), and safety level I, there are particles with a size of 15μm to 25μm, preferably 10μm to 25μm, preferably 10μm to 25μm, preferably 10μm to 50μm, preferably 10μm to 100μm, preferably 10μm to 100μm, preferably not less than 10μm, and more preferably not less than 1μm on the outside of each primary packaging unit (i.e., each individual primary packaging unit). This makes primary packaging for pharmaceuticals in the transportation system particularly suitable for storing injectable solutions (see above).

[0078] The transportation system according to the present invention is a transportation system for transporting secondary packaging (6) of pharmaceuticals, preferably the transportation system according to any of the foregoing embodiments, comprising a transport container (11) comprising:

[0079] i) Optionally, according to any of the preceding claims, there are preferably 2 to 10 partition layers (7), more preferably 4 to 6 partition layers (7); and

[0080] ii) Two drug sub-packages (6), preferably 9 to 21 drug sub-packages (6), more preferably 12 to 16 drug sub-packages (6);

[0081] The secondary packaging of the pharmaceutical product comprises 10 to 200, preferably 25 to 200 primary packaging units. After running the transport simulation program ASTM D4169-16, DC12 (excluding program I), and safety level I, the exterior of each primary packaging unit (i.e., each individual primary packaging unit) contains no more than 6000, preferably no more than 5000, more preferably no more than 2500, more preferably no more than 1000, more preferably no more than 600, more preferably no more than 450, more preferably no more than 400, more preferably no more than 350, more preferably no more than 300, more preferably no more than 250, more preferably no more than 100, more preferably no more than 50, more preferably no more than 25, more preferably no more than 10, more preferably zero particles with a size of 15 μm to 25 μm, preferably 10 μm to 25 μm, preferably 10 μm to 50 μm, more preferably 10 μm to 100 μm, more preferably not less than 10 μm, more preferably not less than 1 μm. This makes the primary packaging of the pharmaceutical product in the transport system particularly suitable for storing injectable solutions (see above).

[0082] A transport system for transporting secondary packaging (6) of pharmaceuticals, preferably a transport system according to any of the foregoing embodiments, includes a transport container (11) comprising:

[0083] i) Optionally, according to any of the preceding claims, there are preferably 2 to 10 partition layers (7), more preferably 4 to 6 partition layers (7); and

[0084] ii) Two drug sub-packages (6), preferably 9 to 21 drug sub-packages (6), more preferably 12 to 16 drug sub-packages (6);

[0085] The secondary packaging (6) of the medicine includes 10 to 200, preferably 25 to 200 primary packaging (5) of the medicine, wherein after running the transport simulation program ASTM D4169-16, DC12 (excluding program I), safety level I, the primary packaging (i.e. each individual primary packaging) contains no more than 6,000, preferably no more than 5,000, more preferably no more than 2,500, more preferably no more than 1,000, more preferably no more than 600, more preferably no more than 450, more preferably no more than 400, more preferably no more than 350, more preferably no more than 300, more preferably no more than 250, more preferably no more than 100, more preferably no more than 50, more preferably no more than 25, more preferably no more than 10, more preferably zero particles with a size of 15μm to 25μm, preferably 10μm to 25μm, preferably 10μm to 50μm, more preferably 10μm to 100μm, more preferably not less than 10μm, more preferably not less than 1μm. This makes primary packaging for pharmaceuticals in the transport system particularly suitable for storing injectable solutions (see above).

[0086] A preferred embodiment of the transport system is that the opening in the secondary packaging (e.g., a box) of the medicine preferably points downwards during transport.

[0087] Additional preferred embodiments

[0088] |1| A separator layer for transporting secondary packaging of pharmaceuticals,

[0089] The separator layer comprises a polymer; and

[0090] The partition layer includes a folded section and a planar section.

[0091] |2|The separating layer according to embodiment|1|, wherein the separating layer

[0092] i) Includes a folded section and two planar sections, wherein the folded section is arranged between the two planar sections; or

[0093] ii) Includes two folded sections and a planar section, wherein the planar section is arranged between the two folded sections; preferably, the partition layer consists of n planar sections and n+1 folded sections, wherein each planar section is arranged between the two folded sections, and n is equal to 2 to 7, preferably equal to 3 to 5, and more preferably equal to 3.

[0094] |3|The separator layer according to embodiment|1| or|2|, wherein the separator layer is composed of a material, preferably wherein the separator layer is formed from a single piece, more preferably wherein the separator layer is formed from a single piece having the following dimensions:

[0095] Length: 500mm to 2000mm;

[0096] Width: 100mm to 400mm; and

[0097] Thickness: 0.5mm to 10mm, preferably not less than 2.0mm and not more than 3.5mm.

[0098] |4|The separator layer according to any one of the foregoing embodiments, wherein the polymer is a thermoplastic, preferably a polyolefin, and more preferably a polypropylene.

