ITBO960648A1 - CONTAINMENT STRUCTURE OF A MACHINE FOR THE PACKAGING OF ARTICLES IN A STERILE ENVIRONMENT - Google Patents

Description

CONTAINMENT STRUCTURE OF A MACHINE FOR THE PACKAGING OF ARTICLES IN A STERILE ENVIRONMENT

DESCRIPTION OF THE INVENTION

The present invention relates to the sector of the construction of automatic machines for packaging products in a sterile or modified environment. In particular, the subject of the present invention is a section of a machine structure for packaging products in a sterile or modified environment, for example medicinal articles.

During their production,? It is necessary that the products, in addition to undergoing a terminal sterilization process, are subjected to production processes, such as packaging, carried out with sterile materials and in sterile environments.

The degree of contamination of the environment is indicated with a so-called class which, in accordance with the US standard FS209E, results from the number of polluting particles found in a unitary volume of air (in this case one cubic foot equal to 0.0283 meters cubes).

The process environment must therefore have a class that depends on the type of medicine to be packaged. Thus, for example, medicinal products that must be administered parenterally, ophthalmic products or those that can be administered nasally must be packaged in a class 100 environment, while tablets, capsules, sugared almonds, suppositories, etc., i.e. those products that enter in the organism by other ways, they can be packaged in higher class environments.

There is also the problem of protecting the operators who attend the manufacturing processes of these products from continuous contact with them, in particular from cytostatic products, which are extremely harmful to the operator. Is it what it is? to protect the environment outside the sterile process areas from pollution with the product that is subjected to this process.

At the same time it is necessary to protect the environment in which the processes are implemented from possible pollution by the operators who access these environments.

Let us now consider an automatic machine intended for the packaging of pharmaceutical items of the first category mentioned, that is? those intended for introduction into the body by parenteral route, ophthalmic products or products that can be administered via the nose.

In fig. 1? illustrated a known structure of this machine, so-called pallet, which provides a cabin 1, also called protection hood, hermetically closed. Inside the booth are located the operating members 50 which physically deal with the packaging operations. This type of protection for the car? also known as isolator, or in isotechnics, since the cabin 1 creates an environment which is practically isolated from the non-sterile external environment, equipped with systems and channels for air treatment.

These systems and ducts are made in such a way as to maintain a unidirectional air flow and to guarantee the maintenance of the desired class inside the insulator, usually located in an uncontrolled class environment.

The shape of the cabin? generally truncated cone. The transit of the materials to make the packages and the medicinal articles to be packaged, from and to the sterile environment, takes place by means of suitable procedures and suitable passage openings of a known type, not shown in the graphic representation, made in such a way as to maintain the air condition inside the cabin.

In particular, there are doors for occasional transit of articles, and openings for continuous transit, through which the articles pass while the air can? only escape following a slight overpressure inside the cabin.

Below the cabin? disposed a casing 3 closed, but not hermetically, which delimits the so-called "gray zone", so-called as it is not sterile, within which the means for moving the operating members located in the overlying cabin are arranged.

The cabin also be brought back on the casing and locked to it by means of appropriate mechanical means, or can it? be made in integral configuration with the same casing.

The base of the cabin? surrounded by a perimeter channel C through which the air inside is made to flow out to be re-introduced into the cabin at its top? by means of recirculation members, substantially constituted by a duct 2 connected to the canalization C and along which? placed a fan 7.

The air is forced through suitable filters 4, called absolute filters, which determine a 99.97% reduction in the presence of particles of a size equal to or greater than 0.3? M, and which are generally located on the top? of the cabin. Periodically replacements are carried out in correspondence with the recirculation organs with sterile air.

The output section of the filters? made in such a way as to give rise to a homogeneous FI flow on the entrance area to the cabin, ideally laminar.

This is why? to keep the environment inside the cabin in suitable conditions,? it is necessary that the air flow exiting the filters 4, which? practically sterile, yes, the most? possible uniform and unidirectional.

To improve the condition of unidirectionality? of the flow, downstream of the filters, a diffuser consisting of a suitably shaped panel is also provided. Access to the inside of the hermetic cabin? allowed in two ways:

- by means of hoses 5 fixed to the walls of the booth and having an inward development; inserting the hand and arm into the hose? It is possible to intervene, within a certain radius, on the operating parts for maintenance, elimination of jams and restoration of normal operating conditions possibly compromised by an anomalous event.

- by opening a hatch, not shown in the figure, which makes it possible to access every part of the cabin but which definitively compromises sterility. inside.

After opening and closing the door, which takes place according to predetermined time intervals, for example to replace parts of the operating elements 50 inside the cabin, a sterilization operation must be carried out, for example with hydrogen peroxide, to make the surfaces of all components located within the sterile zone, as well as the internal surfaces of the booth.

The operation of the machine is then reactivated only after the air has circulated through the filters for a sufficient time to guarantee the restoration of the sterile condition, and this obviously entails considerable costs, both due to the stoppage of production for a period of time. not negligible, than for the actual costs of sterilization.

