WO2025186048A2 - Installation de traitement de récipients pharmaceutiques et procédé pour faire fonctionner une installation - Google Patents

Installation de traitement de récipients pharmaceutiques et procédé pour faire fonctionner une installation

Info

Publication number
WO2025186048A2
WO2025186048A2 PCT/EP2025/054986 EP2025054986W WO2025186048A2 WO 2025186048 A2 WO2025186048 A2 WO 2025186048A2 EP 2025054986 W EP2025054986 W EP 2025054986W WO 2025186048 A2 WO2025186048 A2 WO 2025186048A2
Authority
WO
WIPO (PCT)
Prior art keywords
containers
sterilization
transport
chamber
station
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/054986
Other languages
German (de)
English (en)
Other versions
WO2025186048A8 (fr
WO2025186048A3 (fr
Inventor
Philipp WIMBERGER
Thomas Seiffer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bausch and Stroebel SE and Co KG
Original Assignee
Bausch and Stroebel SE and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bausch and Stroebel SE and Co KG filed Critical Bausch and Stroebel SE and Co KG
Publication of WO2025186048A2 publication Critical patent/WO2025186048A2/fr
Publication of WO2025186048A8 publication Critical patent/WO2025186048A8/fr
Publication of WO2025186048A3 publication Critical patent/WO2025186048A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/08—Sterilising wrappers or receptacles prior to, or during, packaging by irradiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/10—Ultraviolet [UV] radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/24—Apparatus using programmed or automatic operation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B08—CLEANING
    • B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B7/00—Cleaning by methods not provided for in a single other subclass or a single group in this subclass
    • B08B7/0035—Cleaning by methods not provided for in a single other subclass or a single group in this subclass by radiant energy, e.g. UV, laser, light beam or the like
    • B08B7/0057—Cleaning by methods not provided for in a single other subclass or a single group in this subclass by radiant energy, e.g. UV, laser, light beam or the like by ultraviolet radiation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/025—Packaging in aseptic tunnels
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/24—Cleaning of, or removing dust from, containers, wrappers, or packaging ; Preventing of fouling
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B65/00—Details peculiar to packaging machines and not otherwise provided for; Arrangements of such details
    • B65B65/003—Packaging lines, e.g. general layout
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/23—Containers other than laboratory or medical, e.g. bottles or mail
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/122—Chambers for sterilisation

