Method for handling sterilized objects in controlled atmosphere chamber, corresponding device, corresponding object and corresponding machine

Abstract

The invention relates to a method for manipulating sterilized objects (22, 23, 24) in a controlled atmosphere chamber (12), comprising a step of gripping at least one of the sterilized objects (22, 23, 24) from the outside of the chamber (12), and a step of inserting the latter into said chamber (12) through an access aperture defined corresponding to at least one wall (15, 16) thereof, followed by a step of closing said access aperture, and a step of decontaminating the interior of the chamber (12) by transporting a decontaminating agent.

Description

Technical Field

[0001] The present invention relates to a method for manipulating sterilized objects in a controlled atmosphere chamber of a processing unit, a corresponding protective device for protecting objects that can be inserted into the controlled atmosphere chamber, the use of the above-mentioned protective device, the objects that can be inserted into the controlled atmosphere chamber and a packaging machine comprising a controlled atmosphere chamber, in particular a machine for packaging sterilized products or products to be packaged in a controlled atmosphere, such as medical products, medicines, cosmetics or similar products. Background Art

[0002] Machines are known for packaging products whose sterility must also be guaranteed during the packaging step, such as medical products, pharmaceuticals, cosmetics and similar products. These packaging machines have at least one processing unit contained in a controlled atmosphere chamber with hermetically sealed walls in order to isolate the interior from the external environment.

[0003] In order to be able to assemble the objects of the processing unit inside the chamber, the wall of the chamber (usually configured as a glass door hinged to the machine frame) has a specific port called RTP (abbreviation of Rapid Transfer Port) or Alpha-Beta port, which allows the introduction of objects into the chamber without disrupting the controlled atmosphere inside it, and has other ports anchored to the wall and allows a technician stationed outside the chamber to manipulate the components inside the chamber while keeping the chamber hermetically closed.

[0004] The Alpha-Beta port comprises a primary closing unit, also referred to as an "Alpha unit", e.g. consisting of a flange surrounding an access opening which can be closed by a door and which is suitable for coupling to a matching secondary closing unit, also referred to as a "Beta unit", via a suitable mutual coupling interface, which is arranged on a transfer device (e.g. a cylindrical transport container).

[0005] The cylindrical transport container is configured to transport one or more of the objects configured as modular elements inside and outside the chamber, which must have been sterilized before being introduced into the chamber. In the prior art, the step of sterilizing these elements is carried out in an autoclave while they are already inside the cylindrical transport container. In practice, it is provided that the cylindrical transport container, which already contains the modular elements to be sterilized, is placed in the autoclave before being inserted into the chamber. Objects that are too large to pass through the Alpha-Beta port are also sterilized in the autoclave before being assembled in the controlled atmosphere chamber.

[0006] The Alpha-Beta port has a limited diameter, usually up to 350 mm, and therefore does not allow the insertion of objects whose size cannot pass through the channel orifice. These objects that cannot pass through the Alpha-Beta port are usually covered by a covering element and provided enclosed in a closed bag. The covering element and the bag are made of a filter material (e.g. filter paper).

[0007] To carry out the assembly, it is necessary to open the access opening made in the wall of the chamber, thus breaking the protected atmosphere. Subsequently, an operator (in the case of very heavy and bulky objects, there may be two operators) inserts the object into the chamber, placing it in the desired position.

[0008] At this point, a first embodiment of the method known in the prior art provides for closing the access orifice so as to isolate the atmosphere inside the chamber again with respect to the outside. A decontamination cycle is carried out with a decontamination agent, generally vaporized hydrogen peroxide known by the abbreviation VHP (vapor hydrogen peroxide), at the end of which an operator stationed outside the chamber, using waterproof gloves anchored to its walls, opens the bag with the aid of scissors or other sharp instruments, removes it and subsequently assembles the object in the machine.

[0009] We need to clarify that this decontamination step must be distinguished from the previous sterilization step in the autoclave.

[0010] Once the assembly operations of the objects in the chamber have been completed, a decontamination cycle is performed. Decontamination allows the chamber to be given the necessary hygiene and cleanliness requirements, since the entire chamber cannot be sterilized in the autoclave. As we said, only some of the objects that come into direct or indirect contact with the product to be packaged have previously been sterilized in the autoclave, while the parts of the machine that do not come into direct or indirect contact with the product to be packaged do not need to be sterilized.

[0011] One problem with this embodiment is that the operator must perform many delicate operations using the glove anchored to the wall. It is easy to understand that the further away or at a more inclined angle the object to be manipulated is relative to the glove, and / or the larger and / or heavier the object to be manipulated is, the more inconvenient such operations will be. These characteristics of the object may also make it difficult to remove the bag using the glove.

[0012] Another problem with this embodiment is that during the operation of fastening objects performed from the outside using gloves, the gloves may be punctured or damaged, which will compromise the sterility of the chamber. This is a very problematic situation, since changing gloves is time-consuming and laborious, since it is also necessary to perform a new decontamination cycle and verify again that the atmosphere in the chamber has been decontaminated.

[0013] A second embodiment of the method known in the prior art provides that, after inserting the object into the chamber, the operator cuts the bag corresponding to the attachment of the object itself to the machine, making it in any case lie on the object to be protected, although it is no longer hermetically sealed. The object is then secured in its position of use, and the operator then leaves the chamber, which is closed again to isolate the internal atmosphere. At this point, a decontamination cycle is carried out using a decontamination agent, and the operator then removes the bag using a glove anchored to the wall of the chamber and takes it out of the chamber.

