Installation for carrying out process steps on containers
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- OPTIMA PHARMA GMBH
- Filing Date
- 2025-10-28
- Publication Date
- 2026-06-25
Smart Images
Figure EP2025081062_25062026_PF_FP_ABST
Abstract
Description
[0001] System for carrying out process steps on containers
[0002] SCOPE OF APPLICATION AND STATE OF THE ART
[0003] The invention relates to a system for carrying out process steps on containers at least partially under cleanroom conditions, wherein the process steps include at least filling and sealing the containers under cleanroom conditions, and the system comprises a closure supply device for storing and / or conveying and / or sorting the closure elements. The invention further relates to a closure supply device for such a system.
[0004] For example, DE 102022205283 A 1 shows a device for storing, conveying and sorting closure elements.
[0005] TASK AND SOLUTION
[0006] The object of the invention is to create an improved system for carrying out process steps on containers, comprising a closure provision device and a closure provision device for such a system.
[0007] According to a first aspect, a system for carrying out process steps on containers, particularly pharmaceutical containers, is being created, at least partially under cleanroom conditions. The process steps include at least filling and sealing the containers under cleanroom conditions. The system comprises a sealing station and a sealing element supply unit. The sealing station is configured to seal a filled container with a sealing element. The sealing element supply unit is configured to store, convey, and / or sort the sealing elements. The sealing element supply unit includes a functional component, which is particularly autoclavable. One material of the functional component is a plastic.
[0008] According to a second aspect, a system for carrying out process steps on containers, particularly pharmaceutical containers, is being created, at least partially, under cleanroom conditions. The process steps include at least filling and sealing the containers under cleanroom conditions. The system comprises a sealing station and a sealing element supply unit. The sealing station is configured to seal a filled container with a sealing element. The sealing element supply unit is configured to store, convey, and / or sort the sealing elements. The sealing element supply unit includes a functional component, which is, in particular, autoclavable. The functional component is multi-part.
[0009] The terms "a", "a", etc. are used in connection with the application as indefinite articles and not as counters. In particular, it is provided in embodiments that one material of the functional part comprises more than one plastic. The closure provisioning device comprises more than one functional part in embodiments.
[0010] In certain configurations, all individual parts of the multi-part functional component are made of metal, especially stainless steel.
[0011] In some embodiments, at least one component of the multi-part functional part is made of plastic. In others, several components or all components of the multi-part functional part are made of plastic.
[0012] Depending on the application, the individual parts can be connected to each other either non-destructively or non-destructively. Connecting the individual parts is possible, particularly in certain configurations, at least partially automated, for example using a manipulator, and / or tool-free, for example, but not limited to, snap-fit connections and / or magnetic connections.
[0013] Process steps are defined here as any form of handling, processing and / or treatment of an object, in particular a container, and / or its contents, including but not limited to filling, closing, labeling of objects designed as containers, as well as treatments without material change to the object and / or its contents, such as weighing and / or other recording, in particular optical inspection.
[0014] The containers in question are primarily pharmaceutical containers, such as vials, syringes, cartridges or ampoules.
[0015] The cleanroom conditions required for carrying out process steps on containers are defined by the application, in particular by the product being handled and / or the intended use of that product. Specifically, cleanroom conditions require at least a certain degree of sterility. Regulations defining cleanroom conditions include, for example, DIN EN ISO 14644-1 and / or VDI 2083 and / or "The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use" (EU GMP Guide), Annex 1 (currently Volume 4, dated August 22, 2022) and the regulations referenced therein. The cleanroom conditions required, at least in part, for the process steps in the systems disclosed here are, in particular, classes A, B, C, and D according to EU GMP, Annex 1, especially classes A, B, and C.In particular, the filling and sealing of the containers takes place under the cleanroom conditions of this class A.
[0016] The at least one functional component is, in its various configurations, at least partially, or at least largely, made of plastic. Depending on the application, the functional component and / or a component thereof are manufactured from plastic, for example, by machining, injection molding, additive manufacturing, and / or direct forming.
[0017] For use in a system for carrying out process steps under cleanroom conditions, the functional part, at least one component thereof, and / or the materials from which the functional part and / or the component is / are manufactured must be autoclavable. This ensures a high degree of sterility for the functional part. A high degree of sterility is particularly important for the functional part because it comes into contact with the sealing elements. For example, after decontamination of the system, the functional part and / or the component can be introduced into the decontaminated cleanroom while maintaining cleanroom conditions.
[0018] An autoclave is a device for the thermal treatment of components under pressure. During autoclave treatment, components and / or materials are freed from living microorganisms and viruses with a level of process reliability required for the specific application. For the purposes of this application, components and / or materials suitable for withstanding treatment in an autoclave without damage are referred to as "autoclavable." Specifically, these components and / or materials are suitable for withstanding the pressure, humidity, and / or temperature of an autoclave without damage.