Definitions

  • the present invention relates to a plant for processing pharmaceutical containers, comprising at least one processing station for processing the containers, which comprises one of the set of weighing station, filling station, closing station and/or control station.
  • the present invention relates to a method for operating such a system.
  • Such a facility can process pharmaceutical containers, such as vials, syringes, cartridges, or ampoules.
  • the containers can be rigid or non-rigid.
  • the containers are sterilized before being fed into the processing line.
  • Continuously operating cleaning devices are used, where the containers are wet-cleaned and then dried. Cleaning and drying are followed by sterilization.
  • the drying and sterilization steps are carried out, for example, in a sterilization tunnel.
  • Such tunnel dryers have proven effective in practice. However, such tunnel dryers require considerable space and a significant amount of energy. Furthermore, it should be noted that loading a sterilization tunnel before production begins takes a considerable amount of time (e.g., one to two hours).
  • Sterilization tunnels have the disadvantage that they cannot be used to sterilize containers made of plastic materials, which requires the use of a different sterilization process. Sterilization using gamma radiation or electron beam sterilization is conceivable, for example. Media-based sterilization, such as ethylene oxide, is also known. Such sterilization processes are technically complex. In addition, high safety standards must be maintained.
  • Non-stable containers must first be placed in suitable holders for loading during transport through the tunnel. After passing through the tunnel, the containers must be unloaded again, which is complex from a production perspective, as a loading and unloading unit is required.
  • the holders limit the choice of sterilization methods. The holders may come into contact with the containers, partially covering their surfaces, and the sterilization result may be compromised.
  • the containers After sterilization, the containers are transferred to production, where they can be weighed, filled, reweighed, sealed, inspected, and packaged at the processing stations. Additionally, gassing may be required for oxygen-sensitive products (e.g., pre- and post-gassing).
  • the object of the present invention is to provide a system for processing pharmaceutical containers in which sterilized containers can be processed with the least possible manufacturing and production expenditure.
  • a system for processing pharmaceutical containers comprising at least one processing station for processing the containers, which comprises one of the group consisting of a weighing station, a filling station, a closing station and/or a control station, a transport device for the containers and a sterilization device which is arranged upstream of the at least one processing station with respect to a transport direction for the containers and has an illumination device with at least one luminous element for emitting UV light, via which the containers can be sterilized.
  • the present invention is based on the consideration that UV sterilization involves a low manufacturing effort compared to existing sterilization tunnels.
  • the containers can be moved, in particular, relative to the lighting device via the transport device.
  • a continuous or cyclic movement is conceivable, for example.
  • the system can be equipped with loading and unloading units, as in conventional systems are eliminated.
  • Set-up times such as loading times for sterilization tunnels, where thousands of containers may well have to be pre-loaded, can be kept to a minimum.
  • the set-up time in the system according to the invention is advantageously considerably shorter due to the comparatively fewer containers in the sterilization process and is, for example, in the range of minutes.
  • the system according to the invention requires the buffering of relatively few containers during the sterilization process. In the event of a malfunction, the number of containers that are discarded is therefore low compared to conventional systems. Sterilization using UV light (preferably UV-C light) can be carried out in particular without contact. This makes it possible to avoid mechanical stress on the containers and reduce the risk of damage. Another advantage compared to sterilization tunnels is that any damage resulting from temperature-related stress can be avoided.
  • UV light preferably UV-C light
  • a preferred embodiment of the system according to the invention is characterized by a timed and/or continuous operation of the sterilization device during operation of the at least one processing station.
  • this provides the possibility of a continuous process in which newly added containers can be continuously sterilized during the processing of already sterilized containers.
  • the transport can be continuous or timed.
  • the system comprises a container cleaning device arranged upstream of the sterilization device in the transport direction of the containers, said device having a washing device and/or a drying device.
  • the containers Before sterilization using UV light, the containers can be washed and/or dried. External and internal cleaning of the containers is particularly conceivable, with all surfaces of the containers exposed if possible, but in particular those surfaces of the containers that come into contact with the product to be filled.
  • the transport device along the washing device and/or the drying device can be designed in any desired manner, for example as a rotary conveyor and/or a linear conveyor.
  • the cleaning device can, for example, comprise an immersion bath through which the containers are passed.
  • the immersion bath contains a cleaning fluid, which can preferably be used for external and internal cleaning.
  • the cleaning device may, for example, comprise a CCh snow cleaning station for cleaning the containers.
  • the containers can be changed in terms of their position and/or orientation to ensure they are exposed to the cleaning medium as completely as possible. For example, rotation and/or turning and/or translational movement are conceivable.
  • the washing device of the cleaning apparatus advantageously comprises a rotating and/or turning station for rotating and/or turning the containers, which can be arranged, in particular, on or in the immersion bath.
  • a station for translational movement can be provided, in particular, on or in the immersion bath.
  • a station for ultrasonic cleaning of the containers can be arranged on or in the immersion bath.
  • the drying device of the cleaning device can be designed in different ways.
  • the drying device includes a blow-out device for the containers.
  • a nozzle element or blower element is inserted into the respective container and the container is pressurized with gas on its inside.
  • Gas in this context can also be understood as a gas mixture such as air.
  • the drying device of the cleaning device may preferably comprise a blow-off device for the containers, wherein the containers are blown off on the outside.
  • a rotating and/or turning station for rotating and/or turning the containers during blowing, blowing off, and/or heating is conceivable.
  • a station for translational movement can be provided.
  • the drying device of the cleaning device comprises a heating device for the containers, so that they can be dried by heating.
  • the heating device comprises, for example, a heating element that can be inserted into the container.
  • one or more heating elements can be arranged on the outside of the container. It is also conceivable to use a heatable chamber through which the containers are transported.
  • the system is free of a sterilization tunnel for the cleaned containers. This allows for a simplified design of the system.
