Method, corresponding device, corresponding object, and corresponding machine for the manipulation of a sterilized object within a controlled atmosphere chamber

Abstract

A method for manipulating sterilized objects (22, 23, 24) within a controlled atmosphere chamber (12) according to the present invention includes a gripping step of gripping at least one of the sterilized objects (22, 23, 24) from outside the chamber (12), an insertion step of inserting the latter into the chamber (12) through an access opening defined corresponding to the at least one wall (15, 16), a step of subsequently closing the access opening, and a decontamination step of decontaminating the interior of the chamber (12) by delivering a decontaminant.

Description

Technical Field

[0001] The present invention relates to a method for operating a sterilized object in a controlled atmosphere chamber of a processing unit, a corresponding protection device for protecting an object that can be inserted into the controlled atmosphere chamber, a method of using such a protection device, an object that can be inserted into the controlled atmosphere chamber, and a machine having a controlled atmosphere chamber, in particular, a machine for packaging sterilized products such as, for example, medical, pharmaceutical, cosmetic or similar products, or products that are to be packaged in a controlled atmosphere.

Background Art

[0002] For example, machines are known for packaging products that must guarantee their sterility during the packaging step, such as pharmaceuticals, pharmaceuticals, cosmetics and similar products. These packaging machines have at least one processing unit housed in a controlled atmosphere chamber with walls that are hermetically sealed to isolate the interior from the external environment.

[0003] Typically configured as a glass door hinged to the machine frame so that objects of the processing unit can be assembled inside the chamber, its walls have specific ports called RTP (in English, the initials of Rapid Transfer Port) or alpha-beta ports that allow objects to be introduced into the chamber without compromising the controlled atmosphere inside the chamber, and have waterproof gloves anchored to other ports on the wall and arranged outside the chamber to allow an operator to manipulate the components inside the chamber while maintaining the sealed state.

[0004] The alpha-beta port consists of a primary closure unit, also called an "alpha unit", which surrounds an access opening that can be closed by a door, and a flange that can be preferably coupled to a corresponding secondary closure unit, also called a "beta unit", which is provided on a transfer device, such as a cylindrical transfer container, by means of a suitable mutual coupling interface.

[0005] The cylindrical transfer container is configured to transfer an object composed of one or more modular elements inside and outside the chamber, which are modular elements that must be 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 transfer container. In practice, before insertion into the chamber, a cylindrical transfer container filled with modular elements to be sterilized is placed inside the autoclave. Objects that are too large to pass through the alpha-beta port are also assembled in a controlled atmosphere chamber after being sterilized in an autoclave.

[0006] Since the alpha-beta port generally has a limited diameter of up to 350 mm, objects that are too large to pass through the passage opening cannot be inserted. These objects that do not pass through the alpha-beta port are usually supplied enclosed in a closed bag covered by a covering member. The covering element and the bag are made of a filter material, such as filter paper, for example.

[0007] To perform the assembly, it is necessary to open an access opening made in the wall of the chamber, as a result of which the protected atmosphere is impaired. In the case of a single very heavy and bulky object, two operators then insert the object into the interior of the chamber and place it in the intended position.

[0008] A first embodiment of the method known in the prior art, at this point, provides to close the access opening and again isolate the atmosphere inside the chamber from the outside. A decontamination cycle is performed using a decontaminant, typically using vapor hydrogen peroxide known by the abbreviation VHP, on the operator side located outside the chamber, using waterproof gloves anchored to its wall, opening the bag with the aid of scissors or other sharp instruments, removing it, and then assembling the objects inside the machine.

[0009] We must make it clear that this decontamination step must be distinguished from the previous sterilization step in the autoclave.

[0010] When the assembly operation of the objects inside the chamber is completed, a decontamination cycle is executed. Since the entire chamber cannot be sterilized in an autoclave, the decontamination process can meet the necessary hygiene and cleaning requirements inside the chamber. As we have stated, only some of the objects that come into direct or indirect contact with the product to be packaged have been previously sterilized in an autoclave, while the various 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 of the problems with this embodiment is that there are many delicate operations that the operator has to perform using gloves anchored to the wall. It can be easily understood that these operations are more inconvenient the more objects are located at a distance or at an angle from the gloves and are manipulated, and / or the bulkier and / or heavier the objects being manipulated are. These characteristics of the objects can also make it difficult to remove the bag using the gloves.

[0012] Another problem with this embodiment is that during the operation of clamping an object performed from the outside using gloves, if the latter punctures or breaks, the sterility of the chamber will be impaired. This is a very problematic situation because it requires a new decontamination cycle and reconfirmation that the atmosphere inside the chamber has been decontaminated, and glove replacement is time-consuming.

[0013] A second embodiment of the method known in the prior art provides that after the operator inserts an object into the chamber, the bag is cut by the machine corresponding to the attachment part of the object itself, and even if it is no longer airtight, it is left as it is for any case located on the object to be protected. Next, the object is fixed in its use position, and then the operator exits the closed chamber again to isolate the internal atmosphere. At this point, a decontamination cycle using a decontaminant is performed, and then the operator uses gloves fixed to the wall of the chamber to take out the bag and remove it from the chamber.

