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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
  • A61L2/20—Gaseous substances, e.g. vapours
• • 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
  • A61L2/20—Gaseous substances, e.g. vapours
  • A61L2/208—Hydrogen peroxide
• • 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
  • A61L2/22—Phase substances, e.g. smokes, aerosols or sprayed or atomised 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
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/24—Apparatus using programmed or automatic operation
• • 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/26—Accessories or devices or components used for biocidal treatment
• • 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
  • A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• • 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
  • A61L2202/20—Targets to be treated
  • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail

Definitions

• the present disclosure concerns a cap chamber for sterilizing caps or closures, and a method for sterilizing caps.
• components we refer to all components having a surface to which the contents of the packaging container may have access, and as minimum requirement at least that particular surface should be sterilized. In a wider perspective it may be desired to sterilize such components fully, or at least to sterilize a greater area than what is included in the surface that will be in contact with the contents of the packaging container.
• One reason may be to prevent the occurrence of reinfection, i.e. the migration of contaminants from a non-sterile to a sterile area, another may be to prevent contaminants from entering an otherwise sterile area.
• sterilization and similar may be defined as “treatment with a sterilant until sterile”.
• caps are meant to include several types of closure arrangements, such as screw caps, flip caps, snap caps, sports caps, and closure arrangements comprising a cap and a portion of a packaging container, which will be described in greater detail in the description referring to the drawings.
• the present disclosure relates to a cap sterilization device comprising a sterilization chamber having a cap inlet and a cap outlet and guide means for guiding caps through the sterilization chamber.
• the device further comprises a nozzle for injecting a sterilant into the sterilization chamber and at least two exhaust outlets for evacuation of gases from the sterilization chamber.
• the nozzle may be arranged to inject gaseous sterilant towards an open end of the caps.
• the first exhaust outlet may be arranged in the cap inlet and a second exhaust outlet may be arranged in the cap outlet.
• the caps may be arranged to be indexed forward in an intermittent manner while the nozzle is arranged to provide a continuous flow of sterilant.
• a valve may be arranged upstream the nozzle, between the nozzle and a vaporizer, the nozzle being able to selectively redirect a flow from the vaporizer into an exhaust manifold instead of to the nozzle.
• the nozzle may be arranged to provide an amount of sterilant such that the concentration in the sterilization chamber varies with less than 25% over a volume defined by the first exhaust outlet and the second exhaust outlet, counted as maximum concentration compared to minimum concentration in the volume.
• the sterilant may comprise hydrogen peroxide, or a mixture of components one of which is hydrogen peroxide.
• Other examples may include peracetic acid (PAA) and compounds thereof, or other sterilization agents or sterilants.
• PAA peracetic acid
• the intention relates to a method for sterilizing caps.
• Fig. 1 shows a cross sectional side view of a sterilization device, or at least a schematic illustration thereof.
• Fig. 2 is a detailed view, still schematic, of a cap.
• Fig. 3 a schematic side view of a packaging container.
• Fig. 1 is a schematic cross section of a sterilization device 100 having a sterilization chamber 101.
• the sterilization device 100 is shown from one side thereof.
• Caps 102 are arranged to follow guide means 104 through the sterilization chamber 101.
• the caps 102 enter via a cap inlet 106 and exits via a cap outlet 108.
• the caps 102 are fed by gravity, and once a cap 102 is removed from the guide means 104 downstream the sterilization chamber 101 the entire line of caps 102 is incremented one step downstream.
• the removal of caps 102 downstream may be performed in a step to move the cap 102 from the line of caps to a cap-application device or another processing step.
• the caps may in other instances be directed to storage, awaiting later use.
• the one-by-one removal of caps will generate the intermittent motion pattern of caps.
• the sterilization device 100 as disclosed herein may in other embodiments be based on a continuous motion pattern. Furthermore, it is foreseeable to arrange another type of drive, yet use of gravity vouches for simplicity and a non-complex construction inside the sterilization chamber 101.
• a hydrogen peroxide nozzle 110 arranged to inject hydrogen peroxide into the chamber 101.
• the nozzle 110 is furthermore arranged to inject the hydrogen peroxide towards the caps 102.
• the nozzle 110 may be arranged to inject a spray towards and impact an area surrounding a particular cap position such as to fully reach all portions of a cap.
• the sterilant is injected in gaseous form.
• a vaporization device arranged upstream the nozzle 110.
• the temperature in the vaporization device may be 210 °C and for one particular embodiment the consumption includes 0.7 1/h of hydrogen peroxide (3% concentration by volume) and the addition of about 80 1/min of air. All of these parameters may shift depending on the preferred level of sterilization and of the size of the sterilization chamber etc.
• Exhausts 112, 114 are arranged at the cap outlet 108 and the cap inlet 106
• the exhausts ensure that the amount of hydrogen peroxide released to the atmosphere is kept at an absolute minimum, or is completely avoided, by evacuating it to a exhaust manifold leading to a destruction device (not shown). Rather than necessarily having an underpressure, i.e. a lower pressure inside the sterilization chamber than in the immediate surroundings, to prevent hydrogen peroxide or any other sterilant from leaving the
• the present sterilization chamber 101 rather controls gas flows locally in the area of the inlet 106 and the outlet 108 respectively.
• the exhausts 112, 114 efficiently prevents gas passage into and out from the sterilization chamber 101.