Can you? minimize the need? to open the hatch, placing 5 hoses on pi? sides of the booth 1, and the number of hoses must be sufficient to perform all those operations necessary in normal operating conditions which, due to the width of the machine, hoses on one side only would not allow. There? obviously requires easy access to all walls of the structure.

The width of the machine depends on the fact that the arrangement of the transmission members leaving the casing 3, located below it, constrains its dimensions.

A second type of structure schematically illustrated in Fig. 2, again of the pallet type,? intended for the packaging of pharmaceutical items of another category.

The cabin 201, open at its top? 218, and the casing 203 are located, superimposed as in the previous case, inside a sterile chamber 260 connected to recirculation members, not shown. The recirculation organs close to the outside of the clean room by means of a series of ducts, along which? placed a fan.

Do they come like this? generated a unidirectional flow of air F2, inside the clean room 260, and a unidirectional flow of air F21, separated from the flow F2 and therefore of a slightly lower class, which crosses the cabin 201 from the top? open 218 up to the base 208, emerging from the free space 209 which remains between the base itself and the upper surface of the casing 203 below, separated from each other.

Access to the operating areas of the machine? allowed through doors 207 mounted on cabin 201, and for access to clean room 260? the use of suitable clothing is foreseen, as the cabin does not protect the operators who are inside the clean room from the treated product. These clothes also have the function of protecting the environment inside the clean room from possible pollution caused by the operator.

To improve the flow of air towards the top? open 218 of the cabin, around the latter is placed a curtain 220 that originates from the ceiling of the clean room 260, that is? immediately downstream of the sterilization filters 204.

In another structural configuration, which represents a variant of the previous one and which? illustrated in Fig. 2a, the cabin 231? located in the vicinity? of a wall 265 of the clean room 261, close to a window 266 with the edge of the latter tightly joined to the cabin 231.

On the wall of the booth 231 facing the window 266 are mounted hoses 205 which allow to reach some operating members without entering the sterile room and opening the doors.

Also in this case, two separate flows F2a and F2a1 are created, of which the one inside the cabin? slightly lower than the clean room class. The air inside the booth escapes from the free space 239 which remains between the base 238 of the booth and the upper surface of the casing 233 below.

A further known configuration, again of the pallet type,? illustrated in fig. 3. In this case the booth 301 and the casing 303, superimposed, are located inside a sterile chamber 360, connected to recirculation members, not shown, which introduce forced air into the chamber through filters 327. The booth 301? equipped with autonomous ventilation organs 317 which take the air from the sterile room and push it into the cabin 301 through suitable filters 304 placed at the top? of the cabin itself.

From inside the booth 301 the air escapes through the free space 309 which remains between the base 308 of the booth and the upper surface of the underlying casing 303 separated from each other.

This configuration allows to have an overpressure inside the cabin with respect to the clean room, so? that, with the doors closed, there is no entry of particles into the cabin.

In this way, a unidirectional air flow F3 is created in the clean room 360, while another unidirectional air flow F31 is created in the cabin 301 which crosses the operating zone Z3 of the packaging members 350.

Access to the Z3 operational area? made possible by means of doors 307 mounted on cabin 301, and for access to the sterile room 360? the use of suitable hermetically sealed clothing is foreseen, as the cabin does not protect the operators who are inside the clean room from the treated product, so? as the environment inside the clean room would not otherwise be protected from the pollution caused by the operator. A variant of the embodiment just described? illustrated in fig. 3a. The cabin 331, built substantially as in the previous case and superimposed on the casing 363,? placed in support of a wall 365 of the clean room 361, close to a window 366 with the edge of the latter sealed together with the cabin 331.

Hoses 305 are mounted on the side of the cabin 331 facing the window 366, which allow to reach only some of the operating elements without entering the clean room, while on the opposite side? provided a hatch 367.

Also in this case, two separate flows F3a and FSa1 are created, the latter determined by ventilation members 369 affixed to the cabin and conducted through filters 364. The air inside the cabin escapes from the free space 339 which remains between the base 338 of the cabin and the upper surface of the underlying carcass 363.

A further known configuration of the bed machine in question? shown in fig. 4 and also provides that the cabin 401 and the carcass 403 are located inside a sterile room 460.

The clean room? connected to recirculation organs, not shown, which close to the outside by means of a series of ducts along which? placed a fan, and? equipped with 427 filters.

Cabin 401? completely closed with respect to the environment of the clean room, but not hermetically, and? equipped with further recirculation devices 417.

The additional recirculation members 417 comprise a series of vertical ducts for conveying the air drawn from the lower area 408 of the booth 401 towards its top. 418, where relative 404 filters are placed.

In this way, a unidirectional flow F4 of treated air is produced in the clean room 460.

In the booth, another unidirectional flow of sterilized air F4 <1> is created which crosses the operating zone Z4 of the packaging members 450.

Access to the Z4 operational area? made possible by means of doors 407 mounted on booth 401, and for access to clean room 460? the use of suitable hermetically sealed clothing is foreseen, even if the closed recirculation configuration of the cabin already gives? a certain degree of protection from the treated product to the operators present in the clean room. However, even in this case, special measures must be taken to avoid pollution of the environment inside the clean room by the operator.