[0014] One problem with this embodiment is that while the access opening to the chamber is still open, the bag is opened and the operator performs the above operations while inside the chamber, which impairs the sterility of the object that was previously sterilized in the autoclave.

[0015] One problem with the known method is that the material for making the bag allows the passage of the decontaminant deposited on each part of the object that is intended to come into direct or indirect contact with the product to be packaged. This can sometimes lead to potential contamination of pharmaceuticals that is unacceptable from a regulatory perspective and may in some cases cause degradation of the pharmaceuticals themselves.

[0016] In another technical field, more precisely in the field of checking letters or parcels during transportation in a postal system for the delivery of goods, U.S. Patent Application Publication No. 2009 / 047173 discloses a method of decontamination based on ethylene oxide or hydrogen peroxide to eliminate contaminants of biological origin that are pathogenic and thus potentially harmful to human health. When inserted into a controlled atmosphere chamber where the decontamination method is carried out, a rigid waterproof lid shaped to fit the container is provided to protect the interior of the container containing its contents. 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. Furthermore, this document does not address or solve the problems related to the above method considering that there is no need to assemble the container inside the treatment chamber when it is necessary to avoid contact with agents used in sterile pharmaceuticals and decontamination methods, and there is no step of packaging sterile pharmaceuticals.

[0017] Accordingly, there is a need to perfect a protective device for protecting an object inserted into a controlled atmosphere chamber that overcomes at least one of the above-mentioned drawbacks in the prior art, as well as for the objects themselves, methods for manipulating them, and devices for packaging sterile pharmaceuticals.

[0018] To that end, it is necessary to solve the technical problems of maintaining the sterility of the part of the inserted object that is intended to come into direct or indirect contact with the product to be packaged, and preventing the deposition of decontamination agents used in the decontamination cycle in the chamber after the chamber is opened and an object as large as described above is inserted so that it cannot pass through the alpha-beta port.

[0019] In particular, one object of the present invention is to provide a protective device that can maintain the sterility of an object or a part of the object that comes into direct or indirect contact with the product to be packaged both during its transfer between an autoclave and a controlled atmosphere chamber and during subsequent setting operations of the above-mentioned machine.

[0020] Another object of the present invention is to provide a protective device that enables sterilization in an autoclave while allowing an object to be protected from contaminants.

[0021] Another object of the present invention is to perfect a method for the manipulation of a sterilized object within a controlled atmosphere chamber that allows maintaining the sterility of the object.

[0022] Another object of the present invention is to perfect a method of operation that allows limiting as much as possible the use of gloves anchored to the walls of a controlled atmosphere chamber, and in particular, avoiding the need for an operator to work with gloves that expose them to danger.

[0023] Another object of the present invention is to provide an object that can be inserted into a controlled atmosphere chamber configured to be protected by a protective device as described above.

[0024] The applicant has invented, tested, and embodied the present invention to overcome the drawbacks of the prior art and to obtain these and other objects and advantages.

SUMMARY OF THE INVENTION

[0025] The present invention is described and characterized in the independent claims. The dependent claims describe other features of the present invention or variations of the main inventive idea.

[0026] In accordance with the above object, and to solve the technical problems disclosed in a novel and original way, and to achieve considerable advantages as compared with the state of the prior art, a method has been implemented for the manipulation of an object that has already been sterilized and is later introduced into a controlled atmosphere chamber delimited by a plurality of walls. The method includes a gripping step of gripping at least one of the sterilized objects from outside the chamber, an insertion step of inserting the at least one object into the chamber through an access opening defined corresponding to at least one of the plurality of walls, a subsequent step of closing the access opening, and a decontamination step of decontaminating the interior of the chamber by delivering a decontaminant.

[0027] According to one aspect of the invention, prior to the insertion step, a protection step is provided of protecting at least one of the objects in a sealed manner by at least partially a protection device, the protection device being formed of a plastic material that is flexible, elastically deformable, and impermeable to the decontaminant, and including a protection member having a shape adapted to at least a part of at least one of the objects, and in the protection step, at least a part of at least one of the objects is covered by the protection member in such a way as to prevent the decontaminant from contacting at least one of the objects that is protected in a sealed manner during the decontamination step, and the protection member is associated with at least a part of at least one of the objects.

[0028] By doing so, at least in a sealing manner, the object is covered, and in a controlled atmosphere chamber that allows the insertion of decontaminants, especially one or more objects sterilized outside the chamber, in a protective member that does not allow the passage of vaporized hydrogen peroxide, which is commonly used to restore the sanitary state, advantages can be achieved. This significantly limits the risk of contaminating the part of the object intended to come into direct or indirect contact with the product to be packaged, while at the same time making it possible to maintain its aseptic state. Another advantage results from the impermeability of the protective element to the decontaminant of the material made, and the latter surrounds in a way that seals a part of the object in contact with the product, which in the prior art makes the use of a bag enclosing the object and the use of a covering member made of filter paper redundant. The elimination of such a bag simplifies the operation of manipulating the object inside the controlled atmosphere chamber.

