EP2425224A1 - Procédé de contrôle de l'étanchéité d'un réservoir rempli d'un fluide - Google Patents

Procédé de contrôle de l'étanchéité d'un réservoir rempli d'un fluide

Info

Publication number
EP2425224A1
EP2425224A1 EP10709553A EP10709553A EP2425224A1 EP 2425224 A1 EP2425224 A1 EP 2425224A1 EP 10709553 A EP10709553 A EP 10709553A EP 10709553 A EP10709553 A EP 10709553A EP 2425224 A1 EP2425224 A1 EP 2425224A1
Authority
EP
European Patent Office
Prior art keywords
container
fluid
chamber
sensor
carrier gas
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.)
Withdrawn
Application number
EP10709553A
Other languages
German (de)
English (en)
Inventor
Gerald Mathe
Christoph Hahn
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.)
Boehringer Ingelheim International GmbH
Original Assignee
Boehringer Ingelheim International GmbH
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 Boehringer Ingelheim International GmbH filed Critical Boehringer Ingelheim International GmbH
Priority to EP10709553A priority Critical patent/EP2425224A1/fr
Publication of EP2425224A1 publication Critical patent/EP2425224A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/20—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material
    • G01M3/22—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators
    • G01M3/226—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators
    • G01M3/229—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators removably mounted in a test cell
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/08—Investigating permeability, pore-volume, or surface area of porous materials
    • G01N15/082—Investigating permeability by forcing a fluid through a sample

