Tool for holding a sealed transport bag in an autoclave sterilization facility

Abstract

An autoclave sterilization installation for a transport bag (12) provided with a flexible container and a rigid connection portion, the flexible container being connected to the rigid connection portion by a weld, the weld being contained in a plane substantially perpendicular to the longitudinal axis of the connection portion, this plane being called the weld plane, the installation comprising an autoclave sterilization enclosure and a support (50) containing: a support plate (52) configured to be housed in the enclosure, the bag (12) being intended to be placed on the support plate (52) and the rigid connection portion facing away from the support plate (52), and a holding tool (01) placed on the bag (12) in order to limit the mechanical stresses at the weld.

Description

TECHNICAL FIELD

[0001] The present invention relates to a tool for holding a bag in an autoclave sterilization installation, and more particularly to a bag for a double door fluid tight transfer system. BACKGROUND

[0002] In several industrial sectors, notably the nuclear, medical, pharmaceutical and agricultural sectors mentioned, it is necessary or desirable to carry out certain tasks in a confined environment, in order to protect the environment from the effects of, for example, radioactivity, toxicity, etc., or, conversely, to be able to carry out these tasks in a sterile or dust-free environment, or finally for both of the above reasons.

[0003] Transferring a device or a product from one closed volume to another closed volume, without the fluid tightness of each of these volumes with respect to the outside being broken at any time, poses a difficult problem to achieve. This problem can be solved by a double door connection device.

[0004] Such a double door device provided with multiple safety controls is known, for example, from document FR 2 695 343. Each volume is closed by a door mounted on a flange. Each door is engaged with its flange by a bayonet connection or by a hinge and locking system, and the two flanges are intended to be engaged with each other via a bayonet connection.

[0005] For example, one of the closed volumes is formed by an isolator, and the other volume is formed by a flexible container or a fluid tight transfer bag.

[0006] Conventionally, the connection part carried by the isolator is designated the alpha part, and the connection part carried by the container is designated the beta part.

[0007] Seals are provided on the alpha part and on the beta part, to ensure the fluid tightness between the volumes connected.

[0008] Generally, such bags are intended for the aseptic transfer of small parts such as caps, syringe plungers, plastic bottles, etc. on filling lines in the pharmaceutical industry.

[0009] The sterilization can be a steam sterilization by means of an autoclave or a gas sterilization by means of ethylene oxide (EtO).

[0010] The transfer bag adapted to be sterilized via an autoclave or EtO comprises a flexible container comprising two faces, at least one of which forms a water-impermeable but vapor- and gas-permeable microbial barrier. For example, the flexible container comprises a face formed of a non-woven textile sheet of high-density polyethylene fibers, for example under the brand name Tyvek® sold by the company DuPont, and a face made of extruded polyethylene.

[0011] ​The beta part comprises a flange, a door, a seal providing fluid tightness between the flange and the door, and a clamping ring. A connector is welded on the edge of a cut made in the face made of extruded polyethylene. The connector is assembled to the flange by means of the clamping ring.

[0012] The general temperature applied during the autoclave cycle is about 120-125°C up to 134°C in order to shorten the sterilization time. These temperatures are close to the melting temperature of the material of the flexible container. Moreover, a phase of pressure variation occurs, causing a phase of expansion of the flexible container and a phase of retraction.

[0013] Generally, the sterilization installation comprises stacks each receiving at least one bag. In order to increase the number of bags sterilized per sterilization cycle, the height of each stack can be reduced. However, during the expansion phase, the bags located in the lower stacks press against the bottom of the upper stacks. The bags cannot move freely, thereby exerting a mechanical tension, in particular at the weld of the extruded polyethylene film of the connector, so that a weak zone is created, which creates a risk of film tearing during the sterilization cycle or during the handling of the bags, in particular during the connection of the bags to the fluid tight enclosure.

[0014] Therefore, it is sought to reduce the risk of occurrence of such a weak zone. SUMMARY

[0015] Therefore, the object of the present invention is to provide a means allowing autoclave sterilization of bags for a double door fluid tight transfer system, thereby limiting the risk of occurrence of a weak zone on the bags.

