Product manufacturing line, component and sterilizing method

Abstract

A component (1) configured to be used as part of a sterile product manufacturing equipment (2) in an aseptic process comprises a contact part and a heating structure. The contact part (12) is configured to directly or indirectly contact a sterile product. It is made of a thermally conductive material. The heating structure (13) is thermally coupled to the contact part (12). The component (1) according to the invention allows for heat sterilization while the component (1) is assembled in the manufacturing equipment (2) without requiring removal of the component (1).

Description

DESCRI PTIONTitlePRODUCT MANUFACTURING LINE, COMPONENT AND STERILIZING METHODTechnical Field

[0001] 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 component and a sterilizing method involving such manufacturing line.

[0002] Components having a contact part configured to directly or indirectly contact a sterile product, are generally used for various purposes and functionalities in manufacturing lines.Background Art

[0003] In processes of manufacture or preparation of sterile products it is often necessary to perform certain steps in an aseptic environment. For example, in production of parenteral or other drug products typically filling of a drug substance into a container such as a vial, cartridge or syringe has to happen in a sterile environment. For that purpose, often clean rooms such as isolators or restricted access barrier systems (RABS) are involved.

[0004] For automatically or semi-automatically processing the sterile product in the sterile environment components are used which are preferably inert at least at parts contacting the sterile product. For example, in clean rooms of drug product manufacturing lines components are used which do not interact with the drug products or any other elements coming into contact with the drug product.

[0005] More specifically, in pre-filled syringe manufacturing the syringes are filled and closed inside the clean room. Therefore, inside the clean room typically components like stopper filling tubes, chutes for forwarding the stoppers, locks for sorting the forwarded stoppers and similar components are arranged inside the clean room.

[0006] To assure appropriate asepticism, the components inside the clean room have to be sterilized from time to time, e.g., between each process batch or the like. Moreover, in accordance with regulatory rules applying in drug manufacture, the cleaning or sterilizing of the components have to be validated. For example, they may have to be validated to be capable of removing any residue or debris that could detrimentally impact the cleaning process and to be capable of minimizing chemical, microbial and particulate contamination of the product. Also, sterilization may be mandatory for all direct and indirect product contact parts.

[0007] In order to clean and sterilize the components located in a clean room, they usually are demounted and removed from the clean room, transferred into a sterilizing unit such as an autoclave or the like and, after sterilization, mounted again in the clean room. Thereby, the demounting, transfer and mounting may be comparably cumbersome and inefficient. Particularly, when comparably bulky or complicatedly fixed components have to be sterilized usually an essential interruption of the manufacturing or preparation process is caused. This lowers efficiency and productivity of the manufacturing line. Furthermore, the demounting and mounting of the components requires skilled personnel. Also, demounting and mounting bares a comparably high risk of damaging the components or other structures inside the clean room.

[0008] Therefore, there is a need for a product manufacturing line or a sterilizing method allowing an efficient and safe sterilization of components of the product manufacturing line, particularly, of components arranged inside a clean room of the product manufacturing line.Disclosure of the Invention

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

[0010] In particular, in one aspect the invention is a component configured to be used as part of a sterile product manufacturing equipment in an aseptic process. The component comprises a contact part configured to directly or indirectly contact a sterileproduct, and a heating structure thermally coupled to the contact part. The contact part is made of a thermally conductive material.

[0011] The component can be any element or piece being included or involved in the aseptic process which is in direct or indirect contact with the sterile product. In this context the term “sensitive element” as used herein relates to the sterile product itself in the form of a drug or drug product or to another element such as packaging components being in contact or in potential contact with the sterile product. In pharmaceutical product manufacturing, such other elements may be vials, cartridges, syringes, needle shields, sealings, caps, or, particularly, stoppers of syringes, vials or the like.

[0012] The component can be mounted or assembled at least partially in a clean room of the sterile manufacturing equipment. It can be a containment to hold or deliver the sensitive element, a chute, a filling or transfer tube delivering the sensitive element or a similar part.

[0013] The sterile product can particularly be a drug product or a part thereof.