Definitions

  • the invention relates to a method for checking the tightness of a container filled with a fluid, in which a fluid component emerging from the container is detected by using a responsive to the fluid component sensor, wherein the container is in a closed chamber in which leaking fluid component is collected over a predetermined period of time during which a carrier gas stream is bypassed to the sensor and after expiration of the period the carrier gas stream is passed through the chamber to supply the collected fluid component to the sensor and a device, a container and an atomizer to.
  • DE 103 16 332 B4 describes a method for checking the tightness of a container which is filled with a fluid, wherein a fluid component of the fluid received in the container, which emerges from the container without external negative pressure, is detected and used using a sensor which reacts on the fluid component determined value is compared with a specified limit.
  • the container to be tested is arranged in a closed chamber and the fluid component emerging from the container is collected in the chamber for a predetermined period of time.
  • a carrier gas stream is passed through the chamber, which feeds the fluid collected in the closed chamber to the sensor.
  • the carrier gas flow is supplied to the sensor via a bypass.
  • the object in the method is achieved in that during the period in which collected from the container fluid component in the chamber is, the chamber is subjected to a vacuum.
  • the carrier gas stream preferably an air stream
  • the bypass chamber at the chamber to be tested a vacuum is created in the chamber, through which the gas bubble present in the container, in particular the air bubble, enters the container
  • Closing the fluid-filled container is enclosed in the interior of the container, expands and at this expansion and an existing
  • Leakage in the container causes an increase in the concentration of the fluid component in the chamber.
  • the flow of carrier gas through the chamber is directed to the sensor. Due to the applied pressure gradient, the mass transfer taking place in a leaking container can be detected much more quickly with the sensor than with permeation, which takes place only on the basis of a concentration drop. Due to the time advantage over prior art density tests, the inventive method is applicable in mass production for testing a relatively large number of containers.
  • the sensor is adapted to the leaking from the container fluid component.
  • the vacuum is preferably maintained for a period of less than 60 s, in particular less than 40 s, preferably less than 30 s and particularly preferably less than 15 s. Accordingly, the process runs relatively quickly and is to be integrated into a manufacturing process.
  • the vacuum is maintained in the chamber, in particular of the material from which the container consists, the exiting fluid component and the desired accuracy of measurement dependent and easily determined by the skilled person.
  • predetermined climatic conditions are set.
  • the carrier gas stream is heated.
  • the temperature of the carrier gas flow is also a corresponding temperature control of the essential components of the device, in particular the flow-through pipes, valves and the chamber, accompanied.
  • the temperature and humidity of the carrier gas flow are dependent, for example, on the sensor used.
  • the carrier gas stream is passed, for example, at a temperature of 25 ° C through the device.
  • the carrier gas stream is humidified or dehumidified.
  • the carrier gas flow is adjusted to have a relative humidity of 75%.
  • the object is in the apparatus for checking the tightness of a container filled with a fluid comprising a sensor for detecting a leaking from the container fluid component, wherein the container is disposed in a closed chamber, which via a valve control with a gas line and a bypass for a carrier gas stream and connected to the sensor is inventively achieved in that the chamber is connected to a Va kuumpumpe.
  • the device has a relatively simple structure.
  • a controllable valve is provided between the chamber and the vacuum pump.
  • the senor is designed to detect ethanol vapor.
  • the sensor is a semiconductor sensor which changes its resistance due to a change in the concentration of the ethanol vapor present in a leaky container in the wet carrier gas and thus allows a statement about a leakage rate.
  • the senor is coupled to an evaluation and display unit which stores measured values, compares them with limit values and outputs a visually and / or audibly perceptible signal when a limit value is exceeded.
  • the limit is calculated to correspond to a loss of 0.1 mg of ethanol per day, as the fluid in the container is allowed to lose a maximum of 3% of this solvent by diffusion for a storage period of 3 years. Due to the signal, the container is either discharged from the production as a leaking rejects or further processed as a dense container. The operations of loading the chamber with containers and the discharge can be done both automatically and manually.
  • the interior of the chamber is advantageously adapted to the size of the container.
  • the leakproof container in particular for a nebulizer, for use in the method and / or in the chamber of the device is filled with an inhalable ethanolic drug formulation and designed according to any one of claims 11 to 14.
  • the container can also be designed in accordance with the container for a nebulizer or inhaler known from WO 96/06011 A1, WO 00/49988 A2 and WO 99/43571 A1.
  • a container has a rigid metallic outer shell and a bag received therein. The pouch forms a fluid space for drug delivery and collapses as the drug preparation is withdrawn.
  • FIG. 1 shows a schematic representation of a device according to the invention for carrying out the method according to the invention
  • FIG. 2 shows a sectional view of a container to be tested with the device
  • FIG. 3 shows a sectional view of an atomizer in the untensioned state with the container of Fig. 2 and
  • the device comprises a supply line 1 for a carrier gas formed as air, which passes with a specific relative humidity, a predetermined temperature and at a set speed via a first valve device 2 into a chamber 3 in which a container 5 filled with a fluid 5 is arranged is.
  • a discharge line 6 In the chamber 3 protrudes a discharge line 6, the part with a second valve means 7 and a sensor 8 for detecting a leaking from the leaky container 5 Fluid possibly disturb- part.
  • the first valve device 2 is connected via a bypass 12 to the second valve device 7.
  • a vacuum line 9 is inserted into the chamber 3, which communicates with a vacuum valve 11 with the interposition of a third valve device 10.
  • the chamber 3 is then decoupled from the carrier gas stream by the first valve device 2 and the second valve device 7 via the bypass 12 continues to flow through the sensor 8 and finally again, possibly cleaned, gets into the environment.
  • the vacuum pump 11 By means of the vacuum pump 11, a negative pressure is generated in the chamber 3 through which the gas bubble present in the container 5, which is trapped in the interior of the container 5 when closing the container 4 filled with fluid 4, expands when the container 5 is leaking , Otherwise, the vacuum has no significant effect on the container 5.
  • the fluid 4 is an ethanol-containing drug formulation which is filled in the substantially cylindrical container 5 in an amount sufficient (typically 2 to 10 or 2 to 15 ml) to allow multiple doses or applications which is insertable into a nebulizer 13.
  • the container 5 has in its interior a bag-like or tube-like fluid space 14 for receiving the fluid 4.
  • a wall 15 delimiting the fluid space 14 is at least partially flexible, deformable and / or collapsible.
  • the fluid space 4 or the wall 15 is in a first th connection 16 opposite end portion 17 closed by welding the wall 15.