Also for the latter known embodiment? a variant applied to a wall 465 of the clean room 461 is provided, as illustrated in fig.4a.

The cabin 431, built substantially as just described and superimposed on the casing 433,? placed close to a window 466 with the edge of the latter joined tightly to the cabin 431.

Are hoses 405 mounted on the side of the booth 431 facing the window 466 leading to the opposite side? provided a hatch 467.

Also in this case, two separate flows F4a and F4a <1> are created, the latter being determined by the recirculation and ventilation organs 469 affixed to the cabin, and conducted through absolute filters 464.

Access to the clean room? possible with the use of suitable clothing.

Generally, the class that you can? keeping inside the cabin depends on the type of configuration and the systems used.

In the case illustrated in fig.l, the class can? be easily controlled thanks to the realization of the unidirectional flow, to the presence of filters applied to an insulated booth that is sealed with respect to the external environment.

In the embodiments that provide the top? and the base of the open cabin, illustrated in Figures 2 and 2a, the class inside the cabin is not? controllable since? it basically depends on the condition of the air in the clean room. In this case, the cabin has the function of maintaining the portion of flow that crosses the most? possible linear and unidirectional, as well as accident prevention protection. In fact, the condition created inside the cabin does not differ significantly from that of the clean room.

In the configurations illustrated in Figures 3,3a, 4 and 4a the class? instead controllable thanks to the realization of the unidirectional flow and to the presence of filters applied to a cabin closed at at least one end? .

All the structure configurations described above, both the isolator one and the other types mentioned, have a substantial negative characteristic caused by the presence of the casing containing the handling means.

The operating area Z, Z2, Z3, Z4 with reference to figures 1,2,3 and 4, of the packaging members must be located at a height from the level of the floor P such as to allow an easy view from the outside and easy access to the cabin, both through the hoses and by opening the hatch. It therefore inevitably finds itself close to the bottom 6 of the cabin 1 which remains raised from the level P due to the presence of the underlying casing containing the movement members.

The lower area of the cabin, from which the air is sucked through the respective ducts,? seat of turbulence generated by the impact of the unidirectional flow F of the air on the bottom itself.

These turbulences disturb the flow of air rising upwards until it touches and, in some cases, hits the operating area Z, Z2, Z3, Z4 of the packaging members.

This drawback determines a mixing of the polluting particles that stagnate in the bottom of the cabin bringing them right towards the area that must instead be more? protected.

Furthermore, even in the wall arrangements of the machine, in which the access hoses to the operating areas are provided, do not? It is always possible to avoid the opening of the doors following malfunctions or for routine operations, given that the minimum width of the machine, imposed by the presence of the underlying casing and the consequent arrangement of the operating elements, prevents easy access to all points inside the cabin with the use of hoses only.

It is therefore frequent the case in which technical interventions on mechanical units require the operator to enter the clean room and to open the doors, compromising the conditions inside the cabin.

WO-A-93/21965, in the name of Despatch Industries Limited and TL System Corporation, discloses an isolator system comprising a plurality of products. of sides that define an isolated environment within which the operating packaging members are arranged, an upper chamber that extends above the isolated environment, an external duct that emits a sterilizing fluid by means of a plurality of of outlet openings along the upper chamber, and filter members arranged between the upper chamber and the isolated environment. A return conduit connects the external conduit with the isolated environment.

The operative organs are located horizontally on a localized plane within the sterile environment. The width of the structure and the arrangement of the operating organs, prevents complete visibility? of all phases of the packaging process from all sides of the machine, and also prevents? to reach all points of the aforesaid plane with the use of hoses only, forcing frequent door openings, thus compromising the internal environmental condition. This particular disadvantage becomes particularly evident in the so-called wall-mounted solution, in which the operator would not need to enter the clean room for normal maintenance interventions, if it were possible to reach all the operating parts with the use of hoses alone.

The resulting inconvenience? ch? therefore, it becomes extremely difficult to maintain the pre-established class over time within the isolated environment even when its particular configuration, as in the case of a wall,? was created for this very purpose.

It is an object of the present invention to propose a packaging machine structure of the type mentioned in the introduction, modified in such a way as to prevent, or at least drastically reduce, the phenomenon of turbulence in the vicinity. of the operational zone Z, Z2, Z3, Z4 in order to determine a condition pi? stable with reference to the degree of contamination of the environment, i.e. the maintenance of the predetermined class.

An additional purpose? that of realizing a section of the machine structure that has dimensions such as to improve the homogeneity? of the air flow that passes through it, and to subject the operating zone Z, Z2, Z3, Z4 to an action that prevents the onset of perturbations of the air flow in its correspondence.

A further purpose of the invention? that of providing a packaging machine capable of protecting the external environment from contamination with the product that is subjected to packaging.

Finally, it is an object of the present invention to provide a machine with a configuration such that accessibility is made possible. to all the operating parts on one side of the structure only, this feature being of extreme importance in the so-called wall arrangement.

