Product manufacturing lines, components, and sterilization methods

Abstract

A component (1) configured for use as part of a sterile product manufacturing facility (2) in a sterile process includes a contact area and a heating structure. The contact area (12) is configured to come into direct or indirect contact with the sterile product. It is made of a thermally conductive material. The heating structure (13) is thermally bonded to the contact area (12). The component (1) according to the present invention enables heat sterilization while the component (1) is incorporated into the manufacturing facility (2) without requiring the removal of the component (1).

Description

Technical Field

[0001] Technical Field The present invention relates to a component according to the preamble of independent claim 1, and more particularly to a product manufacturing line having such a component and a sterilization method including such a manufacturing line.

[0002] Components having a contact part configured to directly or indirectly contact a sterile product are generally used for various purposes and functions in a manufacturing line.

Background Art

[0003] Background In the process of manufacturing or preparing a sterile product, it is often necessary to perform certain steps in a sterile environment. For example, in the manufacture of parenteral or other pharmaceutical products, typically, the filling of the active ingredient into a container such as a vial, cartridge or syringe must be carried out in a sterile environment. For that purpose, clean rooms such as isolators or restricted access barrier systems (RABS) are often involved.

[0004] To automatically or semi-automatically process a sterile product in a sterile environment, components that are preferably inert at least in the part that contacts the sterile product are used. For example, in the clean room of a pharmaceutical product manufacturing line, components that do not interact with the pharmaceutical product or any other element that contacts the pharmaceutical product are used.

[0005] More specifically, in the manufacture of a prefilled syringe, the syringe is filled and closed inside a clean room. Therefore, components such as a stopper filling tube, a chute for sending the stopper, and a lock for sorting the sent stoppers are typically arranged inside the clean room.

[0006] To ensure proper sterility, components inside the cleanroom must be sterilized periodically, for example, between each process batch. Furthermore, the cleaning or sterilization of components must be validated in accordance with regulatory rules applicable to drug manufacturing. For example, they may need to be validated to remove any residues or debris that could adversely affect the cleaning process, minimizing chemical, microbiological, and particulate contamination of the product. Sterilization may also be mandatory for all direct and indirect product contact points.

[0007] To clean and sterilize components placed in a cleanroom, they are typically removed from the cleanroom, transported to a sterilization unit such as an autoclave, and then reinstalled in the cleanroom after sterilization. This removal, transport, and reinstallation can be relatively cumbersome and inefficient. In particular, if relatively bulky or intricately fixed components must be sterilized, it usually causes an essential interruption to the manufacturing or preparation process. This reduces the efficiency and productivity of the production line. Furthermore, the removal and reinstallation of components requires skilled personnel. Also, removal and reinstallation create a relatively high risk of damaging components or other structures inside the cleanroom.

[0008] Therefore, there is a need for a product manufacturing line or sterilization method that enables efficient and safe sterilization of components in the product manufacturing line, particularly components located inside the cleanroom of the product manufacturing line. [Overview of the project]

[0009] Disclosure of the invention According to the present invention, this need is resolved by a component defined by the features of independent claim 1, a product manufacturing line defined by the features of independent claim 17, and a method defined by the features of independent claim 18. Preferred embodiments are the subject matter of the dependent claims.

[0010] In particular, in one embodiment, the present invention is a component configured for use as part of a sterile product manufacturing facility in a sterile process. The component comprises a contact portion configured to come into direct or indirect contact with the sterile product, and a heating structure thermally bonded to the contact portion. The contact portion is made of a thermally conductive material.

[0011] A component can be any element or part that is included in or involved in a sterile process that comes into direct or indirect contact with a sterile product. In this regard, the term “sensitive element” as used herein refers to the sterile product itself in the form of a drug or drug product, or to another element such as a packaging component that comes into contact with or potentially comes into contact with a sterile product. In pharmaceutical manufacturing, such other elements may be vials, cartridges, syringes, needle shields, seals, caps, or stoppers, particularly for syringes and vials.