[0014] One problem with this embodiment is that the bag is opened while the access port to the chamber is still open and an operator is present in the chamber to perform the above operation, thus compromising the sterility of the objects that have been previously sterilized in the autoclave.

[0015] A problem with the known methods is that the material from which the bag is made allows the passage of detergents which deposit on the parts of the article which come into direct or indirect contact with the product to be packaged. This can lead to potential contamination of the product, which is sometimes unacceptable from a regulatory point of view and can in some cases cause deterioration of the product itself.

[0016] In another technical field, more precisely in the technical field of checking letters or parcels in transit in a postal system for transporting objects, patent application US2009 / 047173 A1 discloses a method provided that, when the container is inserted into a controlled atmosphere chamber, the interior of a container including its contents is protected by a rigid waterproof cover matching the shape of the container, in which a decontamination method based on ethylene oxide or hydrogen peroxide is implemented to eliminate possible contaminants of biological origin, which may be pathogenic and therefore harmful to human health. Since this is a different technical field compared to the known solutions described above, it is obvious that the size and shape of the container are different. Moreover, this document does not even address and solve the problems associated with the above-mentioned method, given that it is not necessary to assemble the container in a treatment chamber and that no step of packaging the sterile product is provided, wherein it is necessary to avoid contact between the sterile product and the reagents used in the decontamination method.

[0017] Therefore, there is a need for a complete protection device for protecting an object to be inserted into a controlled atmosphere chamber, the object itself, a method for manipulating the object, and a machine for packaging sterile products, which can overcome at least one of the disadvantages of the prior art.

[0018] To this end, the following technical problems need to be solved: maintaining the sterility of the parts of the object to be inserted that are intended to come into direct or indirect contact with the product to be packaged, and preventing vaporized hydrogen peroxide from being deposited on the object to be inserted, and usually preventing any detergent used in the decontamination cycle inside the chamber from being deposited on the object to be inserted after the chamber is opened to insert the large object that has not passed through the Alpha-Beta port.

[0019] In particular, an object of the present invention is to provide a protective device that allows maintaining the sterility of the object, or at least of the portion of the object that is in direct or indirect contact with the product to be packaged, during its transport between an autoclave and a controlled atmosphere chamber, and subsequently during the aforementioned machine setting operations.

[0020] Another object of the invention is to provide a protection device which allows the object to be protected from decontamination substances while still allowing it to be sterilized in an autoclave.

[0021] Another object of the invention is to perfect a method for manipulating sterilized objects in a controlled atmosphere chamber which allows maintaining the sterility of the objects.

[0022] Another object of the invention is to perfect a handling method that allows limiting as much as possible the use of gloves anchored to the walls of a controlled atmosphere chamber, in particular avoiding the need for operators to carry out operations with the gloves that could compromise their integrity.

[0023] Another object of the present invention is to provide an object that can be inserted into a controlled atmosphere chamber, wherein the object is configured to be protected by the above-mentioned protection device.

[0024] The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages. Summary of the invention

[0025] The present invention is set forth and characterized in the independent claims. The dependent claims describe other characteristics of the invention or variants to the main inventive idea.

[0026] According to the above objectives, and in order to solve the above technical problems in a new and original way, and to achieve significant advantages over the prior art, a method according to the invention has been embodied for manipulating sterilized objects subsequently introduced into a controlled atmosphere chamber, wherein the chamber is defined by a plurality of walls. The method comprises the steps of grasping at least one sterilized object from the outside of the chamber, inserting at least one sterilized object into the chamber through an access orifice defined in correspondence with one of the walls, then closing the access orifice to restore the sealing of the chamber, and decontaminating the interior of the chamber by delivering a decontaminating agent.

[0027] According to one aspect of the invention, before the inserting step, there is provided a step of at least partially protecting the at least one object by means of a protective device so as to protect it in a sealed manner, the protective device comprising a protective member made of a flexible, elastically deformable plastic material impermeable to the detergent and having a shape matching at least a portion of the at least one object. In the protecting step, the protective member is associated with at least the portion of the at least one object in such a way that at least the portion of the at least one object is covered by the protective member so as to prevent the detergent from coming into contact with the portion of the at least one object protected in a sealed manner during the decontamination step.

[0028] This has at least the following advantages: having a protective member which covers the object in a sealed manner and does not let the passage of detergents (especially vaporized hydrogen peroxide, which is usually used to restore the hygienic conditions of a controlled atmosphere chamber after it has been opened to allow the insertion of one or more objects that have been sterilized outside the chamber). This significantly limits the risk of contamination of the parts of the object intended to come into direct or indirect contact with the product to be packaged, which at the same time allows its sterility to be maintained. Another advantage (coming from the impermeability to detergents of the material made of the protective element and from the fact that the protective element closes in a sealed manner the parts of the object that come into contact with the product) is that the use of bags to close the object, as in the prior art, and of a cover member made of filter paper, is made superfluous. The absence of a bag allows simplifying the operations of manipulating the object inside the controlled atmosphere chamber.