The above objects are achieved in accordance with what is reported in the characterizing parts of the independent claims.

Additional peculiarities? or variants of the construction details of the technical solution in question are highlighted in the subsequent dependent claims.

The characteristics of the invention, not evident up to now, are reported in the following detailed description, with reference to the accompanying drawing tables, in which:

- figures 1,2,2a, 3,3a, 4,4a schematically illustrate a series of packaging machine structures in a sterile environment, all belonging to the known art; fig. 5 schematically illustrates a section of structure made to incorporate the technical solution object of the present invention;

- figures 5a and 5b show in enlarged view, and in section, the bottom of the structure of fig.5, also improved in accordance with the invention;

- figures 6,6a, 7,7a, 8,8a illustrate constructive variants of the structure of fig. 5, corresponding, in their constructive and operating characteristics, to the known variants shown in figures 2,2a, 3,3a, 4, 4a of the known technical solution shown in fig-1;

- fig. 9 illustrates a construction variant referring only to the configuration d? fig. 5, in which a different geometric coupling is made between the cabin and the casing.

With reference to the figures briefly described above, the containment structure of a machine for packaging articles in a sterile environment object of the invention is now described.

In figure 5? illustrated the structure in question in its configuration of the so-called "insulator" type, that is? with a cabin 501 hermetically isolated from the external environment, according to the parameters mentioned in the introduction.

Inside the booth 501 are placed packing members 550 for the articles to be packaged, which operate in an area indicated with Z5.

Access to? The operating areas of the machine? allowed through any doors mounted on cabin 501, not shown in fig. 5.

At the top? and in correspondence with the bottom 506 of the booth 501, an inlet section 507 and an outlet section 508 are respectively formed, connected with ventilation members 540 to generate a unidirectional sterile air flow F5 inside the booth 501.

There are also so-called absolute filters 504 acting on the air flow F5 entering the booth 501.

The air is forced through these filters which determine a 99.97% reduction in the presence of particles of a size equal to or greater than 0.3? M Periodically, changes are made in correspondence with the recirculation organs with new sterile air.

The conformation of the filters and the recirculation organs? such that a uniform unidirectional flow of air is obtained over the entire section.

In the following, the unidirectional flow is always intended to be directed from top to bottom, ci? however not constituting a limitation of the scope affected by the invention.

In this particular embodiment, the filters 504 are located immediately downstream of the inlet section 507 of the cabin.

The recirculation members 540 close to the outside of the cabin by means of a series of ducts 515,516, along which? placed a fan 517. The periodic air changes are carried out in correspondence with the recirculation organs.

Known means for maintaining constant temperature and humidity values can be associated with this type of system. of the treated air.

It is understood, however, that an open circuit could be created, with the introduction into the cabin of sterile air which is released into the external environment, without departing from the scope of the invention.

In correspondence with the lower part of the booth 501, substantially alongside the latter,? placed a carcass 503 which contains the moving members, not shown, of the packing members 550.

The operating members are shaped in such a way that they can be supported and moved laterally, and not from below as in known machine structures. The cabin and the casing are joined together by mechanical assembly. According to another conformation, the cabin and the casing are made in an integral configuration, constituting a single body with each other. This structure, in both the connection configurations between the cabin and the casing, is also defined as "shoulder" by the technicians of the sector.

The lateral positioning of the casing 503 with respect to the cab '501 and the conformation of the operating members 550 which allows this positioning, release the dimensioning of the horizontal and vertical sections of the latter from the dimension of the casing, as well as? from the positioning of the means for transmitting motion from the members in the casing to the operating members in the cabin.

In particular, the operating area Z5 of the packaging members 550 is at a distance from the bottom 506 of the booth 501 such that any turbulence of the air present on the bottom itself cannot affect it or touch it.

This is why? the movement of the moving members to the rear allows the extension of the cabin to be extended downwards, moving the bottom 506 away from the operating area Z5.

Basically, the distance Y assumes an optimal value with respect to the width E from the base of the cabin.

Another immediate result of moving to the rear of the 503 casing? that the cabin can? assume a reduced horizontal cross section.

This allows access to all points inside the booth with 505 hoses mounted on a single booth wall.

The upper side of the casing 503 facing the cabin,? shaped to form an inclined plane 509 which causes a narrowing of the transverse section of the car 501 located immediately below the operating area Z5. The inclination of the 509 plane? 45 degrees.

This narrowing determines an increase in speed? of the air flow F5 and a depression in the area below the operating area Z5, so as to avoid possible returns of air upwards, from below to above the operating area Z5.

However, as illustrated in fig. 9, the machine can? also be made with a different geometric coupling between the cabin and the casing. In fig. 9, in fact, the casing 903 has a rectangular section and the floors 909,910 common with the booth 901 are consecutive, one almost horizontal and the other vertical.

The table 909 has an almost horizontal arrangement, being slightly inclined towards the inside of the cabin, to improve the drainage conditions of the cleaning and sterilization liquids of the machine, as better explained below.

In any case, the almost horizontal plane 909 must be below the operating zone Z9 of the packaging members 950.