[0016] The above mentioned object is reached by means of a means for holding bags for a double door fluid tight transfer system in an autoclave sterilization installation, the bags comprising a connector and a flexible container, the means providing holding of the flexible container at the end thereof where the connector is provided, in such a way as to attenuate the effect of the traction force on the weld between the connector and the flexible container.

[0017] The inventors have found that, by holding the bag at least during the expansion cycle, the risk of occurrence of a weak zone is significantly reduced.

[0018] The holding means make it possible to preserve the integrity of the bag by protecting the weld line between the connector or the flange and the flexible container.

[0019] Particularly advantageously, the holding means provide a reorientation of the traction force exerted on the flexible container, then in a plane of the weld of the film on the connector, and not according to the angle in the sterilization systems of the prior art. Therefore, the weld is less solicited during the expansion phase.

[0020] In a more preferred embodiment, the holding member comprises a tool provided with a face intended to contact the face of the bag comprising the connector, the face comprising a first portion extending in a plane intended to rest on the lateral face of the connector and a second portion extending the first portion and having a curvature intended to be oriented away from the bag.

[0021] The flat first portion provides an orientation of the traction force in the plane of the weld between the connector and the flexible container and the second curved portion hugs the shape of the bag when it is inflated, thereby providing a distribution of the force over a large surface.

[0022] The first portion and the second portion are rigid enough to not deform the bag under the effect of inflation.

[0023] Advantageously, the size of the second curved portion is chosen relative to the height of the shelf so that the free distance between the free end of the curved portion and the shelf positioned above is limited and preferably prevents the bag from folding over the tool.

[0024] The application therefore aims to an autoclave sterilization installation for a bag provided with a flexible container and a rigid connection portion having a longitudinal axis, the flexible container being connected to the rigid connection portion by a weld, the weld being contained in a plane substantially perpendicular to the longitudinal axis of the connection portion, this plane being called the weld plane, the installation comprising an autoclave sterilization enclosure and a support comprising at least one support plate configured to be housed in the enclosure, at least one bag intended to rest on the support plate, the rigid connection portion being oriented opposite the support plate, and a holding tool intended to rest on the flexible container in such a way as to limit the displacement of the flexible container relative to the rigid connection portion.

[0025] Preferably, the support comprises a number of superimposed support plates and at least one holding tool associated with each support plate.

[0026] Advantageously, the holding tool has a size in the direction orthogonal to the support plate that is less than the distance between two superimposed support plates.

[0027] The application also aims to a holding tool for an autoclave sterilization installation according to the application, comprising a first portion provided with a flat face intended to rest near the rigid connection portion and near the bag in such a way that the flat face is in the weld plane or substantially in the weld plane, and a second portion provided with a curved face intended to be oriented by moving away from the support plate.

[0028] Preferably, the tool is rigid enough to deform little under the effect of the inflation of the bag during the autoclave cycle.

[0029] Advantageously, the transverse dimension of the first portion is at least equal to the transverse dimension of the flexible container of the bag.

[0030] According to an additional feature, the holding tool comprises a member for engaging with a support plate of the installation.

[0031] According to an additional feature, the holding tool comprises a member intended to at least partially cling to the rigid connecting portion of the bag.

[0032] For example, the first portion comprises a polygonal section tube, the flat faces being formed at least by the faces of said tube, and the second curved face comprises a curved plate and a stiffener ensuring its rigidity.

[0033] The holding tool can comprise a member fastened to the rigid connecting portion in a given relative position, in such a way that the flat face of the first portion is contained in the plane of the weld.

[0034] The object of the application is also a support plate for a support of an autoclave sterilization installation and an assembly of a holding tool according to the application.

[0035] The support plate can comprise a member cooperating with a member for engaging the holding tool.

[0036] The object of the application is also an autoclave sterilization installation implementing a holding tool according to the application and an autoclave sterilization method of a holding tool according to the application, comprising:

[0037] - positioning at least one bag on a support plate.