[0019] Damage-free treatment is defined as treatment in which the functional part and / or its component and / or the plastic material used for the functional part and / or the component warps only within tolerance limits. Depending on the application, the required germ-killing temperature, particularly for Clostridium botulinum, is at least approximately 121°C. However, depending on the application, higher germ-killing temperatures may be necessary for autoclave treatment.
[0020] In particular, the autoclavable components and / or materials are suitable for withstanding treatments at temperatures above 100°C, for example between at least approximately 100°C and at least approximately 140°C, without damage.
[0021] Treatment in an autoclave takes place under overpressure. In particular, the autoclavable components and / or materials are suitable for withstanding treatments at a pressure of at least 1.5 bar up to, for example, at least approximately 4 bar without damage, for example, treatments at a pressure between at least approximately 1.5 bar and at least approximately 3 bar.
[0022] The duration of treatment in the autoclave depends, among other things, on the treatment temperature, the selected pressure and / or the microorganisms to be destroyed.
[0023] In particular, the autoclavable components and / or materials are suitable for withstanding treatments at the selected temperatures and pressures for a duration of at least 15 minutes, in particular at least 20 minutes, for example up to at least approximately one hour, without damage.
[0024] In certain embodiments, it is provided that individual parts of the multi-part functional part each occupy a maximum of 80%, in particular a maximum of 70%, for example a maximum of 60%, of the total volume occupied by the assembled functional part.
[0025] The multi-part design allows for improved handling when moving the functional part into a cleanroom of the plant.
[0026] In various embodiments, the functional part is a pot-shaped component. A pot-shaped functional part is defined as a component comprising a wall that defines an interior space and has an opening to that interior space. The pot-shaped functional part includes, in particular, a bottom wall, especially a circular and / or rectangular bottom wall, and a side wall projecting from it. The opening is located, in particular, opposite the bottom wall. In some embodiments, the side wall is conical, with the cross-section of the interior space of the functional part increasing from the bottom wall towards the opening. In other embodiments, the side wall is cylindrical, with the cross-section of the interior space of the pot-shaped functional part remaining essentially constant.In some embodiments, the bottom wall is funnel-shaped and has an outlet opening, with the cross-section of the interior of the functional part increasing from the outlet opening towards the opening. In other embodiments, the pot-shaped functional part is designed as a storage component, for example, as a storage container and / or as a sorting and / or conveying pot of a closure dispensing device, particularly in a vibratory conveyor, such as a linear vibratory conveyor and / or a vibratory rotary conveyor.
[0027] In some configurations, the side wall and / or the bottom wall are formed by several individual parts. In some configurations, the individual parts of the functional component comprise elements of both the side wall and the bottom wall. In other configurations, all individual parts comprise only elements of either the side wall or the bottom wall.
[0028] In the various configurations, at least one of the following features is provided:
[0029] - the functional part is a conveying part and / or
[0030] - the functional part is a sorting part and / or
[0031] - the functional part is a storage part, for example a storage container and / or a sorting and / or conveying pot and / or a collection container, and / or
[0032] - the functional part is pot-shaped, for example a storage, sorting and / or conveying pot
[0033] - the functional part has a rail, for example a conveyor trough and / or a slide and / or a sorting and / or conveyor rail.
[0034] In certain embodiments, the closure delivery device is configured to transmit oscillations and / or vibrations to the functional part. In these embodiments, the closure delivery device includes a drive, in particular an electromagnetic drive, which is configured to excite the functional part to oscillations and / or vibrations for conveying and / or sorting the closure elements.
[0035] A functional part that is excited to vibrations and / or oscillations for conveying and / or sorting the closure elements is also referred to above and below as conveying and / or sorting part.
[0036] In various embodiments, the functional part, in particular the conveying and / or sorting part, has an inlet point, an outlet point, and a transport sector between the inlet point and the outlet point. In the case of a pot-shaped functional part, the inlet point is located on or adjacent to a bottom wall, with the closing elements being transported along a curved transport sector, particularly in the direction of an outlet point provided at the opening.
[0037] In certain configurations, the closure provisioning device is set up to transport closure elements along the transport sector.
[0038] Alternatively or additionally, in certain configurations the closure provisioning device is set up to sort closure elements along the transport sector.
[0039] In certain configurations, the closure provisioning device is designed to transport the closure elements from the entry point to the exit point, at least when the closure elements are oriented in a prescribed orientation.
[0040] In particular, sorting the closure elements includes sorting out closure elements from the transport sector, especially sorting out closure elements that are not oriented in the prescribed orientation and / or that overlap each other at least partially.
[0041] In particular, conveying and / or sorting the closure elements, especially in the transport sector, includes a change in the orientation of the closure elements.
[0042] In certain configurations, the transport sector, particularly in the case of a pot-shaped functional part, is at least partially egg-shaped.