Another measure to improve uniformity? of the flow and decrease the possibility of creating turbulence is constituted by a plate 510, which defines, near the bottom 506, an underlying space 511 from which the air coming out of the cabin 501 is sucked, as illustrated in fig. 5a.

Plate 510? affected by a plurality? of holes 512, illustrated in fig. 5b, having diameters with different sizes according to their position.

In particular, the holes 512 along the edges have a smaller diameter than the smaller ones. interior. In this way, a homogeneous distribution on the horizontal section of the plate 510 of the suction effect is obtained.

Air is extracted from space 511 by ducts 513,514 which extend along two of its opposite horizontal edges. To even out the suction effect, yes? furthermore it is envisaged that the space 511 has a decreasing section, in a vertical direction, proceeding from the outer edges towards the inside, with the point of lowest height located in correspondence with the central point of the bottom 506 of the cabin.

The fact that the operating parts are made with external surfaces that are connected as far as possible, removable and without holes also contributes to avoiding creating turbulence.

Furthermore, to facilitate the flow of the sterilization fluids of the cabin towards the bottom, before the start of the production process, all the horizontal surfaces inside the cabin are actually made? with a slight inclination.

The structure of this machine adapts, with appropriate variations, to the application also to other conformations according to schemes already? belonging to the known art and mentioned in the introduction, which define environments with different characteristics.

In particular, with reference to Fig. 6, a second type of shoulder structure is illustrated for the packaging of articles, for example pharmaceuticals.

The cabin 601, open at its top? 618, and the casing 603 are located, side by side and integrated with each other by mechanical assembly as in the previous case, inside a sterile chamber 660 connected to recirculation members 662.

The recirculation members 662 close to the outside of the clean room by means of a series of ducts, along which? placed a fan not shown, and force the air through absolute filters 604 placed on the ceiling of the clean room 660.

Do they come like this? generated a unidirectional flow of air F6, inside the clean room 660, and a unidirectional flow of air F61, separated from the flow F6 and therefore of a slightly lower class, which crosses the cabin 601 from the top? open 618 up to the base 608, emerging from the free spaces 609,610 which remain between the base itself and the underlying carcass 603.

Access to the operating areas of the machine? allowed through doors 607 mounted on booth 601, and for access to clean room 660? the use of suitable clothes is foreseen, since this structure does not protect the operator in the clean room from the treated product, n? the environment inside the clean room is protected from possible pollution caused by the operator.

It should be pointed out that access to operational groups for maintenance operations? also possible on one side at the choice of the machine, thanks to the reduced transversal dimensions.

To improve the flow of air towards the top? open 618 of the cabin, around the latter is placed a curtain 620 that originates from the ceiling of the clean room 660, that is? immediately downstream of the 604 sterilization filters.

As in the previous configuration, the 601 cabin? affected by a narrowing of its cross section located immediately below the operating area Z6, obtained by means of the inclined plane 609, to determine an increase in speed? of the air flow F61 and a depression below the operating zone Z6.

The air flow F61 is cos? pi? stable at zone Z6.

In another structural configuration, which represents a variant of the previous one and which? shown in FIG. 6a, booth 631? located in the vicinity? of a wall 665 of the clean room 661, close to a window 666 with the edge of the latter tightly joined to the cabin 631.

The clean room? equipped with 663 recirculation organs and 664 absolute filters.

605 hoses are mounted on the wall of booth 631 facing window 666, thanks to which? Access to operating groups for maintenance operations is possible.

As for the known wall structures mentioned in the introduction,? It is possible to access the operating groups without entering the clean room, but thanks to the reduced transversal dimensions of the cabin all the operating elements can be reached. Therefore, the number of accesses to the clean room and the necessary door openings is drastically reduced.

Also in this case, two separate flows F6a and F6a1 are created, of which the one inside the cabin? slightly lower than the clean room class. The air inside the booth escapes from the free space 639 which remains between the base 638 of the booth and the upper surface of the casing 633 below.

An? Additional shoulder machine configuration? illustrated in fig. 7. In this case the booth 701 and the casing 703, side by side and integrated with each other by mechanical assembly, are located inside a clean room 760, connected to recirculation members 762 which introduce forced air into the chamber through filters 727. The booth 701 ? equipped with autonomous ventilation organs 717 that take the air from the sterile room and push it into the cabin 701 through suitable filters 704 placed at the top? of the cabin itself. From inside the booth 701 the air escapes through the free spaces 709,710 which remain between the base 708 of the booth and the upper surface of the casing 703 below. In the clean room 760 a unidirectional air flow F7 is created, while in the booth 701 another separate unidirectional air flow F71 is created which passes through the operating zone Z7 of the packaging members 750.

Access to the Z7 operational area? made possible by means of doors 707 mounted on booth 701, and for access to clean room 760? expected the use of suitable clothes since? the operator does not? protected by the product, cos? how the environment inside the clean room is not? protected from possible pollution caused by the operator.