[0099] |5| In any of the preceding embodiments, the cross-section of the folded portion is substantially triangular, trapezoidal, hemispherical, circular, or rectangular, preferably triangular, trapezoidal, or hemispherical, and more preferably triangular.

[0100] |6|The separator layer according to any one of the foregoing embodiments, wherein the separator layer satisfies one or more of the following characteristics:

[0101] i) Weight is 100g / m2 Up to 2000g / m 2 Optimal 200g / m 2 Up to 1000g / m 2 More preferably 300g / m 2 Up to 700g / m 2 More preferably 300g / m 2 Up to 400g / m 2 ;

[0102] ii) The melting point, as measured by differential scanning calorimetry (DSC), is 100°C to 250°C, preferably 130°C to 180°C, and more preferably 160°C to 170°C;

[0103] iii) The partition layer is composed of corrugated plates, preferably double-walled plates;

[0104] iv) During sterilization, preferably during heat sterilization (e.g., heat sterilization up to 60°C), or during chemical sterilization (e.g., chemical sterilization with ethylene oxide), or during sterilization by radiation (e.g., gamma radiation), the separator layer maintains dimensional stability; and / or,

[0105] v) wherein the axial elastic force of the separator layer in the longitudinal direction is 1N to 50N, preferably 1.5N to 40N, more preferably 2N to 35N, and even more preferably 20N to 30N.

[0106] |7|The separator layer according to any one of the foregoing embodiments, wherein the normal elastic force of the separator layer in the longitudinal direction is 0.2N to 5N, preferably 0.3N to 4N, more preferably 0.4N to 3N, and even more preferably 0.5N to 2N.

[0107] |8| A transport system for transporting secondary packaging of pharmaceuticals, comprising a transport container, the transport container including:

[0108] i) The number of partition layers according to any one of the foregoing embodiments is preferably 2 to 10, more preferably 4 to 6; and

[0109] ii) Two sub-packages of medicine, preferably 9 to 21 sub-packages of medicine, more preferably 12 to 16 sub-packages of medicine.

[0110] |9| The transportation system according to any one of the foregoing embodiments

[0111] The partition layer includes a folded section and two planar sections, with the folded section positioned between the two planar sections; and

[0112] The separator is arranged such that the planar section of the separator and the bottom surface of the secondary drug packaging are in contact with each other, and the folded portion of the separator protrudes inward between the two secondary drug packaging packages; and / or, the folded portion of the separator is sized such that it does not contact the secondary drug packaging; and / or, the folded portion of the separator is sized such that it contacts the secondary drug packaging.

[0113] |10| The transportation system according to any one of the foregoing embodiments,

[0114] One or more planar sections of the separator layer contact the bottom surface of the first secondary drug packaging and the top surface of the second secondary drug packaging.

[0115] |11| The transportation system according to any one of the foregoing embodiments, wherein at least one of the following features is satisfied:

[0116] i) The secondary packaging of the medicine is trough-shaped, preferably having an edge along the top surface that extends along the plane of the top surface;

[0117] ii) The secondary pharmaceutical package is sealed on top by a removable protective film, preferably comprising polyethylene, more preferably comprising a permeable microfiber nonwoven fabric made of polyethylene; and / or, iii) the secondary pharmaceutical package includes a nest for the primary pharmaceutical package, wherein the nest preferably comprises 10 to 200 primary pharmaceutical packages.

[0118] |12| The transportation system according to any one of the foregoing embodiments, wherein at least one of the following features is satisfied:

[0119] i) The secondary packaging of the medicine is surrounded by a sealed bag, preferably by two sealed bags;

[0120] ii) The interior of the secondary packaging of the medicine is sterile; and / or,

[0121] iii) The secondary packaging of the medicine has been sterilized using gamma rays, steam or ethylene oxide.

[0122] |13| The transportation system according to any one of the foregoing embodiments, wherein at least one of the following features is satisfied:

[0123] i) The shipping container is made of essentially the same material as the partition layer;

[0124] ii) The ratio of the width of the partition layer to the internal width of the shipping container is equal to 0.8 to 1.5, preferably equal to 0.9 to 1.3, more preferably equal to 1.0 to 1.1; and / or,

[0125] iii) The ratio of the length of the partition layer to the internal length of the transport box is equal to 1.1 to 2.0, preferably equal to 1.2 to 1.9, and more preferably equal to 1.3 to 1.7.

[0126] |14| In the transportation system according to any one of the foregoing embodiments, in the impact test according to "Inclined Impact Test ASTM D880-92 (2015)", the impact velocity is 2.14 m / s, and the damage to secondary packaging, nests and primary packaging of pharmaceuticals does not exceed 50%, preferably not more than 40%, more preferably not more than 30%, more preferably not more than 20%, more preferably not more than 10%, and more preferably not more than 5%.