[0043] In its design, the transport sector is at least partially straightforward.
[0044] In certain embodiments, the movement of the locking elements on the transport sector in at least two non-parallel directions transverse to a transport direction is limited, at least in sections, by segments of the functional part. In particular, in certain embodiments, the functional part has a segment that limits the movement when the system is oriented normally downwards, i.e., against gravity. In certain embodiments, the segment limiting the downward movement is straight, in particular straight and inclined to a horizontal plane, and / or curved, in particular around an axis that is at least substantially vertical. In certain embodiments, a second segment of the functional part limits the movement of the locking elements laterally; that is, the second segment limits movement in a plane parallel to the downward-limiting segment and transverse, in particular perpendicular, to a transport direction.
[0045] The sections limiting the movement of the locking elements in the transport sector are made in particular of a material comprising a plastic.
[0046] In various embodiments, the functional part comprises a transport sector that is at least partially subdivided into a conveying section and a sorting section. The sorting section has sorting contours, whereby the orientation of a closure element transported within the sorting section can be changed by means of the sorting contours, and / or a transported closure element that does not have a prescribed orientation can be removed from the sorting section by means of the sorting contours. The sorting section is located downstream of the conveying section, particularly in the transport direction, in order to correct the orientation of the closure elements after the conveying section and / or to remove incorrectly oriented closure elements from the sorting section downstream of the conveying section.
[0047] The sorting contour can be suitably designed depending on the locking element and the design of the functional part. In some configurations, a section limiting downward movement and / or a section limiting lateral movement has a recess as part of the sorting contour. Alternatively or additionally, a section limiting lateral movement has an obstacle as part of the sorting contour and / or an obstacle is provided vertically spaced from a section limiting downward movement. Locking elements that do not have the prescribed orientation and therefore have a greater vertical extent than locking elements that have the prescribed orientation collide with the obstacle and are thus removed from the sorting section and / or repositioned into the prescribed orientation.
[0048] The functional part includes an insert in various configurations. The insert is made of metal and / or plastic in some configurations. In some configurations, the insert defines a sorting contour.
[0049] In various configurations, the insert is a separate part from the individual parts of a multi-part functional component.
[0050] In the case of a multi-part functional part, the conveying section extends along at least two individual parts of the multi-part functional part and / or the conveying section is formed from at least two of the several individual parts of the multi-part functional part.
[0051] In certain embodiments, a separation between at least two of the multiple individual parts is provided for in a multi-part functional component, with the separation occurring along a separation plane. In these embodiments, at least one of the following features is provided: - the separation plane extends over the entire extent of the functional component; - the separation plane runs transversely, in particular perpendicularly, to the transport direction at least in a subsection of the transport sector; - the separation plane runs horizontally; - the separation plane runs vertically.
[0052] In some configurations, a horizontal dividing plane runs transversely, in particular perpendicularly to an axis of a functional part designed as a sorting and / or conveying pot.
[0053] In this configuration, a vertical separating plane runs parallel to or through an axis of a functional part designed as a sorting and / or conveying bowl.
[0054] Depending on the application, the individual parts can be connected to each other at least at one separation plane, either non-destructively or non-destructively. Connecting the individual parts is possible, particularly in certain configurations, at least partially automated, for example using a manipulator, and / or tool-free, for example, but not limited to, snap-fit connections and / or magnetic connections.
[0055] In some embodiments, the closure provision device includes a sorting device, in particular for aligning the closure elements.
[0056] In certain embodiments, the closure dispensing device includes a vibratory reversing conveyor. A vibratory reversing conveyor is defined above and / or below as a device comprising a sorting and / or conveying bowl and a vibratory and / or vibration drive, wherein vibrations are applied to the sorting and / or conveying bowl by the vibratory and / or vibration drive, and small parts, in particular closure elements, present in the sorting and / or conveying bowl are conveyed towards an outlet by means of these vibrations. In certain embodiments, the sorting and / or conveying bowl has a conveying helix along which the closure elements are conveyed.In some designs, a sorting section with baffles is provided between the conveyor helix and the outlet, whereby closure elements that do not have a desired orientation for subsequent use are thrown back into the sorting and / or conveying pot by means of the baffles, and if possible only closure elements with a desired orientation are conveyed to an outlet of the sorting and / or conveying pot.
[0057] In some embodiments, the closure supply device includes a sorting and / or conveying rail for feeding the closure elements to the closure station. The sorting and / or conveying rail is located, in particular, downstream of an outlet of the sorting and / or conveying bowl and / or a storage component, such as a storage container. In some embodiments, the closure elements and / or other small parts are poured from the sorting and / or conveying bowl and / or the storage component, such as the storage container, onto the sorting and / or conveying rail and sorted on the feed rail. In other embodiments, the closure elements and / or other small parts are conveyed from the sorting and / or conveying bowl to the sorting and / or conveying rail by the vibrations applied to the oscillating and / or vibratory drive.