  • the system may, for example, comprise at least one frame on which the cleaning device, the sterilization device and/or the at least one processing station is/are positioned.
  • the system may comprise at least one isolator device covering the cleaning device, the at least one processing station, and/or the sterilization device.
  • An "isolator device” in this case may be considered a containment, a protective device for air purity, which may be or include an isolator or a RABS (restricted access barrier system).
  • a preferred system according to the invention is characterized by a higher purity class of the system in the area of the at least one processing station and the sterilization device than in the area of the cleaning device.
  • the cleaning device is located in a room with GMP purity class B, C, D, or NC (GMP, Good Manufacturing Practice). After cleaning and drying the containers, the containers are transferred, for example, to a room with GMP purity class A, in which, in particular, the sterilization device and the at least one processing station are located.
  • GMP purity class B GMP purity class B
  • C C
  • D D
  • NC NC
  • the containers are transferred, for example, to a room with GMP purity class A, in which, in particular, the sterilization device and the at least one processing station are located.
  • GMP purity class A in which, in particular, the sterilization device and the at least one processing station are located.
  • a cleanroom containing the sterilization device and at least one processing station is usually raised to a GMP cleanroom level A.
  • the cleanroom is closed and, for example, a decontamination process with H2O2 is carried out in a conventional manner.
  • increasing the pressure in the cleanroom ensures that the decontamination atmosphere is transferred from a higher cleanroom level (especially A) to a lower cleanroom level.
  • purity class e.g. B, C, D or NC
  • media exchange between the rooms is prevented or reduced to a minimum.
  • the at least one luminous element is preferably designed to emit UV-C light. This enables reliable sterilization of the containers.
  • light within the wavelength range from approximately 100 nm to approximately 300 nm can be emitted by at least one luminous element, although longer wavelengths in the UV range are also conceivable.
  • the at least one luminous element can emit UV light in continuous operation and/or pulsed operation. Conveniently, it is possible to switch between continuous operation and pulsed operation.
  • a luminous intensity and/or luminous duration of the at least one luminous element can be controllable and/or regulated.
  • the containers can advantageously be exposed to UV light (and in particular UV-C light) on the outside and/or inside via at least one luminous element.
  • the at least one lighting element can be designed, for example, as an LED module or as a fluorescent tube.
  • the containers can be exposed to UV light (and in particular UV-C light) individually or in groups with two or more containers, for example, via the at least one luminous element.
  • two or more luminous elements are provided.
  • the luminous elements can be identical or different in design.
  • Two or more luminous elements can have identical wavelength ranges of emitted light and/or two or more luminous elements can have different wavelength ranges of emitted light.
  • the transport device may, for example, comprise or form at least one for transporting the containers: At least one transport wheel for the circulating transport of the containers; at least one linear transport for the rectilinear transport of the containers; at least one belt on which the containers can be transported upright; at least one rake transport; at least one robotic device; at least one planar motor drive system; at least one holding part for the suspended transport of the containers.
  • the transport device comprises format parts whose design is adapted to the containers to be processed.
  • the transport device can have two or more format sets with respective format parts, whereby the format parts of different format sets differ from one another with regard to at least one container-specific property.
  • the use of format parts can minimize system downtime. Format changes can be performed manually and/or without tools. Alternatively or additionally, a mechanical format change is conceivable, for example, using a robotic device.
  • the transport device can be designed without format parts, so that a format change can be omitted.
  • the transport device can comprise, for example, holding parts, tongs, grippers, etc., which can preferably be format parts.
  • the transport device is advantageously designed in such a way that the respective container can be exposed to UV light, preferably on the outside and/or inside, in such a way that the container can be sterilized as completely as possible.
  • the transport device can be sterilized using UV light.
  • the sterilization device can preferably, in particular to achieve the aforementioned purpose, comprise a turning station, a rotating station, and/or a station for a translational movement of the containers relative to the at least one luminous element.
  • the respective station can be configured to be active or passive.
  • the sterilization device can, for example, comprise at least one drive element for acting on at least one luminous element and/or at least one container with respect to a relative movement of the at least one container and the at least one luminous element. This enables, for example, a rotation, pivoting, turning, and/or translational movement of the container and/or the luminous element.
  • the movement can be performed before or during the illumination of the container with UV light.
  • the at least one lighting element is stationary and that the containers are movable relative to the at least one lighting element via the transport device and/or by means of the at least one drive element.
  • the containers can be transported continuously or in a timed manner, for example, using the transport device.
  • At least one luminous element is held on a luminous element carrier, which can be inserted into and removed from the container by means of the at least one drive element, for exposing the container's interior to UV light.
  • the luminous element carrier is, for example, needle-shaped and provided with at least one luminous element at or near one end.
  • a plurality of light-emitting element carriers can be provided, with each light-emitting element carrier being insertable into a respective container. This enables, for example, synchronized sterilization of the containers.
  • Containers made of UV-transparent material can also be sterilized internally by illuminating them from the outside.
  • the sterilization device can, for example, comprise at least one chamber through which the transport device runs, wherein at least one luminous element, preferably a plurality of luminous elements, is arranged in the chamber, wherein the containers can be transported through the chamber with at least one deflection.
  • the transport device is designed such that the containers are transported through the chamber along a path with one or more deflections.
  • the path can, for example, be chicane-shaped or meander-shaped.
  • the transport device should be designed so that it is at least partially transparent to UV light, particularly UV-C light, to enable irradiation over as wide a surface as possible.
  • the walls of the chamber can be fully or partially mirrored to reflect UV light.
  • UV light can be shielded at the inlet and/or outlet of the chamber.
  • This shielding can be achieved, for example, by means of a suitable cover element at an inlet and/or outlet.
  • the objects are guided past one or more luminous elements during transport through the chamber, exposing every surface of the container, if possible.
  • a luminous element carrier may be inserted into the respective container for internal sterilization, as described above.