[0029] The protective device has been designed primarily to protect objects that cannot pass through the access orifice of the Alpha-Beta port. However, it has been observed that such a protective device can also be used in a very advantageous way for objects that can pass through the Alpha-Beta port due to their small size. In fact, with the above-described protective device, the opening of the controlled atmosphere chamber no longer involves a loss of sterility of the parts that are in direct or indirect contact with the product to be packaged, and allows, during the subsequent decontamination step for restoring the conditions of the protected atmosphere, to prevent the objects inside the chamber from being contaminated by the detergent. Moreover, thanks to the protective device, while the operator is inside the chamber, he / she can secure the objects in the position of use when the chamber is open, without having to resort to gloves anchored to the walls of the controlled atmosphere chamber. These gloves will be used to remove the protective device only after the chamber has been closed and the decontamination cycle has been performed. This operation does not endanger the integrity of the gloves, since both the gloves and the protective device are made of soft, non-cutting or blunt materials.

[0030] Doing so also facilitates the insertion of objects through the RTP port and also limits the risk of glove damage.

[0031] The object at least partially protected by the protection device is advantageously a component that must be assembled in the chamber during use, more advantageously a mechanical component, and may have an overall dimension at least greater than 350 mm, which is the maximum diameter of the known Alpha-Beta ports. However, as mentioned above, the object may also have a maximum overall dimension of less than 350 mm.

[0032] Preferably, between the step of inserting the at least one object into the chamber and the subsequent step of closing the access aperture, there is provided a step of assembling the at least one object in the chamber.

[0033] According to some embodiments, during said protection step, a filter is associated with said protection member, or with said at least one object, and is configured to allow the passage of steam during a previous sterilization step in an autoclave and at the same time block the passage of said decontamination agent during a decontamination cycle.

[0034] According to a variant, the filter is configured to balance the pressure existing inside the object with the pressure outside it, for example with the pressure inside a controlled atmosphere chamber or with the pressure existing in an autoclave during a sterilization process. In this case, the filter may not have any function related to the sterilization step.

[0035] According to some embodiments, the protection step is provided in that the object to be assembled comprises a central body around which a rigid ring is arranged, which is preferably convex (i.e. protruding outwards) and is configured to serve as an abutment for the protection member when it is associated with the central body, so that the latter is applied to the object in a sealed manner.

[0036] According to some embodiments described herein, after the decontamination step, a removal step and a subsequent extraction step are provided, in which the protective member is removed from the at least one object, and in which the removed protective member is extracted from the chamber.

[0037] According to some embodiments, after the protecting step and before the inserting step a sterilization step is provided, in which the object at least partially protected in a sealed manner by the protecting device is sterilized in a sterilization chamber, such as an autoclave suitable for this purpose.

[0038] According to some embodiments, the object protected in a sealed manner is configured as a modular element.

[0039] According to another aspect of the present invention, there is provided a protective device for at least partially protecting in a sealed manner a sterilized object that can be inserted into a controlled atmosphere chamber, wherein the protective device comprises a protective member configured to protect in a sealed manner at least a portion of the object. The protective member is made of a flexible material that is impermeable to a detergent, is elastically deformable and has a shape that matches the at least a portion of the object. The protective member is also configured to be associated with at least the at least a portion of the object in such a way that at least the portion of the at least one object is covered by the protective member to prevent the detergent from coming into contact with the portion of the object that is protected in a sealed manner.

[0040] Advantageously, the material of which the cover member is made is a plastic material. For example, the material may be selected from silicone, EPDM rubber or polyurethane plastic material. We need to clarify that these materials are suitable for ensuring that the object protected by the cover member is effectively sterilized during the sterilization method in the autoclave and is properly protected during the decontamination operation in the chamber.

[0041] Preferably, the protection device comprises a filter associated with the protection member or the at least one object and configured to allow steam to pass and block the entry of detergents and microorganisms, particles and dirt. More preferably, the filter is a hydrophobic filter. Preferably, the filter is a cartridge filter type and has a size compatible with the Alpha-Beta port. The presence of the filter allows the sterilization of the component to be performed in an autoclave before the component is inserted into the controlled atmosphere chamber, because the filter allows the sterilizing agent to reach the object to be sterilized.

[0042] Note that the filter may be associated with the cover member or with the object, as long as the sufficient condition that the filter is placed in fluid communication with the compartment created between the cover member and the protected portion of the object is met.

[0043] According to some embodiments, the protective member comprises an edge, the edge defining the orifice and configured to be applied around the object in a sealing manner. In particular, the edge is elastic so as to create an airtight seal around the object. The edge is preferably made integrally with the protective member. This facilitates the creation of the cover member and eliminates potential problems with the seal between the edge and the rest of the cover member, while ensuring the elasticity of the edge.

[0044] According to some embodiments, the protective member comprises at least one gripping element made integrally with the shaped edge and protruding outwardly from the shaped edge relative to the access orifice. This allows facilitating the removal of the cover member, which occurs after the controlled atmosphere chamber has been closed and a decontamination process has been carried out to restore the conditions of the protective atmosphere, and which is therefore carried out by an operator on the outside through a glove anchored to the wall of the controlled atmosphere chamber.

[0045] In order to be able to associate the filter with the protective member, the latter preferably comprises a second sterilization aperture surrounded by an attachment element configured to be associated with the filter, in particular with an attachment portion thereof.

[0046] According to one aspect of the invention, there is provided an object capable of being inserted into a controlled atmosphere chamber, in particular a controlled atmosphere chamber of a machine for packaging sterilized products. The object is protected or intended to be protected by a protective device as defined above, the protective device being configured to protect at least a portion of the object in a sealed manner. A protective member has a shape matching at least a portion of the object, is made of a flexible material, is impermeable to a detergent and is elastically deformable. The protective member is also configured to be associated with at least the at least a portion of the object in such a way that the protective member can cover the at least a portion of the object to prevent the detergent from coming into contact with the protected portion of the object. To this end, the protective member comprises a central body and a rigid ring, the rigid ring being arranged around the central body, preferably convex (i.e. protruding outwards from the central body), and the rigid ring being configured to serve as a support for the protective member in such a way that the latter is applied in a sealed manner to the at least one object.