A variant of the embodiment just described? illustrated in fig. 7a. The cabin 731, built substantially as in the previous case and superimposed on the casing 733,? located in the vicinity? of a wall 765 of the clean room 761, close to a window 766 with the edge of the latter tightly joined to the cabin 731.

705 hoses are mounted on the side of cabin 731 facing window 766 while on the opposite side? a 767 door is foreseen. The reduced width of the machine allows easy access to all points inside the cabin also through the hoses, reducing the number of door openings required.

The clean room? connected to recirculation organs 763 and? equipped with 787 filters.

Also in this case, two separate flows F7a and F7a1 are created, the latter being determined by ventilation members 769 affixed to the cabin and conducted through filters. The air inside the cabin escapes from the free space 739 which remains between the base 738 of the cabin and the upper surface of the housing 733 below.

A further configuration of the packaging machine object of the present invention? illustrated in fig.8 and also in this case provides that the cabin 801 and the casing 803 are located inside a sterile room 860 side by side.

The clean room? connected to recirculation organs 862 which close to the outside by means of a series of ducts, along which? placed a fan not shown, and? equipped with absolute filters 827.

Cabin 801? completely closed with respect to the environment of the clean room, but not hermetically, and? equipped with further recirculation organs 817.

The additional recirculation members 817 comprise a series of vertical ducts for conveying the air taken from the base 808 of the booth 801 towards its top. 818, where 804 absolute filters are placed.

This allows to have the inside of the cabin in overpressure with respect to the clean room, so? that, with the doors closed, there is no access of particles inside the cabin.

In the clean room 860 a unidirectional flow F8 of the treated air is determined, while in the cabin a separate unidirectional flow of filtered air F81 is created which crosses the operating zone Z8 of the packaging members 850. Periodic air changes are obviously provided.

As for the previous versions of the machine made in accordance with the present invention,? provision is made for a narrowing of the cross section of the cabin 801 made by means of an inclined plane 809, to increase the speed? of the air flow F81 in correspondence with the operating zone Z8 and to avoid air returns towards the top.

Access to the Z8 operational area? made possible by doors 807 mounted on booth 801, and for access to clean room 860? provided for the use of suitable clothes, even if the cabin gives already? a certain degree of protection of the clean room from contamination with the treated product.

The necessity? of suitable clothes for the operator also results from the fact that the environment inside the clean room is not? protected from possible pollution caused by the operator.

The reduced width of the machine allows access to all the operating parts inside the cabin by opening the doors on one side only at the choice of the structure. Also for the latter known embodiment? a variant applied to a wall 865 of the sterile chamber 861 is provided, as illustrated in fig.8a.

The clean room? connected to recirculation organs 863 which close to the outside by means of a series of ducts, along which? placed a fan not shown, and? equipped with absolute filters 887.

The cabin 831, built substantially as just described and superimposed on the casing 833,? placed close to a window 866 with the edge of the latter joined tightly to the cabin 831.

805 hoses are mounted on the side of booth 831 facing window 866 while on the opposite side? planned a hatch 867.

How already? said, the hoses on one side of the machine are sufficient to reach all the packaging elements inside the booth, in virtue of? of its small transversal dimension.

Also in this case, two separate flows F8a and F8a <1> are created, the latter determined by the additional recirculation organs 869, applied to the cabin, and conducted through absolute filters 864, so as to create an environment of lower class within the cabin than to the clean room. Access to the clean room? possible with the use of suitable clothing.

The advantages deriving from the adoption of the machine structure made as described above are evident.

In general, as for the known configurations described in the introduction, it should be noted that in the case illustrated in fig. 5, the class can? be easily controlled thanks to the realization of the unidirectional flow, to the presence of filters applied to an insulated booth that is sealed with respect to the external environment.

The cabin, in the embodiments that provide for the top? and the open base, illustrated in Figures 6 and 6a, the class inside the cabin is not? controllable since? it basically depends on the condition of the air in the clean room. In this case, the cabin has the function of maintaining the portion of flow that crosses the most? possible linear and unidirectional, as well as safety protection and the condition created inside the cabin does not differ significantly from that of the clean room.

In the configurations illustrated in Figures 7,7a, 8 and 8a the class? on the other hand, it can be controlled thanks to the unidirectional flow and the presence of filters applied to a booth.

However, with respect to the known art, in the so-called shoulder-mounted machine structures built in accordance with the invention, the flow of air inside the cabin is created and above all kept unidirectional at every point, free from turbulence in the areas of greater interest, ie those in which the packaging organs operate, and homogeneous on the entire horizontal section of the booth.

Obtaining an increase in speed? flow and a depression below the operating area actively contributes to the stabilization of the unidirectionality? of the flow in the same area, avoiding air returns towards the top.

This advantage is emphasized in the configurations of Figures 5, 8 and 8a, where? provided for the location, in the vicinity? of the bottom, of a plate affected by holes with different diameters, which offer greater resistance to the passage of air in correspondence with the walls of the cabin, favoring the flow in the central area.

It follows a greater homogeneity? of the outflow of the air on the whole section of the plate, and therefore a greater homogeneity? of the unidirectional flow above it.

