Method for sterilizing a component of a machine operating in a sterile closed environment and for contact with a product to be processing within
Through the sterilization method of double-layer envelope, the problem of contamination is solved when sterilizing and reinstalling machine parts under non-toxic and sterile conditions is solved, and efficient sterilization and safe reinstallation of parts under sterile conditions is achieved.
Patent Information
- Application Number
- CN202380066805.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-09-12
- Filing Date
- 2023-09-07
- Publication Date
- 2025-04-25
AI Technical Summary
When prior art sterilizes and reinstalls machine parts under non-toxic and sterile conditions, it is difficult to avoid exposure of components to possible sources of contamination, resulting in a decrease in the level of closed operating environment, and with the introduction of new standards, VHP cycles are no longer sufficient to restore "A" grade sterile conditions.
The double-layer enclosure method is used to perform sterilization. The first envelope seals the first part of the enclosure and the second part of the component, and is sterilized by sterilization fluid to ensure that the component remains sterile throughout the process and is reinstalled in a sterile environment.
Effectively protect the first part of the component from contamination, ensure that it is reinstalled under sterile conditions, avoid the problem that the VHP cycle cannot meet the new standards, and achieve efficient sterilization under non-toxic and sterile conditions and safe reinstallation of the component.
Smart Images
Figure CN119894543A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the special technical field of processing and / or packaging products (for example, but not limited to, medicines in the form of syrups, ointments, tablets or capsules) under non-toxic and sterile conditions inside a machine or equipment (designed to include a suitable closed operating environment (or closed operating room) without pollution).
[0002] These machines must be designed to include closed working environments, inside which regulations must be observed in order to keep them in completely non-toxic and sterile conditions, for example by means of laminar flow and suitable air filtration systems, thereby preventing any possible sources of contamination from the external environment.
[0003] For example, based on the existing standards, a closed operating environment that must maintain the most stringent aseptic and sterile conditions inside is generally classified by the letter "A", and due to the presence of contamination sources, as the gap between the environment and the sterile environment increases and the aseptic and sterile conditions weaken, the adjacent external environment is gradually classified according to consecutive letters in the alphabet (such as "B", "C" and "D").
[0004] In these specific types of machines, such as isolators (machines known as oRABS or cRBAS), there are a series of components inside a Class "A" closed operating environment (ie a non-toxic and sterile environment) that are intended to come into contact with the product to be processed.
[0005] For example, for packaging drugs inside related containers (such as bottles, vials, syringes, tubes, etc.), a supply nozzle or other supply device (such as a hopper and a vibrating cup) can be used to transfer the product to the inside of the container. The hopper stores collars and / or bottle caps inside to close the container after filling; the bottle caps (or other closing elements) are unloaded into the vibrating cup to continuously supply them to a device for collecting and applying bottle caps or to continuously supply closing elements to the container. Background Art
[0006] Typically, these components include at least a first portion for direct contact with the product and a second portion for coupling to a base or frame located within a closed operating environment, on which operating devices configured to be responsible for driving and operating are mounted.
[0007] For example, a vibration cup includes a first portion that is substantially bowl-shaped and includes a track or conveying channel for bottle caps, the track or conveying channel being used to accommodate the bottle caps therein, and a second portion that is located below the first portion and is used to couple to a base responsible for driving the vibration cup to rotate and vibrate.
[0008] In this particular type of machine, when the product to be processed needs to be replaced, or after the machine has not been in operation for a period of time (which will cause the non-toxic and sterile conditions inside the closed operating environment to be impaired), the following problem will be faced, namely, how to sterilize the parts that are used to be in direct contact with the product to be processed, and then reinsert and reinstall these parts in the closed operating environment in turn to prevent the parts that are used to be in direct contact with the product from being contaminated or coming into contact with the source of contamination.
[0009] In this regard, the prior art method includes: disassembling the components located in the "A" grade closed operating environment and transporting these components to the outside of the closed environment through special openings or windows, that is, transporting them to the external environment (usually "D" grade), where there are special cleaning machines for cleaning (see, for example, Figure 1A ).
[0010] Then, once cleaned, the components are enclosed inside a special envelope, which is then closed and sealed.
[0011] The parts enclosed inside this type of envelope are placed in a second environment (grade "C") that is more sterile than the environment in which the washing machine is operated, and the parts are inserted into a special autoclave for sterilization (see, for example, Figure 1B ).