[0047] In the context of the present application, an object refers to an object or a component provided to be assembled in a controlled atmosphere chamber. The object may be a mechanical component, such as a modular element that can be assembled on a fixed frame present in the chamber.

[0048] In particular, the ring is configured to serve as a seat for the insertion of an edge of the protective member in order to improve the seal around the object and ensure the tightness of the coupling between the object and the protective member.

[0049] Preferably, the ring has a circular or oval circumference. These shapes avoid sharp edges, with which the tightness of the seal may fail. Other shapes of the ring can be provided, as long as they are suitable for ensuring an airtight seal.

[0050] According to some embodiments, in particular embodiments where the object does not have a cylindrical shape, the ring is not aligned or eccentric relative to the central body of the object. This allows facilitating the removal of the protective member and placing at least a portion of the edge and possibly a gripping element integrated in the protective member at a position further away from the object.

[0051] Preferably, the ring is perpendicular to the axis of development of the central body of the object. Alternatively, the ring may be inclined at an angle less than 90° relative to the axis of development of the central body of the object.

[0052] The ring may be made integrally with the central body of the object or firmly connected thereto, for example by welding or gluing. The ring is configured to define a boundary between an area protected by the protective member and an area not protected thereby, it is not in contact with the product and in correspondence with it are provided attachment means for fastening in a machine.

[0053] Advantageously, the object comprises a second sterilization orifice surrounded by an attachment element configured to be associated with the filter, in particular with an attachment portion thereof.

[0054] According to another aspect of the present invention, there is provided a use of the above-mentioned protection device, which is used for manipulating an object that has been sterilized and subsequently inserted into a controlled atmosphere chamber. Specifically, the protection device comprises a cover member, which has a shape matching at least a portion of the object and is made of a flexible plastic material that is impermeable to detergent and can be elastically deformed. The protection member is also associated with at least the at least a portion of the object in such a way that the protection member can cover the at least a portion of the object to prevent at least the portion of the object from contacting with the detergent.

[0055] According to some embodiments of the use, the protective device further comprises a filter which can be associated likewise with the protective member or with the at least one object and which is configured to allow the passage of steam during sterilization in the autoclave and at the same time block the decontamination agent during the decontamination step in the chamber.

[0056] According to another embodiment of the present invention, there is provided a machine for packaging products, in particular for packaging sterilized products or products to be packaged in a controlled atmosphere, the machine comprising a processing unit, the processing unit being provided with a controlled atmosphere chamber defined by a plurality of walls, and at least one sterilized object capable of being inserted into the chamber, wherein the at least one object is at least partially protected by the above-mentioned protective device, i.e., a protective device comprising a protective member having a shape matching at least one part of the object and being made of a flexible, elastically deformable material that is impermeable to detergents so as to prevent the detergents from coming into contact with the protected part of the at least one object.

[0057] According to some embodiments, the protective device further comprises a filter, which may be likewise associated with the protective member or with the at least one object and which is configured to allow the passage of steam during sterilization in the autoclave and at the same time block the decontamination agent during the decontamination step in the chamber.

[0058] Preferably, the component is as described above, ie it comprises a central body and a rigid ring arranged around said central body, said rigid ring being configured to serve as a seat for said protective member in such a way that the latter is applied in a sealed manner on said at least one object. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] These and other aspects, features and advantages of the invention will become apparent from the following description of some embodiments thereof given as non-limiting examples with reference to the accompanying drawings, in which:

[0060] - Figure 1 is a partial and schematic three-dimensional view of a packaging machine comprising a processing unit equipped with a controlled atmosphere chamber;

[0061] - Figure 2 A protective device according to the first embodiment of the present invention is assembled Figure 1 a three-dimensional view of a first object of a packaging machine;

[0062] - Figure 3 for Figure 2 A three-dimensional view of a protective component of a protective device;

[0063] - Figure 4 For those without protective components Figure 2 3D view of objects;

[0064] - Figure 5 for Figure 2 A cross-sectional view of an object;

[0065] - Figure 6 for Figure 5 An enlarged view of detail A;

[0066] - Figure 7 For viewing from different angles Figure 3 A three-dimensional view of a variant of a protective member;

[0067] - Figure 8 For assembly Figure 7 Protection components Figure 2 3D view of objects;

[0068] - Fig. 9 A three-dimensional view of a protection member of a second embodiment of a protection device according to the present invention;

[0069] - Fig.10 for Figure 1 a three-dimensional view of a second object by a processing unit;

[0070] - Fig.11 A three-dimensional view of a protection member of a third embodiment of a protection device according to the present invention;

[0071] - Fig.12 for Figure 1 a three-dimensional view of a third object of a packaging machine; and

[0072] - Fig.13 For assembly Fig.11 Protection components Fig.12 A three-dimensional view of an object.

[0073] We must clarify that in this description, the words and terms used, as well as the numbers in the described drawings, have only the function of better illustrating and explaining the present invention, and their role is to provide a non-limiting example of the invention itself, since the scope of protection is defined by the claims.