The removal of the bottom from the operating area of the packaging members, which however remains at an unchanged distance from the level of the floor P, prevents inevitable turbulence from affecting the products during their packaging.

The "shoulder" structure allows, with particular reference to the wall arrangements, normal maintenance interventions on the operating groups through the hoses without the need? for the operator to enter the clean room, while interventions on the handling parts located in the carcass can be carried out by operating from the gray area, outside the clean room.

These characteristics allow to keep the class of the environment inside the clean room unchanged and therefore to reduce the production resumption times after the interventions.

Furthermore, the "shoulder" configuration, reducing the width of the machine, allows the flow of products being packaged to be clearly visible and accessible from both sides of the booth, unlike what happened with the "pallet" structure of the art. known, for example that described in publication WO-A-93/21965 cited in the introduction.

The air volumes inside the cabin are reduced compared to the cabin of the pallet structure, limiting the recovery times, after opening the doors, by virtue of of the lesser quantity? of the air to be treated. There? it also has a positive effect on the duration of the filters' effectiveness, which is greater than the duration of the filters installed on a pallet structure.

It should be noted that the section of the machine, in which the relationship between the distances X, E and Y? optimal, causes the unidirectional vertical flow to act in the most? effective at the mouth of the bottles carried along the filling line and increases its speed? just below that area. Do they come like this? return of air charged with particles to the top is prevented.

The fact d? having provided the surfaces of the operating elements connected, removable and without holes, also entails the important advantage of a better flow of the fluids used for the sterilization of the environment inside the cabin before starting the production process.

This prerogative in fact considerably reduces the time required for the completion of this operation, as the fluids are drained more easily. .

This is also improved since all horizontal surfaces within the cabin are actually made. with a slight inclination, which favors the flow of fluids towards the bottom.

The surface conformation of the operating parts and of the interior of the cabin also favors cleaning operations since there are no inaccessible areas.

The greater vertical development of the vertical cabin, obtained at par? height of the machine, and the consequent movement of the bottom down also determines a greater ease? of placement on the bottom of any shattered or residues of bottles broken during production, without that there? in any way create disturbance for the continuation of operation.

Thanks to these features? also more? easy to collect and eliminate such fragments or residues deposited on the bottom.

Finally, the proposed machine has a high degree of protection of the external environment from pollution with the product subjected to packaging.

The invention in question? it has obviously been described, with reference to the attached drawings, purely by way of non-limiting example, so that any functional or structural variants or modifications are understood to be included in the scope of protection identified by the previous description and the following claims.

Claims (19)