[0012] The component can be at least partially installed or assembled in the cleanroom of the sterile manufacturing apparatus. It may be a containment section for holding or delivering sensitive elements, a chute, a filling tube or transfer tube for delivering sensitive elements or similar parts.

[0013] Sterile products may, in particular, be drug products or parts thereof.

[0014] As used herein, the term “drug” refers to a therapeutically effective substance, also commonly known as a pharmacokinetic agent (API), as well as combinations of multiple such therapeutically effective substances. The term also includes diagnostic or imaging substances that need to be administered to a patient in liquid form, such as contrast agents (e.g., MRI contrast agents), tracers (e.g., PET tracers), and hormones.

[0015] As used herein, the term “API” refers to the drug as defined above, prepared or restored in a form suitable for administration to a patient. For example, the API may further include excipients and / or other auxiliary components in addition to the drug. The API may be a drug solution, particularly a solution for oral administration, injection, or infusion.

[0016] As used herein, the term “drug product” refers to a finished product comprising an active pharmaceutical ingredient (API) or a combination of APIs. In particular, a drug product may be a ready-to-use product having an API in an appropriate dose and / or form suitable for administration. For example, a drug product may include an administration device, such as a pre-filled syringe.

[0017] The contact area may have a surface or portion intended to come into contact with or touch sensitive elements in a sterile process.

[0018] The term "thermal conductivity" in relation to the material of a contact area may refer to the ability to conduct or transfer heat. In particular, in order to be thermally conductive according to the present invention, the ability of a material to transfer heat can have a minimum thermal conductivity. More specifically, a material can be considered thermally conductive if it has a thermal conductivity of 5 watts per meter per kelvin (W / m·K or W·m-1·K-1) or more, 15 W·m-1·K-1 or more, or 30 W·m-1·K-1 or more.

[0019] The term “thermally coupled” in relation to heating structures and contact parts refers to a configuration that enables the transfer of heat from the heating structure to the contact part. Such thermal coupling may be achieved by the heating structure contacting the contact part, by the heating structure being connected to the contact part via a suitable structure, or similarly.

[0020] The heating structure may be fixed to the contact area or it may be removable from the contact area. A fixed configuration may be advantageous for handling reasons, as the heating structure and the contact area form a single unit, while a removable heating structure may offer several advantages. In particular, it allows for efficient maintenance or replacement of the heating structure as needed, or it allows for temporary removal as needed. For example, if space constraints impose limitations, removing the heating structure when not in use may be beneficial to improve visibility of the area or environment in which the component is installed.

[0021] The components according to the present invention allow for sterilization at the location where they are installed or assembled during operation. Such sterilization is also known as stationary sterilization (SIP). By activating a heating structure, the generated heat is transferred to the contact area, which is heated and sterilized. In particular, the heating structure can sufficiently heat the component or at least its contact area to achieve sterilization. For example, the European Pharmacopoeia describes dry heat sterilization as a suitable means for sterilizing elements involved in pharmaceutical processes (see Chapter 5.1.1.1 of the European Pharmacopoeia).

[0022] Therefore, according to the present invention, it is possible to prevent the removal and reattachment of components involved in the aseptic process. In particular, components can be sterilized by heat while being assembled inside the cleanroom without needing to be removed from the cleanroom. This increases sterilization efficiency and safety. It also reduces or minimizes downtime in the aseptic process during the sterilization of the components involved.

[0023] The contact area can be advantageously made of an inert material. This prevents sensitive elements in contact with the contact area from being affected. In particular, the thermally conductive material of the contact area is preferably stainless steel. Stainless steel can be beneficial because it is intrinsically inert to many sensitive elements, has a suitable thermal conductivity of about 30 W·m-1·K-1, is relatively easy to handle such as cleaning, and is relatively economical.