[0074] To facilitate understanding, the same reference numerals are used, where possible, to identify the same common elements in the drawings. It should be understood that elements and features of one embodiment can be conveniently combined or incorporated into other embodiments without further clarification. DETAILED DESCRIPTION

[0075] Reference Figure 1 , a machine 10 for packaging products, in particular sterile products or products to be packaged in a controlled atmosphere, such as medical products, pharmaceuticals, cosmetics or any other product whose packaging requires an operation in a controlled atmosphere, is described. The packaging machine 10 comprises a processing unit 11 provided with a controlled atmosphere chamber 12 of known type and defined by a plurality of walls 13, 14, 15, 16.

[0076] The chamber 12 is defined by a fixed side wall 13, by a fixed upper wall 14 and by walls 15, 16, with which an access opening may be defined corresponding to the walls 15, 16 for inserting the sterilized items to be packaged into the chamber. For this purpose, the walls 13, 14, 15 and 16 of the chamber 12 may be openable. Specifically, the chamber 12 comprises a first type of openable wall 15 consisting of two panels 17, for example made of glass, hinged corresponding to one side thereof, and a second type of openable wall 16 consisting of a frame 18 and a single panel 19, for example made of glass, hinged thereto.

[0077] The openable walls 15, 16 are each provided in a known manner with one or more portholes 20 to which corresponding operating gloves 21 can be anchored, or the one or more portholes 20 can form part of an Alpha-Beta port through which a partial passage of a corresponding cylinder is provided in order to insert an object into the chamber 12 without disrupting the controlled atmosphere. The operation of the Alpha-Beta port is known per se and will not be described further below. The Alpha-Beta port may be of the type sold by the company Getinge-La Calhène.

[0078] In the example shown, the processing unit 11 is divided into four areas 11A, 11B, 11C, 11D, each of which is located corresponding to a respective openable wall 15, 16 and in which corresponding elements can be inserted and assembled, such as a vibration bowl 22, a distributor 23 and a lid pre-feeder 24. The vibration bowl 22 and the pre-feeder 24 must be assembled in the first area 11A of the processing unit 11, while the distributor 23 can be assembled in the third area 11C.

[0079] Figure 2 A vibrating bowl 22 is shown, onto which a protection device 25 is applied, the protection device 25 consisting of a protection member 26 , usually referred to as a cover, and a filter 27 .

[0080] The cover 26 is integrally made of silicone (i.e., a plastic material that is impermeable to detergents and can be elastically deformed). Silicone has the advantage of being readily available and inexpensive. Other similar materials may be provided, such as EPDM rubber, which has the advantage of not absorbing detergent substances such as vaporized hydrogen peroxide, or polyurethane materials.

[0081] The cover 26 shown here has been designed to have a shape matching the upper portion of the vibration bowl 22 so as to be assembled thereon in a sealed manner to at least cover and isolate the interior thereof ( Figure 2 In particular, the cover 26 includes a rim 28 which defines a compartment 30 ( Figure 3 ). The rim 28 is rounded in shape so as to better adhere to the central body 31 of the vibratory bowl 22 which has a generally circular cross-section.

[0082] The rim 28 , which is made integrally with the cover 26 and is therefore also made of silicone, is provided with two gripping tabs 32 to allow the user to grip the cover 26 in order to easily and quickly remove it from the vibration bowl 22 .

[0083] The cover 26 comprises a circular upper wall 33 and a lower wall 34 connected to the upper wall by side walls 35 and delimited at the bottom by the edge 28 .

[0084] The filter 27 is a cartridge filter of known type, in particular of a size suitable for allowing it to pass through the Alpha-Beta port. In particular, the filter 27 may be of the type sold by the company Pall Life Sciences under the name of a Novasip™ filter.

[0085] In the example shown, the filter 27 is attached to the vibrating bowl 22 ( Figure 2 , Figure 4 as well as Figure 5 To this end, the filter 27 is equipped with a connecting element 36, ie a cylindrical tube which is coaxially positioned with the filter 27 and which is directly connected to the vibration bowl 22 via a sterilization hole 37 provided therein ( Figure 5 ), and are equipped with known connection devices, such as by screw connection or shape interference, which are not shown in the figure for simplicity.

[0086] The vibration bowl 22 is provided with a rigid ring 38 around its cross section, the rigid ring 38 being integrally formed therewith and extending vertically outwardly from its side wall ( Figure 5 and Figure 6 ). In the present example, the ring 38 is contained in a plane perpendicular to the axis of development of the central body 31 of the vibrating bowl 22 , corresponding to its intermediate zone between the upper edge and the bottom.

[0087] The ring 38 has a rounded periphery, substantially corresponding to the shape of the edge 28 of the cover 26 , so that said edge adheres better thereto, thus facilitating a gas-tight seal between the cover 26 and the ring 38 .

[0088] In the example given here, the ring 38 comprises an outer wall 39 perpendicular thereto and provided with a circumferential groove 40 which serves as a seat for the edge 28 of the cover 26 ( Figure 5 and Figure 6 In order to improve stability and sealing with respect to the groove 40, the edge 28 advantageously comprises an inner lip 41 projecting towards the groove 40 so as to engage therewith ( Figure 6 ).

[0089] The ring 38 is preferably misaligned or eccentric relative to the center body 31 of the vibrating bowl 22 so as to have a portion of the outer wall 39 that is further away from the outer wall of the center body 31 ( Figure 4 and Figure 5 ). This allows for easy removal of the cover 26 from the vibratory bowl 22, as will be described in more detail below.