[0058] In various configurations, the closure supply device includes a sorting and / or conveyor rail for feeding the closure elements to the closure station, a storage part and at least one functional part arranged between the sorting and / or conveyor rail and the storage part, for example a conveyor trough and / or a chute.
[0059] In some designs, the functional part and / or at least one component thereof is coated, at least in certain areas.
[0060] In certain embodiments, it is provided that the plastic material of the functional part and / or at least of a component of the functional part has at least one of the following properties: a melting temperature of the plastic is greater than a temperature in an autoclave and / or greater than at least 100°C, in particular greater than 130°C, in particular greater than 150°C, in particular greater than 200°C; a glass transition temperature of the plastic is greater than a temperature in an autoclave and / or greater than at least 100°C, in particular greater than 130°C; a modulus of elasticity (Young's modulus) of at least the plastic is greater than 2 MPa, in particular greater than 3 MPa, for example greater than 5 MPa; chemical resistance to cleaning with acid and / or alkali.
[0061] The melting point is the temperature at which a plastic melts, that is, transitions from a solid to a liquid state. The glass transition temperature, or glass transition temperature, is the temperature at which an amorphous plastic transitions from a rigid, glassy state to a soft, rubbery state. Depending on the type of plastic, the melting point and / or the glass transition temperature determines the plastic's temperature resistance.
[0062] The plastic has sufficient temperature resistance and / or modulus of elasticity to withstand treatment in an autoclave without damage.
[0063] The elastic modulus (Young's modulus) of a plastic can depend on its moisture or water absorption, depending on the specific plastic. The Young's modulus values mentioned above apply at least in a dry state; preferably, they also apply in a moist state, and in particular, the plastic exhibits the aforementioned Young's modulus values under conditions such as those found in an autoclave.
[0064] Chemical resistance refers to the ability of components and / or materials to withstand the effects of chemicals. In certain configurations, the plastic(s) of the functional part exhibit sufficient chemical resistance to the effects of an acid and / or alkali used for cleaning. This cleaning with an acid and / or alkali is performed, in these configurations, after filling and / or after removing the closure elements from the functional part, for example, after removing the closure elements from the sorting and / or conveying bowl, in order to clean the functional part, particularly the sorting and / or conveying bowl, of any abrasion from the previously sorted and provided closure elements. Specifically, the plastic exhibits resistance to the effects of alcohol, ethanol, and / or other acidic and / or alkaline cleaning agents.
[0065] In its various forms, the plastic is a thermoplastic, i.e., a plastic that can be reversibly deformed within a specific temperature range.
[0066] In certain embodiments, the material of the functional part and / or at least one component of the functional part comprises a plastic from the polyetherketone group (PEK). PEK exhibits high temperature resistance. Furthermore, PEK is characterized by high wear resistance. In addition, PEK is resistant to non-oxidizing acids, greases, lubricants, steam, hot water, and concentrated alkalis. Specifically, the material in these embodiments comprises polyaryletherketone (PAEK) and / or polyetheretherketone (PEEK).
[0067] In certain embodiments, the closure provision device is designed to prevent static charges on the functional part and / or on at least one component of the functional part, in particular on a component made of plastic.
[0068] For example, in designs to avoid static charging, it is provided that the functional part and / or individual parts thereof are electrically connected to a ground.
[0069] In certain embodiments, the plastic material of the functional part and / or of at least one component of the functional part is an electrostatically dissipative plastic. An antistatic and / or electrostatically dissipative plastic is defined as a plastic that possesses sufficient electrical conductivity to prevent electrostatic charging due to frictional contact with the locking elements. Depending on the application, a specific volume resistance of the plastic of no more than 10 Ω is particularly important. A 14 [ohm*cm], in particular at most 10 A 13 [ohm*cm], preferably at most 10 A 12 [ohm*cm], for example, at most 10 A 10 [ohm*cm], and in configurations in the range between 10 A 3 [ohm*cm] and 10 A 12 [ohm*cm], in particular according to IEC 60093 (issue date 1993-12) and / or according to DIN EN 61340-2-3 VDE 0300-2-3:2017-05 Electrostatics (issue date 2017-05).
[0070] In certain embodiments, the plastic incorporates additives and / or a coating to reduce electrical resistance. For example, the plastic contains electrically conductive fibers, particularly carbon fibers. In some embodiments, the additives achieve sufficient electrical conductivity to prevent electrostatic charging.
[0071] For example, but not limited to, the plastic is a polyetheretherketone with carbon fiber content and / or one of the plastics TECAPEEK, in particular TECAPEEK CF30, from Ensinger®.
[0072] In some designs, the closure elements are made of rubber. Rubber refers to vulcanizates of natural and synthetic rubbers. The closure elements are designed as plugs and / or caps.