[0024] The heating structure can be embodied in various ways. For example, it may have elements or structures for inductively heating the contact area. Preferably, the heating structure includes a heating filament. Such a filament allows for efficient resistance heating. It can further be efficiently formed and fitted to precisely conform to the correct position for heating the contact area. The filament can be made of metal, a metal alloy, or another conductive material with appropriate resistance.

[0025] Therefore, the component preferably includes a power supply connected to the heating filament. Such a power supply enables the efficient supply of current to the filament, thereby achieving resistive heating.

[0026] Alternatively, the component preferably includes a power adapter connected to a heating filament, the power adapter configured to be coupled to an external power source. When coupled to an external power source, such an adapter allows current to be supplied through the filament, thereby causing resistive heating.

[0027] Preferably, the component includes a filling tube for filling the stopper in the aseptic syringe preparation process. The present invention can be particularly beneficial for such components, which may be referred to as stopper transfer tubes or stopper filling tubes. In particular, such components are typically relatively bulky and may be difficult to remove. In particular, removal can be cumbersome and difficult when spatial conditions, such as within a clean room, are restricted, or when the stopper transfer tube is located near other components that are relatively sensitive and attached. In such situations, the heat sterilization according to the present invention that does not require any removal can be particularly beneficial.

[0028] Preferably, the heating filament is wound around the filling tube. By doing so, essentially, the complete contact portion of the component can be efficiently heated.

[0029] The component preferably includes a first lid configured to close the first end of the filling tube and / or a second lid configured to close the second end of the filling tube. Such lids make it possible to close the filling tube during the operation of the heating structure. By doing so, the interior of the filling tube can be heated efficiently enough for sterilization.

[0030] The contact portion preferably includes the inner surface of the filling tube. Since sensitive elements can advance through the filling tube and thereby contact the filling tube, the inner surface can be or form the contact portion.

[0031] Preferably, the component includes a heat insulator covering the heating structure. Such an insulator can prevent components or parts other than the contact portion from being heated. By doing so, the safety of the system during operation, particularly during sterilization, can be enhanced. In embodiments having a detachable heating structure, the heat insulator may be removable together with the heating structure. In such embodiments, the insulator may be part of the heating structure.

[0032] In this way, the insulation material preferably encloses the filling tube together with the filament. This allows for a safety unit that enables a simple structure and handling.

[0033] More specifically, the component preferably includes a sheath that airtightly encloses the insulation. Such an airtight sheath allows for the prevention or reduction of hot air escaping from the component during heating. This can improve the efficiency and safety of heat sterilization. In embodiments having a removable heating structure and insulation, the sheath may be removable together with the heating structure. In such embodiments, the sheath may also be part of the heating structure.

[0034] The sheath preferably includes a thermal expansion section. Such an expansion section allows for proper dimensional conformity due to the inherent thermal expansion of the material during heating by the heating structure. In particular, this prevents improper stress or force between different materials of the component during heating. In this way, the lifespan and functional capabilities of the component can be increased.

[0035] A heating structure, particularly a heating filament, may be configured and / or arranged so that only one or more specific parts of the component, including the contact area, are heated, while other parts of the component, such as the outer casing (e.g., a sheath), are not heated and are particularly insulated. More specifically, a heating structure, particularly a heating filament, may be configured and / or arranged so that only the filling tube is heated, while other parts of the component, such as the outer casing (e.g., a sheath), are not heated and are particularly insulated. For example, a heating structure, particularly a heating filament, may be embedded in an insulating material configured to insulate the heating structure, particularly the heating filament, outward, towards the outer casing (e.g., a sheath). In particular, the insulating material may completely cover the outer surface of the filling tube and the heating structure, particularly the heating filament, positioned on the outer surface of the filling tube, while the outer casing (e.g., a sheath) surrounds the insulating material and is therefore not heated, but is thermally insulated from the heating structure, particularly the heating filament.

[0036] Preferably, the heating structure is configured to supply a heating output in the range of approximately 300 watts to approximately 1000 watts, in the range of approximately 400 watts to approximately 700 watts, and particularly approximately 500 watts. Such heating power allows for sufficient heating of the contact area to achieve efficient sterilization, while simultaneously ensuring a safe system.