  • the containers can be transported along a meander through the chamber.
  • the transport device can, for example, run between two or more lighting elements at one or more sections in the chamber, which makes it possible, for example, to irradiate from two sides.
  • At least one lighting element can be arranged between two sections of the transport device in the chamber.
  • the lighting element can preferably illuminate containers on both sides located at the respective section.
  • the transport device can, for example, run through the chamber in two or more superimposed levels, with at least one lighting element being arranged in each level.
  • the containers can be sterilized during transport by the transport device.
  • the containers can be removed from the transport device for sterilization by means of a handling device and can then be reinserted into the transport device. This enables, for example, continuous, timed sterilization.
  • the sterilization device can comprise at least one chamber in which at least one luminous element is arranged, wherein at least one container can be inserted into the at least one chamber, sterilized in the chamber using UV light, and subsequently removed from the chamber.
  • at least one container can be inserted into the at least one chamber, sterilized in the chamber using UV light, and subsequently removed from the chamber.
  • the containers can be decoupled from the transport device, for example, via a handling device and transferred into the at least one chamber.
  • the at least one chamber can, for example, be constructed around the transport device, so that the containers moved by means of the transport device are sterilized during transport through the at least one chamber.
  • the transport can, for example, be carried out in a timed manner by a rake transport or by means of a robot within at least one chamber.
  • the at least one container being movable, for example, into and out of the at least one chamber by means of the transport device.
  • the at least one container can be uncoupled from the transport device by means of a handling device and inserted into the at least one chamber, as well as being movable out of the at least one chamber via the handling device and coupled into the transport device for further transport.
  • the at least one chamber can be designed to reflect UV light on the inside.
  • the sterilization device can, for example, comprise two or more chambers arranged one behind the other in the transport direction, which can preferably each be equipped with at least one container simultaneously.
  • an air flow is advantageously provided from an area of higher purity to an area of lower purity in order to avoid possible particle entrainment towards the area of higher purity.
  • the two or more chambers can be positioned side by side or one above the other, for example.
  • the aforementioned air flow can be vertical and/or horizontal, for example.
  • the at least one chamber can be sterilized after a predetermined number of sterilization processes without the container being accommodated therein. This increases process reliability, for example, preventing the carryover of non-sterile particles. Sterilizing the chamber without the container being accommodated preferably enables sterilization of holding parts within the chamber.
  • the sterilization device can preferably be constructed in multiple stages with a plurality of sterilization stages arranged one behind the other in the transport direction, with at least one luminous element being arranged in each sterilization stage.
  • the sterilization stages have an increasing degree of purity in the transport direction and/or at least one separating element is present between successive sterilization stages.
  • the individual sterilization stages can, for example, be arranged in successive chambers, with the separating element separating the chambers from one another and being selectively open or closed.
  • the multiple sterilization stages may include different types of sterilization, for example by UV light, by gamma radiation, by electron beam sterilization, by ethylene oxide and/or H2O2.
  • the system may comprise an isolator device for decontamination using a gas, in particular H2O2.
  • the sterilization device can preferably be decontaminated using such a device before a production cycle.
  • system may comprise a control device for controlling and/or regulating the operation.
  • the user interface is preferably an intuitive HMI (Human Machine Interface).
  • the sterilization device may comprise a sensor device for determining the cleanliness level of the containers during or after the sterilization process.
  • the sterilization device may, for example, be controllable and/or adjustable depending on a signal from the sensor device.
  • the present invention also relates to a method.
  • a method according to the invention for operating a system of the type described above provides that the containers are sterilized via the sterilization device by means of irradiation with UV light before being fed to at least one processing station.
  • Figure 1 a schematic representation of the system according to the invention in a preferred embodiment, wherein Figure 1 also illustrates the process for processing pharmaceutical containers;
  • Figure 2 an enlarged view of detail A in Figure 1 in an exemplary embodiment
  • Figure 3 a schematic representation of a washing device of a
  • Figures 4 and 5 schematic representations of drying devices of a cleaning device of the system from Figure 1;
  • Figure 6 a schematic representation of a sterilization device of the
  • Figures 7 to 11 schematic representations of a sterilization device of the system from Figure 1 at different times;
  • Figures 12 to 15 schematic partial representations of a sterilization device of the system from Figure 1 at different times.
  • Figures 16 to 19 Representations similar to Figures 12 to 15 for a different type of sterilization device in the system.
  • Figure 1 shows a schematic representation of an advantageous embodiment of the system according to the invention for processing pharmaceutical containers, designated overall by reference numeral 100.
  • the containers designated by reference numeral 102 in the drawing can be designed in various ways. For example, these are vials 104, as shown in the application examples in Figures 12 to 19. Alternatively or additionally, the containers 102 can be syringes, cartridges, or ampoules.
  • Figure 1 shows, in addition to the schematic design of the system 100, successive work steps, with arrows 106 symbolizing the sequence of work steps.
  • the containers 102 of the system 100 are transferred to a transfer area 110 in a transfer step 108.
  • the transfer step 108 can vary.
  • Bulk containers can be coupled in via a turntable, for example.
  • Nested objects can be lifted out of a carrier held in a tub or tray. This can be done automatically, for example, using a robotic device.
  • the containers 102 are transferred continuously.
  • the system 100 For transporting the containers 102, the system 100 comprises a transport device 112, which can be configured differently, for example, depending on the work step.
  • the transport device 112 can, for example, comprise at least one rotary conveyor, at least one linear conveyor, at least one rake conveyor, at least one robotic device, and/or at least one holding element for suspended transport of containers 102, in particular non-stable containers.
  • the transport device 112 can be configured for continuous transport and/or operate in a timed manner.
  • the reference numeral 113 indicates a transport direction of the transport device 112.
  • the transfer step 108 is preferably followed by a cleaning step 114, for which a cleaning device 116 is used.
  • a washing step 118 using a washing device 120 of the cleaning device 116, the containers 102 are first washed inside and out.