[0127] |15| The transport system according to any one of the foregoing embodiments includes a transport box comprising: wherein the secondary packaging of the pharmaceuticals comprises 10 to 200 primary packaging packages of the pharmaceuticals; and wherein, after running transport simulation programs ASTM D4169-16, DC12 (excluding programs I and F), and safety level I, there are no more than 450 particles with a size of 15 μm to 25 μm on the outside of the primary packaging packages of the pharmaceuticals.

[0128] |16| The transport system according to any one of the foregoing embodiments, wherein the secondary packaging of the pharmaceuticals comprises 10 to 200 primary packaging packages of the pharmaceuticals, and wherein, after running the transport simulation program ASTM D4169-16, DC12 (excluding programs I and F), safety level I, there are no more than 450 particles with a size of 10 μm to 25 μm inside the primary packaging packages of the pharmaceuticals.

[0129] |17| A transport system for transporting secondary packaging of pharmaceuticals, preferably a transport system according to any one of the foregoing embodiments |8| to |16|, includes a transport container comprising:

[0130] i) Optionally, according to any one of the foregoing embodiments, there are 2 to 10 partition layers, more preferably 4 to 6 partition layers; and

[0131] ii) Two sub-packages of medicine, preferably 9 to 21 sub-packages of medicine, more preferably 12 to 16 sub-packages of medicine;

[0132] The secondary packaging of the pharmaceuticals includes 10 to 200 primary packaging units; and after running the transport simulation procedures ASTM D4169-16, DC12 (excluding procedures I and F), and safety level I, there are no more than 6,000 particles with a size of 15 μm to 25 μm on the outside of the primary packaging units.

[0133] |18| A transport system for transporting secondary packaging of pharmaceuticals, preferably the transport system according to any one of the foregoing embodiments |8| to |16|, includes a transport container, the transport container comprising:

[0134] i) Optionally, according to any one of the foregoing embodiments, there are 2 to 10 partition layers, more preferably 4 to 6 partition layers; and

[0135] ii) Two sub-packages of medicine, preferably 9 to 21 sub-packages of medicine, more preferably 12 to 16 sub-packages of medicine;

[0136] The secondary packaging of the pharmaceuticals includes 10 to 200 primary packaging units; and within the primary packaging units, after running the transport simulation procedures ASTM D4169-16, DC12 (excluding procedures I and F), and safety level I, there are no more than 6,000 particles with a size of 15 μm to 25 μm. Attached Figure Description

[0137] Figure 1 A packaging system including a box, nest, syringe, cover, and protective film is shown.

[0138] Figure 2 A plan view of the partition layer according to an embodiment of the present invention is shown.

[0139] Figure 3 A cross-section of the separator layer according to an embodiment of the present invention is shown.

[0140] Figure 4 A cross-section of a transportation system according to an embodiment of the present invention is shown.

[0141] Figure 5 The number of particles per square centimeter on the outer wall of the Kapoor bottle is shown.

[0142] Figure 6 The number of particles per square centimeter on the inner wall of the box is shown.

[0143] Figure 7 The number of particles per square centimeter on the outer wall of the Kapoor bottle is shown.

[0144] Figure 8 The number of particles per square centimeter on the inner wall of the box is shown.

[0145] List of reference numerals

[0146] 1 Packaging System

[0147] 2. Protective film

[0148] 3. Protective layer

[0149] 4 nests

[0150] 5. Syringes (primary packaging for pharmaceuticals)

[0151] 6 boxes (secondary packaging for medicine)

[0152] 7. Separator layer

[0153] 8. Planar Section

[0154] 9. Sections used to form the folded section

[0155] 10% off high section

[0156] 11 shipping containers Detailed Implementation

[0157] Figure 1 An exploded view of a packaging system (1) for transporting the syringe (5) is shown. The packaging system (1) includes a protective film (2), a cover (3), a nest (4), a syringe ((5), primary packaging for the drug), and a box ((6), secondary packaging for the drug). The shape of the packaging system (1) is defined by the box (6). The syringe (5) is held by the nest (4). The nest (4) is inserted into the box (6). The syringe (5) does not come into direct contact with the box (6). The syringe (5) is covered by the cover (3), and the box (6) is sealed by the protective film (2). The sealed box (6) may be further surrounded by one or more bags (not shown).

[0158] Figure 2 A plan view of the partition layer (7) according to an embodiment of the present invention is shown. Figure 3 A cross-section of the separator layer (7) according to an embodiment of the present invention is shown. (See image from...) Figure 2 and Figure 3 As can be seen, the partition layer (7) is formed in one piece. The partition layer (7) includes a planar section (8), and the folded section (10) is formed by folding the partition layer (7) through the section (9) used to form the folded section.