[0037] Preferably, the component includes a temperature sensor positioned to sense the temperature of the contact area. The temperature sensor can be positioned to measure the temperature of the contact area directly or indirectly. It can be mounted, for example, on the back side of the contact area opposite to the side that contacts the sensitive element. Alternatively, it can be mounted, for example, on the first or second lid, thereby measuring the temperature inside the filling tube when the filling tube is closed by the respective lid. The temperature sensor can monitor the system during heating and sterilization. In this way, overheating can be prevented on the one hand, and sufficient heat can be supplied for an appropriate amount of time to achieve adequate sterilization on the other hand.

[0038] In another embodiment, the present invention relates to a product manufacturing line configured to prepare a pharmaceutical product having a container filled with an active pharmaceutical ingredient. The product manufacturing line comprises a cleanroom and components as described above, the components being at least partially located in the cleanroom. The product manufacturing line according to the present invention enables the achievement of the effects and benefits described above in relation to the components according to the present invention and its preferred embodiments.

[0039] In yet another embodiment, the present invention is a method for sterilizing components installed in a cleanroom of the product manufacturing line described above. The method includes the step of heating the contact areas of the component by activating a heating structure of the component while the component is installed in the cleanroom. The method according to the present invention makes it possible to effectively achieve the effects and benefits described above in relation to the component according to the present invention and its preferred embodiments.

[0040] Preferably, the contact surfaces of the components are heated to about 160°C for about 2 hours, to about 180°C for about 1 hour, or to about 200°C for about 5 minutes. Such heating allows for proper and sufficient sterilization to be achieved.

[0041] Preferably, the method includes the step of wiping the contact surfaces of the component before heating. In particular, such wiping allows for the removal of contaminants from the contact surfaces, which may not be adequately affected by heat sterilization. For example, when handling syringe stoppers with the component, silicone oil, which is often present when the stopper is involved, may remain on the contact surfaces. Such silicone oil may not be removable by heat and may affect or even hinder heat sterilization. [Brief explanation of the drawing]

[0042] The components, product manufacturing lines, and methods according to the present invention will be described in further detail below with reference to the drawings, using exemplary embodiments. [Figure 1] A perspective view of a stopper transfer pipe as an embodiment of the component according to the present invention is shown. [Figure 2] Figure 1 shows a front view of the stopper transfer pipe. [Figure 3] Figure 2 shows a side view of the stopper transfer pipe from Figure 1, partially cut along line AA. [Figure 4] As an embodiment of the product manufacturing line according to the present invention, a schematic diagram of a syringe manufacturing line including the stopper transfer tube shown in Figure 1 is presented. [Modes for carrying out the invention]

[0043] Description of implementation In the following description, certain terms are used for convenience and are not intended to limit the invention. The terms “right,” “left,” “up,” “down,” “under,” and “above” refer to directions in the figures. The terms include those explicitly mentioned, their derivatives, and terms with similar meanings. Additionally, spatially relative terms such as “beneath,” “below,” “lower,” “above,” “upper,” “proximal,” and “distal” may be used to describe the relationship between one element or feature shown in the figures and another element or feature. These spatially relative terms are intended to encompass various positions and orientations of the device in use or operation, in addition to the positions and orientations shown in the figures. For example, if the device in the figure is inverted, an element described as “below” or “below” another element or feature would be considered “above” or “over” the other element or feature. Therefore, the exemplary term “downward” may encompass both upward and downward positions and orientations. The device may be in other orientations (90-degree rotation or other orientations), and the spatially relative descriptors used herein may be interpreted accordingly. Similarly, descriptions of movement along various axes and movement about various axes include the positions and orientations of various specific devices.