[0038] - positioning a holding tool on said bag.

[0039] - positioning the support plate loaded with said bag and holding tool in an autoclave enclosure.

[0040] - performing an autoclave cycle.

[0041] - removing said bag.

[0042] Advantageously, the autoclave sterilization method applies to a fluid-tight transfer bag. BRIEF DESCRIPTION OF DRAWINGS

[0043] The application will be better understood on the basis of the following description and the attached drawings, in which:

[0044] Figure 1A Longitudinal cross-sectional view of a transfer bag on a unit, showing the connection by means of a double door fluid-tight transfer device.

[0045] Figure 1B Explanatory view of only the beta portion.

[0046] Figure 2A isometric view of an example of a bag for a fluid tight transfer system capable of being sterilized by an autoclave sterilization facility.

[0047] Figure 2B is a side view of a connection area between a connector and a flexible container.

[0048] Figure 3A is a side view schematically illustrating an example of a support for an autoclave facility.

[0049] Figure 3B is a detail view of a holding tool at a facility of Figure 3A

[0050] Figure 4 is an isometric view of an example of a holding tool implemented in an autoclave facility.

[0051] Figure 5 is a side view of a holding tool of Figure 4

[0052] Figure 6 is an isometric view of another example of a holding tool.

[0053] Figure 7 is an isometric view of another example of a holding tool.

[0054] Figure 8A is a side view of another example of a beta holding tool.

[0055] Figure 8B is a top view of a holding tool of Figure 8A DETAILED DESCRIPTION

[0056] In the following description, the application will be described with reference to the application of holding a fluid tight transfer bag, wherein the flange of the bag is connected to a flexible container, for example by means of a clamping ring that engages the flange with a container welded on the flexible container. The application also applies to the holding of a bag whose flexible container is directly welded on the flange.

[0057] In the present application, the expression "substantially in the same plane" is used to define two components located in the same plane or two components in two planes with a small angle between them, the angle being less than 20°.

[0058] Figure 1A A schematic representation of a double door fluid tight transfer system is shown, in which a flexible transfer bag according to the application can be implemented.

[0059] Generally, a double door transfer system has a rotational symmetry around an axis X, which is the axis of the isolator flange.

[0060] ​​​In the following description, the two closed volumes to be connected correspond respectively to the isolator 10 and to the flexible container 12.

[0061] The isolator 10 is delimited by a wall 14, only part of which is shown. Figure 1A Conventionally, the isolator 10 is for example equipped with remote means for the operation, such as a remote manipulator and / or a glove (not shown) engaged with the wall 14, thanks to which a centralized control mechanical device can be manipulated from the inside of this unit 10. The container 12 is also delimited by a wall 16, as shown in particular in Figure 1A The wall 16 is formed by a flexible bag, obtained for example by welding two sheets (for example of rectangular shape) of film via the edges. The bag comprises an opening fastened in a sealed manner to a flange.

[0062] The double-door fluid-tight transfer device mainly comprises an isolator flange 18, a container flange 20, an isolator door 22 which generally closes the circular opening delimited by the isolator flange 18, and a container door 24 which generally closes the opening delimited by the container flange 20. The isolator flange 18 and the container flange 20 are fastened respectively on the wall 14 of the unit 10 and on the wall 16 of the container 12. In this example, the door of the isolator 22 is hinged on the isolator flange 18 by means of a hinge 26.

[0063] The means generally designated by the reference 28 make it possible to control the opening and the closing of the doors 22 and 24.

[0064] The fastening of the container door 24 on the container flange 20 is for example ensured by a bayonet joint 30, as described in the document FR 2695 343. In order to allow the engagement of the container flange 20 on the isolator flange 18 and the engagement of the container door 24 on the isolator door 22, for example, the double-door fluid-tight transfer system also comprises two other bayonet joints, designated respectively by the references 32 and 34. The three bayonet joints 30, 32 and 34 are arranged in such a way that, after the container flange 20 has been placed alongside the isolator flange 18, the rotation of the container 12 around its axis, for example in the clockwise direction, has the effect of engaging the container flange 20 with the isolator flange 18, of engaging the container door 24 with the isolator door 22, and of disengaging the container door 24 from the container flange 20. The last two operations are carried out consecutively, in such a way that the opening of the container only occurs after the container door 24 has been engaged with the isolator door 22 to form a double door.

