JP7337142B2 - Holding device for container containing filling tube and use of the device - Google Patents

Description

The present invention relates to the field of devices for storage, support and automated handling of containers for pharmaceutical use, especially prior to filling operations.

More specifically, the present invention relates to a device for holding containers having at least one fill tube or neck, such as pouches for pharmaceutical use.

Pouches are often used as containers for pharmaceutical solutions, for example, pouches contain liquid media for reconstituting solutions for parenteral administration or lyophilized solutions such as Dual-Mix® pouches. These pouches contain at least one tube that allows filling of the pouch and, if applicable, extraction of liquid from the pouch.

The use of pouches for pharmaceutical purposes requires the use of products of guaranteed safety and traceability. For certain applications, particularly aseptic procedures, these pouches should be sterilized prior to performing the filling process to prevent microbial contamination of the product to be contained in the container. These pouches or containers also need to be able to guarantee the absence of solid particle contamination and chemical contamination. However, it is understood that the device of the present invention is not limited to this type of application.

However, handling of pouches for purposes of sterilizing and filling them is a potential source of solid particle contamination and chemical contamination, contamination that cannot be remedied by sterilization of the pouches.

Contamination by solid particles is a major concern during handling of the pouches, especially filling leaving a trail for solid particles that may be airborne in the environment or carried by personnel handling the pouch. It can be produced by opening a tube tube. Chemical contamination, on the other hand, can be caused by contact between the pouch and other materials during handling and sterilization.

Therefore, when handling pouches, it is necessary to take as many precautions as possible to ensure a product that complies with pharmaceutical industry standards.

Protocols for product sterilization and conditioning require organization and close supervision, and organization is currently not facilitated by the lack of pouch-specific storage tools. The pouch organization also determines the irradiation intensity required to properly sterilize a batch of pouches and/or other containers. Therefore, when a sterilization protocol optimum is determined for a batch of containers, it is desirable to reproduce the container organization used during the determination of said protocol. Therefore, there is a need for tools for organizing containers that allow reproducible organization and storage of containers to ensure the effectiveness of container sterilization.

Similarly, there is a growing need for apparatus for storing and supporting pharmaceutical containers that allow automation of unit production operations, particularly apparatus for supporting containers that are suitable for handling the containers by robotic arms.

It is an object of the present invention to provide a holding device for containers comprising a filling tube or neck that allows handling and optimized storage of the containers, especially for the purpose of performing sterilization and filling methods.

Another object of the present invention is to provide a retention device that makes it possible to prevent particle contamination during handling prior to sterilization and filling.

To this end, the invention provides a holding device for a container having at least one fill tube or neck, said device having a support surface including a front surface defining a front surface of the holding device. The front face of the support surface has at least one gripping member for holding the filling tube or neck of a container intended to be held in a position parallel to the support surface by the device.

A holding device according to the present invention includes:
a temporary fastener for the opening of the fill tube or neck of the container intended to be held by said holding device;
and at least one hook element for attaching the retaining device to or suspending the retaining device from another support.

In one embodiment, the temporary fastener is formed by a wall extending substantially perpendicular to the front surface of the support surface, the wall being arranged parallel to the at least one gripping member.
This wall forming the temporary fastener may also have, alone or in combination, the following functions.
- the wall corresponds to at least one upper surface of the support surface placed in a vertical position;
- the wall abuts at least one gripping member;

In one embodiment, the temporary fastener comprises a closure such as a spike that can be at least partially introduced into the opening of at least one fill tube or neck of the container intended to be held by the holding device. have.

In a preferred embodiment of the invention, the holding device has a plurality of gripping members, which are formed by longitudinal depressions in the front face of the support surface, the depressions intended to be held by the holding device. It has a recessed section of sufficient width to at least partially insert the filling tube or neck of a closed container.

In another embodiment, the retaining device has a second indentation parallel and substantially symmetrical to the first indentation. These two parallel indentations thus form a plurality of gripping members, where the concave section is aligned between the two indentations to determine the position of the container.

