Classifications

• • 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
  • A61L2/16—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
• • 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
  • A61L2103/05—Living organisms or biological materials
• • 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
• • 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
• • 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
  • A61L2202/121—Sealings, e.g. doors, covers, valves, sluices
• • 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
• • 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
  • A61L2202/15—Biocide distribution means, e.g. nozzles, pumps, manifolds, fans, baffles, sprayers
• • 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
  • A61L2202/16—Mobile applications, e.g. portable devices, trailers, devices mounted on vehicles

Definitions

• the present invention relates to a feeding station for the decontamination of substantially identical containers to be fed in succession to a subsequent aseptic treatment station, for example a chamber for processing in a controlled atmosphere (also known as an "isolator"), or to an aseptic filling line (for example for pharmaceutical products), or to a station for the aseptic insertion of other vessels into the containers.
• a subsequent aseptic treatment station for example a chamber for processing in a controlled atmosphere (also known as an "isolator"), or to an aseptic filling line (for example for pharmaceutical products), or to a station for the aseptic insertion of other vessels into the containers.
• the containers that are particularly adapted to be used with the feeding station according to the invention are "nests” or “tubs”, i.e. trays or tubs that accommodate or are adapted to accommodate, preferably in an ordered and stabilized manner, smaller vessels such as vials, bottles, ampoules, cartridges, carpules®, test tubes and/or syringes, before and/or after filling.
• Other possible containers that are adapted to be used with the feeding station according to the invention are sterile bags.
• the aim of the present invention is to provide a feeding station for feeding decontaminated containers to an aseptic treatment station, or line, that is capable of improving the known art in one or more of the above mentioned aspects.
• an object of the invention is to make it possible to increase the production rate of the aseptic treatment station, or line.
• Another object of the invention is to avoid the use at least of the outermost (secondary) bag to seal the containers before introducing them into the aseptic treatment station, or line.
• the present invention sets out to overcome the drawbacks of the background art in a manner that is alternative to any existing solutions.
• Another object of the invention is to provide a feeding station that is highly reliable, easy to implement and of low cost.
• the feeding station for the decontamination of substantially identical containers while they are fed in succession to a subsequent station or line for aseptic treatment comprises a tunnel formed by a plurality of treatment chambers arranged side by side in succession along a container conveyance direction, conveyance means being provided in said treatment chambers and being adapted to convey the containers along said conveyance direction through said treatment chambers, characterized in that each treatment chamber is subjected to an internal pressure that is higher than the atmospheric pressure by introducing air, gas or vapor and, at its inlet and its outlet, said treatment chamber is delimited by respective partitions which can move between a crossing position, in which they leave open a respective passage opening of the container, and a position for maintaining said internal pressure, wherein said passage opening is reduced so as to allow a suction, through a residual opening, of said air, gas or vapor toward the outside of the treatment chamber in order to maintain said internal pressure.
• an aseptic treatment line comprising a loading line or entrance for loading containers, the feeding station arranged downstream of the loading line so as to receive said containers from the loading line or entrance, and an aseptic treatment station arranged downstream of the feeding station so as to receive the decontaminated containers, said aseptic treatment station comprising at least one assembly for filling the containers.
• the aims and objects of the invention are also achieved by a method of decontamination of containers for pharmaceutical products while they are being conveyed through a feeding station toward an aseptic treatment station or line, said feeding station comprising a tunnel defined by a plurality of treatment chambers arranged in succession along a conveyance direction between an entrance and an exit, each treatment chamber being delimited by respective partitions respectively upstream and downstream with respect to said conveyance direction, said method comprising the steps of:
• Figure 1 is a perspective view of a feeding station according to the invention, in which the side panels have been removed to show the inside of the tunnel;
• Figure 2 is a side view of the feeding station of the previous figure, with some components removed for clarity;
• FIG. 3 is another perspective view of the feeding station in the previous figures, seen from the side of the transmissions;
• Figure 4 is a detail seen from below of the conveyance means used in the feeding station in the previous figures;
• Figure 5 shows an exit partition of one of the treatment chambers of the feeding station of Figure 1, in the passthrough position
• Figure 6 shows the partition of the previous figure but in a position for maintaining the internal pressure
• Figure 7a is a front elevation view of a partition in the passthrough position
• Figure 7b is a detail of the view of the previous figure, which also shows the bulk of the container on a plane at right angles to the conveyance direction;
• Figure 8 is a front elevation view of the partition of Figure 7a in the position for maintaining the pressure
• Figure 9 shows the flows aspirated from the treatment chambers of the feeding station of Figure 1 ;
• Figure 10 is a detail view of a series of annular distribution units of one of the treatment chambers in the previous figures.
• a feeding station is adapted for the decontamination of substantially mutually identical containers 2 (particularly for pharmaceutical products) which are fed or conveyed one after the other, in succession and with the same orientation, to a subsequent aseptic treatment station or line 100, for example a chamber for treatment in a controlled atmosphere (also known as an "isolator").
• the aseptic treatment station 100 may comprise an assembly for filling the containers.
• the containers 2 are tubs, i.e. the tubs specific to the pharmaceutical sector described above, and they are mutually identical in shape and dimensions.
• the feeding station 1 can be easily adapted to the decontamination of other containers, as long as they are substantially mutually identical and fed in a line with the same orientation, with respect to the conveyance direction T.
• the containers 2 can be individually supplied decontaminated and inside a single, respective sealed bag (to be opened before introducing the container into the feeding station 1), without the need for a secondary bag which contains the latter.
• the containers 2 can be made, for example, of polymeric material, of glass or of metal.
• the feeding station 1 comprises a loading entrance or line 10, for example a conveyor belt 20 or a motorized roller conveyor, and a tunnel formed by a plurality of treatment chambers 11, 12, 13 which are arranged side by side in succession along a conveyance direction T of the containers 2 and which are closed gas-tight all around the conveyance direction T.
• a loading entrance or line 10 for example a conveyor belt 20 or a motorized roller conveyor
• a tunnel formed by a plurality of treatment chambers 11, 12, 13 which are arranged side by side in succession along a conveyance direction T of the containers 2 and which are closed gas-tight all around the conveyance direction T.
• conveyance means that are adapted to convey, with continuous motion, the containers 2 along the tunnel in the conveyance direction T and which are described below.
• Such internal pressure is preferably lower than the pressure inside the aseptic treatment station 100 downstream of the feeding station 1, in order to prevent any flows of contaminant agents toward the aseptic treatment station 100.
• the overpressure applied in the treatment chambers 11, 12, 13 with respect to the atmospheric pressure can be less than 100 pascals, for example less than 25 pascals.
• the pressure inside each one of the treatment chambers 11, 12, 13 is kept at a value comprised between 8 and 20 pascals of overpressure with respect to the atmospheric pressure, more preferably between 10 and 15 pascals above the atmospheric pressure.
• the overpressure inside the treatment chambers 11 and 12 can be approximately 10 pascals, while the overpressure inside the treatment chamber 13 can be approximately 15 pascals and the overpressure inside the isolator 100 can be 25 pascals.
• the treatment chambers consist preferably of a first, preparation chamber 11, a second, decontamination chamber 12, for example using vaporized hydrogen peroxide (VHP), and a third, rinsing chamber 13.
• VHP vaporized hydrogen peroxide
• Air is introduced under pressure into the preparation chamber 11, such air being conveniently heated (and filtered) to increase the surface temperature of the containers 2 and so prevent the condensation of the decontaminant agent (for example VHP) in the subsequent decontamination chamber 12.