[0065] The assembly formed by the isolator flange and the isolator door is generally designated as the "alpha part".

[0066] The assembly formed by the container flange 20, the door 24 of the container and the seal 25, which is mounted on the flange and ensures the fluid-tightness between the flange and the door and between the flange and the fluid-tight transfer device, is generally designated as the "beta part".Figure 1B The assembly is shown. In this example, the beta part also contains a connector 36 intended to be fastened to the flexible container, a clamping ring 38 to engage the connector with the flange, and a seal 40 interposed between the flange 20 and the connector 36, so as to ensure the fluid tightness of the assembly.

[0067] The connector 36 comprises an annular base 36.1 and a tubular sleeve 36.2. The annular base is intended to be welded to one of the sheets of the flexible container, and the tubular sleeve is intended to engage the flange via the clamping ring.

[0068] During creation of the weld, the annular base 36.1 and the sheet 46 are substantially in the same plane.

[0069] The transfer bag then comprises a beta connection part and a flexible container.

[0070] Figure 2A An example of a transfer bag 12 is shown, comprising a beta connection part (similar to the beta connection part in Figure 1B ) and a flexible container 42.

[0071] Figure 2B The flexible container 42 is shown, comprising for example a wall 44 and a wall 46, wherein the wall 44 is made of a non-woven textile of high-density polyethylene fibers (for example sold under the brand ), and the wall 46 is made of extruded high-density polyethylene.

[0072] The two walls 44, 46 are sheets, in the illustrated example rectangular, superposed at their outer edges and welded to each other. The shape of the sheets can be different, for example sheets in the shape of a disc are within the scope of the invention.

[0073] The wall 46 comprises an opening in its outer contour to which the connector 36 is welded.

[0074] Figure 2B A detail view of the weld S between the connector and the outer contour of the wall 46 is shown. The weld S is contained in a plane P.

[0075] The flange is assembled on the tubular sleeve 36.2 of the connector 36 in a fluid-tight manner by means of the seal and the clamping ring.

[0076] Figure 3A A side view of a schematic representation of an example of a support of an autoclave installation loaded with a transfer bag is shown. In this representation, the bag is in an inflated state.

[0077] The support 50 comprises several shelves, in the example shown five shelves, each loaded with a bag. Each shelf comprises a support plate 52 on which rests a bag. The bag 12 is in contact with the support via the wall 44 which does not comprise a flange. The distance h between the two support plates 52 is sufficient to accommodate the flange of the bag, without the flange of the bag coming into contact with the upper support plate. The support plates 52 are held relative to each other by vertical uprights 54.

[0078] Preferably, the support plates 52 are perforated so as to allow circulation of the sterilization fluid.

[0079] Advantageously, the support 50 is provided with castors 56 so as to facilitate positioning of the support 50 and removal of the support 50 from the sterilization enclosure.

[0080] The support 50 also comprises, for each transport bag, a retaining member 58 configured to retain the bag, and more particularly the part of the flexible container 42 located in the vicinity of the flange, in such a way as to at least limit, advantageously prevent, displacement thereof, so that the annular base 36.1, the weld S and the sheet 46 remain in substantially the same plane or indeed a plane which is virtually coincident.

[0081] The retaining member 58 comprises a tool Oi comprising at least one first portion 60 intended to come into contact with the flexible container.

[0082] In this example, the first portion 60 comprises a flat surface 62 formed at least by the face of a stem 63 of axis Y.

[0083] The width of the stem depends on the size of the bag. It is generally of the order of a few centimetres, for example between 1.5 cm and 10 cm.