A retaining device according to the invention can also have a male assembly element on one of its sides and a female assembly element complementary to the male assembly element on the opposite side. This embodiment allows assembling several strips together and increasing the dimensions of the device in the longitudinal plane.

In one embodiment of the invention, the retaining device has at least two hook elements in the form of eyelets and the corners of the retaining device are rounded.

The retainer may be made of a material that is resistant to sterilization by irradiation and/or made of a material similar to that of the container it is intended to hold, such as polypropylene. This embodiment makes it possible to avoid creating additional extracts during sterilization.

The invention also relates to the use of the holding device of the invention for storing one or more pouches containing at least one filling tube and/or vials containing a filling neck.

Other advantages, objects and specific configurations of the present invention will become apparent from the following description given, which is illustrative and by no means limiting, with reference to the accompanying drawings.

1 is an isometric representation of a retaining device according to the present invention; Fig. 4 is another representation in an isometric view of a retaining device according to the present invention;

First of all, it should be noted that the invention has been described with reference to its purpose, i.e. the container for which the retaining device is designed. Nevertheless, the container is not part of the invention.

In particular, the invention relates to a holding device for a container held by said device for gripping the fill tube or neck of said container. To this end, the device includes a support surface including a front surface that also defines the front surface of the retaining device and on which the at least one gripping member resides.

In the following description, the vertical orientation of the holding device is considered in which the filling tube or neck is held by at least one gripping member in a vertical position and is substantially parallel to the support surface. When the holding device is in this vertical position, it will have reference marks on the top and bottom. The pouch held by the gripping member has, according to these reference marks, the opening of the filling tube and the body of the container directed towards the upper side of the device, i.e. the pouch is on the lower side and/or the holding under the device.

Figures 1 and 2 show a preferred, non-limiting example of the invention in which the holding device has a general strip shape and is designed to hold a tube for filling a plurality of containers, in particular pouches. 1 shows an embodiment. However, the shape, size and number of containers that can be held by the device are non-limiting and therefore some variations are possible without departing from the scope of the invention.

1 and 2 show an isometric representation of a retaining device 10 according to the invention. FIG. 1 shows the device from elevation, giving priority to the representation of the underside of the device. FIG. 2 also shows the holding device 10 from an elevation angle, with priority being given to the view of the upper side of the device.

As seen in Figures 1 and 2, the retention device 10 includes a support surface 100 that includes a front surface on which a plurality of gripping members reside. Each gripping member is used to hold the fill tube of the container in a position substantially parallel to the support surface. In this embodiment, the gripping member is formed by a first recess 200 longitudinally arranged in front of the support surface and a second recess 200' parallel to the first recess.

The term "indentation" is understood herein to mean an alternating succession of concave sections 250 and solid sections 260 on the support surface of the device. When the device is placed in a vertical position, the first indentation 200 is considered the upper indentation and the second indentation 200' is considered the lower indentation.

Each recess 200, 200' includes a plurality of recessed sections 250 that determine the position of the tube or neck of the container held by the device of the present invention. The container tube or neck is inserted by applying pressure to the recessed sections 250 of the recesses 200, 200' to attach them to the retaining device, the dimensions of the recessed sections 250 being the dimensions of the fill tube or neck of the container to be retained. is selected as a function of In the illustrated view, the recessed section 250 has a width and depth suitable for filling tubes of pouches for pharmaceutical applications.

Advantageously, the solid sections 260 of the recesses 200, 200' have flat surfaces to allow the devices to be stacked together. Similarly, the bottom of each concave section 250 includes a rounded shape that matches the shape of the fill tube.

The use of indentations 200, 200' as gripping members optimizes storage space while facilitating manufacturing, allowing a small space to accommodate a significant number of containers. In other embodiments, the device is designed with other known types of gripping members, such as pliers.

In the preferred embodiment, the provision of two symmetrical parallel recesses 200, 200' in the top and bottom advantageously allows each tube to be attached to the two sections at different heights, thus reducing the number of recesses. The pressure required to secure the tube in concave section 250 is limited, allowing improved support of the container by the retainer.