[0029] The protection device is mainly designed to protect objects that do not pass through the access opening of the alpha-beta port. However, it has been observed that due to its small size, this protection device can also be used in a very advantageous way for objects that can pass through the alpha-beta port. In fact, according to a protection device as described above, the opening of the controlled atmosphere chamber no longer involves a loss of aseptic state in the part that comes into direct or indirect contact with the product to be packaged, and in subsequent steps to restore the state of the protected atmosphere, it is possible to prevent the objects inside the chamber from being contaminated by the decontaminant. Furthermore, thanks to the protection device, the operator can fix the object in the use position without relying on gloves anchored to the walls of the controlled atmosphere chamber when the chamber is open and while he / she is inside the chamber. These gloves are only used to remove the protection device after closing the chamber and performing the decontamination cycle. This operation does not compromise the integrity of the gloves because both these and the protection device are made of soft, non-cutting, or blunt materials.

[0030] In addition, it facilitates the insertion of an object passing through the RTP port and can limit the risk of tearing the glove.

[0031] The object to be at least partially protected by the protection device is preferably a component that must be assembled inside the chamber during use, more preferably a mechanical component, and can have an overall size greater than at least 350 millimeters, which is the maximum diameter of a known alpha-beta port. However, as described, the object can also have a maximum overall size of less than 350 mm.

[0032] Preferably, a step of assembling at least one of the objects inside the chamber is provided between the step of inserting at least one of the objects into the interior of the chamber and the step of closing the access opening.

[0033] According to some embodiments, in the protection step, a filter configured to allow the passage of steam while blocking the passage of the decontaminant is associated with the protection member or the at least one object.

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

[0035] According to some embodiments, the protection step provides that the object to be assembled includes a central body, and around the central body, preferably in a relief manner, that is, protruding outwardly, and a rigid ring is provided that is configured to function as a contact portion to the protection member when the protection member is associated with the central body in such a way that the central body seals to the object.

[0036] According to some embodiments described herein, after the decontamination step, a removal step of removing the protective member from at least one object is provided, and subsequently, an extraction step of extracting the removed protective member from the chamber is provided.

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

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

[0039] According to another aspect of the present invention, a protection device for at least partially protecting a sterilized object that can be inserted into a controlled atmosphere chamber in a sealed manner is provided, the protection device including a protective member configured to protect at least a part of the object in a sealed manner. The protection device is formed of a material in which the protective member is flexible and elastically deformable, has impermeability to the decontaminant, and has a shape adapted to at least a part of at least one of the objects. The protective member is configured to be associated with at least a part of at least one of the objects in such a way that the protective member covers at least a part of at least one of the objects so as to prevent the decontaminant from contacting at least a part of at least one of the objects protected in a sealed manner.

[0040] Advantageously, the material of which the covering member is made is a plastic material. This material can be selected, for example, from silicon, ethylene-propylene-diene monomer (EPDM) rubber or polyurethane plastic material. It must be made clear that these materials are suitable for ensuring both that the object protected by the covering member is effectively sterilized during the sterilization process in an autoclave and that it is properly protected during the decontamination operation in the chamber.

[0041] Preferably, the protection device is associated with a protection member or at least one object and comprises a filter configured to allow the passage of steam and to block the entry of both decontaminant and microorganisms, microparticles and dirt. More preferably, the filter is a hydrophobic filter. Preferably, the filter is of the cartridge filter type and has a size compatible with that of an alpha-beta port. Due to the presence of the filter, since the filter allows the sterilizing agent to reach the object to be sterilized, the components can be sterilized in an autoclave before being inserted into a controlled atmosphere chamber.

[0042] It should be noted that the filter can be associated with the covering member or the object if a sufficient condition is met, that is, the filter is placed in a fluid communication state having a compartment made between the covering member and the protected part of the object.

[0043] According to some embodiments, the protection member defines an opening and includes an edge so as to be applied in a manner that seals around the object. In particular, the edge is elastic in order to make an airtight seal around the object. The edge is preferably made of a single piece with the protection member. This facilitates the creation of the covering member and removes potential problems with the seal between the edge and the rest of the covering member while ensuring the elasticity of the edge.

[0044] According to some embodiments, the protective member is made of a single piece having a shaped edge and comprises at least one gripping element projecting outwardly with respect to the access opening. Thereby, after closing the controlled atmosphere chamber and performing a decontamination treatment to restore the state of the atmosphere to be protected, it is possible to facilitate the removal of the covering member, and thus this removal is performed externally by the operator via a glove fixed to the wall of the controlled atmosphere chamber.

[0045] So that the filter can be associated with the protective member, preferably the latter comprises a second sterilization opening surrounded by a filter and in particular having its own mounting part and a mounting element configured to be associated with said filter.