• the air can be introduced from a respective intake 34 connected to the discharge outlet of a respective pump (not shown) and can be distributed inside the treatment chamber 11 using a plurality of annular distribution units 31, which are connected to the entrance 34 and arranged side-by-side along the conveyance direction T so as to surround the conveyance means 21a-21b of the containers 2.
• Each distribution unit 31 has, all around the conveyance direction T i.e. all around the conveyance means, holes or nozzles 37 that are adapted to continuously spray the hot air in a direction substantially transverse to the conveyance direction T, so as to sweep over the containers 2 in transit.
• the decontaminant agent gas or vapor
• the decontaminant agent is introduced under pressure into the decontamination chamber 12 in order to decontaminate the surface of the containers 2 arriving from the preparation chamber 11.
• the decontaminant agent is preferably VHP (with concentrations comprised between 3000 and 20000 ppm) but, alternatively, decontaminant gases such as nitrogen dioxide or chlorine dioxide can be used.
• each distribution unit 32 has, all around the conveyance means 21a-21b, holes or nozzles 37 that are adapted to continuously spray the decontaminant gas or vapor in a direction substantially transverse to the conveyance direction T, so as to completely sweep over the surface of the containers 2 in transit.
• each treatment chamber 11, 12, 13 there is a suction vent 41, 42, 43, 44 which is adapted to extract by suction, preferably continuously, the air or the vapor sprayed by the distribution units 31, 32, 33 and to thus keep the overpressure of each treatment chamber 11, 12, 13 substantially constant.
• the suction vent 44 can lead directly to the chamber 13, while the other vents 41-43 lead to a region of the tunnel that is outside the treatment chambers 11-12. This avoids the situation where the extracted flow could dilute the agents used inside one or more of the treatment chambers (for example VHP, as described below).
• each treatment chamber 11, 12, 13 there is preferably a respective intermediate chamber 15, 16 which leads to a respective one of the vents 42 and 43 for the suction of the air or of the vapor from the treatment chamber upstream and/or downstream of the respective intermediate chamber 15, 16.
• respective partitions which can move, preferably vertically in a direction at right angles to the conveyance direction T of the containers 2.
• the preparation chamber 11 is delimited at the entrance and at the exit, respectively, by the movable partitions 111b and 112b.
• the decontamination 12 and rinsing 13 chambers are also delimited, respectively, by the movable partitions 121b-122b and 131b- 132b.
• the partitions 11 lb-112b, 121b-122b and 131b-132b can move between a passthrough position for containers, in which a respective passage opening 161 for the containers 2 is open, and a position for maintaining the internal pressure of the chamber (i.e. the overpressure generated in it), in which the above mentioned passage opening 161 is reduced and preferably is not entirely closed by at least one movable partition for each treatment chamber 11-13.
• the movement of the partitions 11 lb-112b, 121b-122b and 13 lb-132b between the above-mentioned two positions is commanded through automatic detection of the transit of each container 2, for example obtained using a laser, and actuation means which are each associated with a respective one of the movable partitions.
• the actuation means can be provided by way of an actuation cylinder 27, fixed in a box beside the tunnel, and a lever system for lifting/lowering a respective movable partition 11 lb-112b, 12 lb- 122b, 13 lb- 132b.
• a piston of the actuation cylinder 27 is hinged on a first lever 28, for example a rocker arm, which is pivoted on a rotation axis A.
• a second lever 29b, arranged inside the tunnel, is connected with one of its ends to the first lever 28 via a transmission shaft 29a which is coaxial to the rotation axis A, so that a rotation of the first lever 28 caused by the linear motion of the piston of the cylinder 27 is rigidly transmitted to the second lever 29b.
• a second end of the second lever 29b is connected to a respective movable partition 111b- 112b, 121b-122b, 131b-132b so that a rotation of the second lever 29b is converted to a vertical translation of the movable partition between the passthrough position and the position for maintaining the internal pressure.
• a rotation of the second lever 29b is converted to a vertical translation of the movable partition between the passthrough position and the position for maintaining the internal pressure.