CLAIMS 1. Containment structure of a machine for packaging articles in a sterile environment, which structure includes: - an insulated booth 501,801,831,901 and able to constitute a sterile environment for components for packing 550,850,950 of said articles; - a carcass 503,803,833,903 placed in proximity? of said booth 501,801,831,901 to contain moving members of said packing members 550,850,950; - recirculation members 540,817,869 adapted to generate a unidirectional flow of air F5, F8 <1>, F8a <1> inside said booth from an inlet section 507,818 to an outlet section 508,508 of the booth 501,801,831,901 itself; - filtering members 504,808,864 of the unidirectional flow F5, F8 <1>, F8a <1> of air entering said cabin 501,801,831,901; said structure? characterized by the fact that: - said casing 503,803,833,903 is located alongside, and in correspondence with the lower part of said cabin 501,801,831,901 so? that the operating area Z5, Z8, Z9 of said packaging members 550,850,950 is located at a distance from the bottom 506 of the booth 501,801,831,901 such that any air turbulence present at the bottom 506 does not affect the operating area Z5, Z8, Z9. 2. Structure according to rev. 1, characterized in that said booth 501,801,831? affected by a narrowing of its cross section made, immediately below said operative zone Z5, Z8, by means of an inclined plane 509,809 to determine an increase in speed? of the unidirectional air flow F5, F8 <1>, F8a <1> and a depression in the area of said cabin below the operating area Z5, Z8, so as to avoid, in correspondence with said operating area Z5, Z8, returns of air upwards. 3. Structure according to rev. 1, characterized by the fact that in the vicinity? of the bottom 506 of said cabin? a plate 510 is located, which delimits an underlying space 511 from which the air outgoing from the booth 501,801,831 is aspirated, with said plate 510 affected by a plurality of elements. of holes 512 having diameter with different sizes according to their position. 4. Structure according to rev. 2, characterized in that said holes 512 have a larger diameter in the central area of said plate 510 and smaller along its edges. 5. Section according to rev. 3, characterized by the fact that the air is extracted from the space delimited below said plate by means of channels 513,514 which extend along the opposite horizontal edges of the space itself, which has a decreasing section, vertically, proceeding from the outer edges inwards, with the point of lowest height located in correspondence with the central point of the bottom 506 of the cabin. 6. Structure according to rev. 1, characterized in that said recirculation members 540,817,869 close to the outside of said cabin 501,801,831 by means of a series of ducts 515,516, along which? placed a fan 517, respectively connected to said inlet section 507 and to said outlet section 508. 7. Structure according to rev. 6, characterized in that said booth 501? hermetically closed from the external environment. 8. Structure according to rev. 1, characterized in that said cabin 801,831 and said casing 803,833 are located inside a sterile chamber 860,861 connected to relative recirculation members 862,863 and equipped with relative filters 827,887 to generate a unidirectional flow of filtered air F8, F8a inside a said clean room 860,861. 9. Structure according to rev. 8, characterized by the fact that said booth 831? located in the vicinity? of a wall 865 of said clean room 861, close to a window 866 with the edge of the latter tightly joined to the cabin 831 and with at least one hose 805 mounted on the side of the cabin 831 facing the window 866. 10. Containment structure of a machine for packaging items in a sterile environment, which structure includes: - a booth 601,631, open at the top and at the bottom, inside which packing members 650 for said articles are placed; - a carcass 603,633 placed in proximity? of said booth 601,631 for containing moving members of said packaging members 650, said booth 601,631 and said carcass 603,633 being located inside a sterile chamber 660,661; - recirculation members 662,663 connected to said clean room 660,661 with interposed relative filters 604,664 to generate a unidirectional flow of air F6, F6a inside said clean room 660,661 and a separate unidirectional flow of air F6 <1>, F6a <1> inside said cabin 601,631; said structure? characterized by the fact that: - said casing 603,633 is located alongside and in correspondence with the lower part of said booth 601,631, with a free space left between them through which said separate air flow F6 <1>, F6a <1> inside said booth 601,631, with the operating area Z6 of said packaging members 650 located at a distance from the bottom 608,638 of the booth 601,631 such that any air turbulence present at the bottom 608,638 itself cannot affect the aforementioned operating area Z6. 11. Structure according to rev. 1, characterized in that said booth 601,631? affected by a narrowing of its cross section made, below said operating area Z6, by means of an inclined plane 609, to determine an increase in speed? of the unidirectional air flow F6 <1>, F6a <1> and a depression in the area of said cabin below the operating area Z6, so as to avoid, in correspondence with said operating area Z5, Z8, air returning towards the tall. 12. Structure according to rev. 11, characterized by the fact that around the top? open 618 of the cabin? placed a curtain 620 that originates from the ceiling of the clean room 660,661 downstream of the filters 604,664. 13. Structure according to rev. 10, characterized by the fact that said booth 661? located in the vicinity? of a wall 665 of said clean room 661, close to a window 666 with the edge of the latter tightly joined to the booth 631 and with at least one hose 605 mounted on the side of said booth 631 facing the window 666. 14. Containment structure of a machine for packaging articles in a sterile environment, which structure includes: - a booth 701,731, open at the top and at the bottom, inside which packing members 750 for said articles are placed; a carcass 703,733 placed in proximity? of said booth 701,731 for containing moving members of said packaging members 750, said booth 701,731 and said carcass 703,733 being located inside a sterile chamber 760,761; - recirculation members 762,763 connected to said sterile chamber 760,761 with interposed relative filters 727,787 to generate a unidirectional flow of air F7, F7a inside said sterile chamber 760,761; - ventilation organs 717,769 applied on the top? open of said booth 701,731 with interposition of filters 704,764 to create a separate unidirectional flow of filtered air F7 <1>, F7a <1> inside said booth 701,731; said structure? characterized by the fact that: - said casing 703,733 is located alongside and in correspondence with the lower part of said booth 701,731, with a free space 709,739 left between them through which said separate flow of filtered air F7 <1>, F7a <1> exits to said booth 701,731, with the operating area Z7 of said packaging members 750 located at a distance from the bottom 708,738 of the booth 701,731 such that any air turbulence present at the bottom 708,738 itself cannot affect the aforementioned operating area Z7 . 15. Structure according to rev. 1, characterized in that said booth 701,731? affected by a narrowing of its cross section made, below said operating zone Z7, by means of an inclined plane 709, to determine an increase in speed? of the unidirectional flow of filtered air F7 <1>, F7a <1> and a depression in the area of said booth below the operating area Z7, so as to avoid, in correspondence with said operating area ZI, air returns upwards . 16. Structure according to rev. 14, characterized by the fact that said cabin 761? located in the vicinity? of a wall 765 of said clean room 761, close to a window 766 with the edge of the latter tightly joined to the cabin 731 and with at least one hose 705 mounted on the side of said cabin 731 facing the window 766. 17. Structure according to claims 1,10,14, characterized by the fact that said operating members 550,650,750,850 are made with connected, removable external surfaces without holes 18. Structure according to claims 1,10,14, characterized in that all the horizontal surfaces inside the cabin 501,531,601,631,701,731,801,831 are made with a slight inclination. 19. Structure according to rev. 1, characterized in that said booth 901? affected by a narrowing of its cross section made immediately below said operative zone Z9 in correspondence with two consecutive sides 909,910 of said casing 903, with said sides arranged one horizontal and the other vertical, to determine an increase in speed? of the unidirectional flow of the air and a depression in the area of said cabin below the operating area Z9, so as to avoid in correspondence with said operating area Z9 the air returning upwards.