The retaining device of the present invention is advantageously designed to prevent particulate contamination of containers held and processed for purposes of sterilization and filling operations. For this purpose, the holding device includes temporary fasteners for opening the filling tube or neck of the container held by said device.

In the embodiment shown in FIGS. 1 and 2, the temporary fasteners extend generally perpendicular to the front surface of the support surface and along the longitudinal axis relative to the plurality of gripping members 200, 200'. It is formed by parallel arranged walls 300 . In this way a temporary closure of the opening of the filling tube of the container is obtained, especially when the tube is introduced into the gripping member such that its opening abuts said wall. The wall 300 forming the temporary fastener is therefore of sufficient size to close said opening.

When the retention device 10 is placed in a vertical position so that the pouch and its fill tube are also vertically supported, the temporary fasteners are located on the top side of the retention device and above the at least one gripping member 200, 200'. It is considered that In the embodiment shown in Figures 1 and 2, the wall 300 forming the temporary fastener abuts the upper recess 200 so that when the device is placed in a vertical position, the upper surface of the retainer 10 is also aligned. Also define. This embodiment advantageously allows the walls of the solid section 260 of the upper recess 200 to be used to improve closure of the opening of the tube.

In another embodiment (not shown), it is possible to design the device with a space between the wall 300 and the gripping members 200, 200', e.g. In such a way as to retain the tube of a pouch incorporating a tight closure, it is possible to reuse the retaining device after the filling operation.

In another embodiment (not shown), the temporary fastener is a closure for at least one of the openings in the fill tube or neck of each container intended to be held by the gripping members 200, 200'. Designed with a body. This closure may, for example, be an appropriately sized spike that is at least partially introduced into the opening of the filling tube or neck. According to another embodiment, the temporary fastener comprising said closure makes it possible to hold at least one tube or neck of a container held by the device of the invention and comprises gripping members 200, 200. ' is optional.

The retaining device of the present invention also includes at least one hook element 40 for attaching the retaining device 10 to another support, thus facilitating storage, loading and handling of the containers retained by said device. Preferably, said at least one hook element 40 allows the device to be secured in a vertical support position, and a temporary fastener 300 is located on the upper side of the device.

In a preferred embodiment (shown in Figures 1 and 2) the retainer comprises two hook elements 40, 40' extending from the upper surface of the retainer, said hook elements comprising an eyelet shape. Each eyelet is located on an opposite longitudinal side of support surface 100 and is used to mount retainer 10 in a vertical position such that support surface 100 extends longitudinally along a horizontal axis.

The eyelet shape of the hook elements 40, 40' advantageously allows handling of the holding device by robotic systems, especially for the purpose of automatic handling of pouches on a filling line.

Preferably, the corners or corners of the retaining device of the present invention are rounded to prevent breakage of packages into which the retaining device, including the container to be retained, may be introduced.

The holding device of the invention also comprises elements that allow its lateral assembly, ie the assembly by the side of the device which is marked when said device is in the vertical support position. In the preferred embodiment shown in Figures 1 and 2, the retention device includes a male assembly element 60 on one side of the device. This male assembly element complements the female assembly element 70 located on the opposite side of the device.

It is therefore possible to assemble several holding devices 10 together via their sides. This embodiment advantageously allows for increasing the longitudinal support surface 100 of the device and thus increasing the capacity to handle more containers simultaneously.

In one embodiment, each position for holding the fill tube or neck of a container is advantageously numbered, thus allowing optimized monitoring of each container held by the holding device of the present invention.

Preferably, the retaining device of the invention comprises a color different from the color of the container retained by the device of the invention. For example, in the case of a whitish or clear colored pharmaceutical pouch, the retainer includes a contrasting color such as blue.

The holding device 10 is made of a material that is resistant to sterilization by irradiation, i.e. retains its mechanical and technical properties to ensure its support and holding function even after said sterilization, and also the chemical properties of the container to be sterilized. made of materials that cannot cause physical contamination. The device of the invention is particularly resistant to sterilization by beta radiation, which is often used in the sterilization process of materials for medical use. The retaining device of the invention can be manufactured by plastic injection.

