This invention lies in the field of devices for the storage, support and automated handling of containers for pharmaceutical use, particularly before filling operations.
More particularly, the invention relates to a device for holding containers including at least one filling tube or neck, such as pouches for pharmaceutical use.
Pouches are often used as containers for pharmaceutical solutions, for example pouches containing solutions for parenteral administration, or liquid solvents for reconstituting a freeze-dried solution such as Dual-Mix® pouches. These pouches include at least one tube allowing their filling and where applicable the extraction of the liquid from the pouch.
The use of pouches for a pharmaceutical purpose requires the use of a product of guaranteed safety and traceability. In certain applications, particularly aseptic procedures, it is necessary for these pouches to be sterilized before the implementation of the filling processes, to prevent any microbiological contamination of the product that will be contained in said container. These pouches or containers must also make it possible to ensure the absence of contamination by solid particles and chemical contamination. It is however understood that the device of the present invention is not limited to this type of application.
However, the handling of the pouches for the purpose of sterilizing them and filling them is a potential source of contamination by solid particles and chemical contamination, a contamination that the sterilization of the pouches does not make it possible to correct.
The contamination by solid particles can be generated during handling of the pouches and especially by opening of the filling tube, which leaves a way in for possible solid particles in suspension in the environment, or even particles carried by the personnel handling the pouches. The chemical contamination meanwhile can be caused by contact between the pouches and other materials during their handling and sterilization.
It is thus necessary to take as many precautions as possible when handling the pouches in order to guarantee a product compliant with the standards of the pharmaceutical industry.
The protocols for sterilization and conditioning of the product require organization and rigorous monitoring, an organization that is currently not made any easier by the lack of pouch-specific storage tools. In addition, the organization of the pouches also determines the required intensity of irradiation for the correct sterilization of a batch of pouches and/or other containers. Thus, when the optimal conditions of a sterilization protocol have been determined for a batch of one container, it is desirable to replicate the organization of the containers used during the determination of said protocol. It is therefore necessary to have a tool for organizing containers allowing replicability of organization and storage of the containers, in order to guarantee the effectiveness of their sterilization.
Similarly, there is an increasing need for devices for storing and supporting pharmaceutical containers allowing the automation of unit production operations, particularly devices for supporting containers suitable for their handling by robot arms.
The aim of this invention is to make provision for a holding device for containers including a filling tube or neck allowing their handling and an optimized storage, particularly for the purpose of implementing sterilization and filling methods.
Another aim of the invention is to make provision for a holding device making it possible to prevent contamination by particles during the handling that precedes sterilization and filling.
For this purpose, the invention makes provision for a holding device for containers including at least one filling tube or neck, said device including a supporting surface including a front face defining a front face of the holding device. The front face of the supporting surface includes at least one gripping member for holding a filling tube or neck of a container intended to be held by said device in a position parallel to said supporting surface.
The device for holding the invention further includes:
In an embodiment, the temporary fastener is formed by a wall extending substantially perpendicularly with respect to the front face of the supporting surface, said wall being disposed parallel with respect to the at least one gripping member.
This wall forming the temporary fastener can also include the following features, taken alone or in combination:
In an embodiment, the temporary fastener includes a closing body, such as a spike, which can be at least partly introduced into the opening of the at least one filling tube or neck of the container intended to be held by the holding device.
In a preferred embodiment of the invention, the holding device includes a plurality of gripping members, and said gripping members are formed by a longitudinal indentation on the front face of the supporting surface, said indentation including recessed sections of sufficient width to at least partly insert a filling tube or neck of the container intended to be held by said holding device.
In another embodiment, the holding device includes a second indentation, parallel and substantially symmetrical with the first indentation. These two parallel indentations thus form the plurality of gripping members, wherein the recessed sections are aligned between the two indentations and determine the locations of the containers.
The holding device according to the invention can also include a male assembly element on one of its lateral sides, and on its opposite lateral side, a female assembly element complementary to said male assembly element. This embodiment makes it possible to assemble several strips together and to increase the dimension of the device in a longitudinal plane.