[0159] Figure 4 A cross-section of a transport system according to an embodiment of the present invention is shown. The transport box (11) has four rows, each row comprising three packaging systems (1) arranged side by side. The packaging systems (1) in each row and their respective rows are separated by partitions (7). The packaging systems (1) in each row do not contact each other. In the event of a lateral impact, the force is cushioned by the folded portions (10) of the partitions (7). It can be seen that, in the preferred transport orientation, the opening side of the box points downwards, and the folded portions also point downwards (see...). Figure 4 ).

[0160] Measurement methods

[0161] The axial elastic force along the longitudinal direction is measured as follows:

[0162] A piece is cut from the separator, comprising a folded section and two planar segments with a length of 60 mm (i.e., from the corresponding outer fold to the end of the piece). The sample is clamped in a universal testing machine (Test GmbH, model 106.2 kN) with the clamps centered on the planar segments and spaced 20 mm from the folded section (i.e., from the corresponding outer fold). The clamps are then oriented to be spaced apart, creating a gap of at least 3 cm between the two planar segments; for example, the clamp spacing is set to 14 cm. The clamps are tightened to securely hold only the material. Measurements are taken in the vertical direction. During the actual measurement, the upper clamp moves downward at a constant speed of 500 mm / min, continuously applying the required force. The measurement terminates once the two planar segments come into contact. This can be represented by a force that rapidly increases and eventually exceeds 25 N (the endpoint). The axial elastic force in the longitudinal direction was measured when the gap between the two planar sections was 26.5 mm, that is, the force at 26.5 mm before the clamp had been moved close enough to make the value exceed 25 N. This measurement was repeated 10 times with a new separator layer to form an average value.

[0163] The normal elastic force along the longitudinal direction is measured as follows:

[0164] In transportation systems, such as Schott AG Or CartriQ TM Inserted in, for example, by The transport box (i.e., the bottom layer is a secondary pharmaceutical package) is constructed. A separator is inserted on top of the bottom layer, which includes the secondary packages. This separator is configured such that, in each case, there is a folded section between the secondary pharmaceutical packages and optionally between each secondary pharmaceutical package and the wall of the transport box, and the flat section is located above the secondary pharmaceutical packages. The folded sections protrude downwards into the gaps between the secondary pharmaceutical packages. The separator is tensioned because the separator, just folded before testing, is longer than the length of the transport box, and / or because the folded or bent folded sections extend into the gaps. The force required to prevent the separator from slackening (i.e., bending upwards) from the tensioned state for 10 seconds is measured. To do this, a weight is placed in the middle of the middle flat section (for odd-numbered flat sections) or in the middle of one of the middle sections (for even-numbered flat sections) and pressed downwards. The position of the separator is marked on the wall of the transport box with a fine pencil. The weight is then released, and the timer is stopped. After 10 seconds, it is checked whether the separator bearing the weight has slackened beyond the mark (i.e., whether it has bent beyond the mark). Repeat the test with different weights to determine just enough to prevent the separator from rising above the marked weight (= normal elastic force in the longitudinal direction) within 10 seconds.

[0165] The particulate contamination measurements on the exterior of the primary packaging are as follows:

[0166] Under laminar conditions (unter laminarer) Next, remove the primary packaging from the secondary packaging. Then, reseal the primary packaging to prevent the test liquid from seeping into it. Ten sealed primary packaging units (e.g., sealed at both ends with plugs and with an outer surface area of ​​15.76 cm²) are used. 2 (The Kapoor flask used in Example 3) was placed in a beaker containing 100 mL of the test liquid. To remove particles from the surface, the solution was stirred for 20 seconds at 300 to 350 rpm using a magnetic stirrer. After 15 minutes, 5 mL of the solution was analyzed using a liquid particle counter (Pacific Technology HIAC Royco, Model 9703), and particle contamination was determined based on background measurements of the test liquid. This method and instrument reliably determine particles with a size greater than 0.5 μm. A total of 5 analyses were performed on the test liquid. The number of particles per square centimeter on the outer surface (particles / cm²) was then calculated using the average of the obtained values, the outer surface area, and the number of primary drug packages. 2 ).

[0167] The particulate contamination inside the box was measured as follows:

[0168] Under laminar flow conditions, the protective film, protective layer, and nest containing the primary pharmaceutical packaging are removed from the box. The box is then rinsed with 100 mL of test liquid, rotated several times, and transferred to a beaker. After 15 minutes, 5 mL of the solution is analyzed using a liquid particle counter (Pacific Technology HIAC Royco, model 9703), and particulate contamination is determined based on background measurements of the test liquid. This method and instrument reliably determine particles larger than 0.5 μm. A total of five analyses are performed on the test liquid. The particle count is calculated based on the area of ​​the box's interior (i.e., inner wall) and the measured values.