[0012] The envelope in which the components are sealed is made of a material suitable for allowing the passage of a sterilizing fluid and maintaining sterile conditions inside the envelope to avoid external contamination.
[0013] Then, once the sterilization process is complete, the component is housed within the enclosure in a completely sterile environment and is isolated from the outside environment by the enclosure.
[0014] The closed envelopes containing the sterilized components are then transferred to a Grade "B" environment adjacent to the Grade "A" closed environment (see Figure 1C ), or transfer it to a Class “C” external environment and from there insert it into a Class “A” closed environment or even directly into the closed operating environment of the machine.
[0015] The envelope is then cut away from the component to allow the component to be remounted on the associated base or frame.
[0016] These operations can be performed from the outside through special windows or passages present in the outer wall of the machine, or with the machine open and the operator entering a closed operating environment.
[0017] These processes inevitably expose those parts of the components that come into direct contact with the product to be processed to possible contamination, thus degrading the closed operating environment.
[0018] Currently, once the components are reinstalled, a sterilization cycle (known as a VHP cycle) is carried out inside a closed operating environment by a flow of hydrogen peroxide in the form of steam in order to sterilize all exposed parts of the components.
[0019] Currently, implementation of a VHP cycle is considered effective as a method of sterilizing components that are reinstalled within a closed operating environment, and therefore is also effective for restoring Grade "A" nontoxic and aseptic conditions within the closed operating environment.
[0020] Now, in the near future, with the introduction of new standards for this particular technical area, performing a VHP cycle will no longer be considered sufficient to restore Grade “A” sterile conditions within a closed operating environment.
[0021] The question therefore arises how to sterilize components and reinsert and reinstall them in a closed operating environment of a machine operating under aseptic conditions in order to avoid contamination of the parts of the components that are intended to come into direct contact with the product (such as contamination that would render them unusable in a Grade "A" environment, as performing a VHP cycle would no longer be considered sufficient to restore suitable aseptic conditions for the parts that may have been exposed to contamination). Summary of the invention
[0022] The object of the present invention is therefore to provide a new method for sterilizing machine parts operating in a sterile closed environment and intended to come into contact with the product to be processed inside the closed environment, which is able to eliminate the above-mentioned disadvantages.
[0023] In particular, the object of the present invention is to provide a method that allows sterilization of components that come into contact with products to be processed inside a sterile closed environment and reinstallation of the components within a sterile closed operating environment, thereby protecting the parts of the components that come into contact with the product from external contamination.
[0024] The above advantages are achieved according to the content of the claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The features of the present invention will become apparent from the following description of a non-limiting preferred embodiment of the sterilization method implemented in conjunction with the accompanying drawings, in which:
[0026] Above Figure 1A , Figure 1B and Figure 1C shows the layout of various environments with different levels of contamination, which are located outside and around the Class "A" closed operating environment, within which the product processing and packaging operations will be carried out under non-toxic and aseptic conditions;
[0027] FIG. 2A to FIG. 2IThe preferred operation sequence of the sterilization method proposed by the present invention is schematically shown;
[0028] Figure 3A and Figure 3B A possible form of carrying out a step of the method of the present invention is shown in each case in the form of a vertical cross-section;
[0029] FIG. 4A to FIG. 4D is an application schematic diagram of some steps for sterilizing a vibrating cup in the method of the present invention;
[0030] FIG. 5A to FIG. 5C is a schematic diagram of the application of some steps for sterilizing a hopper in the method of the present invention;
[0031] FIG. 6A to FIG. 6C Schematic diagram of the application of some steps for sterilizing a supply head having a liquid dispensing nozzle in the method of the present invention. DETAILED DESCRIPTION
[0032] Figure 2A A machine (M) is schematically shown located in a closed environment (A), which is maintained under aseptic conditions, for example by means of laminar flow and the use of suitable filters; in this closed environment, a product will be packaged or processed using a component (P) (for example, a container is filled with a drug and then closed using a closing element (such as a bottle cap)).
[0033] Figure 2A Also schematically shown is a component (P), which comprises a first part (P1) and at least a second part (P2), the first part being intended to be in direct contact with the product to be processed inside the sterile closed environment (A), and the second part being suitable for being mounted and coupled to a base (T) or frame (T) of a machine (M) located in the closed environment (A) and comprising corresponding drive means for driving and operating the component (P).