In an embodiment of the invention, the holding device includes at least two hooking elements in the shape of eyelets, and corners of the holding device are rounded.
The holding device can be made of a material resistant to sterilization by irradiation, and/or of a similar material to the material of the container that it is intended to hold, such as polypropylene. This embodiment makes it possible to avoid generating any additional extractables during sterilization.
The invention also relates to the use of the holding device of the invention for storing one or more pouches including one or more filling tubes and/or vials including a filling neck.
Other advantages, aims and particular features of this invention will become apparent from the following description given, in an explanatory and in no way limiting aim, with reference to the appended drawings.
First of all, it must be noted that the invention is described with reference to its purpose, i.e. in relation to the container for which the holding device is designed. Nonetheless, the container is not part of the invention.
Specifically, the invention relates to a holding device for containers that will be held by said device owing to the gripping of the filling tube or neck of said containers. For this purpose, the device includes a supporting surface including a front face also defining the front face of the holding device, and on which is present at least one gripping member.
In the following description, we will consider a vertical direction of the holding device wherein a filling tube or neck is held by the at least one gripping member in a vertical position, and substantially parallel to the supporting surface. When the holding device is found in this vertical position, it is considered that it has an upper side and a lower side with a reference mark. A pouch held by the gripping member has, according to these reference marks, the opening of the filling tube directed toward the upper side of the device, and the body of the container, i.e. the pouch, on the lower side and/or below the holding device.
As can be seen in
The term “indentation” is here understood to mean an alternating succession of the recessed sections 250 and the solid sections 260 over the supporting surface of the device. When the device is put in the vertical position, the first indentation 200 is considered as the upper indentation and the second indentation 200′ as the lower indentation.
Each indentation 200, 200′ includes a plurality of recessed sections 250 determining the locations of the container tubes or necks to be held by the device of the invention. The container tubes or necks are inserted by applying pressure into the recessed sections 250 of the indentations 200, 200′ to attach them to the holding device, the dimensions of the recessed sections 250 being chosen as a function of the dimensions of the container filling tubes or necks to be held. On the illustrated figures, the recessed sections 250 have a width and depth suitable for the filling tubes of pouches for pharmaceutical use.
Advantageously, the solid sections 260 of the indentations 200, 200′ have flat surfaces allowing the devices to be stacked together. In the same way, the bottom of each recessed section 250 includes a rounded shape adapting to the shape of a filling tube.
The use of indentations 200, 200′ as gripping members makes it possible to optimize storage space and to receive a significant number of containers in a reduced space, while being easy to manufacture. In other embodiments, the device is designed with other known types of gripping member, such as pincers.
In the preferred embodiment, the provision of two symmetrical parallel indentations 200, 200′, upper and lower, advantageously allows each tube to be attached on two sections at different heights, thus limiting the pressure needed to fix the tubes in the recessed sections 250 of the indentations, and making it possible to improve the support of the containers by the holding device.
The holding device of the invention is advantageously designed to prevent the contamination by particles of the containers held and handled for the purpose of the sterilization and filling operations. For this purpose, the holding device includes a temporary fastener for opening the filling tubes or necks of the containers that are held by said device.
In the embodiment illustrated on
When the holding device 10 is put in the vertical position, in such a way as to also support a pouch and its filling tube vertically, it is considered that the temporary fastener is located on the upper side of the holding device, as well as above the at least one gripping member 200, 200′. In the embodiment illustrated in
In another embodiment (not illustrated), it is possible to design the device with a space between said wall 300 and the gripping members 200, 200′, for example making it possible to re-use the holding device after the filling operations, in such a way as to hold the tube of a pouch incorporating the final closure of the opening of said tube.
In another embodiment (not illustrated), the temporary fastener is designed with a closing body for at least one of the openings of the filling tubes or necks of each container intended to be held by the gripping members 200, 200′. This closing body can for example be a spike of the appropriate dimensions to be introduced at least partially into the openings of said filling tubes or necks. According to another embodiment, the temporary fastener including said closing body makes it possible to hold the at least one tube or neck of the containers held by the device of the invention, and the gripping members 200, 200′ are optional.