[0084] The tool Oi also comprises a second portion comprising a curved face 64 extending the first flat face 62 and also intended to come into contact with the flexible container 42, mainly during the sterilization phase during which the container is inflated. The second curved face 64 is in close contact with the bag when it is inflated. The radius of curvature is chosen so as to follow the natural radius of the bag when it is inflated, and in this way prevents the bag from folding over the tool.

[0085] In this example, the tool Oi is fastened to the support plate on which the bag is placed. For example, the tool Oi comprises a member 61 which cooperates with a member of the support plate so as to ensure its fixing relative to the plate. For example, the longitudinal end of the stem 63 comprises a hole through which a screw is screwed into the support plate, or the longitudinal end comprises a member which clamps the edge of the support plate. The tool Oi is then fastened to the support plate 52 on either side of the bag 12, taking into account its axis X.

[0086] The forces to which the tool O1 is subjected during the inflation phase of the bag are very significant. More particularly for this tool, the first flat face and the second curved face are implemented sufficiently rigid so as not to deform or little deform when the bag inflates.

[0087] In this example, the first part 60 comprises a stem 63 formed from a tube with a rectangular section, for example made of stainless steel, and having excellent rigidity for bending, and the second curved face 64 comprises a curved sheet, for example made of stainless steel. Advantageously, a stiffener 65 is provided on the face of the sheet opposite the face intended to come into contact with the flexible container. In this example, the stiffener 65 is a vertical plate fastened to the tube and to the sheet, for example by welding. The first flat face 62 and the second curved face 64 are welded to one another. Alternatively, a thick rigid sheet can be implemented for forming the first flat face and / or the second curved face, however such a tool would have a higher mass. Furthermore, as another alternative, the first flat face and the second curved face are made from a single piece, for example a single sheet provided with stiffeners to give the single sheet sufficient rigidity.

[0088] The operation of the holding tool O1 will now be described.

[0089] The bag 12 is placed on the support plate 52 with the face of the bag not provided with a flange in contact with the support plate 52.

[0090] The tool O1 is placed above the bag on the side on which the flexible container extends, at the level of the area located as close as possible to the flange 20. The first flat face 62 is intended to be supported with the flexible container and at the side of the flange.

[0091] The tool O1 is then fastened on the support plate 52 to fix the relative position of the tool and the bag.

[0092] The transport bags are placed on all the support plates and the holding tools are positioned on each bag. In this example, the bags are loaded with elements which will then be sterilized simultaneously. In another example, empty bags are sterilized.

[0093] For example, after the bags and the tools O1 are positioned, the support plates are arranged one above the other.

[0094] The support 50 is then placed in a sterilization enclosure (not shown).

[0095] The sterilization cycle begins. The air in the enclosure is removed and replaced with steam in order to saturate the volume of the enclosure. The pressure in the enclosure increases via the injection of steam. The pressure in the enclosure varies during the sterilization cycle, causing the bags to inflate and retract.

[0096] When the bag is inflated, the bag is held in the area close to the flange in such a way that the membrane 46 of the connector 36 and the base 36.1 are maintained in substantially the same plane thanks to the tool Oi. The membrane 46 is then substantially maintained in the plane of the weld S. The traction force F is thus maintained in the plane of the weld, reducing the risk of damaging the weld Figure 3B

[0097] Furthermore, when inflated, the membrane 46 is tight against the first flat face 62 and the second curved face 64. The second curved face 64 provides continuity with the first flat face 62, preventing the bag from coming into contact with the line which would weaken the bag. The traction force is distributed over the entire surface of the second curved face 64. The greater the radius of curvature of the second curved face 64, the greater the traction force exerted by the inflated flexible container which is distributed over a large surface.

[0098] Thus, thanks to this holding tool, the risk of a weak zone appearing around the flange is reduced.

[0099] The tool has a length I which is at least equal to the diameter of the connector 36 and preferably at least equal to the transverse dimension L of the bag 12, which makes it possible to prevent a section from breaking at the end of the tool when the bag is inflated.