[0046] According to one aspect of the invention, there is provided an object that can be inserted into a controlled atmosphere chamber, in particular a machine for packaging sterilized products. The object is protected or intended to be protected by a protective device as described above configured to protect at least a part of the object in a sealed state. This protective member has a shape adapted to at least a part of the object, is made of a flexible material, is impermeable to decontaminants, and is elastically deformable. The protective member is further configured to be associated with at least one of the at least one part of the object in such a way that the protective member covers at least one of the at least one part of the object so as to prevent the decontaminant from contacting the protected part of the object. For this purpose, the protective member includes a central body and a rigid ring disposed around the central body, preferably in relief, i.e., projecting outwardly from the outside of the central body, and configured to function as a contact portion to the protective member in the way the protective member is applied to the at least one object in a sealing manner.

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

[0048] In particular, the ring is configured to act as a pedestal for the insertion of the edge of the protective member so as to improve the sealing around the object and ensure the tightness of the connection between the object and the protective member.

[0049] Preferably, the ring has a perimeter with a circular or oval shape. These shapes address the possibility of a sealing clamp failure and avoid sharp edges. Other shapes of the ring can be provided as long as they are suitable for ensuring airtight sealing.

[0050] According to some embodiments, when the object does not have a cylindrical shape, the ring is offset or eccentric with respect to the central body of the object. This makes it possible to more easily position the removal of the protective member, at least a part of the edge, and, possibly, the gripping elements integrated within the protective member, at a position further away from the object.

[0051] Preferably, the ring is perpendicular to the longitudinal axis of the central body of the object. Alternatively, the ring can be inclined by an angle of less than 90 degrees with respect to the longitudinal axis of the central body of the object.

[0052] The ring can be made as a single piece together with the central body of the object or can be firmly connected thereto, for example, by welding or adhesion. This ring defines a boundary between the area protected by the protective member and the area not thereby protected without contacting the product, and, correspondingly, mounting means are provided for fastening within the machine.

[0053] Advantageously, the object comprises a second sterilization opening surrounded by a filter and an attachment element configured to be associated, in particular, with its attachment part.

[0054] According to another aspect of the present invention, a method of using the above-described protection device is provided for the manipulation of an object that has been sterilized and subsequently inserted into a controlled atmosphere chamber. In particular, the protection device is formed of a material that is flexible, elastically deformable, and impermeable to the decontaminant, and includes a covering member having a shape adapted to at least a portion of the at least one object. The protection member is also configured to be associated with at least a portion of the object in such a way as to cover at least a portion of the object and prevent the decontaminant from contacting at least a portion of the object.

[0055] According to some embodiments of this method of use, the protection device can be associated with the protection member or the at least one object, and includes a filter configured to allow the passage of vapor and simultaneously block the passage of the decontaminant during the decontamination step within the chamber.

[0056] According to another aspect of the present invention, a machine for packaging a product, in particular a sterilized product or a product packaged within a controlled atmosphere chamber, is provided, including a processing unit provided with a controlled atmosphere chamber delimited by a plurality of walls, and at least one sterilized object that can be inserted into the chamber. The at least one object is at least partially protected by a protection device as described above, i.e., a protection device including a protection member formed of a material that is flexible, elastically deformable, and impermeable to the decontaminant and having a shape adapted to at least a portion of the at least one object, and configured to prevent the decontaminant from contacting the protected portion of the at least one object.

[0057] According to some embodiments, the protection device can equally be associated with the protection member or the at least one object and further includes a filter configured to allow the passage of the vapor during decontamination in the autoclave and to block the passage of the decontamination agent during the decontamination step in the chamber.

[0058] Preferably, the above-described component includes a central body and a rigid ring provided around the central body and configured to function as a contact portion to the protection member when the protection member is applied in a sealed manner on the at least one object.

[0059] These and other aspects, features, and advantages of the present invention will become apparent from the following description of some embodiments given by way of non-limiting illustration with reference to the accompanying drawings.

Brief Description of the Drawings

[0060]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Mode for Carrying Out the Invention

[0061] We must clarify in this specification that the expressions and terms used, as well as the accompanying drawings described similarly, have the sole function of better illustrating and explaining the present invention, and these functions are for providing non-limiting examples of the invention itself because the scope of protection for the invention is defined by the claims.

[0062] For ease of understanding, if possible, the same reference numerals are used to label the same common elements in the drawings. It should be understood that the elements and features in one embodiment can be combined as appropriate or incorporated into other embodiments without further explicit indication.

[0063] Referring to FIG. 1, a machine 10 for products to be packaged, particularly for sterilized products or products to be packaged in a controlled atmosphere such as pharmaceuticals, preparations, cosmetics, and other products, is described. The packaging machine 10 is of a known type and includes a processing unit 11 having a controlled atmosphere chamber 12 defined by a plurality of walls 13, 14, 15, 16.

[0064] Chamber 12 is formed by a fixed lateral wall 13, a fixed upper wall 14, and walls 15, 16 corresponding to access openings for inserting already sterilized objects to be packaged within the chamber. For this purpose, the walls 13, 14, 15, 16 of chamber 12 can be opened. In particular, chamber 12 comprises a first type of closable wall 15 consisting of two panels 17, for example made of glass, hinged corresponding to one of its sides, and a second type of closable wall 16 consisting of a frame 18 hinged thereto and a single panel 19 made of glass.