[0090] Figure 7 and Figure 8 A variant of the cover 26 is shown which is equipped with a sterilization opening 42 which is equipped with an attachment sleeve 43 to connect the filter 27 thereto. In this case, the vibration bowl 22 does not have to have its sterilization opening 37 or in any case be closed gas-tight in a known manner, for example by a stopper. Since the connection sleeve 43 is arranged on the upper wall 33 of the cover 26, the connection element 36 is here arranged to be curved in order to position the filter 27 in a more stable position.

[0091] The protective device 25 described so far allows the sterility of the interior of the vibration bowl 22 to be maintained even after the vibration bowl 22 has left a sterilization chamber such as an autoclave 100 in which the vibration bowl 22 has been sterilized. Figure 1 ), which facilitates its assembly in the processing unit 11 within the controlled atmosphere chamber 12.

[0092] A method for handling the vibrating bowl provides for placing the protective device 25 on the vibrating bowl 22, applying the cover 26 thereto, in particular abutting the edge 28 of the cover 26 against the outer wall 39 of the ring 38, in order to ensure a gas-tight seal with the vibrating bowl 22. Please note that no bag is provided to enclose the assembly consisting of the vibrating bowl 22 and the protective device 25. We must also clarify that the filter 27 of the protective device 25 can be fastened equally to the cover 26 or to the vibrating bowl 22, as described above.

[0093] Subsequently, the vibration bowl 22 equipped with the protection device 25 is sterilized in a sterilization chamber configured as an autoclave 100, for example ( Figure 1 ), the latter being generally autonomous and independent with respect to the chamber 12, since it can also be placed at a considerable distance therefrom, for example even in an industrial facility different from the one in which the chamber 12 is arranged. Despite the impermeable material of the hood 26 and the seal between the hood 26 and the vibrating bowl 22, sterilization is possible thanks to the filter 27, which is configured to let the steam pass during sterilization in the autoclave and at the same time block the decontamination agent (i.e. hydrogen peroxide) during the step of decontaminating the chamber 12.

[0094] At the end of the sterilization step in the autoclave 100, the vibrating bowl 22 equipped with the protection device 25 is inserted into the processing unit 11 ( Figure 1). Given the size of the vibration bowl 22, it cannot be inserted into the controlled atmosphere chamber 12 through the Alpha-Beta port. Therefore, it is necessary to introduce the vibration bowl 22 through an access opening defined corresponding to at least one of the walls 13, 14, 15, 16. In the example shown, the access opening is defined by opening a wall 15 of the chamber 12, in particular corresponding to the first zone 11A in the example given herein. By way of non-limiting example, the opening of the wall 15 is performed by rotating a panel 17 constituting the wall 15, as Figure 1 As shown. Alternatively, it can be provided that the opening is performed by removing the panel of the wall. Obviously, the opening of the wall 15 determines the loss of sterility inside the chamber 12.

[0095] Once the wall 15 has been opened, the vibration bowl 22, still equipped with the protection device 25, is inserted into the chamber 12 and it is assembled in the processing unit 11. Note that the assembly is performed without the use of the glove 21 anchored to the walls 15, 16 of the chamber 12.

[0096] Subsequently, once assembly is complete, the previously opened wall 15 is closed and a step of decontaminating the interior of the chamber 12 is then carried out by dispensing vaporized hydrogen peroxide or any other type of suitable decontaminating agent.

[0097] Due to the impermeable material of the cover 26 and the presence of the filter 27 impermeable to vaporized hydrogen peroxide, the vibrating bowl 22, in particular its internal compartment 30, is protected from any contamination by vaporized hydrogen peroxide, which therefore does not deposit on the parts of the vibrating bowl 22 that can come into contact with the product.

[0098] After the decontamination step, the cover 26 is removed. The operator grasps one or more gripping tabs 32 through the glove 21 anchored to the walls 15, 16 of the controlled atmosphere chamber 12 and pulls them to widen the edge 28 and thus disengage the latter, in particular its inner lip 41, from the groove 40 of the outer wall 39 of the ring 38. The eccentric position of the ring 38 relative to the vibrating bowl 22 facilitates the removal of the cover 26. In fact, by pulling on the tabs 32 located in the portion of the ring 38 farthest from the central body 31 of the vibrating bowl 22, the edge 28 of the cover 26 is sufficiently far from the central body 31 to be able to pass over it without further pulling on the gripping tabs 32.

[0099] If the filter 27 is connected to the cover 26, it will obviously be removed with it. On the other hand, if the filter 27 is connected to the vibration bowl 22, it can remain in the controlled atmosphere chamber 12.

[0100] The hood 26 is then removed from the controlled atmosphere chamber 12 through the Alpha-Beta port.

[0101] Since the cover 26 of the protection device 25 described so far is made of a material capable of elastic deformation, it has a predetermined shape that must match the objects 22, 23, 24 to be protected. The cover 26 described so far has a shape suitable for the vibration bowl 22.

[0102] exist Fig. 9 In the alternative embodiment shown, the cover 44 provided for the dispenser 23 comprises a lower wall 45, an upper wall 46 and four side walls 47, 48, 49, 50 shaped to define a parallelepiped compartment, and an elliptical edge 51 delimiting the internal compartment 30. Also in this embodiment, the edge 51 is provided with gripping tabs 53.

[0103] This cover 44 is suitable for being applied to the above-mentioned dispenser 23, which is equipped with an insert support structure 55 ( Fig.10 ) with a plurality of aligned nozzles 54, the support structure 55 serving as the central body of the distributor 23 and around which a ring 56 is arranged which is functionally completely similar to the ring 38 of the vibrating bowl 22. The ring 56 has a shape matching the shape of the edge 51 of the cover 44, which in turn is completely similar to the edge 28 of the cover 26 (see Figure 6 ). The cover 44 is configured to wrap around the nozzle 54, while the edge 51 is configured to create an airtight seal with the ring 56 of the support structure 55.