[0169] The particulate contamination inside the primary packaging of the pharmaceutical product was measured as follows:

[0170] Under laminar flow conditions, the protective film, protective layer, and nest containing the primary drug packaging are removed from the box. Then, all inner surfaces of the primary drug packaging are rinsed with the test liquid by filling it with the nominal fill volume of test liquid for the primary drug packaging, rotating it several times, and then transferring it to a beaker. If the primary drug packaging has more than one opening, the opening can be sealed with a particle-free membrane. After 15 minutes, 5 mL of the solution is analyzed using a liquid particle counter (Pacific Technology HIAC Royco, model 9703), and particulate contamination is determined based on the background measurement of the test liquid. If the nominal volume of the primary packaging is less than the required amount for testing, the test liquid from multiple primary packaging units of the same type is pooled together. This method and instrument can reliably determine particles with a size greater than 0.5 μm. A total of 5 analyses are performed on the test liquid. The particle number is calculated based on the area of ​​the interior (=inner wall) of the primary drug packaging and the measured value.

[0171] The impact test used here is the "Inclined Impact Test ASTM D880-92 (2015)", but with a load of 1.2 times, i.e., an impact velocity of 2.14 m / s instead of the standard 1.75 m / s. Damage is generally considered to be breakage, kinking, and / or cracking in the primary and / or secondary drug packaging.

[0172] When a test specimen deforms and can no longer return to its initial shape, kinking is evident, meaning kinking can be seen, especially cracking. Cracks are characterized by localized separation of the material with a small width but considerable length and depth. Fracture is the breaking of molecular bonds, thus the test specimen has a free surface (fracture surface).

[0173] Example

[0174] Example 1 and Example 2

[0175] A polypropylene piece measuring 108cm in length and 22cm in width The fabricated separator is folded to create four triangular folded sections and three planar segments, with each folded section having a side length of 5.3 cm and each planar segment being 22 cm long. The separator thickness ranges from 2.0 mm to 3.5 mm. The transport box (i.e., transport system) has dimensions of 77 × 23 × 50.8 cm (length × width × height) and is also made of polypropylene. Manufactured. The primary and secondary packaging used for the pharmaceutical product are commercially available boxes sealed in film (CartriQ from Schott AG). TM ).

[0176] The normal and axial elastic forces are determined as described above:

[0177] Example thickness Normal elasticity Axial elastic force # [mm] [N] [N] 1 2.0 0.6 6.4 2 3.5 2.1 28.0

[0178] Example 3 and Example 4

[0179] Two shipping boxes are provided; one with a flat partition without folding height (Example 3), and the other with a partition according to an embodiment of the invention (Example 4). For this purpose, a shipping box with a length, width, and height of 770*230*508mm and made of polypropylene is used. Two shipping containers (= transportation system) are constructed, each containing three commercially available boxes (CartriQ from Schott AG) in each row. TM The box was sealed with a thin film, opening facing down. Then, a flat piece without folds, measuring 758*220*3.5mm, was placed inside a shipping box. Polymer inserts, while polypropylene is placed in another shipping box. A separator layer with a length of 108 cm and a width of 22 cm was fabricated. This separator layer was folded into four triangular folded sections and three planar sections, with each folded section having a side length of 5.3 cm and each planar section being 22 cm long. The separator layer was 2.0 mm thick. Another box and another corresponding separator layer were then placed into the transport box, and this process was repeated until the transport box was full. Subsequently, the transport simulation program ASTM D4169-16, DC12 (excluding program I), safety level I, as described above, was run to determine the number and size of particles on the outer surface of the Kapoor bottle (= primary packaging of the pharmaceutical product) and the inner wall of the box (= secondary packaging of the pharmaceutical product). The results are shown in... Figure 5 (Number of particles on the outer wall of the primary packaging of the medicine) and Figure 6 In the (number of particles on the inner wall of the secondary packaging of the medicine), the black bars represent the corresponding number of particles in Example 3. The grid bars represent the corresponding number of particles in Example 4.

[0180]

[0181] From the table and Figure 5 and Figure 6 It is evident that, compared to a completely planar separator layer, by using a separator layer according to an embodiment of the invention, the number of particles on the outer surface of the primary pharmaceutical packaging (= Kapoor vial) is reduced by more than half across all size ranges. Similarly, compared to a completely planar separator layer, by using a separator layer according to an embodiment of the invention, the number of particles on the inner wall of the secondary pharmaceutical packaging (= box) is significantly reduced across all size ranges. In Examples 3 and 4, particles larger than 25 μm are almost undetectable (particle count < 0.1).