[0073] In its various configurations, the system comprises a cleanroom structure with a housing, wherein the cleanroom conditions are created inside the housing of the cleanroom structure, and at least the closing station and the closing provision device are arranged inside the housing of the cleanroom structure.
[0074] In particular, the cleanroom setup includes a barrier device. The barrier device protects the cleanroom environment by separating it from the surroundings. In certain configurations, the cleanroom setup comprises an isolator (especially a closed or open one). An isolator is defined as a decontaminated unit that allows its interior to be isolated from the external environment. In certain configurations, the cleanroom environment is created within the interior of a closed or open restricted access barrier system (RABS). Cleanroom setups, especially isolators and RABS, are used particularly in the manufacture, processing, and / or handling of pharmaceutical products, biopharmaceutical products, biological products, highly potent products, and / or other highly sensitive products.
[0075] According to a third aspect, a closure dispensing device for a system for carrying out process steps on containers, particularly pharmaceutical containers, is created, at least partially, under cleanroom conditions. The process steps include at least filling and closing the containers under cleanroom conditions. The closure dispensing device is designed for storing, conveying, and / or sorting the closure elements. The closure dispensing device comprises a functional part, which is particularly autoclavable, and the material of the functional part includes a plastic.
[0076] According to a fourth aspect, a closure dispensing device for a system for carrying out process steps on containers, particularly pharmaceutical containers, is created, at least partially, under cleanroom conditions. The process steps include at least filling and closing the containers under cleanroom conditions. The closure dispensing device is designed for storing, conveying, and / or sorting the closure elements. The closure dispensing device comprises a multi-part functional component, particularly an autoclavable, and in particular a multi-part, pot-shaped functional component. In certain embodiments, one component of the multi-part functional component is made of a plastic.
[0077] The closure delivery device has, in particular, one or more of the properties described above.
[0078] In particular, two directions within the meaning of this disclosure are perpendicular to each other if the angle between these directions is at least 20 degrees, in particular at least 45 degrees, and / or if these two directions are at least mostly, in particular at least approximately, perpendicular to each other.
[0079] In particular, a feature is at least largely realized in an entity within the meaning of this disclosure if the feature is realized in at least 65%, and in particular in at least 80% of the entity, and / or if the feature is realized at least approximately in the entity.
[0080] In particular, a feature is realized at least approximately in an entity within the meaning of this disclosure if the feature is realized in at least 90% of the entity and / or if the feature is realized with technically irrelevant deviations and / or technically caused deviations.
[0081] BRIEF DESCRIPTION OF THE DRAWINGS
[0082] Further advantages and aspects of the invention will become apparent from the claims and from the description of exemplary embodiments of the invention, which are explained below with reference to the figures. These figures show:
[0083] Fig. 1 shows a system for carrying out process steps, and
[0084] Fig. 2 shows a closure provisioning device, in particular for a system according to Fig. 1; and
[0085] Fig. 3 shows a further embodiment of a closure provisioning device, in particular for a system according to Fig. 1. DETAILED DESCRIPTION OF THE EXAMPLES OF EXECUTION
[0086] Fig. 1 schematically shows a system 1 for carrying out process steps on containers not shown in Fig. 1, in particular on pharmaceutical containers, at least partially under cleanroom conditions.
[0087] The depicted Annex 1 is in particular an Annex 1 for filling and closing containers.
[0088] The depicted system 1 comprises four stations 22, 24, 26, and 28 for this purpose, wherein a first station 22 is designed as a first weighing station or tare weighing station for recording the empty weight of the containers, a second station 24 as a filling station, a third station 26 as a second weighing station or gross weighing station for recording the filled weight of the containers, and a fourth station 28 as a closing station. However, other configurations with fewer or additional stations and / or with alternative stations are conceivable.
[0089] The system 1 further includes a transport system 3 for transporting the containers to, away from and / or through the processing stations 22, 24, 26, 28. Depending on the application, the containers are transported individually or as a group, for example in a nest.
[0090] The system 1 includes an inlet 10 for the containers to be filled and an outlet 12 for filled and sealed containers.
[0091] As schematically indicated by a dashed line, the processing stations 22, 24, 26, 28 are arranged in a cleanroom enclosed by a housing 4. The inlet 10 and / or the outlet 12 serve as an airlock to and from the cleanroom in certain configurations.
[0092] The housing 4 is specifically designed as a barrier device, which protects a cleanroom condition inside the housing 4 by separating it from the environment.
[0093] Fig. 2 schematically shows a closure delivery device 20, particularly, but not limited to, a system 1 according to Fig. 1. The closure delivery device 20 shown in Fig. 2 comprises a first functional part 200 and a second functional part 201. The first functional part 200 and / or the second functional part 201 are, in certain embodiments, autoclavable.