[0034] For example, component (P) may consist of a cup pre-arranged to receive inside it bottle caps which will be used to close the container when it is filled with the respective product, and which is arranged to vibrate so as to be able to supply the bottle caps in sequence to the cup collection point.
[0035] The cup will include a first portion for receiving the bottle cap and a second portion for mounting on a base within the closed environment and including suitable means for driving the cup to vibrate.
[0036] The method of the present invention has application in sterilizing all those components used to process products inside a sterile closed environment, which components are implemented as comprising a first part and a second part, the first part being intended to be in direct contact with the product to be processed and the second part being intended to be mounted and coupled to a base or frame located within the closed environment and comprising means for driving the components.
[0037] In this regard, for example, FIG. 4A to FIG. 4D , FIG. 5A to FIG. 5C as well as FIG. 6A to FIG. 6C Examples of this method for three types of components are shown, which can be used to fill containers (such as shaker cups) in a sterile closed environment. FIG. 4A to FIG. 4D ),hopper( FIG. 5A to FIG. 5C ) and a supply head with a nozzle for dispensing liquid and / or pasty substances ( FIG. 6A to FIG. 6C )).
[0038] Combination FIG. 2A to FIG. 2I , the following contains the main and specific steps of the method of the present invention.
[0039] The method comprises the following steps:
[0040] Removing (F1) a part (P) from a base (T) or frame (T) of a machine (M) located in an enclosed environment (A) ( Figure 2B );
[0041] In a first step, the component (P) is transferred (F2) to the outside of the sterile closed environment (A) and the component (P) is inserted into the interior of the cleaning machine (L) in order to perform a cleaning cycle of the component (P) ( Figure 2C ).
[0042] Once the cleaning cycle is complete, the method comprises the following steps:
[0043] The first step is to wrap (F3) a component (P) with a first envelope (B1), comprising: completely wrapping a first portion (P1) of the component (P) that is intended to be in direct contact with the product, and a second portion (P2) of the component (P) is not wrapped; the second portion is intended to be coupled and mounted on a base (T) or a frame (T) located in a closed environment (A), and is exposed and accessible through a hole (F) present in the first envelope (B1); wherein the first wrapping step (F3) comprises: sealingly coupling an edge of the hole (F) to a portion of the component (P) between the first portion (P1) and the second portion (P2) of the component (P) to isolate the first portion (P1) of the component (P) from the external environment ( Figure 2D );
[0044] The second step, wrapping (F4), comprises: using the second envelope (B2) to completely wrap the first envelope (B1) and the second portion (P2) of the component (P) exposed from the first envelope (B1), so that the first envelope (B1) and the second portion (P2) of the component exposed from the first envelope (B1) through the hole (F) are completely enclosed in the second envelope (B2), and the second envelope (B2) is closed ( Figure 2E );
[0045] In a second step, the component (P) partially wrapped in the first envelope (B1) and completely contained in the closed second envelope (B2) is transferred (F5) into a sterilizer (S) so as to perform a sterilization cycle with the aid of a sterilizing flow, wherein the first envelope (B1) and the second envelope (B2) are made of a material that allows the sterilizing flow to pass through, so that the sterilizing flow can sterilize the second part (P2) of the component (P) that is exposed through the hole (F) of the first envelope (B1) and is accessible and arranged in the second envelope (B2), as well as the first part (P1) of the component (P) that is closed in the first envelope (B1). Figure 2F ).
[0046] Then, once the sterilization cycle is complete, the method comprises the following steps (see Figure 2G ):
[0047] a third step, transferring ( F6 ) the component (P) in a position towards said sterile closed environment (A), with the first portion (P1) wrapped in the first envelope (B1) and completely enclosed in said second envelope (B2);
[0048] Cut off (F7) the second envelope (B2);
[0049] In the fourth step, with the first envelope (B1) still sealed around the first part (P1) of the component (P) and the second part (P2) of the component (P) exposed and accessible through the hole (F) of the first envelope (B1), the component (P) is transferred (F8) into the sterile closed environment (A), and the second part (P2) of the component (P) is mounted on a base (T) or frame (T) in the sterile closed environment, keeping the first part (P1) of the component sealed in the first envelope (B1).