[0182] Furthermore, in Examples 3 and 4, the shipping boxes were packaged as described above, and the impact test described above was performed. In Example 3, where 66% of the outermost pharmaceutical sub-packages (= boxes) facing the impact side in the shipping box with a planar separator were damaged, only 2% of the outermost pharmaceutical sub-packages (= boxes) facing the impact side were damaged when the separator according to an embodiment of the present invention was used.

[0183] Example 5 and Example 6

[0184] Two shipping containers are provided: one shipping container has a flat partition without folding height (Example 5), and the other shipping container has a partition according to an embodiment of the invention (Example 6). For this purpose, a container with a length, width, and height of 77*23*50.8mm and made of polypropylene is used. Two shipping containers (= transportation system) are constructed, each containing three commercially available boxes (CartriQ from Schott AG) in each row. TM The box was sealed with a thin film, opening facing down. Then, a flat surface measuring 758*220*3.5mm without folds was placed inside a shipping box. Polymer inserts, while polypropylene is placed in another shipping box. A separator layer with a length of 108 cm and a width of 22 cm was fabricated. This separator layer was folded to form four triangular folded sections and three planar segments placed within them. The side length of each folded section was 5.3 cm, and each planar segment was 22 cm long. The thickness of the separator layer was 2.0 mm. Then, a box and a corresponding separator layer were placed into a transport box, and this process was repeated until the transport box was full. Subsequently, after running the transport simulation programs ASTM D4169-16, DC12 (excluding programs I and F), and safety level I, the number and size of particles on the outer surface of the Kapoor vial (= primary packaging of the pharmaceutical product) and on the inner wall of the box (= secondary packaging of the pharmaceutical product) were determined as described above. The results are shown in... Figure 7 (Number of particles on the outer wall of the primary packaging of the medicine) and Figure 8 In the (number of particles on the inner wall of the secondary packaging of the medicine), the black bars represent the corresponding number of particles in Example 5. The grid bars represent the corresponding number of particles in Example 6.

[0185]

[0186] From the table and Figure 7 and Figure 8It is evident that, compared to a completely planar separator layer, by using a separator layer according to an embodiment of the invention, the number of particles on the outer surface of the primary pharmaceutical packaging (= Kapoor vial) is reduced by more than half across all size ranges. Similarly, compared to a completely planar separator layer, by using a separator layer according to an embodiment of the invention, the number of particles on the inner wall of the secondary pharmaceutical packaging (= box) is significantly reduced across all size ranges. In Examples 5 and 6, particles larger than 25 μm are almost undetectable (particle count < 0.1).

[0187] Furthermore, in Examples 5 and 6, the packaging transport boxes were packaged as described above, and the impact test described above was performed. In the case where 66% of the outermost pharmaceutical secondary packaging (=box) facing the impact side was damaged in the transport box with the planar separator (Example 5), only 2% of the outermost pharmaceutical secondary packaging (=box) facing the impact side was damaged when the separator according to an embodiment of the present invention was used.

[0188] Examples 7 and 8

[0189] Two shipping containers are provided: one shipping container has a flat partition without folding height (Example 7), and the other shipping container has a partition according to an embodiment of the invention (Example 8). For this purpose, a container with a length, width, and height of 770*230*508mm and made of polypropylene is used. Two shipping containers (= transportation system) are constructed, each containing three commercially available boxes (CartriQ from Schott AG) in each row. TM The box was sealed with a thin film, opening facing down. Then, a flat surface measuring 758*220*3.5mm without folds was placed inside a shipping box. Polymer inserts, while polypropylene is placed in another shipping box. A separator layer with a length of 108 cm and a width of 22 cm was fabricated. This separator layer was folded into four triangular folded sections and three planar segments placed within them. The side length of each folded section was 5.3 cm, and each planar segment was 22 cm long. The thickness of the separator layer was 2.0 mm. Then, another box and another corresponding separator layer were placed into the transport box, and this process was repeated until the transport box was full. Subsequently, after running the transport simulation program ASTM D4169-16, DC12 (excluding procedures I and F), safety level I, the number and size of particles on the outer surface of the Kapoor bottle (= primary packaging of the pharmaceutical product) and on the inner wall of the box (= secondary packaging of the pharmaceutical product) were determined as described above. The results are shown in... Figure 7 (Number of particles on the outer wall of the primary packaging of the medicine) and Figure 8 In the (number of particles on the inner wall of the secondary packaging of the medicine), the black bars represent the corresponding number of particles in Example 7. The grid bars represent the corresponding number of particles in Example 8.

[0190]

[0191] From the table and Figure 7 and Figure 8 It is evident that, compared to a completely planar separator layer, by using a separator layer according to an embodiment of the invention, the number of particles on the outer surface of the primary pharmaceutical packaging (= Kapoor vial) is reduced by more than half across all size ranges. Similarly, compared to a completely planar separator layer, by using a separator layer according to an embodiment of the invention, the number of particles on the inner wall of the secondary pharmaceutical packaging (= box) is significantly reduced across all size ranges. In Examples 7 and 8, particles larger than 25 μm are almost undetectable (particle count < 0.1).

