The present invention refers to the special construction sector for controlled contamination equipment.
In particular, the invention relates to a magnetic-operated closing device, comprising a door and relative actuation devices, suitable for installation in low-contamination equipment, which requires sealing, and intended to operate in environments with any Class of contamination according to GGMP standards.
Within the scope of the invention, controlled atmosphere equipment is included, for example: insulators, which are closed rooms in which toxic products are treated or packaged or which require particular conditions of low contamination or asepsis, usually kept at a pressure less than atmospheric, and in which the operators remain outside and carry out operations using sealed gloves fixed to a wall; the clean rooms, of any Class of contamination among those provided for example in the GGMP standard (from Class A to Class D), in which the operator, after a complex and accurate disinfection and dressing operation, is made able to enter a substantially sterile environment without compromising its class of contamination; the “rabs”, barriers that limit access to a limited environment, kept at a low level of contamination by a continuous flow of purified and decontaminated air; and, in general, to all controlled contamination environments, operating in any class of contamination.
The subject equipment is used in various fields, including pharmaceutical, cosmetic and food sectors, and allow to define chamber, insulated from the outside, in which various types of products are placed to be treated or packaged.
In particular, in the controlled environment packaging processes, the containers of the product to be packed are introduced into the packaging environment after being subjected to washing and sterilization operations. These latter operations are carried out in sterilizers, dryers, depyrogenation ovens, washing and disinfection machines, or in equipment that perform two or more of the above operations in combination. The sterilization operations can, for example, be carried out in an autoclave with machines that use saturated steam, a water/steam mixture, superheated water, or hydrogen peroxide or ethylene oxide (ETO).
In order to maintain the degree of sterility and low contamination obtained for the containers, the equipment described above is sealedly connected to the relative isolator, or to another controlled contamination environment.
For convenience and purely by way of example, in the description of the state of the art relating to the invention and in the detailed description of the invention itself, reference will be made to its application in a sterilizer, of the saturated steam type or equivalent, and to the connection of the latter to an isolator intended for packaging pharmaceutical products.
A saturated steam sterilizer operates at high temperatures and pressures and is designed to carry out, in consecutive cycles, the introduction of batches of containers, their treatment and their subsequent extraction and forwarding to a packaging line contained within a isolator.
To ensure correct operation, it is equipped with one or more sealed doors, designed to allow access to the containers, to isolate the sterilizer from the external environment during their sterilization operations, and finally to allow the transfer of the sterilized containers. to the packaging line contained in the insulator, without any contact with the external environment.
For this reason, a sterilizer usually has an entrance door and an exit door, the latter intended to interface the internal compartment of the sterilizer with the controlled atmosphere one of the insulator.
The sterilizer is equipped with systems for maintaining low contamination conditions, of a degree equal to that of the environment of the insulator to which it is connected, of a known type, which will not be further detailed as they are not directly relevant to the invention.
As is known to those who approach the design of such equipment, great attention must be paid to the shape of the various elements in order to limit as much as possible any accumulation areas of impurities such as, for example, dust or residues of products used in previous production operations, that are difficult to reach during cleaning and sanitizing operations.
It is easy to understand how the doors represent, from this point of view, critical components, due to the presence of hinges, any members for automatic movement, lock units and more, with numerous interstices, hidden corners, the presence of lubricants, possible generation of polluting particles due to wear of parts, sliding and so on.
It is easy to understand how the doors represent, from this point of view, critical components, due to the presence of hinges, any members for automatic movement, lock units and more, with numerous interstices, hidden corners, the presence of lubricants, possible generation of polluting particles due to wear of parts, sliding and so on. The technical problem which the present invention aims to address is therefore that of providing a magnetically operated closure device suitable for installation in a sterilizer, also in association with a subsequent isolator, as well as in other equipment operating in a controlled contamination environment, that need access with tight closures.