[0094] The first functional part 200 is designed as a pot-shaped functional part, in particular as a sorting and / or conveying pot. The illustrated pot-shaped functional part 200 comprises a circular base wall and a side wall projecting from it.
[0095] The first functional part 200, together with a first vibratory drive 202, forms a vibratory reversing conveyor 20 with a discharge 2001. The pot-shaped functional part 200 can be driven into vibration by the first vibratory drive 202 in order to transport closure elements (not shown in the figures) from inside the pot-shaped functional part 200 towards the discharge 2001. The illustrated first functional part 200 has a sorting section with obstacles or baffles, whereby closure elements that do not have the desired orientation for subsequent use are thrown back into the sorting and / or conveying pot by means of the obstacles or baffles, and, if possible, only closure elements with the desired orientation are conveyed to the discharge 2001. In some embodiments, the sorting and / or conveying pot also serves to store the closure elements and is, for example, also a storage component.
[0096] The second functional part 201 is designed as a sorting and / or conveyor rail. In the illustrated embodiment, a second vibratory drive 203 is assigned to the second functional part 201, by which the second functional part 201, designed as a sorting and / or conveyor rail, can be driven to vibrate in order to transport the locking elements (not shown) along the second functional part.
[0097] The outlet 2001 of the first functional part 200 and the second functional part 201, designed as a sorting and / or conveyor rail, each comprise several parallel tracks along which the locking elements can move. The number of tracks can be appropriately determined by a specialist depending on the application.
[0098] The first, pot-shaped functional part 200 is multi-part in various embodiments and comprises at least two individual parts. In particular, separation occurs along a schematically depicted parting plane 2002. Figure 2 schematically shows a horizontal parting plane 2002 that runs transversely, and in particular perpendicularly, to an axis of the first functional part 200, which is designed as a sorting and / or conveying pot. However, the depicted parting plane 200 is merely exemplary. The first, pot-shaped functional part 200, or in a multi-part embodiment at least one individual part of the first functional part 200, is / are made of a plastic in various embodiments. In particular, the functional part 200, or individual parts thereof, is made of a plastic that allows the first functional part 200 and / or the individual part of the first functional part 200 to be treated in an autoclave without damage to the functional part 200 and / or the individual part.
[0099] Alternatively or additionally, the second functional part 201, designed as a sorting and / or conveyor rail, or in the case of a multi-part design, at least one individual part of the second functional part 201, is in embodiments made of a plastic, in particular a plastic which allows treatment of the second functional part 201 and / or the individual part in an autoclave without damage to the second functional part 201 and / or the individual part.
[0100] Fig. 3 schematically shows an embodiment of a closure provision device 20, in particular but not limited to a system 1 according to Fig. 1.
[0101] The closure provisioning device 20 shown in Fig. 3 comprises a first functional part 200, a second functional part 201, a third functional part 205 and a fourth functional part 206. The first functional part 200 and / or the second functional part 201 and / or the third functional part 205 and / or the fourth functional part 206 are autoclavable in certain embodiments.
[0102] The first functional part 200 serves, in some embodiments, to store the closure elements. For example, the first functional part 200 is a storage part. In some embodiments, the first functional part 200 is designed as a pot-shaped functional part, in particular as a storage container or bunker, as schematically shown in Fig. 3. The depicted pot-shaped functional part 200 comprises a funnel-shaped bottom wall 2003 with an outlet opening, and a side wall 2004 projecting from the bottom wall 2003.
[0103] In the illustrated embodiment, the closure provision device 20 comprises a second functional part 201, which is designed as a sorting and / or conveyor rail.
[0104] The second functional part 201, designed as a sorting and / or conveyor rail, comprises several parallel tracks along which the closure elements can be moved. The number of tracks can be appropriately determined by a specialist depending on the application. As shown in Fig. 3, the illustrated closure supply device 20 further comprises a third functional part 205 designed as a conveyor trough with an outlet 2050. The third functional part 205, designed as a conveyor trough, is arranged downstream of the outlet opening of the first functional part 200, which is designed as a storage container. Closure elements discharged from the storage container via the outlet opening are moved through the conveyor trough 201 towards a downstream device.
[0105] In various configurations, the following device is the sorting and / or conveyor rail 201.
[0106] In the illustrated embodiment, the subsequent device is a fourth functional part 206, also designed as a conveying trough. The fourth functional part 206, designed as a conveying trough, moves the closure elements further towards a subsequent device.
[0107] In the illustrated embodiment, the following device is the first functional part designed as a sorting and / or conveyor rail.
[0108] The fourth functional part 206 comprises several parallel tracks at its outlet 2060, along which the locking elements are movable. The number of tracks corresponds in particular to the number of tracks of the first functional part 201.
[0109] In the illustrated embodiment, each of the second functional part 201, the third functional part 205 and the fourth functional part 206 is assigned a vibration drive 203, by which the functional parts 201, 205, 206 can each be driven to vibrate in order to transport the locking elements (not shown) along the respective functional part 201, 205, 206.