[0014] The term “drug” as used herein relates to a therapeutically active agent, also commonly called active pharmaceutical ingredient (API), as well as to a combination of plural such therapeutically active substances. The term also encompasses diagnostic or imaging agents, like for example contrast agents (e.g. MRI contrast agents), tracers (e.g. PET tracers) and hormones, that need to be administered in liquid form to the patient.

[0015] The term “drug substance” as used herein relates to a drug as defined above formulated or reconstituted in a form that is suitable for administration to the patient. For example, besides the drug, a drug substance may additionally comprise an excipient and / or other auxiliary ingredients. A drug substance may be a drug solution, in particular a solution for oral administration, injection or infusion.

[0016] The term “drug product” as used herein relates to a finished end product comprising a drug substance or a plurality of drug substances. In particular, a drug product may be a ready-to-use product having the drug substance in an appropriate dosage and / or in an appropriate form for administration. For example, a drug product may include an administration device such as a prefilled syringe or the like.

[0017] The contact part can have a surface or portion intended to touch or contact the sensitive element in the aseptic process.

[0018] The term “thermally conductive” in connection with the material of the contact part can relate to an ability of conducting or transferring heat. In particular, to be thermally conductive in accordance with the invention the ability of the material to transfer heat may have a minimum thermal conductivity. More specifically, a material can be considered thermally conductive when having a thermal conductivity of 5 Watt per Meter and Kelvin (W / m K or W m-1 K-1 ) or more, of 15 W m-1 K-1 or more, or of 30 W m-1 K-1 or more.

[0019] The term “thermally coupled” in connection with the heating structure and the contact part relates to an arrangement allowing to transfer 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 an appropriate structure, or in a similar fashion.

[0020] The heating structure can be fixed to the contact part or it can be detachable therefrom. Whereas a fixed configuration may be beneficial for handling reasons since the heating structure and contact part form one unit, a detachable heating structure may provide a number of advantages. In particular, it allows for efficient maintenance or replacement of the heating structure if required. Or, it allows for being temporarily removed as the need may be. For example, if space constraints are limiting it may be beneficial to remove the heating structure when it is not used to improve visibility in the area or environment where the component is mounted.

[0021] The component according to the invention allows sterilization at the location where it is mounted or assembled in operation. Such sterilization is also referred to as sterilization in place (SIP). By activating the heating structure, generated heat is transferred to the contact part such that the contact part is heated and sterilized. In particular, by means of the heating structure the component or at least its contact part can be sufficiently heated to achieve sterilization. For example, the European Pharmacopoeia describes dry heat sterilization as an appropriate measure to sterilize elements involved in pharmaceutical processes (cf. chapter 5.1.1.1 of the European Pharmacopoeia).

[0022] Thus, in accordance with the invention de-mounting and re-mounting of components involved in aseptic processes can be prevented. In particular, the components can be sterilized by heat while being assembled inside a clean room without requiring removal from the clean room. Like this, sterilization efficiency and safety can be increased. Also, the down time of the aseptic process during sterilization of the components involved can be reduced or minimized.

[0023] The contact part can advantageously be made of an inert material. Like this, it can be prevented that sensitive elements contacting the contact part are affected. In particular, the thermally conductive material of the contact part preferably is stainless steel. Stainless steel can be beneficial as it is essentially inert for many sensitive elements, as it has an appropriate thermal conductivity of about 30 W m-TK-1 , as it is comparably easy to handle such as clean and as it is comparably economic.

[0024] The heating structure can be embodied in various ways. For example, it can have an element or structure for inductively heating the contact part. Preferably, the heating structure comprises a heating filament. Such filament allows for efficiently resistively heating. It further can be efficiently formed and adapted to accurately suit at the correct location for heating the contact part. The filament can be made of a metal, a metal alloy or another electrically conductive material having an appropriate resistance.

[0025] Thereby, the component preferably comprises a power source connected to the heating filament. Such power source allows to efficiently provide electric current through the filament thereby achieving resistive heating.

[0026] Alternatively, the component preferably comprises a power adapter connected to the heating filament, wherein the power adapter is configured to be coupled to an external power source. When being coupled to an external power source such adapter allows provision of electric current through the filament thereby inducing resistive heating.