[0044] To avoid repetition in the figures and descriptions of various aspects and exemplary embodiments, it should be understood that many features are common to many aspects and embodiments. If an aspect is omitted from the description or figures, it does not mean that that aspect is missing from embodiments that incorporate it. Rather, the aspect may be omitted for clarity and to avoid redundant explanation. In this context, the following applies to the remainder of this description: For clarity, if a figure contains reference numerals not described in the directly relevant part of the specification, a preceding or succeeding part of the specification is referenced. Furthermore, for clarity, if not all features of a part in a figure are referenced, another drawing showing the same part is referenced. Similar numbers in two or more figures represent the same or similar elements.

[0045] Figure 1 shows a perspective view of a stopper transfer tube 1 as an embodiment of the component according to the present invention. The stopper transfer tube 1 is configured to be used in an aseptic process as part of an aseptic product manufacturing facility, such as the syringe manufacturing line 2 shown in Figure 4.

[0046] The stopper transfer tube 1 generally has a twisted shape, with two straight cylindrical sections inclined toward each other. It has a longitudinal axis 18, which is also correspondingly twisted. An airtight sheath 15 is visible from the outside. In the situation shown in Figure 1, the stopper transfer tube 1 is closed by two lids 16. The stopper transfer tube 1 is also equipped with mounting members 17 for rigid fixing to a target position in the syringe manufacturing line 2. In particular, the stopper transfer tube 1 can be suspended to a desired position during operation in a cleanroom by the mounting members 17.

[0047] In Figure 2, the stopper transfer tube 1 is shown in a front view with the lid 16 removed. As can be seen, the stopper transfer tube 1 has a filled tube 11 with a hollow interior 19 and an inner surface that forms a contact area 12. During operation, the stoppers are transferred through the hollow interior 19 to the target position. As a result, they come into contact with the contact area 12. The stoppers are also used to eventually close the drug chamber of the syringe and therefore come into contact with the active pharmaceutical ingredient, and thus must be kept sterile.

[0048] The filling tube 19 is made of stainless steel. The sheath 15 forms a front portion 151 that covers the longitudinal end sections of the filling tube 11 and other elements, as will be described in more detail below.

[0049] Figure 3 shows the stopper transfer tube 1 in a partially cut view, revealing its internal elements. A metal heating filament 13 is wound around the filling tube 11. Because the filling tube 11 is made of steel, the contact area 12 is thermally bonded to the filament 13. The filament 13 is configured to resistively heat when power or current is supplied.

[0050] The filament 13 is embedded in an insulating material 14 configured to insulate the filament 13 outward. The insulating material 14 completely covers the outer surfaces of the filling tube 11 and the filament 13. The sheath 15 is embodied as a sheet that airtightly encloses the insulating material 14, i.e., the thermal insulation. At the longitudinal end of the filling tube 11, the sheath 15 is folded so that a front portion 151 is formed. This front portion 151 covers the filament 13 and the insulating material 14. Furthermore, the sheath 15 has multiple thermal expansion sections (not visible in Figure 3) to allow for compensation of the different thermal expansion properties of the different materials involved, namely the filament, filling tube, and insulating material.

[0051] The lid 16 is connected to the filling tube 11 via a hinge, thereby allowing it to flap over the filling tube 11 to cover and close the interior 19. This provides a first or left-side lid 16 to securely close the first or left-side longitudinal end of the filling tube 11, and a second or right-side lid 16 to securely close the second or right-side longitudinal end of the filling tube 11. The left-side lid 16 includes a temperature sensor 161 configured to measure the temperature of the inter-ion 19 in the filling tube 11. This is configured to indirectly detect the temperature of the contact area 12.

[0052] The stopper transfer tube 1 further includes a power adapter connected to the heating filament 13 (not visible in Figure 3). The power adapter is configured to be coupled to an external power source. More specifically, the filament 13, together with the power adapter, forms a heating structure of the stopper transfer tube 1 configured to supply a heating output of approximately 500 watts.