[0050] Finally, the method comprises the following steps:
[0051] Cutting (F10) the first envelope (B1) from the first portion (P1) of the component (P) ( Fig.2I ).
[0052] Due to the use of two envelopes (in particular, the first envelope (B1), which is sealingly wrapped around the first part (P1) of the component (P) intended to be in direct contact with the product to be processed in the sterile closed environment (A), and includes a hole (F) through which the second part (P2) of the component (P) can be reached), using the method of the present invention, once the sterilization step has been carried out, the removal of the second envelope and the installation of the component into the closed environment can be started, while the first part of the component remains sealed in the first envelope and isolated from the external environment, thereby protecting it from any possibility of contamination.
[0053] Thus, using the method of the present invention, the first part of the component (i.e. the part intended to be in direct contact with the product to be processed in the sterile closed environment) remains protected and sealed in the first envelope for all the time required to reinstall the component on the relevant base or frame.
[0054] This also greatly facilitates operations for reinstalling the component, which can be carried out even when the machine is open, since the first part of the component always remains enclosed in the first envelope and protected by the seal; or the component can be installed even when the machine is closed, using a special opening for inserting the hand or arm of an operator wearing suitable protective gloves.
[0055] Further and other preferred aspects of the method of the invention are described below.
[0056] In a first preferred aspect, the method comprises: using a first sealing ring (1) and a second sealing ring (2), and applying the first sealing ring (1) and the second sealing ring (2) on opposite sides of the hole (F) to sandwich a portion of the first sleeve (B1) surrounding the hole (F) therebetween.
[0057] In particular, the method comprises: using a first sealing ring (1) which is suitable for being sealably coupled (for example, by inserting a first elastic element) to a portion (10) on a component between a first portion (P1) and a second portion (P2) of the component (P); and using a second sealing ring (2) which is suitable for being sealably coupled (for example, by inserting a second elastic element) to a portion (20) of a base (T) or a frame (T) when the second portion (P2) of the component (P) is mounted and coupled to a base (T) or a frame (T).
[0058] For example, in the case where the component (P) consists of a vibrating cup, FIG. 4A to FIG. 4D As schematically shown, the first sealing ring (1) can be fixed to a portion of the lower edge of the bowl portion (the first part of the component) of the vibrating cup, which surrounds the lower portion of the vibrating cup (the second part of the component), which is intended to be coupled and mounted on a base (T) responsible for driving the vibrating cup to vibrate.
[0059] The second sealing ring (2) can be fixed to a portion of the upper edge of the base (T) on which the cup is mounted.
[0060] In the case where the method of the present invention is to be applied to a vibrating cup that already exists and is intended to be installed in a machine in a sterile closed environment, the method will include: adjusting multiple locations of the lower edge of the vibrating cup and multiple locations of the upper edge of the base so as to respectively accommodate a first sealing ring and a second sealing ring for clamping the edge of the hole located in the first envelope in a sealing coupling manner.
[0061] On the other hand, in the event that a new machine has to be designed for use in a sterile closed environment, a vibrating cup and its base (already having appropriately shaped associated upper and lower edges) can be provided for use in the machine so as to be able to accommodate, in a sealed coupling manner, a first sealing ring and a second sealing ring for clamping the edges of the hole of the first envelope.
[0062] Figure 4A A vibrating cup (P) is shown which has been wrapped around the inside of a first envelope (B1) so that a first portion (P1) of the vibrating cup (P) intended to come into contact with a bottle cap of a closed container is sealed within the first envelope (B1), wherein a second portion (P2) of the vibrating cup (P) is positioned in a hole (F) of the first envelope (B1).
[0063] The first envelope (B1) is sealingly fixed to the lower part (10) of the vibrating cup by means of a first sealing ring (1) previously applied to the edge of the hole (F).
[0064] Figure 4C yes Figure 4A A partial perspective view of .
[0065] Figure 4B A vibrating cup (P) according to the method of the invention is shown in a partial perspective view, the vibrating cup being partially enclosed in a first envelope (B1) and completely located in a second envelope (B2).
[0066] Figure 4D A vibrating cup (P) according to the method of the invention is shown in schematic cross-sectional form, mounted by coupling a corresponding second portion (P2) to a base (T) located within a closed environment (A), wherein a first envelope (B1) has been cut open.