[0104] In this embodiment, the filter 27 can be connected only to the cover 44 , which for this purpose comprises an attachment sleeve 57 surrounding a sterilization aperture 58 .

[0105] Note that the dispenser 23 has lateral dimensions that allow it to be inserted into the chamber 12 through the Alpha-Beta port and, therefore, without disrupting the controlled atmosphere. However, it has been observed that, according to the method previously described, the use of the protection device 25 allows the dispenser 23 to be assembled without the use of the gloves 21 anchored to the walls 15, 16 of the controlled atmosphere chamber. Thanks to the airtight seal created between the edge 51 of the hood 44 and the ring 56 of the support structure 55, and due to the impermeability of silicone, once the assembly of the dispenser 23 has been completed, after the chamber 12 has been closed, the nozzle 54 of the dispenser 23 is well protected from the vaporized hydrogen peroxide used in the step of decontaminating the chamber 12.

[0106] exist Fig.11In another embodiment shown, the cover 59 has a shape that matches the pre-feeder 24. To this end, the cover 59 has a generally cylindrical shape and is provided with a bottom 60 that defines the internal compartment 30 together with a side wall 61, the side wall 61 being defined at the bottom (i.e., the portion opposite to the bottom 60) by an edge 62. Two gripping tabs 63 protrude outward from the edge 62, and the two gripping tabs 63 are preferably located at radially opposite positions to each other. The cover 59 also includes an attachment sleeve 64 surrounding a sterilization orifice 65 provided in the bottom 60.

[0107] The edge 62 is inclined at an angle of about 45° relative to the deployment axis of the cover 59. Thus, the edge 62 has a generally elliptical shape and, except for this shape, has the same structure as the edges 28, 51 of the covers 26, 44 (e.g., Figure 6 shown).

[0108] A pre-feeder 24 ( Fig.12 and Fig.13 ) is known per se and has a hollow central body 66 whose surface extends to define a feed ramp 67 open at its free end and partially blocked by an intermediate wall 68.

[0109] The plug pre-feeder 24 includes a ring 69 configured to be wrapped in a sealed manner by the edge 62 of the cover 59 ( Fig.13 ). The ring 68 is advantageously similar to the rings 28, 56 of the vibrating bowl 22 and the dispenser 23 ( Figure 6 ), except that it is also inclined about 45° relative to the deployment axis of the central body 66 of the pre-feeder 24 to match the edge 62 of the cover 59. The cover 59 is then coaxial with the pre-feeder 24, thereby facilitating a reduction in the overall size of the assembly.

[0110] It is clear that changes and / or additions of components may be made to the method for manipulating objects in a controlled atmosphere chamber, the protective device 25, the objects capable of being inserted into a controlled atmosphere chamber and the product packaging machine as described above without departing from the field and scope of the invention as defined in the claims.

[0111] It is also clear that, although the invention has been described with reference to certain specific examples, a person skilled in the art will be able to implement other equivalent forms of a method for manipulating an object in a controlled atmosphere chamber, a protective device 25, an object capable of being inserted into a controlled atmosphere chamber, and a product packaging machine having the features set forth in the claims and therefore falling within the scope of protection defined thereby.

[0112] In the following claims, reference signs in parentheses serve only to facilitate reading and they are not to be regarded as limiting factors with respect to the protective scope defined by the claims.

Claims

1. A method for manipulating an object (22, 23, 24) which has been sterilized and subsequently introduced into a controlled atmosphere chamber (12) defined by a plurality of walls (13, 14, 15, 16), comprising: The step of grasping at least one of the sterilized objects (22, 23, 24) from outside the chamber (12); The invention relates to a method for preparing a sterile sterile container comprising: inserting the at least one sterilized object (22, 23, 24) into the chamber (12) through an access opening defined by at least one of the plurality of walls (13, 14, 15, 16); subsequently closing the access opening; and decontaminating the interior of the chamber (12) by delivering a decontaminating agent, characterized in that, before the inserting step, there is provided a step of at least partially protecting at least one of the objects (22, 23, 24) by a protective device (25) so as to protect it in a sealed manner, the protective device (25) comprising a protective member (26, 44, 59) which is provided with a protective member (26, 44, 59) and ... which is provided with a protective member (26, 44, 59) which is provided with a protective member (26, 44, 59) which is provided with a protective member (26, 44, 59) which is provided with a protective member ( 4, 59) is made of a flexible, elastically deformable plastic material that is impermeable to the detergent and has a shape that matches at least a portion of the at least one object (22, 23, 24), wherein, in the protecting step, the protective member (26, 44, 59) is associated with at least the portion of the at least one object (22, 23, 24) in such a way that at least the portion of the at least one object (22, 23, 24) is covered by the protective member (26, 44, 59) so as to prevent the detergent from coming into contact with the portion of the at least one object (22, 23, 24) that is protected in a sealed manner during the decontamination step.

2. The method according to claim 1, characterized in that During the protection step, a filter (27) is associated with the protection member (26, 44, 59) or with the at least one object (22, 23, 24) and is configured to allow the passage of steam and block the passage of the detergent.