[0065] Each of the closable walls 15, 16 can anchor the corresponding operating glove 21 in a known manner or comprises one or more port holes 20 that can form part of an alpha-beta port, through which a partial passage of a corresponding cylinder for inserting an object into chamber 12 is provided without compromising the controlled atmosphere. The operation of the alpha-beta port is known per se and will not be described hereinafter. The alpha-beta port may be of the type sold, for example, by Getinge-La Calhene.

[0066] In the illustrated example, the processing unit 11 is divided into four zones 11A, 11B, 11C, 11D, each of which is arranged corresponding to each of the closable walls 15, 16 and into which corresponding elements, such as a vibrating bowl 22, a dispenser 23, and a lid-type preliminary feeder 24, etc., can be inserted and assembled. The vibrating bowl 22 and the pre-feeder 24 need to be assembled within the first zone 11A of the processing unit 11, while the dispenser 23 can be assembled within the third zone 11C.

[0067] Figure 2 shows the vibrating bowl 22 to which the protection device 25 is applied, which generally consists of a protection member 26 called a cover and a filter 27.

[0068] The cover 26 is made of a single silicon, i.e., a plastic material that is impermeable to the decontaminant and elastically deformable. Silicon has the advantages of being easily available and inexpensive. Additionally, it is possible to provide EPDM rubber or a similar material such as a polyurethane material, which has the advantage of not absorbing decontaminating substances such as evaporating hydrogen peroxide.

[0069] The cover 26 shown here is designed to have a shape that fits onto the upper part of the vibrating bowl 22 so that it can be assembled in a way that seals over it at least to cover and isolate its interior (see Figure 2). In particular, the cover 26 has an edge 28 that partitions a compartment 30 inside the cover itself (see Figure 3). The edge 28 is circular in shape and adheres well to the central body 31 of the vibrating bowl 22, which has a generally circular cross-section.

[0070] The edge 28, which is made integrally with the cover 26 and is thus also made of silicon, is provided with two gripping tabs 32 that allow the user to grip the cover 26 in order to easily and quickly remove it from the vibrating bowl 22.

[0071] The cover 26 includes a circular upper wall 33 and a lower wall 34 that is connected to the upper wall by a lateral wall 35 and is delimited at the bottom by the edge 28.

[0072] The filter 27 is a known type of cartridge filter having a size suitable for passing alpha-beta ports. Specifically, the filter 27 may be of the type commercially available under the name Novasip® filter by Pall Life Sciences.

[0073] In the example shown, the filter 27 is attached to the vibrating bowl 22 (see FIGS. 2, 4, and 5). For this reason, the filter 27 is located coaxially with the connecting element 36, that is, the sterilization opening 37 provided therein (see FIG. 5), and is directly connected to the vibrating bowl 22 through the sterilization opening 37, and includes a cylindrical tube provided with connection means known, for example, by screwing or shape interference, which is not shown in the drawings for simplicity.

[0074] The vibrating bowl 22 is made of a single part around its cross section and has a rigid ring 38 extending outward and perpendicularly from its transverse wall (see FIGS. 5 and 6). In this example, the ring 38 is housed in a plane perpendicular to the longitudinal axis of the central body 31 of the vibrating bowl 22 and corresponds to the intermediate area between its upper edge and lower edge.

[0075] The ring 38 has a circular circumference and substantially corresponds to the shape of the edge 28 of the cover 26, and has the advantage of having an airtight seal between the cover 26 and the ring 38 so that the edge adheres better thereto.

[0076] In the example shown here, the ring 38 has an outer wall 39 perpendicular thereto and has a circumferential groove 40 acting as a pedestal for the edge 28 of the cover 26 (see FIGS. 5 and 6). Corresponding to the groove 40 to improve stability and sealing performance, the edge 28 preferably has an inner lip 41 protruding toward the groove 40 for engaging therewith (see FIG. 6).

[0077] The ring 38 is preferably offset or eccentric with respect to the central body 31 of the vibrating bowl 22, so that the outer wall 39 has a location further away from the outer wall of the central body 31 (see FIGS. 4 and 5). Thereby, as will be described in more detail below, the cover 26 can be easily removed from the vibrating bowl 22.

[0078] Figures 7 and 8 show a modification of the cover 26 with a sterilization opening 42 having a mounting sleeve 43 for connecting the filter 27 to itself. In this case, the vibrating bowl 22 does not necessarily need to have its sterilization opening 37, or in any case, it is sealed airtight in a known manner, for example by a stopper. Since the connecting sleeve 43 is provided on the upper wall 33 of the cover 26, here the connecting element 36 is provided curved in such a way as to direct the filter 27 into a more stable position.

[0079] The protection device 25 described so far makes it possible to maintain the sterility inside the vibrating bowl 22 even when the vibrating bowl 22 is removed from the sterilization chamber, for example, the autoclave 100 (see FIG. 1) in which it has been sterilized, which facilitates its assembly within the processing unit 11 within the controlled atmosphere chamber 12.