[0067] According to the method of the invention, the second part (P2) of the vibrating cup (P) is sealingly coupled to the upper part (20) of the base (T) or frame (T) by means of a second sealing ring (2) which has been previously applied to the edge of the hole (F).
[0068] When the parts to be sterilized are fed from the hopper ( FIG. 5A to FIG. 5C) or a supply head with a dispensing nozzle for liquid or pasty substances ( FIG. 6A to FIG. 6C ) is composed, the same situation is repeated.
[0069] In these cases, the method can also be applied to these hoppers and supply heads by adjusting the profiles of the corresponding edges of multiple parts of the hopper or supply head already existing in the art (the profiles of the edges for coupling to the head or frame on which they will be mounted so as to be able to accommodate the first sealing ring and the second sealing ring in a coupled manner for clamping the edges of the hole for clamping the first sleeve).
[0070] Optionally, during the design step of the new machine, the hopper and supply head intended for use in the new machine can also be designed to already include contours and edges of the first sealing ring and the second sealing ring for accommodating in a coupled manner the edges of the hole for clamping the first sleeve, so as to be able to implement the method of the present invention.
[0071] Figure 5A A hopper (P) according to the method of the invention is shown, which is partially wound with a related first part (P1) inside a first envelope (B1) and is wound with a related second part (P2) for coupling with a frame (T) at a hole (F) of the first envelope (B1) and completely enclosed in a second envelope (B2).
[0072] Figure 5B shows the step of mounting on a frame (T) a hopper (P) also wrapped with a corresponding first portion (P1) of a first envelope (B1) according to the method of the invention; and Figure 5C The hopper (P) is shown at the end of the cleaning cycle, wherein the first envelope (B1) has been cut away.
[0073] Fig. 6A A supply head with a nozzle according to the method of the present invention is shown, which supply head is partially wound with a related first part (P1) in a first sleeve (B1), and is wound with a related second part (P2) for coupling with a frame (T) at the position of a hole (F) in the first sleeve (B1) and is completely enclosed in a second sleeve (B2).
[0074] Figure 6B The step of mounting a supply head (P) with a nozzle, also wrapped with a corresponding first part (P1) in a first envelope (B1), on a frame (T) is shown according to the method of the invention; and Figure 6C The supply head (P) with the nozzle is shown at the end of the purge cycle, wherein the first envelope (B1) has been cut away.
[0075] However, the method of the present invention is also applicable to sterilizing other types of components used within the sterile closed environment of a machine that will operate under non-toxic and aseptic conditions to package products (e.g., pharmaceuticals) in associated containers as well as the above-mentioned components.
[0076] In another possible aspect, based on the type and form of machine used to maintain the Class A sterile closed environment, the method may include implementing the step of performing (F9) a decontamination cycle within the sterile closed environment ( Figure 2H ).
[0077] For example, before removing the first envelope, the method of the present invention may include: performing a decontamination cycle (such as but not limited to a VHP cycle) within the closed environment to decontaminate the outer portion of the closed first envelope (B1) and the portion surrounding the first envelope at the location of the hole (i.e., the area on the component where the second portion that remains exposed relative to the first envelope is coupled to a base or frame located within the closed environment).
[0078] In this way, any final remnants of the contamination source can be removed before continuing with the cutting of the first envelope.
[0079] According to another preferred aspect, in order to implement the first step of wrapping (F3) the component (P) with a first envelope (B1), the method comprises: realizing the first envelope (B1) by a first film, in which a hole (F) is made, the size of which is suitable for enclosing the second part (P2) of the component (P), or in which there is already a hole (F) whose size is suitable for surrounding the second part (P2) of the component.
[0080] A first film is applied around the component (P) so that the second part (P2) of the component is located at the hole (F), and then the film is sealed and wrapped around the first part (P1) of the component (P) and closed, thereby forming a first envelope (B1), in which the first part (P1) of the component is enclosed inside it and the second part (P2) of the component (P) remains exposed and accessible through the hole (F).