[0053] Figure 4 is a schematic diagram of an embodiment of a pre-filled syringe (PFS) manufacturing line 2 as a product manufacturing line according to the present invention. The PFS manufacturing line 2 is configured to prepare pharmaceuticals having ready-to-use syringes filled with active pharmaceutical ingredients. --It comprises a cleanroom 5 and a replaceable stopper container 3. Inside the cleanroom 5 are arranged a stopper transfer tube 1 and processing components such as a chute 41, a pot 42, a feeder 43, a lock 44, and a swivel 45.

[0054] The stopper container 3 is located outside the cleanroom 5. It is used to transport sterile stoppers into the process. To place the stoppers into the process, the stopper container 3 is connected to the stopper transfer tube 1 via a high-speed transfer port (RTP). The stopper transfer tube 1 feeds the stoppers into a chute 41 and a pot 42, both of which are arranged to vibrate. From the pot 42, the stoppers are sent to a stopper lock 44 via a feeder 43 configured to vibrate linearly. The lock 44 then sorts and positions the stoppers for further processing in the appropriate equipment, and a swivel distributes them. In particular, the distributed stoppers are pushed into a filled syringe to close the syringe.

[0055] To sterilize the equipment, for example, after the completion of a batch, most components in contact with the stopper may be removed from the cleanroom and moved to an autoclave in accordance with applicable regulatory rules. However, as exemplified by the stopper transfer tube 1, the chute 41, pot 42, feeder 43, lock 44, and swivel 45 are embodied in the present invention so that they can be heat-sterilized. All of these components 41, 42, 43, 44, and 45 must be thermally isolated from other elements to prevent unintended heating. For example, vibrating components must be thermally isolated from their respective vibrating drive units to prevent damage to the drive units.

[0056] To sterilize the stopper transfer tube 1, in an embodiment of the method according to the present invention, the inner surface of the filling tube 11 is first physically wiped to remove any residue from the contact area 12. In particular, the inner surface of the filling tube 11 is wiped with a cleaning agent. The specific purpose of wiping is to remove silicone oil droplets from the contact area 12. Stoppers are often coated with silicone oil, which can contaminate the contact area 12.

[0057] After wiping, the filling tube 11 is closed by flapping the lid 16 at the longitudinal end of the filling tube 11. The filling tube 11 is then heated by the filament 13. In particular, current is supplied through the filament 13 so as to be resistively heated. Heat is transferred from the filament 13 to the filling tube 11, and the contact area 12 is also heated. More specifically, the contact area 12 is heated at 200°C for 5 minutes. Proper heating is monitored by sensors 161 on each lid 16.

[0058] After heating, the lid 16 flips off the filling tube 11 so that it is open and ready to receive and transfer the next batch of stoppers. The stopper transfer tube 1 remains installed inside the cleanroom 5 throughout the entire sterilization process.

[0059] This specification and accompanying drawings illustrating aspects and embodiments of the present invention should not be construed as limiting the claims defining the invention. In other words, although the present invention is illustrated and described in detail in the drawings and the above description, such illustrations and descriptions should be considered illustrative or typical, not limiting. Various mechanical, compositional, structural, electrical, and operational modifications can be made without departing from the spirit and scope of this specification and the claims. In some cases, well-known circuits, structures, and techniques are not shown in detail so as not to obscure the present invention. Therefore, those skilled in the art will understand that modifications and alterations can be made within the scope and spirit of the following claims. In particular, the present invention encompasses further embodiments having any combination of features from the different embodiments described above and below.

[0060] Furthermore, this disclosure also encompasses all further features shown individually in the drawings, which may not be described in the above or below description. Also, a single alternative form of an embodiment described in the drawings and description, and a single alternative form of its features, may be abandoned from the subject matter of the invention or the disclosed subject matter. This disclosure includes subject matter consisting of features defined in the claims or exemplary embodiments, as well as subject matter having such features.