[0080] A method for the operation of the vibrating bowl provides for placing the protection device 25 on the vibrating bowl 22, applying the cover 26 thereto, in particular applying the edge 28 of the cover 26 against the outer wall 39 of the ring 38, ensuring an airtight seal with the vibrating bowl 22. It should be noted that no bag is provided for enclosing the assembly consisting of the vibrating bowl 22 and the protection device 25. It should also be made clear that the filter 27 of the protection device 25 can be fixed equally to the cover 26 or the vibrating bowl 22 as described above.

[0081] Next, the vibrating bowl 22 equipped with the protection device 25 is sterilized in a sterilization chamber configured as an autoclave 100 (see FIG. 1), the latter being in an industrial plant different from, for example, the industrial plant where the chamber 12 is located and being able to be placed at a considerable distance therefrom, so that it is generally autonomous and independent with respect to the chamber 12. The filter 27 is configured to allow steam to pass through during sterilization in the autoclave while blocking the decontaminant, i.e., hydrogen peroxide, during the step of decontaminating the chamber 12, so that sterilization can be performed despite the impermeable material of the cover 26 and the seal between the latter and the vibrating bowl 22.

[0082] 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 (see FIG. 1). Depending on the size of the vibrating bowl 22 provided, it cannot be inserted into the atmosphere chamber 12 controlled through the alpha-beta port. Therefore, the vibrating bowl 22 must be introduced through the necessary opening defined corresponding to at least one of the walls 13, 14, 15, 16. In the illustrated example, the access opening is defined by releasing the wall 15 of the chamber 12 and corresponds in particular to the first zone 11A in the example given here. As a non-limiting example, the opening of the wall 15 occurs by rotating the panel 17 and lifting it up as shown in FIG. 1. Alternatively, this release is effected by disassembling the panel of the wall. Obviously, opening the wall 15 will compromise the sterility inside the chamber 12.

[0083] Once the wall 15 is opened, the vibrating bowl 22 still equipped with the protection device 25 is inserted into the chamber 12 and assembled to the processing unit 11. It should be noted that this assembly is performed without using the gloves 21 anchored to the walls 15, 16 of the chamber 12.

[0084] Subsequently, once the assembly is completed, the previously opened wall 15 is closed, and then the step of decontaminating the interior of the chamber 12 is carried out by supplying vaporized hydrogen peroxide, or any other suitable type of decontaminant.

[0085] Due to the impermeable material of the cover 26 and the presence of the filter 27 which is impermeable to vaporized hydrogen peroxide, the vibrating bowl 22, particularly its internal compartment 30, is protected from any contamination by vaporized hydrogen peroxide and thus cannot deposit on a part of the vibrating bowl 22 and come into contact with the product.

[0086] Following the decontamination step, the cover 26 is removed. The operator grips one or more gripping tabs 32 through the gloves 21 anchored to the walls 15, 16 of the controlled atmosphere chamber 12, pulls them to widen the edge 28, and thus separates the latter, particularly its inner lip 41, from the groove 40 of the outer wall 39 of the ring 38. The removal of the cover 26 is facilitated by the eccentric position of the ring 38 relative to the vibrating bowl 22. In fact, by pulling the tab 32 located at the part of the ring 38 furthest 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 allow it to pass through without the need to pull the gripping tab 32 further.

[0087] If the filter 27 is connected to the cover 26, it is obvious that it is removed together with it. On the other hand, if the filter 27 is connected to the vibrating bowl 22, it can remain inside the controlled atmosphere chamber 12.

[0088] Then, the cover 26 is extracted from the controlled atmosphere chamber 12 through the alpha-beta port.

[0089] Since the cover 26 of the protection device 25 described so far is made of an elastically deformable material, it has a predetermined shape that needs to be adapted to the objects 22, 23, 24 to be protected. The cover 26 described so far has a shape suitable for the vibrating bowl 22.

[0090] In another embodiment shown in FIG. 9, the cover 44 provided for the dispenser 23 includes a lower wall 45, an upper wall 46, four lateral walls 47, 48, 49, 50 shaped to define a parallelepiped compartment, and an oval edge 51 that separates the internal compartment 30. Also in this embodiment, a gripping tab 53 is provided on the edge 51.

[0091] This cover 44 is suitable for application to the dispenser 23 described above. The dispenser 23 includes a plurality of aligned nozzles 54 inserted into a support structure 55 (see FIG. 10) that is used as a central body for the dispenser 23. Around it, a ring 56 that is functionally similar to the ring 38 of the vibrating bowl 22 is arranged. The ring 56 has a shape adapted to the edge 51 of the cover 44 and is completely similar to the edge 28 of the cover 26 (see FIG. 6). The cover 44 is configured to wrap around the nozzles 54, and the edge 51 is configured to form an airtight seal with the ring 56 of the support structure 55.

[0092] In this embodiment, the filter 27 can be connected only to the cover 44, and for this purpose, it includes a mounting sleeve 57 surrounding a sterilization opening 58.