  • a subsequent drying step 122 using a drying device 124 of the cleaning device 116, the containers 102 are then dried inside and out.
  • the containers 102 are then subjected to a sterilization step 126 using a sterilization device 128.
  • a lighting device 130 with at least one light element 132 is used.
  • the light element 132 is configured to emit UV light.
  • the containers 102 are sterilized using the UV light.
  • the luminous element 132 is designed to emit UV-C light.
  • the UV light can be emitted in continuous or pulsed mode.
  • the containers 102 can be exposed to UV light via the at least one luminous element, preferably on the outside and inside.
  • the lighting element 132 can be designed in different ways, for example flat, point-like, as an LED module or as a fluorescent tube.
  • the containers can be exposed to UV light, for example individually or in groups, with two or more containers 102, via the lighting element 132.
  • the lighting can be controlled and/or regulated. It is conceivable to monitor the function of the lighting device 130 to ensure the function of the sterilization device 128 and thus the sterility of the containers 102.
  • the system 100 preferably comprises a control device 134 for controlling and/or regulating the operation.
  • the control device 134 can be operatively connected to the respective components of the system 100.
  • the cleaned and sterilized containers 102 are processed in a subsequent processing step 136 at at least one processing station 138 from the group consisting of a weighing station, filling station, closing station, and/or inspection station.
  • processing stations 138 are provided, although only one station is shown as an example in Figure 1.
  • the processing station(s) 138 can be of conventional design.
  • the system 100 may include a weighing station, a filling station, a closing station and a control station as processing stations 138.
  • the system 100 has a high degree of purity at least in the area of the sterilization device 128 and the processing station 138.
  • this can be purity level A according to GMP (Good Manufacturing Practice).
  • the system 100 can comprise an isolator device 140, which, for example, covers a frame 142 with the sterilization device 128 and the processing station 138.
  • the degree of purity may be lower and may, for example, be purity grade B, C, D or NC according to GMP.
  • the transfer area 110 and the cleaning device 116 can be arranged on a common frame 142 and optionally covered by an isolator device 140.
  • system 100 the containers to be processed are cleaned and sterilized prior to processing, as mentioned above. This can be done continuously and/or intermittently. UV-C-based sterilization allows for a simple design of system 100. Compared to conventional systems, less space is required. In particular, a sterilization tunnel, the requirements of which were described above, can be eliminated. Accordingly, system 100 preferably does not include such a sterilization tunnel.
  • the system 100 Before processing the containers 102, the system 100 is raised to GMP cleanliness level A in the area of the sterilization device 128 and the processing station 138. For example, this area of the system 100 is sealed off and a decontamination process is carried out, for example, by evaporating hydrogen peroxide.
  • a pressure gradient is ensured within the system 100, with the pressure being higher in the area of purity level A than in other areas. Any transport of media thus takes place from the area of higher purity level to the area of lower purity level (for example, in the direction of the cleaning device 116 and at the transfer area 110). This prevents the introduction of particles that could lead to decontamination into the sterilization device 128 and the processing station 138.
  • FIG. 3 schematically shows a possible embodiment of the washing device 120 of the cleaning device 116.
  • the washing device 120 comprises an immersion bath 144 through which the containers 102 are conveyed by means of the transport device 112.
  • the containers 102 are cleaned using a cleaning fluid, preferably on the outside and inside.
  • the cleaning fluid can be water, to which a cleaning chemical can be added to increase cleaning performance.
  • a station for ultrasonic cleaning of the containers can be arranged on or in the immersion bath 144. It may be advantageous if the washing device has at least one station 146 for turning, rotating, and/or translational movement, so that the surfaces of the containers 102 are exposed as much as possible and can be exposed to the cleaning fluid. Accordingly, the station 146 can be a turning station, a rotating station, or a translational movement station.
  • the washing device 120 can have, for example, a rinsing station 148 as an additional station, with which containers 102 are rinsed inside and/or outside.
  • a nozzle element 150 can be inserted into the respective container 102, for example.
  • Nozzle elements 152 serve, for example, to clean the outside of the containers 102.
  • one or more drive elements 154 are preferably provided.
  • the drive element 154 can act on the container(s) 102 and/or on the corresponding component of the system 100. Accordingly, the containers 102 can be moved relative to the component, or the component relative to the container 102. It is also conceivable that both the container 102 and the component are moved. This also applies to the components of the system 100 explained below and will not be explained separately there.
  • Figure 3 shows an example of the drive element 154 for moving the nozzle elements 150 relative to the containers 102.
  • FIG. 4 schematically shows a structure of the drying device 124, which includes, for example, heating elements 156.
  • the heating elements 156 can be inserted into the containers 102 by means of the drive element 154 in order to dry the inside. Furthermore, heating elements 156 can be provided on the outside to dry the outer surfaces of the containers 102.
  • the containers 104 can be moved, as explained above using the example of the washing device 120.
  • the drying of the containers 102 can be carried out with a container opening facing downwards or upwards or, depending on the station 146, in a different orientation.
  • the containers in the drying device 124 are only dried, which saves a considerable amount of time, and are subsequently sterilized using UV light.
  • a blowing element 158 can be used, in particular for drying the inside of the containers 102.
  • FIG. 5 A further schematic representation of a drying device 124 is shown in Figure 5.
  • the drying device 124 comprises a chamber 160, which in this case forms a tunnel.
  • the containers 102 are moved through the chamber 160 by means of the transport device 112.
  • a change in position and/or orientation can be made therein, for example, by means of the transport device 112 or a station 146.
  • Heating elements 156 are arranged in chamber 160 to dry the containers 102 on the outside and inside. Relative movement to chamber 160 serves, in particular, to expose both the outside and inside surfaces to achieve a high degree of drying.
  • Figures 3 to 5 show holding parts 162, by means of which the containers 102 are transported in the transport device 112. After drying, it is advantageous if the holding parts 162 remain in the area with the lower purity level B, C, D, or NC. In the area with the higher purity level A, separate holding parts 162 are preferably used to prevent particles from being carried into this area.
  • Figure 6 shows a schematic representation of a preferred embodiment of the sterilization device 128.
  • the sterilization device 128 comprises or forms a chamber 164 in which a wall 166 encloses an interior space 168.
  • the transport device 112 is guided through the chamber 164, from an inlet 170 to an outlet 172.
  • the transport device 112 is designed such that a transport path 174, in which containers 102 are guided or along which the containers 102 are transported (for example by means of holding parts 162), has at least one deflection 176.