[0192] Furthermore, in Examples 7 and 8, the packaging transport boxes were subjected to the impact test described above. In the case where 66% of the outermost pharmaceutical secondary packaging (=box) facing the impact side was damaged in the transport box with the planar separator (Example 7), only 2% of the outermost pharmaceutical secondary packaging (=box) facing the impact side was damaged when the separator according to an embodiment of the present invention was used.

[0193] Examples 9 and 10

[0194] Two shipping containers are provided: one shipping container has a flat partition without folding height (Example 9), and the other shipping container has a partition according to an embodiment of the invention (Example 10). For this purpose, a container with a length, width, and height of 770*230*508mm and made of polypropylene is used. Two shipping containers (= transportation system) are constructed, each containing three commercially available boxes (CartriQ from Schott AG) in each row. TM The box was sealed with a thin film, opening facing down. Then, a flat surface measuring 758*220*3.5mm without folds was placed inside a shipping box. Polymer inserts, while polypropylene is placed in another shipping box. A separator layer with a length of 108 cm and a width of 22 cm was fabricated. This separator layer was folded into four triangular folded sections and three planar segments placed within them. The side length of each folded section was 5.3 cm, and each planar segment was 22 cm long. The thickness of the separator layer was 2.0 mm. Then, another box and another corresponding separator layer were placed into the transport box, and this process was repeated until the transport box was full. Subsequently, after running the transport simulation program ASTM D4169-16, DC12 (excluding program I), safety level I, the number and size of particles on the outer surface of the Kapoor bottle (= primary packaging of the pharmaceutical product) and the inner wall of the box (= secondary packaging of the pharmaceutical product) were determined as described above. The results are shown in... Figure 7(Number of particles on the outer wall of the primary packaging of the medicine) and Figure 8 In the (number of particles on the inner wall of the secondary packaging of the medicine), the black bars represent the corresponding number of particles in Example 9. The grid bars represent the corresponding number of particles in Example 10.

[0195]

[0196] From the table and Figure 7 and Figure 8 It is evident that, compared to a completely planar separator layer, by using a separator layer according to an embodiment of the invention, the number of particles on the outer surface of the primary pharmaceutical packaging (= Kapoor vial) is reduced by more than half across all size ranges. Similarly, compared to a completely planar separator layer, by using a separator layer according to an embodiment of the invention, the number of particles on the inner wall of the secondary pharmaceutical packaging (= box) is significantly reduced across all size ranges. In Examples 9 and 10, particles larger than 25 μm are almost undetectable (particle count < 0.1).

[0197] Furthermore, in Examples 9 and 10, the packaging transport boxes as described above were subjected to the impact test as described above. In the case where 66% of the outermost pharmaceutical secondary packaging (=box) facing the impact side was damaged in the transport box with the planar separator (Example 9), only 2% of the outermost pharmaceutical secondary packaging (=box) facing the impact side was damaged when the separator according to an embodiment of the present invention was used.

Claims

1. A transport system for transporting secondary packaging of pharmaceuticals, comprising: shipping container Two secondary packages of medicine were found in the shipping box, and A separating layer that separates the two secondary drug packages from each other and from the shipping box; The two secondary drug packages each comprise 10 to 200 primary drug packages; After running the transportation simulation programs ASTM D4169-16, DC12, excluding Program I, and Safety Level I, conditions selected from the following groups exist: The number of particles with a size of 2 μm to 25 μm per square centimeter is not more than 20.0 on the outside and / or inside of each primary packaging of the drug. On the outside and / or inside of each primary packaging of the medicine, there are no more than 6.0 particles per square centimeter with a size of 5 μm to 25 μm. On the outside and / or inside of each primary packaging of the medicine, there are no more than 2.0 particles per square centimeter with a size of 10 μm to 25 μm. On the exterior and / or interior of each primary pharmaceutical package, there are fewer than 0.1 particles per square centimeter with a size greater than 25 μm; and Any combination thereof.

2. The transport system of claim 1, wherein the transport system includes a partition layer having planar sections, and wherein the partition layer is located between two secondary pharmaceutical packages within a transport container.

3. The transportation system according to claim 2, wherein the separator layer comprises a polymer layer having a planar section extending in the axial direction along the longitudinal direction and a folded portion extending normally to the longitudinal axis, the separator layer having a normal elastic force of 0.2N to 5N.

4. The transportation system according to claim 3, wherein the partition layer further comprises a second planar section, wherein the folded portion is arranged between the planar section and the second planar section.