[0100] Preferably, when the bag 12 is placed on the support plate 52, with another support plate 52 placed above the support plate 52 and the bag able to be held in place, the free end of the second curved surface is positioned relatively close to the upper plate in order to prevent the bag from folding over the second curved portion.

[0101] Preferably, the edge of the first flat face 62 and the free end of the second curved face 64, oriented towards the connector, are configured to limit the risk of damaging the bag. For example, the edge and the free end have a circular cross section along the transverse cross section, the radius of curvature of which is sufficiently great so as not to risk degrading the bag.

[0102] Figure 6 Another embodiment of a holding tool O2 is illustrated.

[0103] In this example, the holding tool is configured to cooperate with the beta portion. The holding tool O2 comprises a portion 66 in the form of a ring which engages the first flat portion 60 and is intended to surround the beta portion. The inner diameter of the ring 66 is slightly greater than the outer diameter of the beta flange, the gap allowing the passage of the portion 66 around the flange. The ring makes it possible to fix the position of the tool relative to the beta flange. Thus, the beta flange no longer has any degree of freedom of movement, which makes it possible to overcome the variability of the positioning of the bag by the operator on the rack relative to the holding tool.

[0104] Figure 7 ​Another example of a holding tool O3 is shown, the holding tool O3 comprising a portion 68 which engages the first flat portion and forms a housing partially around the beta portion (e.g. 180° or less than 180°). The portion 68 makes it possible to position the flange abutting the tool and to inhibit variability of the positioning of the beta flange relative to the tool. Furthermore, easier positioning relative to the ring is provided.

[0105] Figure 8A and Figure 8B Another example of a holding tool O4 is shown, the holding tool O4 being configured to engage the beta portion of the transport bag. The holding tool comprises fastening means 69 for fastening to the beta portion in such a way as to orient and maintain the first flat face 62 in the plane of the weld S.

[0106] In this example, the fastening means 69 comprise two parallel plates 70 between which the clamping ring of the beta portion is received. Each plate 70 comprises a first straight edge 70.1 fastened on the longitudinal face of the stem 63, and a second edge 70.2 opposite the first edge 70.1, the second edge 70.2 being a concave circular arc extending over a number of 180° and having a radius such that the second edge 70.2 surrounds the radius of the beta portion on either side of the clamping ring. The two plates 70 are substantially parallel to the flat face.

[0107] When the clamping ring mounted around the connector and the flange is received between the two plates 70, the flange is positioned abutting the tool and the variability of the positioning of the beta flange relative to the tool is inhibited. An axial clearance can be provided between the clamping ring and the plates 70. Alternatively, the clamping ring is held between the plates, for example by clamping or by snap fit.

[0108] The holding tool is then engaged with the bag and the flat face is parallel to the membrane 46 in the plane of the weld. When the bag is inflated, this provides a hold on the orientation of the traction force in the plane of the weld or substantially in the plane of the weld, due to the orientation of the first flat face 62 being fixed relative to the flange. The engagement of the holding tool with the beta portion has the advantage of allowing the relative position between the weld and the tool, more particularly the first flat portion, to be controlled very well, since this position is fixed by the dimensions of the holding tool.

[0109] Alternatively, the fastening means 69 comprise a clamping ring intended to be mounted around, for example, the clamping ring 38.

[0110] The tool O4 can be mounted on the flange before or after the bag is positioned on the support plate 52.

[0111] In the alternatives O2, O3 and O4, the holding tool is configured to engage with the support plate on which the bag is placed. For example, the holding tool comprises a portion which engages the first flat portion and forms a housing partially around the beta portion (e.g. 180° or less than 180°). The portion makes it possible to position the flange abutting the tool and to inhibit variability of the positioning of the beta flange relative to the tool. Furthermore, easier positioning relative to the ring is provided. Figure 4The tool's fastening components are similar to fastening components.

[0112] Because this invention reduces the risk of damage to the welded parts via the traction of the bag, shorter autoclave cycles can be envisioned due to the faster descent into a vacuum. Therefore, sterilization productivity can be increased.