[0027] Preferably, the component comprises a filling tube for filling stoppers in an aseptic syringe preparation process. For such components, which may be referred to as stopper transfer tubes or stopper filling tubes, the invention may be particularly beneficial. Specifically, such components typically are comparably bulky such that they may be difficult to demount. Particularly, when the spatial situation is restricted such as in clean rooms or if comparably sensible other components are located near the mounted stoppertransfer tubes, demounting may be cumbersome and difficult. In such situation, heat sterilization in accordance with the invention, which does not require any demounting at all, may be particularly beneficial.

[0028] Preferably, the heating filament is wound around the filling tube. Like this, essentially the complete contact part of the component can efficiently be heated.

[0029] The component preferably comprises a first lid configured to close a first end of the filling tube and / or a second lid configured to close a second end of the filling tube. Such lids allow to close the filling tube during activation of the heating structure. Like this, the interior of the filling tube can efficiently be heated to a sufficient extent for sterilization.

[0030] The contact part preferably comprises an internal surface of the filling tube. Since the sensitive element may be advanced through the filling tube and thereby contacting the latter, the internal surface may be or may form the contact part.

[0031] Preferably, the component comprises a thermal insulation covering the heating structure. Such insulation may prevent that components or parts other than the contact part are heated. Like this, safety of the system in operation and particularly during sterilization may be increased. In embodiments having a detachable heating structure, the thermal insulation may be detachable together with the heating structure. In such embodiments the insulation may be part of the heating structure.

[0032] Thereby, the thermal insulation preferably is encasing the filling tube together with the filament. Like this, a safe unit may be provided enabling a simple construction and handling.

[0033] More specifically, the component preferably comprises a mantle gas-tightly enclosing the thermal insulation. Such gas-tight mantle allows for preventing or reducing hot air escaping the component during heating. Like this, efficiency and safety of heat sterilization may be increased. In embodiments having a detachable heating structure and thermal insulation, the mantle may be detachable together with the heating structure. In such embodiments the mantle may also be part of the heating structure.

[0034] The mantle preferably is equipped with a thermal expansion section. Such expansion section allows for achieving appropriate dimensional adaptation due to intrinsic material heat expansion during heating by means of the heating structure. In particular, itallows to prevent inappropriate stress or force between the different materials of the component during heating. Like this, longevity and functional capability of the component can be enhanced.

[0035] The heating structure, in particular the heating filament, may be configured and / or arranged such that only one or more specific parts of the component including the contact part are heated, while preferably other parts of the component, e.g. an outer casing, such as the mantle, are not heated, but especially are thermally insulated. More specifically, the heating structure, in particular the heating filament, may be configured and / or arranged such that only the filing tube is heated, while preferably other parts of the component, e.g. an outer casing, such as the mantle, are not heated, but especially are thermally insulated. For example, the heating structure, in particular the heating filament, may be embedded into an insulation material which is configured to thermally insulate the heating structure, in particular the heating filament, towards an outside, e.g. towards an outer casing, such as the mantle. In particular, an insulation material may completely cover an outer surface of the filling tube and the heating structure, in particular the heating filament, arranged at the outer surface of the filling tube, while an outer casing, such as the mantle, encloses the insulation material and thus is not heated, but thermally insulated towards the heating structure, in particular the heating filament.

[0036] Preferably, the heating structure is configured to provide heating power in a range of about 300 Watt to about T000 Watt, in a range of about 400 Watt to about 700 Watt, and particularly of about 500 Watt. Such heating power allows for sufficiently heating the contact part to achieve efficient sterilization and, at the same time, provide a safe system.

[0037] Preferably, the component comprises a temperature sensor arranged to sense a temperature of the contact part. The temperature sensor can be positioned to directly or indirectly measure the temperature of the contact part. It can, e.g., be mounted to a backside of the contact part which is opposite to the side contacting the sensitive element. Or it can, e.g., be mounted to the first or second lid, thereby measuring a temperature inside the filling tube when the latter is closed by the respective lid. By means of the temperature sensor, the system can be monitored during heating and sterilization. Like this, on one hand an overheating may be prevented and on the other hand it may be assured that sufficient heat is provided for an appropriate time to achieve sufficient sterilization.