5. The transport system according to claim 4, wherein the separator is arranged such that the planar section and the second planar section and the bottom surfaces of the two secondary pharmaceutical packages respectively contact each other, and the folded portion protrudes between the two secondary pharmaceutical packages such that the two secondary pharmaceutical packages do not contact each other.

6. The transport system according to claim 3, wherein the planar section contacts the bottom surface of the first of the two pharmaceutical sub-packages and the top surface of the second of the two pharmaceutical sub-packages.

7. The transport system according to claim 3, wherein the normal elastic force is 0.5N to 2N.

8. The transport system according to claim 3, wherein the separator layer has an axial elastic force of 1 to 50 N.

9. The transport system according to claim 8, wherein the axial elastic force is 20 to 30 N.

10. The transport system of claim 1, wherein the two secondary pharmaceutical packages are trough-shaped, having an edge along the top surface that extends along the plane of the top surface.

11. The transport system of claim 1, wherein the two secondary pharmaceutical packages have sterile interiors.

12. The transport system of claim 3, wherein the transport container is made of the polymer of the separator layer.

13. The transport system of claim 3, wherein the partition layer has a width, the transport container has an internal width, and the transport system has a width-to-internal-width ratio of 0.8 to 1.

5.

14. The transport system of claim 13, wherein the partition layer has a length, the transport container has an internal length, and the transport system has a ratio of the length to the internal length of 1.1 to 2.

0.

15. The transport system of claim 3, wherein the partition layer has a length, the transport container has an internal length, and the transport system has a ratio of the length to the internal length of 1.1 to 2.

0.

16. The transport system according to claim 1, wherein in an impact test according to ASTM D880-92 (2015) of the inclined plane impact test, the impact velocity is 2.14 m / s and the damage to the primary packaging (5) of the pharmaceutical product does not exceed 50%.

17. The transportation system of claim 1, wherein after running the transportation simulation program ASTM D4169-16, DC12, excluding program I, safety level I, conditions selected from the group consisting of: On each individual inner wall of the secondary packaging of the medicine, there are no more than 40.0 particles per square centimeter with a size of 2μm to 25μm; On each individual inner wall of the secondary packaging of the medicine, there are no more than 16.0 particles per square centimeter with a size of 5μm to 25μm; On each individual inner wall of the secondary packaging of the medicine, there are no more than 3.5 particles per square centimeter with a size of 10 μm to 25 μm; On each individual inner wall of the secondary packaging of the medicine, there are no more than 0.9 particles per square centimeter with a size of 15μm to 25μm; On each individual inner wall of the secondary pharmaceutical packaging, there were fewer than 0.0 particles per square centimeter with a size greater than 25 μm; and Any combination thereof.

18. The transport system of claim 1, wherein after running the transport simulation program ASTM D4169-16, DC12, Excluding Program I, Safety Level I, there are no more than 6,000 particles per square centimeter having a size of 15 μm to 25 μm on the outside and / or inside of each individual primary pharmaceutical package.

19. The transport system of claim 1, wherein after running the transport simulation program ASTM D4169-16, DC12, Excluding Program I, Safety Level I, there are no more than 50,000 particles per square centimeter having a size of 2 μm to 25 μm on the outside and / or inside of each individual primary pharmaceutical package.

20. A transport system for transporting secondary packaging of pharmaceuticals, comprising: shipping container Two secondary packages of medicine were found in the shipping box, and A separating layer that separates the two secondary drug packages from each other and from the shipping box; The two secondary drug packages each comprise 10 to 200 primary drug packages; After running the transportation simulation programs ASTM D4169-16, DC12, excluding Program I, and Safety Level I, conditions selected from the following groups exist: On each individual inner wall of the secondary packaging of the medicine, there are no more than 40.0 particles per square centimeter with a size of 2μm to 25μm; On each individual inner wall of the secondary packaging of the medicine, there are no more than 16.0 particles per square centimeter with a size of 5μm to 25μm; On each individual inner wall of the secondary packaging of the medicine, there are no more than 3.5 particles per square centimeter with a size of 10 μm to 25 μm; On each individual inner wall of the secondary packaging of the medicine, there are no more than 0.9 particles per square centimeter with a size of 15μm to 25μm; On each individual inner wall of the secondary pharmaceutical packaging, there were fewer than 0.0 particles per square centimeter with a size greater than 25 μm; and Any combination thereof.

21. A transport system for transporting secondary packaging of pharmaceuticals, comprising: shipping container Two secondary packages of medicine were found in the shipping box, and A separating layer that separates the two secondary drug packages from each other and from the shipping box; The two secondary drug packages each comprise 10 to 200 primary drug packages; After running the transport simulation procedures ASTM D4169-16, DC12, excluding Procedure I, Safety Level I, there are no more than 6,000 particles per square centimeter with a size of 15 μm to 25 μm on the outside or inside of each individual primary pharmaceutical package.

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