[0110] In the illustrated embodiment, a collection container 2007 for closure elements not conveyed towards the outlet 201 is provided on one side of the second functional part 201, which is designed as a conveying trough.
[0111] In embodiments, as schematically shown in Fig. 3, a collection container 2010 is provided to collect sorted closure elements at a sorting section, in particular at the sorting and / or conveyor rail 201.
[0112] For example, in certain configurations, a facility, in particular a comprehensive one,
[0113] A manipulator designed to move at least one of the collection containers 2007, 2010, for example both collection containers 2007, 2010, in particular to move them automatically, in order to transfer sorted closure elements collected in the collection container 2007, 2010 back into a functional part 200 designed as a storage part, in particular semi-automatically, for example fully automatically. For example, the collection container 2007, 2010 is a functional part, in particular made of plastic and / or comprising a component made of plastic, for example made of a plastic that allows the collection container 2007, 2010 and / or the component to be treated in an autoclave without damage to the collection container 2007, 2010 and / or the component.
[0114] The first, pot-shaped functional part 200, or in the case of a multi-part design at least one individual part of the first functional part 200, is / are made of a plastic. In particular, the functional part 200 or individual parts thereof is made of a plastic that allows the first functional part 200 and / or the individual part of the first functional part 200 to be treated in an autoclave without damage to the functional part 200 and / or the individual part.
[0115] Alternatively or additionally, the second functional part 201 and / or the third functional part 205 and / or the fourth functional part 206, or in the case of a multi-part design, at least one individual part of the second functional part 201 and / or the third functional part 205 / or the fourth functional part 206, is made of a plastic, in particular a plastic which allows treatment of the second functional part 201 and / or the individual part in an autoclave without damage to the second functional part 201 and / or the individual part.
[0116] The closure elements are fed to the first functional part 200, designed as a storage container, via an opening 5 on a wall 40 of the housing 4 (see Fig. 1), as schematically shown in Fig. 3. For example, the opening is designed as an alpha port of an alpha-beta port system. For example, a bag containing closure elements (not shown), designed as a beta component, can be connected to the alpha port on an outside of the wall 40 in order to transfer closure elements from the bag into the interior of the housing without contact with the environment.
[0117] For example, a chute 50 is provided on an inner side of the opening 5, through which the closure elements are fed to the first functional part 200, which is designed as a storage container. For example, the chute 50 is made of an autoclavable material. The chute 50 is inclined relative to a horizontal plane, so that the closure elements move along the chute due to gravity. The chute 50, or in the case of a multi-part design, at least one component of the chute 50, is / are made of a plastic. In particular, the chute 50, or components thereof, is made of a plastic that allows the chute 50 and / or the component to be treated in an autoclave without damage to the chute 50 and / or the component.
[0118] For example, slide 50 is a functional part of the closure provisioning device 20.
Claims
Patent claims 1. Plant for carrying out process steps on containers, in particular pharmaceutical containers, at least partially under cleanroom conditions, the process steps comprising at least filling and closing the containers under cleanroom conditions, the plant comprising a closing station (26) and a closure supply device (20), the closing station (26) is configured to close a filled container with a closure element, the closure supply device (20) is configured to store and / or convey and / or sort the closure elements, wherein the closure supply device comprises a functional part (200, 201), in particular an autoclavable part, and a material of the functional part (200, 201) comprises a plastic.
2. Plant for carrying out process steps on containers, in particular pharmaceutical containers, at least partially under cleanroom conditions, the process steps comprising at least filling and closing the containers under cleanroom conditions, the plant comprising a closing station (26) and a closure supply device (20), the closing station (26) is configured to close a filled container with a closure element, the closure supply device (20) is configured to store and / or convey and / or sort the closure elements, wherein the closure supply device comprises a functional part (200, 201), in particular a pot-shaped functional part (200), and the functional part (200, 201) is multi-part.
3. System according to claim 2, characterized in that a material of at least one individual part of the multi-part functional part comprises plastic.
4. System according to claim 2 or 3, characterized in that Individual parts of the multi-part functional part (200, 201) shall occupy at most 80%, in particular at most 70%, for example at most 60%, of the total volume occupied by the assembled functional part.
5. System according to one of claims 2 to 4, characterized in that the multi-part functional part is designed as a pot-shaped functional part (200) comprising a bottom wall and a side wall projecting therefrom, wherein in particular the side wall and / or the bottom wall is formed by several individual parts.
6. Plant according to one of the preceding claims, characterized in that at least one of the following features is provided: - the functional part is a conveying part and / or - the functional part is a sorting part and / or - the functional part is a storage part and / or - The functional part is pot-shaped, for example a storage container and / or a sorting and / or conveying pot and / or a collection container - the functional part has a rail, for example a conveyor trough (206, 206) and / or a slide (50) and / or a sorting and / or conveyor rail (201).