[0038] In another aspect, the invention is a product manufacturing line configured to prepare a pharmaceutical drug product having a container filled with a drug substance. The product manufacturing line comprises a clean room and a component as described above, wherein the component is arranged at least partially in the clean room. The product manufacturing line according to the invention allows for achieving the effects and benefits described above in connection with the component according to the invention and its preferred embodiments.

[0039] In a further other aspect, the invention is a method of sterilizing a component mounted in a clean room of a product manufacturing line described above. The method comprises heating a contact part of the component by activating a heating structure of the component while the component is mounted in the clean room. The method according to the invention allows for efficiently achieving the effects and benefits described above in connection with the component according to the invention and its preferred embodiments.

[0040] Thereby, the contact part of the component preferably is heated to about 160°C for about two hours, to about 180°C for about one hour, or to about 200°C for about five minutes. Such heating allows to achieve an appropriate and sufficient sterilization.

[0041] Preferably, the method comprises a step of wiping the contact part of the component before heating. In particular, such wiping allows for removing contaminants from the contact part, which may not be sufficiently affected by heat sterilization. For example, when stoppers for syringes are handled by the component, silicone oil which is often present when stoppers are involved may residue on the contact part. Such silicone oil may not be removable by heat and may affect or even prevent heat sterilization.Brief Description of the Drawings

[0042] The component according to the invention, the product manufacturing line according to the invention and the method according to the invention are described in more detail hereinbelow by way of exemplary embodiments and with reference to the attached drawings, in which:Fig. 1 shows a perspective view of a stopper transfer tube as an embodiment of a component according to the invention;Fig. 2 shows a front view on the stopper transfer tube of Fig. 1 ;Fig. 3 shows a side view of the stopper transfer tube of Fig. 1 partially cut along the line A-A of Fig. 2; andFig. 4 shows a schematic view of a syringe manufacturing line including the stopper transfer tube of Fig. 1 as an embodiment of a product manufacturing line according to the invention.of Embodiments

[0043] In the following description certain terms are used for reasons of 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 terminology comprises the explicitly mentioned terms as well as their derivations and terms with a similar meaning. Also, spatially relative terms, such as "beneath", "below", "lower", "above", "upper", "proximal", "distal", and the like, may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the devices in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both positions and orientations of above and below. The devices may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes include various special device positions and orientations.

[0044] To avoid repetition in the figures and the descriptions of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from a description or figure does not imply that the aspect is missing from embodiments that incorporate that aspect. Instead, the aspect may have been omitted for clarity and to avoid prolix description. In this context, the following applies to the rest of this description: If, in order to clarify the drawings, a figure contains reference signs which are not explained in the directly associated part of the description, then it is referred to previous or following description sections. Further, for reason of lucidity, if in a drawing not all features of a part are provided with reference signs it is referred to other drawings showing the same part. Like numbers in two or more figures represent the same or similar elements.

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

[0046] The stopper transfer tube 1 generally has a kinked shape with two straight cylindric portions being angled relative to each other. It has a longitudinal axis 18 which, accordingly, is kinked as well. From the outside a gas-tight mantle 15 is visible. In the situation shown in Fig. 1 , the stopper transfer tube 1 is closed by two lids 16. Further, the stopper transfer tube 1 is equipped with a mounting member 17 for solid fixation at a target position in the syringe manufacturing line 2. In particular, by means of the mounting member 17, the stopper transfer tube 1 can be hanging at a position desired in operation inside a clean room.

[0047] In Fig. 2 the stopper transfer tube 1 is shown in a front view, wherein the lid 16 is removed. As can be seen, the stopper transfer tube 1 has a filling tube 11 with a hollow interior 19 and an inner surface forming a contact part 12. In operation, stoppers are transferred through the hollow interior 19 to a target location. Thereby, they touch the contact part 12. And since the stoppers in the end are used to close drug chambers of syringes, they get into contact with the drug substance such that they have to be sterile.

[0048] The filling tube 19 is made of stainless steel. The mantle 15 forms a front portion 151 covering a section of the longitudinal ends of the filling tube 11 and other elements as explained in more detail below.