[0061] Furthermore, certain features or groups of features disclosed in the drawings and relevant sections of this specification can be combined with more general embodiments of the invention, as disclosed in connection with the description of the invention. In particular, such certain features or groups of features may be presented in more general embodiments of the invention, separated from other specific features shown in the drawings. For example, the mounting member shown in Figure 1 and described in relevant sections of this specification can also be implemented in the general subject matter of the invention without needing to similarly implement other structural features of the embodiment in Figure 1. Those skilled in the art will understand that certain features from the description of the drawings can be incorporated into the descriptive embodiments of the invention.

[0062] Furthermore, in the claims, the phrase “comprising” does not exclude other elements or processes, and the indefinite article “a” or “an” does not exclude plurals. A single unit or process may perform the function of several features described in the claims. Even if certain means are described in different dependent claims, this does not mean that combinations of these means cannot be used conveniently. Terms such as “essentially,” “about,” and “approximately” related to attributes or values ​​also define that attribute or its exact value. In the context of a given number or range, the term “about” refers to a value or range that is, for example, within 20%, 10%, 5%, or 2% of a given value or range. Components described as being combined or connected may be directly combined electrically or mechanically, or indirectly combined through one or more intermediate components. No reference numeral in the claims should be construed as limiting the scope.

Claims

1. A component (1) configured to be used as part of a sterile product manufacturing facility (2) in a sterile process, A contact portion (12) configured to come into direct or indirect contact with a sterile product, wherein the contact portion (12) is formed from a thermally conductive material, A component (1) characterized by including a heating structure (13) that is thermally bonded to the contact portion (12).

2. The component (1) according to claim 1, comprising a filling tube (11) for filling a stopper in a sterile syringe preparation process.

3. The component (1) according to claim 2, comprising a first lid (16) configured to close a first end of the filling tube (11), and preferably a second lid (16) configured to close a second end of the filling tube (11).

4. The component (1) according to claim 2 or 3, wherein the contact portion (12) includes the inner surface of the filling tube (11).

5. The component (1) according to any one of claims 1 to 4, comprising an insulating material (14) covering the heating structure (13).

6. The component (1) according to any one of claims 2 to 4 and 5, wherein the insulating material (14) surrounds the filling tube (11) together with the filament, and the component (1) preferably comprises a sheath (15) that airtightly surrounds the insulating material (14), and the sheath (15) preferably comprises a thermal expansion section.

7. The component (1) according to any one of claims 1 to 6, wherein the thermal conductive material of the contact portion (12) is stainless steel.

8. The component (1) according to any one of claims 1 to 7, wherein the heating structure (13) includes a heating filament (13).

9. The power supply connected to the heating filament (13), or The component (1) according to claim 8, comprising a power adapter connected to the heating filament (13), which is configured to be coupled to an external power supply.

10. The component (1) according to any one of claims 2 to 4, or any one of claim 8 or 9, wherein the heating filament (13) is wound around the filling tube (11).

11. The component (1) according to any one of claims 1 to 10, wherein the heating structure (13) is configured to supply a heating output in the range of about 300 watts to about 1000 watts, in the range of about 400 watts to about 700 watts, and particularly about 500 watts.

12. The component (1) according to any one of claims 1 to 11, further comprising a temperature sensor (161) arranged to sense the temperature of the contact portion (12).

13. A product manufacturing line (2) configured to prepare pharmaceuticals by filling containers with active pharmaceutical ingredients, Cleanroom (5) and The component (1) according to any one of claims 1 to 12 and Includes, The component (1) is located in the cleanroom (5) and is part of a product manufacturing line (2).

14. A method for sterilizing a component (1) installed in a cleanroom (5) of a product manufacturing line (2) according to claim 13, comprising heating the contact portion (12) of the component (1) by activating a heating structure (13) of the component (1) while the component (1) is installed in the cleanroom (5), and preferably wiping the contact portion (12) of the component (1) before heating.

15. The method according to claim 14, wherein the contact portion (12) of the component (1) is heated to approximately 160°C for approximately 2 hours, to approximately 180°C for approximately 1 hour, or to approximately 200°C for approximately 5 minutes.

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