[0081] In another aspect, in addition, in order to implement the first step of wrapping (F3) the component (P) with the first envelope (B1), the method may include: using a first envelope (B1) that has been formed and has a hole (F); the hole has a size suitable for surrounding the second part (P2) of the component and has an open part; the open part is used to enable the first part (P1) of the component (P) to be introduced into the first envelope (B1) so that the second part (P2) of the component is set at the hole (F), and then closing the open part of the first envelope (B1) to seal its interior and isolate the first part (P1) of the component (P) from the external environment.
[0082] In another possible aspect, in order to carry out the step of removing (F1) the component (P) from the base (T) or frame (T) of the machine (M), the method may comprise: once the component (P) has been removed from the base (T) or frame of the machine (M), inserting the component (P) into a protective housing (H) (see Figure 2B left) and remove the protective cover (H) before inserting the part (P) into the cleaning machine (see Figure 2C in the figure above).
[0083] According to the method for implementing a sterilization step, the method preferably comprises: using or realizing a first envelope (B1) and a second envelope (B2) in the form of a multilayer material or consisting of a material having a permeability allowing the passage of a fluid used for sterilization.
[0084] In another advantageous preferred aspect, the method may include implementing a step of automatically cutting (F10) a first envelope (B1) from a first portion (P1) of a component (P) by using a cutting device (30), the cutting device being mounted on a base (T) or frame (T) of a machine (M) within a closed environment (A), and the cutting device being activated to remove portions of the first envelope (B1) once a second portion (P2) of the component (P) is mounted and coupled to the base (T) or frame (T).
[0085] For example, the method may include using a cutting device (30) comprising at least one sliding element (31) movably mounted on a base (T) or a frame (T) and having a cutting profile (32) (see, for example, Figure 3A Two possible implementation forms of the sliding element are shown in , in which the cutting profile is formed by a hollow element, which is coupled with an abutment for clamping and cutting the various parts of the envelope; or Figure 3B The cutting contour is formed by the blade).
[0086] Once the second portion (P2) of the component (P) is mounted and coupled to the base (T) or frame (T), the sliding element (31) can be driven to translate relative to the base (T) or frame (T) so that the cutting profile (32) abuts and cuts a portion of the first sleeve (B1) located near the edge of the hole (F).
[0087] Therefore, in summary, the method of the present invention makes it possible to sterilize components intended to come into direct contact with products to be processed in a sterile closed environment, and to reinstall the components within a sterile closed environment, while preventing and protecting the parts of the components intended to come into contact with the products from any contamination, since these parts are sealed inside the first envelope until the components are mounted on a relevant base or frame located in the closed environment.
[0088] Only then will the first envelope be removed, thereby releasing the first portion of the component contained therein, which will be completely sterile and ready for a new production cycle within the sterile closed environment.
Claims
1. A method for sterilizing a part (P) of a machine (M) operating in a closed environment (A) and intended to come into contact with a product to be processed inside said sterile closed environment (A), The device to be sterilized comprises at least a first part (P1) and at least a second part (P2), the first part being intended to be in direct contact with the product to be processed inside the sterile closed environment (A), the second part being suitable for coupling and mounting on a base (T) or frame (T) of a machine (M) located inside the sterile closed environment (A) and comprising drive means for driving and operating the part (P), in, The method comprises the following steps: removing (F1) said component (P) from said base (T) or said frame (T) of said machine (M) located in said closed environment (A); In a first step, the component (P) is transferred (F2) to the outside of the sterile closed environment (A) and the component (P) is inserted into the interior of the cleaning machine (L) in order to perform a cleaning cycle of the component (P); Wherein, once the cleaning cycle is completed, the method comprises the following steps: The second part (P2) of the component (P) is not wrapped; the second part is intended to be coupled and mounted on a base (T) or a frame (T) located in the closed environment (A), and is exposed and accessible through a hole (F) present in the first envelope (B1); wherein the first wrapping step (F3) includes: sealingly coupling the edge of the hole (F) to a portion of the component (P) between the first part (P1) and the second part (P2) of the component (P) to isolate the first part (P1) of the component (P) from the external environment; The second step, wrapping (F4), comprises: using a second envelope (B2) to completely wrap the first envelope (B1) and the second portion (P2) of the component (P) exposed from the first envelope (B1), so that the first envelope (B1) and the second portion (P2) of the component exposed from the first envelope (B1) through the hole (F) are completely enclosed in the second envelope (B2), and the second envelope (B2) is closed at the same time; The second step is to transfer (F5) the component (P) partially wrapped in the first envelope (B1) and completely contained in the closed second envelope (B2) into a sterilizer (S) so as to perform a sterilization cycle with the help of a sterilizing flow, wherein the first envelope (B1) and the second envelope (B2) are made of a material that allows the sterilizing flow to pass through, so that the sterilizing flow can sterilize the second part (P2) of the component (P) that is exposed through the hole (F) and is accessible and arranged in the second envelope (B2) and the first part (P1) of the component (P) that is closed in the first envelope (B1); Wherein, once the cleaning cycle is completed, the method comprises the following steps: a third step of transferring (F6) said component (P) in a position towards said sterile closed environment (A) with said first portion (P1) wrapped in said first envelope (B1) and completely enclosed in said second envelope (B2); cutting off (F7) said second envelope (B2); Step 4, with the first envelope (B1) still sealed around the first part (P1) of the component (P) and the second part (P2) of the component (P) exposed and accessible through the hole (F) of the first envelope (B1), transferring (F8) the component (P) into the sterile closed environment (A), and mounting the second part (P2) of the component (P) on the base (T) or frame (T) in the sterile closed environment (A), keeping the first part (P1) of the component sealed in the first envelope (B1); The first envelope (B1) is cut away (F10) from the first portion (P1) of the part (P).