Another object of the invention is to propose a closing device, comprising a magnetically operated door, whose conformation has been carefully studied in all its parts to obtain surfaces that are as simple and smooth as possible, and which is free of gaps and/o points that are difficult to access in ordinary cleaning and sanitizing operations, where impurities, bacteria or other contaminants incompatible with the intended use of the door may stagnate and proliferate.
Another object of the invention is to obtain a magnetic actuation of the aforementioned door with a few simple components, which is reliable, compact, which does not generate particles due to chafing and wear, with fluid movements and also constructed in such a way as to respect the maximum the declared needs of easy cleaning and sanitization.
A further object of the invention provides that the magnetic door and the other components of the closing device are made of stainless materials, chemically stable and which allow to undergo all the cleaning treatments necessary for certification for all degrees of low contamination, required by current regulations, without their surfaces being deteriorated, damaged or releasing contaminating or harmful substances.
These and other objects are fully achieved by a magnetically operated closing device for controlled atmosphere devices, comprising a sliding door and which further comprises:
The characteristic features of the present invention will become clear from the following description of preferred embodiments of the magnetically operated door for controlled-atmosphere appliances according to the object, in accordance with what is proposed in the claims and with the aid of the attached drawings, in which:
In the above figures, and with reference to preferred embodiments of the invention, reference number 10 has indicated a magnetic operated closing device which forms the subject of the present invention. The closing device 10, in detail, comprises a sliding door 11 and an actuation unit 12, associated with the door 11 to lead it on command, alternatively, between an inoperative or open position N and an operating or closing position W, as will be better detailed below.
The sliding door 11 is intended mainly, even if not exclusively, to be used in equipment 1 for the sterilization, washing or depyrogenation of containers intended to be filled with products to be packaged in controlled contamination environments, for example, pharmaceutical, toxic products or easily perishable. For this reason, the above devices are usually connected, by way of non-limiting example, to an isolator 100 for the packaging of pharmaceutical products.
As already mentioned in the introduction, the scope of application of the closure device 10 extends, in addition to equipment operating in the pharmaceutical sector, to similar or equivalent equipment used in the chemical, biotechnological, food or cosmetic sectors, or in any case it is in any case It is necessary to have an access opening/closing device that does not have parts that are not easily accessible, not subject to accumulation of dust or debris, and that does not have components that can themselves release dust or debris, even in small quantities.
In the illustrated embodiments of the invention, the sliding door 11 is advantageously made with a box-like shape, and has flat faces, substantially free of recesses and prominences which can limit the immediate accessibility to all its parts. The door 11 is supported by a frame 2 which constitutes the supporting structure of a saturated steam sterilizer, or of other equipment for the treatment of containers according to what has already been expressed previously. In particular, the sliding door 11 is associated with the frame 2 so as to be external and close to it.
The frame 2, made up of sheet metal panels preferably of stainless steel, conforms an access mouth 20 to a compartment 21; the latter communicates, in operational configuration, with an internal compartment of the insulator 100, and is usually crossed by means for the transport of the containers, for example a conveyor belt, not visible in the drawings for reasons of illustrative simplicity and as not directly relevant to the invention.
The frame 2 supports, on its outside, a linear rod 3, for example cylindrical, suitable for constituting a linear guide with which the sliding door 11 is engaged; the latter, as already mentioned, is movable between an operating position W, in which it is covering the aforesaid access mouth 20 to isolate the compartment 21 from the external environment, and an inoperative N, in which the sliding door 11 it is located alongside the same access mouth 20, making the compartment 21 accessible from the outside.
The internal face 11B of the sliding door 11, facing the access mouth 20, is provided to be pressure-pressed, in correspondence with its operating position W, by an inflatable gasket 22, arranged in a closed ring in the aforementioned frame 2, to circumscribe the access mouth 20 itself (see in particular
In a first embodiment of the sliding door 11 (
Advantageously, linear guide elements 4 are also provided, suitable for keeping the lower part of the sliding door 11 close to the frame 2; the aforementioned linear guide elements 4, not described in detail as they are known, comprise sliding rollers 40 (see in particular
The drive unit 12 is provided with moving members 5, provided to impart to the door 11 the opening and closing strokes between the aforementioned operating positions W and inoperative positions N, and vice versa.