3. The method according to claim 1 or 2, characterized in that: The protecting step is provided in that the at least one object (22, 23, 24) comprises a central body (31, 55, 66) around which a rigid ring (38, 56, 69) is arranged, the rigid ring (38, 56, 69) being configured to serve as a seat for the protecting member (26, 44, 59) when the protecting member (26, 44, 59) is associated with the central body (31, 55, 66).

4. The method according to any one of the preceding claims, characterized in that After the decontamination step, a removal step is provided, in which the protective member (26, 44, 59) is removed from the at least one object (22, 23, 24), and a subsequent removal step is provided, in which the protective member (26, 44, 59) is removed from the chamber (12).

5. The method according to any one of the preceding claims, characterized in that A sterilization step is provided after the protection step and before the insertion step, in which the objects (22, 23, 24) which have been protected at least partially in a sealed manner by the protection device (25) are sterilized in a sterilization chamber (100).

6. The method according to any one of the preceding claims, characterized in that The objects (22, 23, 24) protected in a sealed manner are configured as modular elements.

7. A protection device (25) for at least partially protecting in a sealed manner at least one sterilized object (22, 23, 24) that can be inserted into a controlled atmosphere chamber (12), the protection device (25) comprising a protection member (26, 44, 59) configured to protect in a sealed manner at least a portion of the object (22, 23, 24), the protection device (25) being characterized in that the protection member (26, 44, 59) is made of a flexible, detergent-impermeable, The protective member (26, 44, 59) is made of an elastically deformable material and has a shape matching the at least part of the object (22, 23, 24), and the protective member (26, 44, 59) is also configured to be associated with at least the at least part of the object (22, 23, 24) in such a way that at least the part of the at least one object (22, 23, 24) is covered by the protective member (26, 44, 59) to prevent the detergent from contacting the part of the object (22, 23, 24) that is protected in a sealed manner.

8. The protection device (25) according to claim 7, characterized in that It comprises a filter (27) which can be associated with the protective member (26, 44, 59) or with the at least one object (22, 23, 24) and is configured to allow the passage of steam and block the passage of the detergent.

9. The protection device (25) according to claim 7 or 8, characterized in that The protective member (26, 44, 59) comprises an elastic edge (28, 51, 62) which delimits an internal compartment (30) and is configured to be applied around the at least one object (22, 23, 24) in an airtight manner.

10. An object (22, 23, 24) capable of being inserted into a controlled atmosphere chamber (12) and protected by a protection device (25), the protection device (25) comprising a protection member (26, 44, 59), the protection member (26, 44, 59) being configured to protect at least a portion of the object (22, 23, 24) in a sealed manner, characterized in that The protective member (26, 44, 59) has a shape matching at least a portion of the object (22, 23, 24) and is made of a flexible, elastically deformable material that is impermeable to the detergent. The protective member (26, 44, 59) is also configured to be associated with at least the at least a portion of the object (22, 23, 24) in such a way that the protective member (26, 44, 59) can cover the at least a portion of the object (22, 23, 24) to prevent the detergent from contacting the protected portion of the at least one object (22, 23, 24).

11. The object (22, 23, 24) according to claim 10, characterized in that The protective member (26, 44, 59) comprises a central body (31, 55, 66) around which a rigid ring (38, 56, 69) is arranged, the rigid ring (38, 56, 69) being configured to serve as a seat for the protective member (26, 44, 59) in such a way that the latter is applied in a sealed manner to the at least one object (22, 23, 24).

12. Use of a protective device (25) for handling objects (22, 23, 24) which have been sterilized and subsequently inserted into a controlled atmosphere chamber (12), characterized in that The protective device (25) comprises a protective member (25, 44, 59), the protective member (25, 44, 59) having a shape matching at least a portion of the at least one object (22, 23, 24) and being made of a flexible, elastically deformable material that is impermeable to the detergent, the protective member (26, 44, 59) also being associated with at least the at least a portion of the object (22, 23, 24) in such a way that the protective member (26, 44, 59) can cover at least the at least a portion of the object (22, 23, 24) to prevent at least the portion of the object (22, 23, 24) from coming into contact with the detergent.

13. The use according to claim 12, characterized in that The protection device (25) comprises a filter (27) which can be associated with the protection member (26, 44, 59) or with the at least one object (22, 23, 24) and is configured to allow the passage of steam and block the passage of the detergent.

14. A product packaging machine (10) comprising a processing unit (11) provided with a controlled atmosphere chamber (12) defined by a plurality of walls (13, 14, 15, 16), and at least one sterilized object (22, 23, 24) which can be inserted into said chamber (12), characterized in that The at least one object (22, 23, 24) is at least partially protected by a protective device (25), the protective device (25) comprising a protective member (26, 44, 59), the protective member (26, 44, 59) having a shape matching at least a portion of the at least one object (22, 23, 24) and being made of a flexible, elastically deformable material that is impermeable to a detergent so as to prevent the detergent from contacting the protected portion of the at least one object (22, 23, 24).

15. The packaging machine (10) according to claim 14, characterized in that The protection device (25) comprises a filter (27) which can be associated with the protection member (26, 44, 59) or with the at least one object (22, 23, 24) and is configured to allow the passage of steam and block the passage of the detergent.

16. The packaging machine (10) according to claim 14 or 15, characterized in that The at least one object (22, 23, 24) comprises a central body (31, 55, 66) around which a rigid circumferential ring (38, 56, 69) is arranged, the rigid circumferential ring (38, 56, 69) being configured to serve as a seat for the protective member (26, 44, 59) in such a way that the latter is applied in a sealed manner to the at least one object (22, 23, 24).

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