[0093] The dispenser 23 has a lateral size that allows it to be inserted into the chamber 12 via the alpha-beta port means, and it should be noted that this does not impair the controlled atmosphere. However, it has been observed that by using the protection device 25, it is possible to assemble the dispenser 23 following the aforementioned method without using the gloves 21 anchored to the walls 15, 16 of the controlled atmosphere chamber 12. Due to the hermetic seal formed between the edge 51 of the cover 44 and the ring 56 of the support structure 55, and also due to the impermeability of the silicon, when the chamber 12 is closed after the assembly of the dispenser 23, the nozzle 54 of the dispenser 23 is sufficiently protected from the vaporized hydrogen peroxide used in the step of decontaminating the chamber 12.

[0094] In another embodiment, as shown in FIG. 11, the cover 59 has a shape adapted to the pre-feeder 24. For this purpose, the cover lid 59 has a substantially cylindrical shape and provides a bottom 60 that cooperates with the lateral wall 61 to delimit the internal compartment 30, the latter being delimited at the lower part, i.e., the part opposite to the bottom 60, by an edge 62. Two gripping tabs 63 project outwardly from the edge 62, and these are preferably arranged at diametrically opposite positions with respect to each other. Also, the cover 59 is provided with a mounting sleeve 64 that surrounds the sterilization opening 65 provided in the bottom 60.

[0095] The edge 62 is inclined by an angle of approximately 45 degrees with respect to the longitudinal axis of the cover 59. Thus, the edge 62 has a substantially elliptical shape, and apart from this shape, it has the same structure as each of the edges 28, 51 of the covers 26, 44 (shown in FIG. 6).

[0096] The pre-feeder 24 (see FIGS. 12 and 13), which is usually provided to supply the stopper, is known per se and has a hollow central body 66, the surface of which extends to define a supply ramp 67 that opens at its free end and is partially obstructed by an intermediate wall 68.

[0097] The stopper pre-feeder 24 includes a ring 69 configured to be wrapped in a state sealed by the edge 62 of the cover 59 (see FIG. 13). This ring 68 is similar to the rings 28, 56 of the vibrating bowl 22 and the dispenser 23 (the structure shown in FIG. 6), except that it is inclined by approximately 45 degrees with respect to the longitudinal axis of the central body 66 of the pre-feeder 24 so as to match the edge 62 of the cover 59. Next, the cover 59 is coaxial with the pre-feeder 24 for the advantage of reducing the overall size of the assembly.

[0098] It is obvious that the method for operating an object in a controlled atmosphere chamber, the protection device 25, the object that can be inserted into the controlled atmosphere chamber, and the product packaging machine, as described so far, may be modified and / or added without departing from the field and scope of the present invention as defined by the claims.

[0099] Although the present invention has been described using several specific examples, it is clear that those skilled in the art will be able to achieve equivalent forms having the features as described in the claims for the operation of an object in a controlled atmosphere chamber, the protection device 25, the object that can be inserted into the controlled atmosphere chamber, and the product packaging machine.

[0100] In the following claims, the sole purpose of the reference in parentheses is for ease of reading and should not be considered as a limiting element regarding the protection scope defined by the same claims.

Claims

1. A method for the manipulation of objects (22, 23, 24) that have already been sterilized and are subsequently introduced into a controlled atmosphere chamber (12) delimited by a plurality of walls (13, 14, 15, 16), comprising: The method comprises: a gripping step of gripping at least one of the sterilized objects (22, 23, 24) from outside the chamber (12); an insertion step of inserting the at least one object (22, 23, 24) into the chamber (12) through an access opening defined corresponding to at least one of the plurality of walls (13, 14, 15, 16); subsequently, a step of closing the access opening; a decontamination step of decontaminating the interior of the chamber (12) by delivering a decontaminant; and prior to the insertion step, a protection step is provided of protecting at least one of the objects (22, 23, 24) in a sealed manner by at least partially a protection device (25), the protection device (25) is formed of a plastic material that is flexible, elastically deformable, and impermeable to the decontaminant, and includes a protection member (26, 44, 59) having a shape adapted to at least a portion of at least one of the objects (22, 23, 24), In the protection step, during the decontamination step, the protection member (26, 44, 59) covers at least a portion of at least one of the objects (22, 23, 24) so as to prevent the decontaminant from contacting at least one of the objects (22, 23, 24) protected in a sealed manner, characterized in that the protection member (26, 44, 59) is associated with at least a portion of at least one of the objects (22, 23, 24).

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

3. In the protecting step, the at least one object (22, 23, 24) includes a central body (31, 55, 66), and around the central body, a rigid ring (38, 56, 69) is provided which is configured to function as an abutting portion to the protecting member (26, 44, 59) when associated with the central body (31, 55, 66). The method according to claim 1 or 2, characterized in that.

4. After the decontaminating step, a removing step in which the protecting member (26, 44, 59) is removed from the at least one object (22, 23, 24), and Subsequently, an extracting step in which the protecting member (26, 44, 59) is extracted from the chamber (12) is further provided. The method according to any one of claims 1 to 3, characterized in that.