  • the transport device 112 is designed such that the containers 102 are guided through the chamber 164 along a meander 178.
  • the meander 178 accordingly forms a plurality of deflections 176 on the transport path 174, in this case seven.
  • the lighting device 130 in the present case comprises a plurality of lighting elements 132. These are arranged such that the containers 102 are moved past the lighting elements 132 and, as a result of the deflections 176, are positioned in different relative positions to the lighting elements 132, whereby the surfaces of the containers 102 are exposed as far as possible to exposure to UV light.
  • the luminous elements 132 can be configured identically or differently. Two or more luminous elements 132 can have identical wavelength ranges of emitted light and/or two or more luminous elements 132 can have different wavelength ranges of emitted light.
  • the transport device 112 runs between two or more lighting elements in several sections 180, so that the containers 102 can be exposed to UV light from opposite sides.
  • At least one lighting element 132 is arranged between two sections 180 of the transport device 112 in the chamber 160.
  • At least one schematically illustrated cover element 182 can be arranged at the inlet 170 and/or at the outlet 172 in order to prevent the escape of UV light from the interior space 168.
  • a section of the transport device 112 can also be provided with a chicane (for example an S-chicane) or the like.
  • Figure 6 shows an embodiment in which the containers 102 are transported in one plane through the chamber 164. It is conceivable that the sterilization device 128 has a Has a plurality of levels in which the containers 102 can be transported. Bottom walls and/or intermediate floors of the chamber 164 can be designed to be transparent to UV light.
  • the transport device 112 can also be fully or partially transparent to UV light. This is symbolized in Figure 6 by a dashed contour 184. In contrast, a solid contour 186 in Figure 6, for example, can symbolize a configuration of the transport device 112 that is not transparent to UV light to protect the environment.
  • a different advantageous embodiment of the sterilization device 128 is shown in Figures 7 to 11 and is illustrated therein during different working steps.
  • At least one chamber 188 is provided along the transport device 112, with preferably several chambers 188 arranged one behind the other in the transport direction 113 being provided.
  • Four chambers 188 are shown as an example, but their number is not limiting.
  • At least one lighting element 132 of the lighting device 130 is arranged in each chamber 188.
  • At least one container 102 can be positioned in each chamber 188 for sterilization purposes.
  • the sterilization device 128 is configured to sterilize two containers 102 at a time.
  • the transport device 112 can be designed such that it is capable of moving the containers 102 into and out of the chamber.
  • a handling device 190 can be provided, via which the containers 102 are uncoupled from the transport device 112 and introduced into the chamber 188. After sterilization, the containers 102 are moved out of the chamber 188 again via the handling device 190 and coupled into the transport device 112.
  • the handling device 190 can, for example, be designed as a robot.
  • holding parts 192 can be provided, which can be part of a chamber wall.
  • the containers 102 are sterilized step by step, for example.
  • the containers 102 are first introduced into the first chamber 188 in the transport direction 113 (the left chamber 188 in Figures 7 and 8).
  • the containers 102 are then removed from the chamber 188 and transported to the next chamber 188. This continues until the containers 102 have been sterilized step by step in all four chambers 188.
  • containers 102 are sterilized only once in each chamber 188 and then transported further via the transport device 112. Containers 102 are not transported successively into each of the chambers 188.
  • Figures 7 and 8 show how the containers 102 are first introduced into the chambers 188.
  • Figure 9 shows the further transport of the containers 102.
  • Figure 11 shows how a next pair of containers 102 is picked up.
  • the work step illustrated in Figure 10 is optional. It is conceivable that after a predetermined or predeterminable number of sterilization processes of containers 102, a respective chamber 188 is sterilized without a container accommodated therein.
  • the containers 102 change in position and/or orientation within the respective interior of the chamber 188 compared to a previous chamber.
  • the containers 102 are gripped in different ways.
  • suitable holding parts 162, grippers, clips, or the like can be used to release the containers 102 at different locations. Accordingly, the holding parts, clips, or grippers can engage the containers 102 at different points.
  • the sterilization device 128 there is an air flow opposite to the transport direction 113, from the "clean" containers 102 to the "dirty” containers 102. This prevents a distribution of contaminating particles in the transport direction 113. It is advantageous if the chambers 188 are designed to be at least partially reflective to UV light on the inside of walls and/or holding parts, clips, grippers, or the like. Similarly, it is advantageous if the chamber 164 is designed to be fully or partially reflective on the inside.
  • Figures 12 to 15 show a preferred embodiment of the sterilization device 128 at different times during the sterilization of a container 102.
  • the lighting device 130 is provided with a light-emitting element carrier 194 on which at least one light-emitting element 132 is arranged.
  • the light-emitting element 132 is arranged at the end of a needle-shaped light-emitting element carrier 194.
  • the drive element 154 By means of the drive element 154, the light-emitting element carrier 194 can be inserted into and withdrawn from the container 102 in order to sterilize the interior surfaces of the container 102. This proves particularly advantageous when the container 102 is made of a material that is impermeable to UV light.
  • Figures 12 to 15 show the container 102 with the container opening arranged at the top, it is understood that the container 102 could be oriented in any desired space.
  • the embodiment of the sterilization device 128 according to Figures 16 to 19, which correspond in sequence to Figures 12 to 15, has several lighting elements 132, in this case three, on the lighting element carrier 194.
  • this allows for even more targeted illumination of critical areas, such as the neck area of vials 104.
  • the sterilization device 128 may include a plurality of light-emitting element carriers 194, allowing a plurality of containers 102 to be sterilized simultaneously. This may be performed, for example, in a synchronized mode.
  • Sterilization of containers 102 using the luminous element carriers 194, as shown in Figures 12 to 19, can be provided in the embodiments of Figures 6 to 11.
  • sterilization can be carried out in several stages. Accordingly, sterilization stages 196 arranged one after the other in the transport direction 113 can be through which the containers 102 pass. Preferably, the sterilization stages 196 have an increasing degree of purity in the transport direction.
  • FIG 2 schematically shows a plurality of sterilization stages 196 during sterilization step 126 (i.e., in this case, there are several individual steps).
  • Separating elements 198 can be arranged between the individual sterilization stages 196 to prevent particle carryover and/or to ensure that the degree of purity increases in the transport direction 113.
  • the sterilization stages 196 can be configured with different functionalities.
  • the separating elements 198 can, for example, be designed in the form of bulkheads.