• the sterilant containing atmosphere of the sterilization chamber 101 will be pulled towards both the inlet 106 and towards the outlet 108, meaning that as soon as a cap 102 enters through the inlet 106 the sterilization treatment will commence.
• the cap 102 When passing an impact area of the sterilization spray the cap 102 will experience a maximum load of sterilant, after which the concentration may gradually decrease, yet be maintained, until the cap 102 leaves the sterilization chamber 101 through the outlet 108.
• the caps 102 pass the sterilization chamber 101 with their open end directed towards the hydrogen peroxide nozzle 110.
• the purpose of the nozzle 110 is not merely to supply an adequate amount of sterilant to the interior of a cap 102, but also to ensure an adequate concentration of sterilant in the sterilization chamber as a whole.
• the nozzle 110 is arranged in such a way that it is aligned with a particular cap position, meaning that as the caps are moved incrementally through the sterilization chamber they will all at one position be facing the sterilization nozzle 110, and the spray will be directed to the interior of the cap 102.
• the condensed sterilant After application and as the surface temperature of the cap 102 increases the condensed sterilant will start to vaporize such that a minimum amount of sterilant leaves the sterilization chamber via the caps. Furthermore, the flow balance of the sterilization chamber will be such that there is a flow of surrounding air entering through the outlet and the inlet respectively, and even though this air will leave through the nearest exhaust it will still fulfil a function of preventing sterilant from leaving into the surroundings.
• the source of heat is in the present embodiment only the heated sterilant spray, and the caps are only tempered by means of being stored in a particular temperature before being fed to the cap sterilization device. The present case does not exclude the possibility of using heaters (or coolers) to temper the caps or the sterilization device, if needed to increase controllability.
• the concentration of sterilant will be evenly distributed within the constraints of the sterilization chamber 101, at least in a volume defined by the first exhaust outlet 112 and the second exhaust outlet 114 as indicated by the dotted area in Fig. 1.
• the boundaries of the dotted area should not be construed as exact.
• the flow around the cap in the vicinity of the exhaust outlets may vary a bit, but given that the variation in the concentration of sterilant within the defined area may be less than 25%, the main variations being formed in the boundaries. Outside of the boundaries the concentration of sterilant may be negligent since surrounding air free from sterilant may be pulled in to the cap inlet and the cap outlet and straight into the exhaust outlets 112 and 114 respectively.
• the present device provides sterilization by means of a direct spray of sterilant combined with an overall increased concentration of sterilant providing a topical sterilization of all accessible surface of a cap 102 sterilized in the sterilization chamber 101.
• the sterilant leaves the nozzle 110 in a continuous manner in order to maintain a desired concentration of sterilant inside the sterilization chamber 101.
• a valve 116 may be switched directing the flow of sterilant directly to an exhaust manifold 113 rather than into the sterilization chamber through the nozzle 110.
• the signal to the valve to effect the switch will come from a control unit the details of which are not relevant for explaining the present device.
• the guide means 104 are arranged to localize the caps 102 during their passage through the sterilization chamber. While fulfilling that main purpose they should avoid shadowing (covering) too much of the caps 102, since that may inhibit proper sterilization. Also, the guide means 104 are arranged to maintain a distance between the caps 102 and a back wall of the sterilization chamber 101, i.e. the wall remote to the hydrogen peroxide nozzle 110. The purpose is to enable hydrogen peroxide to reach all surfaces of each cap. To that end it may be preferred to introduce the caps through the inlet 106 at a temperature being below the condensation point of the sterilant at prevailing conditions. In this way the sterilant will condensate at all surfaces of the cap or closure 102.
• Fig. 2 is a view in the a longitudinal axis of the guide means 104, i.e. a partial view from above of Fig. 1, illustrating one example of how guide means may be arranged.
• the caps 102 may be caused to rotate along a longitudinal axis (an axis extending parallel to an axis of rotational symmetry of the cap.
• Fig. 2 there are more guiderails 104 arrange to one side of the cap 102.
• a closure arrangement may be more suitable in the context of the embodiment shown in Fig. 2, as was mentioned in the summary portion.
• cap is used to designate all such closure arrangements.
• the packaging container 122 as shown in Fig. 3, may comprise a packaging-laminate sleeve 124 e.g.
• a packaging laminate comprising plastic and paper layers as is commonly used.
• the sleeve 124 may be directly fused to the closure arrangement, yet the two components may also be connected via a plastic shoulder portion 126.
• An example of such a packaging container is the one commercialized under the name Tetra Evero® Aseptic.
• the 120 may be used to attach the closure arrangement onto a flat or folded piece of packaging laminate. Examples of this latter packaging container may be the ones commercialised by the present applicant under the names, Tetra Rex®, Tetra

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

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Citations (7)

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• 2015
  • 2015-02-11 ES ES15708130T patent/ES2853376T3/es active Active
  • 2015-02-11 WO PCT/EP2015/052884 patent/WO2015121308A1/en not_active Ceased
  • 2015-02-11 RU RU2016136344A patent/RU2684936C2/ru active
  • 2015-02-11 CN CN201580007870.4A patent/CN105979974B/zh active Active
  • 2015-02-11 EP EP15708130.8A patent/EP3104898B1/en active Active
  • 2015-02-11 BR BR112016018462-9A patent/BR112016018462B1/pt active IP Right Grant
  • 2015-02-11 JP JP2016551727A patent/JP6594326B2/ja active Active
  • 2015-02-11 US US15/118,765 patent/US9981055B2/en active Active
  • 2015-02-11 MX MX2016010061A patent/MX2016010061A/es unknown
  • 2015-02-11 KR KR1020167021974A patent/KR20160122726A/ko not_active Withdrawn

Patent Citations (7)

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