  • the container or its outer shell 18 in this end region 17 on a bottom piece 19 which closes the outer shell 18 the end face firmly and which is provided with a ventilation opening 20.
  • the at least substantially rigid outer sheath 18 preferably connects the connection 16 or a connection piece 21 fixing the connection piece 21 sufficiently rigidly with the bottom piece 19 in order to be able to insert the container 5 into the atomizer 13 by appropriate pressure on the bottom piece 19 and / or to be able to pull the container 5 out of the atomizer 13 by pulling on the bottom piece 19 again.
  • the film-like wall 15 in the container 5 is at least partially deformable, in order to allow a possible slight collapse of the fluid space 14 in the removal of fluid 4, since the fluid space 14 is largely sealed gas-tight.
  • the wall 15 has a multilayer structure and has an outer layer, a preferably metallic barrier layer, in particular a metal foil, and an inner layer and optionally further layers.
  • the individual layers can be formed, for example, by coating, laminating or in any other suitable manner.
  • the barrier layer is designed in particular as an aluminum layer or foil.
  • the outer shell 18 is partially extruded onto the wall 15, that is, from the outside, and lies with its inside indirectly on the outside of the wall 15, as is the case in a contact area 22 indicated in FIG. 2.
  • a sleeve is first formed from the film material forming the wall 15 by longitudinal welding of a corresponding material strip. Then the outer shell 18 is extruded as an endless tube.
  • the wall 15 is at least partially or in total detachable from the outer shell 18, since the outer shell 18 is not fixed to the wall 15 connects.
  • the outer shell 18 is made of a first material, which does not bind to the outer layer of the wall 15 or a second material which forms the outer layer of the wall 15. The two materials are therefore preferably different, but also adhesion preventers can be used.
  • the first material is preferably a PE (polyethylene) or a PET (polyethylene terephthalate).
  • PE polyethylene
  • PET polyethylene terephthalate
  • connection 16 or the connecting piece 21 is attached, wherein a suitable material, such as PE or PET, which connects to the wall 15 and / or outer shell 18, is selected for the connecting piece 21.
  • connection piece 21 has been injection-molded or the connection 16 has been attached
  • the container 5 or fluid space 14 can be closed in the opposite end region 30; of course, this can also be done first, ie before the connection piece 21 or connection 16 is attached.
  • the fluid space 14 is filled with the fluid 4 before the closure of the connection 16, in particular before the insertion of a closure part 23, and the closure part 23 is welded gas-tight to the connection piece 21 in order to close the connection 16.
  • the fluid 4 is filled before closing the wall 15 in the end region 17, in which case then the connection 16 at the other end of the container
  • the container 5 can be used in the nebulizers or inhalers described in the following references or based on their principles: EP 1 236 517, EP 1 561 484, EP 1 562 094, EP 1 604 701, JP 2004-0283245, JP 2004-249208, JP 2004-283244, JP 2005/058421, US 2002/0153006, US 2003/0100964, US 2003/0127538, US 2004/0163646, US 2005/0034723, US 2005/0133029, US 2005/0172957, US 2005/0224076, US 2005/0268911, US 5,915,378, WO 03/041774, WO 2004/022128, WO 2004 / 039442, WO 2004/078244.
  • the closure part 23 of the container 5 has a septum 25 pierceable by a delivery tube 24 of the atomizer 13 and may additionally be closed by an optional seal 41 which is evident through the delivery tube 24.
  • the atomizer 13 is designed as a portable inhaler and works without propellant gas.
  • a respirable aerosol 43 is formed, which can be inhaled or inhaled by a user, not shown.
  • the container 5 is used with the fluid 4.
  • the atomizer 13 is provided with a pressure generator 26 for the promotion and / or atomization of the fluid 4, in particular in each case in a predetermined, optionally adjustable dosage amount.
  • the atomizer 13 or pressure generator 26 has a holder 27 for the container 5, an associated, only partially shown drive spring 28 with an associated, for unlocking manually operable locking element 29, preferably designed as a capillary conveyor tube 24, an optional valve, in particular Check valve 30, a pressure chamber 31 and a discharge nozzle 32 in the region of a mouthpiece 33 or other end piece.
  • the Container 5 is clamped or latched by means of the holder 27, thus fixed in the atomizer 13 such that the delivery tube 24 dips into the fluid space 14 and / or is fluidically connected thereto.
  • the holder 27 with the container 5 and the delivery tube 24 is moved downwards and a dose of the fluid 4 is sucked out of the container 5 via the check valve 30 into the pressure chamber 31 of the pressure generator 26.
  • the fluid space 14 (bag) collapses as a function of the removal of fluid 4, as indicated schematically by the dashed line in the lower region of the fluid space 14 in FIG. 4, for example.
  • the fluid 4 in the pressure chamber 31 is pressurized by the conveyor tube 24 is moved back up with now closed check valve 30 by the force of the drive spring 28 and now as Pressure stamp works. This pressure expels the fluid 4 through the discharge nozzle 32, where it is atomized into the respirable aerosol 43.
  • the container 5 is moved back by the drive spring 28 to its original position.
  • the container 5 thus performs a lifting movement during the tensioning process and during the sputtering process.
  • the atomizer 13 comprises an upper housing part 34 and a counter-rotating inner part 35 with an upper part
  • the holding element 39 is designed such that accidental opening of the atomizer 13 or removal of the lower housing part 38 is excluded. In particular, to release the lower housing part 38, the retaining element 39 must be pressed against spring force. For insertion and / or replacement of the container 5, the lower housing part 38 is detachable from the atomizer 13.
  • the lower housing part 38 can be rotated relative to the upper housing part 34, wherein the inner part 35 is rotated.
  • the drive spring 28 is tensioned in the axial direction via a gear not shown in detail, acting on the holder 27.
  • the atomizer 13 optionally has a device for forced ventilation of the container 5, in particular the outer shell 18, on.
  • a device for forced ventilation of the container 5, in particular the outer shell 18, on When clamping for the first time, the container 5 or the outer casing 18 pierces at the bottom, wherein an axially acting spring 40 arranged in the lower housing part 38 comes to rest on the bottom part 19 of the container 5, which with a piercing element 42 forms a bottom-side, in particular gas-tight, Seal for ventilation.
  • an axially acting spring 40 arranged in the lower housing part 38 comes to rest on the bottom part 19 of the container 5, which with a piercing element 42 forms a bottom-side, in particular gas-tight, Seal for ventilation.
  • a piercing element 42 forms a bottom-side, in particular gas-tight, Seal for ventilation.
  • Fluid space 14 (bag) with the fluid 4 and the wall 15 undamaged.
  • the flexible fluid space 14 collapses.
  • the ambient air can be compensated for pressure via the ventilation or piercing opening flow into the container 5.
  • the container 5 To use the atomizer 13, the container 5 must first be used, for which purpose the lower housing part 38 is removed. Subsequently, the container 5 is inserted into the inner part 35. Here, a head-side opening or connecting takes place through the delivery pipe 24, which pierces the head-side seal 41 of the container 5 and is introduced through the connection 16 into the interior of the container 5 or fluid space 14. Subsequently, the lower housing part 38 is replaced. Now, the first-time tensioning of the atomizer 13 can take place.
  • Valve device 38 Housing base