Landscapes

  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Toxicology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

La présente invention concerne une installation (100) destinée à assurer le traitement de récipients pharmaceutiques (102), qui comprend au moins un poste de traitement (138) pour traiter les récipients (102), qui comprend un poste parmi les postes suivants : poste de pesage, poste de de remplissage, poste de fermeture et/ou poste de contrôle, un dispositif de transport (112) pour lesdits récipients (102) et un dispositif de stérilisation (128) qui est situé en amont dudit au moins un poste de traitement (138) par rapport à une direction de transport (113) des récipients (102), un dispositif d'éclairage (130) comportant au moins un élément lumineux (132) destiné à émettre de la lumière UV au moyen de laquelle les récipients (102) peuvent être stérilisés. En outre la présente invention concerne un procédé.
PCT/EP2025/054986 2024-03-06 2025-02-25 Installation de traitement de récipients pharmaceutiques et procédé pour faire fonctionner une installation Pending WO2025186048A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102024106456.0 2024-03-06
DE102024106456.0A DE102024106456A1 (de) 2024-03-06 2024-03-06 Anlage zum Verarbeiten pharmazeutischer Behälter und Verfahren zum Betreiben einer Anlage

Publications (3)

Publication Number Publication Date
WO2025186048A2 true WO2025186048A2 (fr) 2025-09-12
WO2025186048A8 WO2025186048A8 (fr) 2025-10-02
WO2025186048A3 WO2025186048A3 (fr) 2026-01-08

Family

ID=94820979

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2025/054986 Pending WO2025186048A2 (fr) 2024-03-06 2025-02-25 Installation de traitement de récipients pharmaceutiques et procédé pour faire fonctionner une installation

Country Status (2)

Country Link
DE (1) DE102024106456A1 (fr)
WO (1) WO2025186048A2 (fr)