The holding device of the invention also includes at least one hooking element 40 for attaching the holding device 10 to another support, thus facilitating the storing, warehousing and handling of the containers held by said device. Preferably, said at least one hooking element 40 makes it possible to fix the device in a vertical support position, wherein the temporary fastener 300 is located on the upper side of the device.
In the preferred embodiment (illustrated in
The eyelet shape of the hooking elements 40, 40′ advantageously allows the handling of the holding device by a robotic system, particularly for the purpose of the automated handling of the pouches on the filling line.
Preferably, the angles or corners of the holding device of the invention are rounded to prevent the breaking of an item of packaging into which the holding device including the containers to be held might be introduced.
The holding device of the invention also includes elements allowing its lateral assembly, i.e. an assembly by the lateral faces of the device, marked when said device is in the vertical support position. In the preferred embodiment illustrated in
It is thus possible to assemble several holding devices 10 together via their lateral faces. This embodiment advantageously makes it possible to increase the longitudinal supporting surface 100 of the device, and therefore the ability to handle a greater number of containers at the same time.
In an embodiment, each location for holding a filling tube or neck of a container is advantageously numbered, thus allowing the optimized monitoring of each container held by the holding device of the invention.
Preferably, the holding device of the invention includes a different color from that of the containers to be held by the device of the invention. For example, in the case of pouches for pharmaceutical use of whitish or transparent color, the holding device includes a color forming a contrast such as blue.
The holding device 10 is made of a material resistant to sterilization by irradiation, i.e. a material that keeps its mechanical and technical properties to continue to ensure its supporting and holding function after said sterilization, and also able to not generate chemical contamination of the container to be sterilized. The device of the invention is in particular resistant to sterilization by beta rays, often used in sterilization processes for materials for pharmaceutical use. The holding device of the invention can be manufactured by plastic injection.
Preferably, the holding device 10 is made of a similar material to the material of the container to be held to avoid generating chemical contamination of said container. Specifically, the production of the holding device in a material similar to that of the containers to be held, makes it possible to avoid generating additional extractables that can migrate to the containers during sterilization, i.e. to avoid generating chemical contamination of the containers due to the possible molecules released from the holding device during sterilization. For example for a pouch-holding device, polypropylene will be preferred.
The invention thus makes provision for a holding device useful for storing, organizing, warehousing and handling containers including at least one tube or at least one neck for filling, particularly pouches for pharmaceutical use containing solutions for parenteral administration and/or Dual-Mix® pouches. The holding device of the invention can also be used with containers such as vials or ampoules including a filling neck.
For example, the holding device 10 can be used firstly for conveying open pouches by limiting the risk of contamination by particles and making it possible to have an optimized organization and monitoring of the pouches during the sterilization process. Indeed, the temporary fastener 300 of the holding device makes it possible to prevent particles entering through the openings of the containers during prior filling operations.
However, the holding device of the invention disposes of only one temporary fastener for each filling tube or neck held by the gripping members 200, 200′. In the case of a pouch including two tubes, it is necessary to block the second tube by another means, for example a connector in order to guarantee the prevention of particulate contamination.
The holding device 10 can also be used for the optimal storing of pouches before filling operations. To do this, the holding devices including the pouches are introduced into packaging bags, under vacuum or not (the device being suitable for avoiding the puncturing of these packages due to its rounded corners) and/or in cardboard boxes, by stacking them one on top of the other, to store them without excessive bulk and in an organized manner before its use.
Following the fixing of the containers in the holding device, it is possible to automate their handling owing to the hooking elements allowing the handling of the device by a robotic system thus limiting the human intervention required for the filling operations. Similarly, the hooking elements 40, 40′ facilitate the storage of the container in a locker or presentation box for storing finished products.
Number | Date | Country | Kind |
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1856309 | Jul 2018 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2019/067800 | 7/3/2019 | WO |