2. The method according to claim 1, comprising: A first sealing ring (1) and a second sealing ring (2) are used and applied on opposite sides of the hole (F) to sandwich a portion of the first sleeve (B1) surrounding the hole (F) therebetween; wherein the first sealing ring (1) is suitable for sealingly coupling to a portion (10) of the component (P) between the first portion (P1) of the component (P) and the second portion (P2) of the component (P); and wherein the second sealing ring (2) is suitable for sealingly coupling to a portion (20) of the base (T) or the frame (T) when the second portion (P2) of the component (P) is mounted and coupled to the base (T) or the frame (T).
3. The method according to any one of claims 1 and 2, wherein the first step of wrapping (F3) the component (P) with the first envelope (B1) comprises: The first envelope (B1) is realized by a first film, in which a hole (F) is made, the size of which is suitable for enclosing the second part (P2) of the component (P), or in which a hole (F) of a size suitable for surrounding the second part (P2) of the component already exists, the first film is applied around the component (P) so that the second part (P2) of the component is located at the hole (F), and then the film is folded around the first part (P1) of the component (P) and closed, thereby forming the first envelope (B1), the first part (P1) of the component is enclosed inside it, and the second part (P2) of the component (P) remains exposed and accessible through the hole (F).
4. The method according to any one of claims 1 and 2, wherein the first step of wrapping (F3) the component (P) with the first envelope (B1) comprises: A first envelope (B1) is used which has been formed and has a hole (F); the hole has a size suitable for surrounding the second part (P2) of the component and has an open portion, the open portion being used to enable the first part (P1) of the component (P) to be introduced into the first envelope (B1) so that the second part (P2) of the component is arranged at the hole (F), and then the open portion of the first envelope (B1) is closed to seal its interior and isolate the first part (P1) of the component (P) from the outside.
5. A method according to any one of claims 1 to 4, wherein the step of cutting (F10) the first envelope (B1) from the first part (P1) of the component (P) is automatically performed by using a cutting device (30), the cutting device being mounted on the base (T) or frame (T) of the machine (M) within the closed environment (A), and once the second part (P2) of the component (P) is mounted and coupled to the base (T) or frame (T), the cutting device can be activated to remove parts of the first envelope (B1).
6. A method according to claim 5, wherein the step of cutting (F10) the first sleeve (B1) is performed using a cutting device (30), the cutting device comprising at least one sliding element (31) movably mounted on the base (T) or the frame (T) and having a cutting profile (32); wherein once the second part (P2) of the component (P) is mounted and coupled to the base (T) or the frame (T), the sliding element (31) can be driven to translate alternately relative to the base (T) or the frame (T), so that the cutting profile (32) abuts and cuts a portion of the first sleeve (B1) located near the edge of the hole (F).
7. A method according to any one of the preceding claims, comprising: Prior to carrying out the step of cutting ( F10 ) said first envelope ( B1 ) from said first portion ( P1 ) of said component (P), a step of carrying out a purge cycle ( F9 ) in said closed environment is carried out.