[0113] Furthermore, the tool makes it possible to have a reduced internal support plate space, thus making it possible to increase the number of cycle bags per autoclave.

[0114] Figure 4 and Figure 5 The tool is described in an application for holding a single bag together. The tool can be applied to several bags placed close together, wherein a rod 63 extends from one side of a row of bags to the other. A component for securing the rod to a support plate between two bags is conceivable.

[0115] In another embodiment, the retaining tool engages with the upper support plate. The retaining tool is then simultaneously positioned to the stack of the support plate and directly relative to the lower bag intended to be retained.

[0116] Advantageously, the tool is made of stainless steel, which provides significant rigidity and excellent resistance to sterilization via autoclave (steam, temperature, pressure).

Claims

1. An autoclave sterilization installation for a bag provided with a flexible container (42) and a rigid connection portion having a longitudinal axis, the flexible container (42) being connected to the rigid connection portion by a weld (S) contained in a plane, called weld plane, substantially perpendicular to the longitudinal axis of the rigid connection portion, the autoclave sterilization installation comprising an autoclave sterilization enclosure and a support (50), the support (50) comprising: at least one support plate (52) configured to house at least one bag (12) in the autoclave sterilization enclosure, the bag being intended to be placed on the support plate (52), the rigid connection portion being oriented opposite the support plate (52): and a holding tool (01, 02, 03, 04) intended to be placed on the flexible container (42) in such a way as to be as close as possible to the rigid connection portion and to be fastened to the support plate (52) on either side of the bag (12), so as to limit the displacement of the flexible container (42) relative to the rigid connection portion.

2. The autoclave sterilization facility of claim 1, wherein, The support (50) comprises several superimposed support plates (52) and at least one holding tool (01, 02, 03, 04) associated with each support plate (52).

3. The autoclave sterilization facility according to claim 1 or 2, wherein, The holding tool (01, 02, 03, 04) has a dimension in a direction orthogonal to the support plate (52) that is less than the distance between two superimposed support plates (52).

4. A holding tool for an autoclave sterilization facility according to one of claims 1 to 3, comprising: a first portion (60) provided with a flat face (62) intended to be placed in the vicinity of the rigid connection portion and in the vicinity of the bag, so that the flat face (62) is in the weld plane or substantially in the weld plane; and a second portion provided with a curved face (64) intended to be oriented by moving away from the support plate (52), wherein the first portion (60) comprises a tube having a polygonal section, the flat face (62) being formed by at least one face of the tube, and wherein the curved face (64) comprises a curved plate and a stiffener (65) ensuring the rigidity of the curved face.

5. The holding tool according to claim 4, wherein The transverse dimension of the first portion (60) is at least equal to the transverse dimension of the flexible container (42) of the bag.

6. The holding tool according to claim 4 or 5, comprising means for engaging (61) with a support plate (52) of the autoclave sterilization installation.

7. The holding tool according to claim 4 or 5, comprising means (66, 68) intended to at least partially surround the rigid connection portion of the bag.

8. The holding tool according to claim 4 or 5, comprising fastening means (69) fastened to the rigid connection portion in such a way that the flat face (62) of the first portion (60) is contained in the weld plane in a given relative position.

9. Assembly of a support plate of a support of an autoclave sterilization installation and a holding tool according to one of claims 4 to 8.

10. The assembly of claim 9, wherein, The holding tool comprises means for engaging (61) with the support plate (52) of the autoclave sterilization installation, and the support plate comprises means for cooperating with the means for engaging the holding tool.

11. Autoclave sterilization method implementing an autoclave sterilization installation according to one of claims 1 to 3 and a holding tool according to one of claims 4 to 8, comprising: positioning at least one bag on a support plate; positioning a holding tool on the bag; positioning the support plate loaded with the bag and the holding tool in an autoclave sterilization enclosure; performing an autoclave cycle; removing the bag.

12. The autoclave sterilization method of claim 11, wherein, The bag is a fluid-sealed transfer bag.

Images