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3033043C2 (de) * 1980-09-03 1985-06-27 Silberzahn, Helmut, 6950 Mosbach Vorrichtung zum Sterilisieren von Behältern
CA1319808C (fr) * 1988-05-10 1993-07-06 Etsuo Shimamura Methode pour steriliser un materiau d'emballage stratifie
GB0001673D0 (en) * 2000-01-26 2000-03-15 Sheppard Raymond W Ultra-violet container/closure sterilisation system
JP2002080017A (ja) * 2000-06-26 2002-03-19 Hoshin Kagaku Sangyosho:Kk 殺菌装置
US6517776B1 (en) * 2000-11-03 2003-02-11 Chevron Phillips Chemical Company Lp UV oxygen scavenging initiation in angular preformed packaging articles
US20030150475A1 (en) * 2002-02-11 2003-08-14 Lorne Abrams Method and apparatus for sanitizing reusable articles
DE102004032861A1 (de) * 2004-07-07 2006-02-02 Khs Maschinen- Und Anlagenbau Ag Verfahren sowie Vorrichtung zum Sterilisieren von Behältern mit UV-Strahlung
US7931859B2 (en) * 2005-12-22 2011-04-26 Intelligent Hospital Systems Ltd. Ultraviolet sanitization in pharmacy environments
DE102008007428B4 (de) * 2008-02-01 2016-02-11 Khs Gmbh Verfahren sowie Vorrichtung zum Sterilisieren von Packmitteln
HUE028812T2 (en) * 2013-06-21 2017-01-30 Alegre Alex Guamis Continuous packaging using ultraviolet-C light to sterilize bottles
CN104512581A (zh) * 2013-09-30 2015-04-15 山东工大机械有限公司 智能化无菌包装生产线
WO2016100997A1 (fr) * 2014-12-22 2016-06-30 Red Bull Gmbh Procédé et dispositif de traitement de produits alimentaires et/ou de récipients au moyen d'un fluide de traitement
JP7079474B2 (ja) * 2018-01-24 2022-06-02 株式会社ブリッジス 殺菌装置及び殺菌方法
US12419979B2 (en) * 2021-12-03 2025-09-23 Eyenovia, Inc. Pulsed ultraviolet in-line sterilization system for primary drug containers

Also Published As

Publication number Publication date
WO2025186048A8 (fr) 2025-10-02
WO2025186048A3 (fr) 2026-01-08
DE102024106456A1 (de) 2025-09-11

Similar Documents

Publication Publication Date Title
EP2594493B1 (fr) Dispositif de stérilisation intérieure et extérieure de préforms au moyen du rayonnement d'un support de chargement et méthod et ligne de traitement correspondant
DE69624715T2 (de) Isolierungsmodul zum formen und verpacken von im wesentlichen verunreinigungsfreien gegenständen
EP2371397B1 (fr) Dispositif de stérilisation de récipients
EP2724731B1 (fr) Dispositif de stérilisation extérieure des conteneurs plastiques
EP0479010B1 (fr) Dispositif et procédé de stérilisation, de remplissage et de fermeture d'une ouverture de remplissage
DE102010045832B4 (de) Aseptik Sterilisationseinheit für Reinraum auf Blasrad
EP3668553B1 (fr) Dispositif de décontamination, système isolateur et procédé de fonctionnement
EP2848263A2 (fr) Dispositif de stérilisation des parisons de plastique à la stérilisation intérieure et externe simultanée
WO2019121723A1 (fr) Dispositif de traitement de récipients
EP4227232A2 (fr) Dispositif et procédé de traitement et notamment de stérilisation de récipients
DE10134037B4 (de) Vorrichtung zur Plasmasterilisation von Behältern, insbesondere Flaschen
JP2004236806A (ja) 電子線による容器外装の滅菌装置
WO2025186048A2 (fr) Installation de traitement de récipients pharmaceutiques et procédé pour faire fonctionner une installation
DE102019126917A1 (de) Behälterbehandlungsanlage zum Behandeln von Behältern
EP3624860A1 (fr) Procédé et dispositif pour stériliser un objet au moyen d'une source de lumière pulsée
DE69405809T2 (de) Kontinuierliche Sterilisation
EP4201433A1 (fr) Dispositif et procédé de traitement et notamment de stérilisation de récipients
DE102024106492A1 (de) Übergabevorrichtung für pharmazeutisches Produktionsmaterial, Anlage mit einer derartigen Übergabevorrichtung und Verfahren zum Einbringen von pharmazeutischem Produktionsmaterial in eine Anlage
EP4445921B1 (fr) Procédé pour introduire des articles d'un emballage dans la chambre de traitement d'une enceinte de confinement dans des conditions aseptiques et dispositif de sas
EP4663209A1 (fr) Procédé de transfert en série d'objets à travers une chambre de traitement pour un traitement ultérieur dans un confinement dans des conditions aseptiques et installation de production correspondante
DE202021101846U1 (de) Transportvorrichtung zum Transportieren von vormontierten Fahrzeugsitzen
DE102023135551A1 (de) Vorrichtung zum Herstellen von Behältern mit Schleusenraum zum Ausschleusen von aussortierten Vorformlingen und/oder aussortierten Behältern aus einem Reinraum
DE102024130764A1 (de) System zur partikulären und mikrobiologischen Abreicherung und Inaktivierung von Waren
EP4424330A1 (fr) Procédé de transfert en série de fûts par une chambre de traitement pour le traitement ultérieur dans un confinement dans des conditions aseptiques et installation de production correspondante
DE102024130769A1 (de) System zur partikulären und mikrobiologischen Abreicherung und Inaktivierung von Waren mit einem Fördersystem

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 25708393

Country of ref document: EP

Kind code of ref document: A2