Preferably, the holding device 10 is made of a material similar to that of the container to be held, in order to avoid chemical contamination of said container. Specifically, by manufacturing the retainer with a material similar to the container to be retained, it avoids the production of additional extractables that may migrate into the container during sterilization, i.e., the retainer during sterilization. It is possible to avoid the occurrence of chemical contamination of the container by molecules that may be released from the For example, for a pouch retainer, polypropylene would be preferred.

Accordingly, the present invention provides a container comprising at least one tube or at least one neck for filling, in particular pouches for pharmaceutical use and/or Dual-Mix® pouches containing solutions for parenteral administration. , holding devices useful for organizing, warehousing and handling. The retention device of the present invention can also be used with containers such as vials or ampoules that include fill necks.

For example, the retention device 10 can be used primarily for carrying open pouches by limiting the risk of particle contamination and allowing optimized organization and monitoring of the pouches during the sterilization process. . In fact, the temporary fastener 300 of the holding device makes it possible to prevent particles from entering through the opening of the container during the previous filling operation.

However, the retention system of the present invention places only one temporary fastener for each fill tube or neck retained by gripping members 200, 200'. For pouches containing two tubes, the second tube must be closed by another means, eg a connector, to ensure prevention of particle contamination.

The holding device 10 can also be used for optimal storage of pouches prior to filling operations. To do this, the holding device, including the pouches, may or may not be under vacuum (the device has rounded corners which is suitable for avoiding bursting of these packages) and/or it may be exposed to excess pressure before use. To store them in a compact and organized way, they are placed in a packaging bag by stacking them inside a cardboard box.

Following the fixation of the container in the holding device, their handling can be automated due to the hook elements, which make it possible to limit the handling of the device by robotic systems and thus the human intervention required for the filling operation. . Similarly, hook elements 40, 40' facilitate storage of the container in a locker or presentation box for storing finished products.

Claims (8)

A holding device (10) for a container having a fill tube or neck, said holding device (10) having a support surface (100) having a front surface defining a front surface of said holding device (10), said Said front face of the support surface (100) has at least one gripping member for holding at least one filling tube or neck of a container intended to be held in a position parallel to said support surface by said holding device. and the holding device is
Temporary fastener for the opening of at least one filling tube or neck intended to be held by said holding device , extending substantially perpendicular to said front face of said support surface (100) It is formed by a wall (300), said wall being arranged parallel to said at least one gripping member (200), said wall (300) forming said temporary fastener being connected to said at least one gripping member (200). a temporary fastener abutting the gripping member (200) ;
at least one hook element (40) for attaching the holding device to another support or for suspending the holding device from another support. 2. Retaining device according to claim 1 , wherein the wall (300) forming the temporary fastener corresponds to the upper surface of the support surface (100) placed in a vertical position. Said temporary fastener may be introduced at least partially into said opening of said at least one filling tube or neck of said container intended to be held by said holding device (10), such as a spike. 3. A retaining device according to claim 1 or 2 , having a closure of . Said holding device (10) comprises a plurality of gripping members (200), said gripping members being formed by longitudinal depressions (200) in front of said support surface (100), said depressions (200) being , a recessed section (250) of sufficient width to at least partially insert the filling tube or neck of the container intended to be held by the holding device (10). or a holding device according to claim 1. 5. Retaining device according to claim 4 , wherein the retaining device (10) has a second recess (200') parallel to and substantially symmetrical to the first recess (200). The holding device (10) has a male assembly element (60) on one of its sides and a female assembly element (70) complementary to the male assembly element on the opposite side. Item 6. The holding device according to any one of items 1 to 5 . Said retaining device (10) has at least two hook elements (40, 40') in the form of eyelets, said retaining device has a general strip shape and the corners of said retaining device are rounded. A holding device according to any one of claims 1 to 6 , wherein the holding device comprises: The holding device (10) is made of a material that is resistant to sterilization by irradiation and/or of which the container intended to be held by the device is made, such as polypropylene. A holding device according to any one of the preceding claims, wherein the holding device is made.

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