[0049] Fig. 3 shows the stopper transfer tube 1 in a partially cut view such that internal elements are visible. Around the filling tube 1 1 a heating filament 13 made of a metal is wound. Since the filling tube 11 is made of steel, the contact part 12 is thermally coupled to the filament 13. The filament 13 is configured to resistively heat when being provided with electrical power or an electric current.

[0050] The filament 13 is embedded into an insulation material 14 which is configured to thermally insulate the filament 13 towards an outside. The insulation material 14 completely covers an outer surface of the filling tube 11 and the filament 13. The mantle 15 is embodied as a sheet gas-tightly enclosing the insulation material 14, i.e. , the thermal insulation. At the longitudinal ends of the filling tube 11 , the mantle 15 is folded over suchthat the front portion 151 is formed. Thereby, the front portion 151 covers the filament 13 and the insulation material 14. Further, the mantle 15 is equipped with plural thermal expansion sections (not visible in Fig. 3) to allow compensation of the differing thermal expansion properties of the different materials involved, i.e., the materials of the filament, the filling tube and the insulation material.

[0051] The lids 16 are connected to the filling tube 11 via a hinge such that they can be flapped onto the filling tube 11 to cover and close the interior 19. Thereby, a first or lefthand lid 16 is provided to tightly close a first or left-hand longitudinal end of the filling tube 11 , and a second or right-hand lid 16 is provided to tightly close a second or right-hand longitudinal end of the filling tube 11 . The left-hand lid 16 is equipped with a temperature sensor 161 arranged to measure a temperature in the interion 19 of the filling tube 11. Thereby, it is configured to indirectly sense a temperature of the contact part 12.

[0052] The stopper transfer tube 1 further comprises a power adapter connected to the heating filament 13 (not visible in Fig. 3). The power adapter is configured to be coupled to an external power source. More specifically, the filament 13 together with the power adapter form a heating structure of the stopper transfer tube 1 which is configured to provide a heating power of about 500 Watt.

[0053] Fig. 4 is a schematic illustration of an embodiment of a pre-filled syringe (PFS) manufacturing line 2 as a product manufacturing line according to the invention. The PFS manufacturing line 2 is configured to prepare pharmaceutical drug products having ready-to-use syringes filled with a drug substance. It comprises a clean room 5 and an exchangeable stopper container 3. Inside the clean room 5, the stopper transfer tube 1 and processing components including a chute 41 , a pot 42, a feeding 43, a lock 44 and a swivel 45 are arranged.

[0054] The stopper container 3 is positioned outside the clean room 5. It is used to transport sterile stoppers to the process. To provide the stoppers into the process, the stopper container 3 is coupled to the stopper transfer tube 1 via a Rapid Transfer Port (RTP). The stopper transfer tube 1 forwards the stoppers to the chute 41 and the pot 42, both of which are arranged to vibrate. From the pot 42, the stoppers are forwarded to the stopper lock 44 via the feeding 43 which is configured to linearly vibrate. The lock 44 then sorts and positions the stoppers and the swivel distributed them for being furtherprocessed in appropriate equipment. In particular, the distributed stoppers are forced into the filled syringes to close the syringes.

[0055] For sterilizing the equipment, e.g., after completion of a batch, in accordance with the applicable regulatory rules, most components being in contact with the stoppers may be demounted from the clean room and transferred to an autoclave. However, as exemplified by means of the stopper transfer tube 1 , the chute 41 , the pot 42, the feeding 43, the lock 44 and the swivel 45 are embodied in accordance with the invention such that they can be heat sterilized. All these components 41 , 42, 43, 44, 45 have to be thermally isolated from other elements to prevent unintended heating. For example, the vibrating components have to be thermally isolated from the respective vibrating drive, in order to prevent damaging the drive.

[0056] To sterilize the stopper transfer tube 1 , in an embodiment of the method according to the invention, initially the internal surface of the filling tube 11 is physically wiped in order to remove residuals on the contact part 12. In particular, the internal surface of the filling tube 11 is wiped using a cleaning agent. A particular aim of the wiping is to remove silicone oil droplets from the contact part 12. Stoppers are often provided with silicone oil which may contaminate the contact part 12.