• the passage opening 161 which is, alternately, opened and partially obstructed by the respective movable partition 11 lb- 112b, 12 lb- 122b, 13 lb- 132b can be defined by an opening which is provided in a respective fixed wall, I lla, 121a, 131a at the entrance and 112a, 122a, 132a at the exit, of each treatment chamber 11, 12, 13 and which can be passed through by each container 2 during the conveyance.
• the opening on each one of the fixed walls 11 la-112a, 121 a- 122a, 13 la-132a has a shape that is substantially complementary to the transverse space occupation of the container 2 with respect to the conveyance direction T so that, while the container 2 is passing through the opening, the passage opening 161 is reduced by the transverse space occupation of the container 2 in transit.
• the containers 2 are inserted at the entrance 20 of the tunnel in a row (i.e. one behind the other, along the conveyance direction T) and with a same, predefined orientation, so that the area of the above mentioned interspace 163 around the container is kept substantially constant for all the containers 2 in transit and can be determined so as to also define the area of the residual opening 162.
• each movable partition 11 lb-112b, 12 lb- 122b, 13 lb- 132b can slide in a position parallel and adjacent to a respective one of the fixed walls 111a- 112a, 121a-122a, 131a-132a so that the residual opening 162 of the passage opening 161 is partially delimited by the edge 160 of the U-shaped recess and partially by an edge of the opening of the fixed wall 11 la- 112a, 121a- 122a, 131a-132a that defines the passage opening 161, as shown in Figure 8.
• the conveyance means for conveying the containers 2 through the tunnel comprise a roller conveyor 21a, 21b, in which the rollers are arranged in each treatment chamber 11-13 in alternation with the distribution units 31, 32, 33 along the conveyance direction T.
• the rollers are arranged in each treatment chamber 11-13 in alternation with the distribution units 31, 32, 33 along the conveyance direction T.
• the rollers 21a, 21b can be moved by means of a sprocket-and-chain system, in which a respective sprocket 24 keyed on one end of each roller 21a, 21b engages a transmission chain 25 which is common to all the sprockets 24 and is driven by a motor 26.
• the sprockets 24, the chain 25 and the motor 26 are mounted in the same box at the side of the tunnel in which the means for actuating the movable partitions and the connecting pipes between the distribution units 31-33 and the entrances 34-36 are mounted.
• a (laser) sensor Upon the arrival of each container 2 before the fixed wall 11 la-12 la- 13 la for entrance to each treatment chamber 11-13 and before the fixed wall 112a- 122a- 132a for exit from each treatment chamber 11-13, a (laser) sensor detects the passage of the container 2 and commands the movement of the corresponding movable partition 11 lb-121b-13 lb or 112b- 122b- 132b to the passthrough position.
• the contoured opening of the fixed wall llla-121a-131a or 112a- 122a- 132a that is passed through i.e.
• the corresponding passage opening 161 is substantially filled by the transverse space occupation of the container 2, leaving the interspace 163 and thus keeping the internal pressure of the corresponding treatment chamber, into/out of which the container 2 enters/exits, substantially constant with respect to the previous situation, i.e. the situation with the corresponding partition 11 lb-121b-13 lb or 112b- 122b- 132b in the position for maintaining the pressure.
• the corresponding movable partition 11 lb-121b-13 lb or 112b-122b-132b returns to the position for maintaining the pressure, again by virtue of detection using a transit sensor (for example a laser sensor).
• a transit sensor for example a laser sensor
• the feeding station according to the invention enables a continuous production at greater speeds (for example, 6 containers per minute), not least by virtue of the fact that the tunnel constitutes an open system, in which the treatment chambers are always in mutual communication, although with a variable passage opening.

Landscapes

• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Epidemiology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Apparatus For Disinfection Or Sterilisation (AREA)
• Warehouses Or Storage Devices (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=83900164

Family Applications (1)

Country Status (6)

Families Citing this family (1)

Family Cites Families (3)

• 2022
  • 2022-08-18 IT IT102022000017385A patent/IT202200017385A1/it unknown
• 2023
  • 2023-07-27 CA CA3261204A patent/CA3261204A1/en active Pending
  • 2023-07-27 WO PCT/EP2023/070840 patent/WO2024037852A1/en not_active Ceased
  • 2023-07-27 EP EP23749011.5A patent/EP4572808A1/de active Pending
  • 2023-07-27 CN CN202380053169.0A patent/CN119562834A/zh active Pending
  • 2023-07-27 JP JP2025507692A patent/JP2025527332A/ja active Pending

Also Published As

Similar Documents

Legal Events