5. After the protecting step and before the inserting step, a sterilizing step in which the object (22, 23, 24) which is at least partially protected in a sealed manner by means of using the protecting device (25) is sterilized in a sterilizing chamber (100). The method according to any one of claims 1 to 4, characterized in that.

6. The object (22, 23, 24) protected in a sealed manner is configured as a modular element. The method according to any one of claims 1 to 5, characterized in that.

7. A protecting device (25) for at least partially protecting a sterilized object (22, 23, 24) which can be inserted into a controlled atmosphere chamber (12) in a sealed manner, The protecting device (25) includes a protecting member (26, 44, 59) configured to protect at least a part of the object (22, 23, 24) in a sealed manner, The protecting device (25) is The protecting member (26, 44, 59) is flexible and elastically deformable, formed of a material having impermeability to the decontaminant, and has a shape adapted to at least a part of at least one of the objects (22, 23, 24). Furthermore, the protective member (26, 44, 59) is configured to be associated with at least a part of the at least one object (22, 23, 24) such that the decontaminant does not contact the at least one object (22, 23, 24) protected in a sealed manner, by covering at least a part of the at least one object (22, 23, 24) with the protective member (26, 44, 59). A protective device (25), characterized in that. **Claim 8** The protective device (25) according to claim 7, characterized in that it comprises a filter (27) that can be associated with the protective member (26, 44, 59) or the at least one object (22, 23, 24), and is configured to allow the passage of vapor and block the passage of the decontaminant. **Claim 9** The protective device (25) according to claim 7 or 8, characterized in that the protective member (26, 44, 59) defines an internal compartment (30) and includes elastic edges (28, 51, 62) configured to apply a hermetic sealing method around the at least one object (22, 23, 24). **Claim 10** An object (22, 23, 24) that can be inserted into a controlled atmosphere chamber (12) and protected by a protective device (25), the protective device (25) including a protective member (26, 44, 59) configured to protect the object (22, 23, 24) in a manner that seals at least a part of the object (22, 23, 24). The protective member (26, 44, 59) has a shape adapted to at least a part of the object (22, 23, 24), is flexible and elastically deformable, and is formed of a material that is impermeable to the decontaminant. The object (22, 23, 24), characterized in that the protective member (26, 44, 59) is configured to be associated with at least a part of the at least one object (22, 23, 24) such that the decontaminant does not contact the at least one object (22, 23, 24) protected in a sealed manner, by covering at least a part of the at least one object (22, 23, 24) with the protective member (26, 44, 59). **Claim 11** The protective member (26, 44, 59) includes a central body (31, 55, 66), and around the central body, a rigid ring (38, 56, 69) is provided which is configured to function as an abutting portion to the protective member (26, 44, 59) when the protective member (26, 44, 59) is applied onto the at least one object (22, 23, 24). The object (22, 23, 24) according to claim 10, characterized in that.

12. A method of using a protective device (25) for the operation of an object (22, 23, 24) that has already been sterilized and is later inserted into a controlled atmosphere chamber (12), The protective device (25) is formed of a material that is flexible, elastically deformable, and impermeable to a decontaminant, and includes a protective member (26, 44, 59) having a shape adapted to at least a part of at least one of the objects (22, 23, 24), The protective member (26, 44, 59) is configured to be associated with at least a part of the object (22, 23, 24) in such a way as to cover at least a part of the at least one object (22, 23, 24) so as to prevent the decontaminant from contacting the at least one object (22, 23, 24) protected in a sealed manner. A method of use, characterized in that.

13. The protective device (25) is capable of being associated with the protective member (26, 44, 59) or the at least one object (22, 23, 24), and includes a filter (27) configured to allow the passage of steam and block the passage of the decontaminant. The method of use according to claim 12, characterized in that.

14. A processing unit (11) provided with a controlled atmosphere chamber (12) partitioned by a plurality of walls (13, 14, 15, 16), At least one sterilized object (22, 23, 24) that can be inserted into the chamber (12), The at least one object (22, 23, 24) is at least partially protected by a protective device (25), The protection device (25) has a shape adapted to at least a part of the at least one object (22, 23, 24), and is flexible and elastically deformable so as to prevent a decontaminant from coming into contact with the protected part of the at least one object (22, 23, 24), and includes a protection member (26, 44, 59) formed of a material having impermeability to the decontaminant, the product packaging machine (10) being characterized thereby.

15. The protection device (25) is capable of being associated with the protection member (26, 44, 59) or the at least one object (22, 23, 24), and includes a filter (27) configured to allow the passage of vapor and block the passage of the decontaminant, the product packaging machine (10) according to claim 14 being characterized thereby.

16. The at least one object (22, 23, 24) includes a central body (31, 55, 66), and a rigid ring (38, 56, 69) is provided so as to function as a contact portion to the protection member (26, 44, 59) when the protection member (26, 44, 59) is applied in a sealed manner on the at least one object (22, 23, 24) around the central body, the product packaging machine (10) according to claim 14 or 15 being characterized thereby.

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