The moving organs 5, in the first embodiment, comprise a linear module 50, arranged parallel to the top of the cylindrical stem 3 and consisting of a tubular sheath 51, inside which is housed a transmission belt 52, for example toothed, taut between two return wheels 53, one of which keyed on an electric gearmotor 54 and therefore made motive.
A branch of the transmission belt 52 has a linear cursor 55 fitted with magnets 56, suitably positioned, arranged outside the aforementioned sheath 51, intended to be dragged by the transmission belt 52.
In a preferred embodiment, the magnets 56 are permanent magnets, but according to particular needs, the adoption of electromagnets can also be provided.
The actuation unit 12 further comprises a magnetic plate 6, fixed to the upper face of the sliding door 1 so as to be counterfeited to the slider 55 and to undergo the action of the magnetic field generated by the same. The magnetic plate 6 also includes one or more permanent magnets, suitably positioned to respond to changes in the magnetic field produced by the cursor 55 with the generation of a linear thrust with direction parallel to the aforementioned cylindrical rod 3, according to the known principles that define the operation of the linear actuators and according to their construction techniques, to which reference is made for convenience.
According to the embodiments shown in the figures, a sufficient space is provided between the magnets 56 and the magnetic plate 6 to prevent contact between the two and such as to ensure the correct entrainment of the sliding door 1 by magnetic attraction.
In a second embodiment of the closing device 10 (
The aforementioned electric gearmotor 54 which drives the driving wheel 53 is located, for example, outside one of the heads of the cylindrical rod 3, while the slider 55 with the permanent magnet 56 is also arranged inside the latter and facing the overlying magnetic plate 6 associated with the sliding door 11.
In a third embodiment of the closing device 10 (
The latter is arranged at the top in the figures attached by way of example only, therefore the operating position W of the sliding door 11 is that raised in
The moving members 5, substantially identical to what has already been said with reference to the first embodiment, are located laterally with respect to one of the cylindrical stems 5; in
In
The first sliding door 1F is associated with the access mouth 20 in the front wall 2F, which flows into the compartment 21, made inside the frame 2 and capable of constituting, in this case, the operating environment for the treatment of the containers.
The second sliding door 11R is associated with an outlet 23 present in the rear wall 2R; in this way the compartment 21 of the sterilizer 1 is directly communicating with the chamber of the insulator 100 or isolated from it according to the position, respectively inoperative N or operative W of the same second sliding door 11R.
In all the embodiments of the closure device 10 described above, coupling elements 7 are provided, shown schematically in
To ensure perfect positional control of the door 11, the closing device 1 provides suitable position sensors, not shown, suitable for detecting and signaling the achievement of the operational closing positions W and inoperative opening positions N of the door 11 itself.
From the above description, the advantages offered by the closing device 10 object of the present invention compared with the traditional closing devices, which constitutes a valid solution for the main application of intended use, in combination with a steam sterilizer saturated, or with other similar equipment or in any case intended to treat objects in an environment with very low contamination and perfectly isolated from the outside.
Particularly advantageous is the possibility offered by the closure device 10 to conform all the components of the device so as to obtain linear and smooth surfaces, substantially free of interstices and/or points which are difficult to access in ordinary and extraordinary cleaning and decontamination operations; in this way the accumulation of substances at least potentially capable of compromising the degree of cleanliness required for the sterilizer 1, or for the other equipment with which the closing device 10 is associated is avoided.
The door 11 thus made also exhibits fluid movements and with low friction.
It is however understood that what described above has an exemplifying and non-limiting purpose, therefore any detail variations that may become necessary for technical and/or functional reasons, are considered from now on to fall within the same protective sphere defined by the claims below.
Number | Date | Country | Kind |
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102019000009960 | Jun 2019 | IT | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IB2020/055971 | 6/24/2020 | WO |