[0057] After wiping, the filling tube 11 is closed by flapping the lids 16 on the longitudinal ends of the filling tube 11 . Then the filling tube 11 is heated by means of the filament 13. In particular, electric current is provided through the filament 13 such that it is resistively heated. The heat is transferred from the filament 13 to the filling tube 11 such that the contact part 12 is heated as well. More specifically, the contact part 12 is heated to 200°C for five minutes. Proper heating is monitored by the sensor 161 of the respective lid 16.

[0058] After heating the lids 16 are flipped off the filling tube 11 such that it is open and ready for receiving and transferring a next batch of stoppers. During the complete sterilization process, the stopper transfer tube 1 stays mounted in the clean room 5.

[0059] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limiting the claims defining the invention. In other words, while the invention is illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical,compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this description and the claims. In some instances, well-known circuits, structures and techniques have not been shown in detail in order not to obscure the invention. Thus, it will be understood that changes and modifications may be made by those of ordinary skill within the scope and spirit of the following claims. In particular, the present invention covers further embodiments with any combination of features from different embodiments described above and below.

[0060] The disclosure also covers all further features shown in the Figs, individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description and single alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter. The disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features.

[0061] Also, specific features or groups of features as disclosed in the figures and the associated sections of the description may be combined with the more general embodiments of the invention as disclosed in connection with the description of the invention. In particular, such specific features or groups of features may be provided in the more general embodiments of the invention in isolation from other specific features shown in the figures. For example, the mounting member depicted in Fig. 1 and described in the associated portion of the description may also be embodied in the general subject matter of the invention without requiring other structural features of the embodiment of Fig. 1 to be embodied as well. It is understood that those skilled in the art are able to incorporate specific features from the description of the figures into the embodiments of the description of the invention.

[0062] Furthermore, in the claims the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single unit or step may fulfil the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms “essentially”, “about”, “approximately” and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. The term “about” in the context of a given numerate value or range refers to a value or rangethat is, e.g., within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. Any reference signs in the claims should not be construed as limiting the scope.

Claims

CLAIMS1. A component (1 ) configured to be used as part of a sterile product manufacturing equipment (2) in an aseptic process, comprising a contact part (12) configured to directly or indirectly contact a sterile product, wherein the contact part (12) is made of a thermally conductive material, characterized by comprising a heating structure (13) thermally coupled to the contact part (12).

2. The component (1 ) of claim 1 , comprising a filling tube (11 ) for filling stoppers in an aseptic syringe preparation process.

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

4. The component (1 ) of claim 2 or 3, wherein the contact part (12) comprises an internal surface of the filling tube (11 ).

5. The component (1 ) of any one of the preceding claims, comprising a thermal insulation (14) covering the heating structure (13).

6. The component (1 ) of any of claims 2 to 4 and claim 5, wherein the thermal insulation (14) is encasing the filling tube (11 ) together with the filament, wherein the component (1 ) preferably comprises a mantle (15) gas-tightly enclosing the thermal insulation (14), wherein the mantle (15) preferably is equipped with a thermal expansion section.

7. The component (1 ) of any one of the preceding claims, wherein the thermally conductive material of the contact part (12) is stainless steel.

8. The component (1 ) of any one of the preceding claims, wherein the heating structure (13) comprises a heating filament (13).

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

10. The component (1 ) of any one of claims 2 to 4 and any one of claim 8 or 9, wherein the heating filament (13) is wound around the filling tube (11 ).11 . The component (1 ) of any one of the preceding claims, wherein the heating structure (13) is configured to provide a heating power in a range of about 300 Watt to about 1 ’000 Watt, in a range of about 400 Watt to about 700 Watt, and particularly of about 500 Watt.

12. The component (1 ) of any one of the preceding claims, comprising a temperature sensor (161 ) arranged to sense a temperature of the contact part (12).

13. A product manufacturing line (2) configured to prepare a pharmaceutical drug product having a container filled with a drug substance, comprising a clean room (5), and a component (1 ) according to any one of the preceding claims, wherein the component (1 ) is arranged in the clean room (5).

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

15. The method of claim 14, wherein the contact part (12) of the component (1 ) is heated to about 160°C for about two hours, to about 180°C for about one hour, or to about 200°C for about five minutes.

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