Landscapes

  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Abstract

Dans le cas d'un procédé destiné à contrôler l'étanchéité d'un réservoir (5) rempli d'un fluide (4), selon lequel un composant du fluide sortant du réservoir (4) est enregistré au moyen d'un capteur (8) réagissant au composant du fluide, le réservoir (5) se trouve dans une chambre fermée (3), dans laquelle le composant du fluide sortant est collecté sur une période prédéfinie, pendant laquelle un flux de gaz porteur est acheminé par un by-pass (12) au capteur (8) et, après l'écoulement de cette période, le flux de gaz porteur est acheminé à travers la chambre (3) pour amener le composant du fluide collecté au capteur (8). Pendant la période où le composant du fluide sortant du réservoir (5) est collecté dans la chambre (3), la chambre (3) est mise sous vide.
EP10709553A 2009-04-28 2010-03-22 Procédé de contrôle de l'étanchéité d'un réservoir rempli d'un fluide Withdrawn EP2425224A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP10709553A EP2425224A1 (fr) 2009-04-28 2010-03-22 Procédé de contrôle de l'étanchéité d'un réservoir rempli d'un fluide

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09158923 2009-04-28
EP10709553A EP2425224A1 (fr) 2009-04-28 2010-03-22 Procédé de contrôle de l'étanchéité d'un réservoir rempli d'un fluide
PCT/EP2010/053667 WO2010124907A1 (fr) 2009-04-28 2010-03-22 Procédé de contrôle de l'étanchéité d'un réservoir rempli d'un fluide

Publications (1)

Publication Number Publication Date
EP2425224A1 true EP2425224A1 (fr) 2012-03-07

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP10709553A Withdrawn EP2425224A1 (fr) 2009-04-28 2010-03-22 Procédé de contrôle de l'étanchéité d'un réservoir rempli d'un fluide

Country Status (2)

Country Link
EP (1) EP2425224A1 (fr)
WO (1) WO2010124907A1 (fr)

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CN103048094B (zh) * 2012-12-19 2014-11-26 山东省农业机械科学研究所 喷雾器密封性能倾斜试验装置
DE102015106279A1 (de) * 2015-04-23 2016-10-27 Mobilplan Industrie- Und Umwelttechnik Ventileinrichtung und Verfahren zum Betrieb der Ventileinrichtung
EP3527966B1 (fr) 2018-02-14 2021-12-22 3S GmbH Procédé et dispositif de détermination d'une indication de fuite d'un objet d'essai rempli de fluide d'essai
GB202016265D0 (en) * 2020-10-14 2020-11-25 Vacuum Eng Services Ltd Leak testing
WO2026033407A1 (fr) * 2024-08-09 2026-02-12 Antares Vision S.P.A. Système de détection d'un gaz traceur

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Also Published As

Publication number Publication date
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