7. System according to one of the preceding claims, characterized in that the closure provisioning device (20) is configured to transmit vibrations and / or oscillations to the functional part.
8. System according to one of the preceding claims, characterized in that the functional part (200, 201) has an entry point, an exit point and a transport sector between the entry point and the exit point, wherein the closure provisioning device (20) is configured to transport and / or sort the closure elements along the transport sector, wherein in particular the closure provisioning device (20) is configured to transport the closure elements from the entry point to the exit point, at least when the closure elements are oriented in a prescribed orientation.
9. System according to one of the preceding claims, characterized in that the functional part (200, 201) has a transport sector, wherein at least sectionally a movement of the locking elements on the transport sector in at least two non-parallel directions transverse to a transport direction is limited by sections of the functional part (200, 201), wherein the limiting sections are in particular made of a material comprising a plastic.
10. System according to one of the preceding claims, characterized in that the functional part (200, 201) has a transport sector, wherein the transport sector is at least partially divided into a conveying section and a sorting section, wherein the sorting section has sorting contours and the orientation of a closure element transported in the sorting section can be changed by means of the sorting contours and / or a transported closure element which does not have a prescribed orientation can be removed from the sorting section by means of the sorting contours.
11. System according to one of the preceding claims, characterized in that the conveying section extends along at least two individual parts of the multi-part functional part and / or the conveying section is formed from at least two of the several individual parts of the multi-part functional part.
12. System according to one of the preceding claims, characterized in that a separation is provided between at least two of the several individual parts, wherein the separation takes place along a separating plane, wherein in particular at least one of the following features is provided: the separating plane extends over an entire extent of the functional part; the separating plane runs transversely to the transport direction at least in a partial section of the transport sector; the separating plane runs horizontally; the separating plane runs vertically 13. System according to one of the preceding claims, characterized in that the closure provision device (20) comprises a sorting device, in particular for aligning the closure elements.
14. Plant according to one of the preceding claims, characterized in that the closure provision device (20) has a vibratory rotary conveyor comprising the pot-shaped functional part (200) and a vibratory drive (202) connected thereto.
15. System according to one of the preceding claims, characterized in that the closure provision device (20) has a functional part designed as a sorting and / or conveyor rail (201) for feeding the closure elements to the closure station (26), wherein in particular the sorting and / or conveying rail (201) is arranged downstream of an outlet of the pot-shaped functional part (200).
16. System according to one of the preceding claims, characterized in that the plastic of the material of the functional part (200, 201) and / or of at least one component of the functional part (200, 201) has at least one of the following properties: a melting temperature of the plastic is greater than a temperature in an autoclave and / or greater than at least 100°C, in particular greater than 130°C, in particular greater than 150°C, in particular greater than 200°C; a glass transition temperature of the plastic is greater than a temperature in an autoclave and / or greater than at least 100°C, in particular greater than 130°C; a modulus of elasticity is greater than 2 MPa; the plastic has chemical resistance for cleaning with acid and / or alkali.
17. System according to one of the preceding claims, characterized in that the material of the functional part (200, 201) and / or of at least one component of the functional part (200, 201) comprises a plastic from the group of polyetherketones, for example a polyaryletherketone and / or polyetheretherketone.
18. System according to one of the preceding claims, characterized in that the closure provision device (20) is configured to avoid static charges on the functional part (200, 201) and / or on at least one component of the functional part (200, 201).
19. System according to one of the preceding claims, characterized in that the plastic of the material of the functional part (200, 201) and / or of the at least one component of the functional part (200, 201) is an antistatic and / or electrostatically dissipative plastic, and / or the plastic of the material of the functional part (200, 201) and / or of the at least one component of the functional part (200, 201) has a coating and / or additives to reduce electrical resistance.
20. System according to one of the preceding claims, characterized in that a material of the closure elements comprises rubber, and / or the closure elements are designed as plugs and / or caps.
1. A system according to one of the preceding claims, characterized in that the system comprises a cleanroom structure with a housing, wherein the cleanroom conditions are created inside the housing of the cleanroom structure, and at least the closing station (26) and the closure provisioning device (20) are arranged inside the housing (4) of the cleanroom structure. 2.Closure dispensing device for a plant for carrying out process steps on containers, in particular pharmaceutical containers, at least partially under cleanroom conditions, the process steps comprising at least filling and closing the containers under cleanroom conditions, the closure dispensing device (20) is configured for storing and / or conveying and / or sorting the closure elements, wherein the closure dispensing device comprises a functional part (200, 201), in particular an autoclavable, and in particular a pot-shaped functional part (200, 201), and a material of the functional part (200, 201) comprises a plastic and / or the functional part (200, 201) is multi-part, wherein in particular a material of a single part of the multi-part functional part (200, 201) comprises a plastic.