• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    A method for checking a tightness of a flexible container (2) for a fluid, in particular a fluid medicament, wherein the container (2) at least partially - preferably completely - with a gas-permeable layer (3) is covered, the container (2) together with gas-permeable layer (3) is placed in a flexible, substantially gas-tight bag (4), the substantially gas-tight bag (4) is evacuated by pumping through a bag opening (5), the container (2) is filled with a noble gas, and the presence of noble gas, which via a leak from the container (2) through the gas-permeable layer (3) via the bag opening (5) emerges is detected.
    公开号:AT519682A1
    申请号:T50408/2017
    申请日:2017-05-12
    公开日:2018-09-15
    发明作者:
    申请人:Mits Gmbh；
    IPC主号:
    专利说明:

    Summary
    Method for checking the tightness of a flexible container (2) for a fluid, in particular a fluid medicament, the container (2) being at least partially, preferably completely - covered with a gas-permeable layer (3), the container (2) including the gas-permeable layer ( 3) is arranged in a flexible, essentially gastight bag (4), the essentially gastight bag (4) is evacuated by pumping it out through a bag opening (5), the container (2) is filled with a noble gas, and the presence of Noble gas, which leaks from the container (2) through the gas-permeable layer (3) via the bag opening (5), is detected.
    (Fig.1) / 17
    The present invention relates to a method for checking the tightness of a flexible container for a fluid, in particular for a fluid medicament, and the flexible container for a fluid medicament itself.
    Such flexible containers for fluid drugs can be used, for example, as so-called single-use bags to store and transport very high-quality, liquid biopharmaceuticals. They can exist as two plastic layers welded on the edges - especially plastic films - that are flexible ("flexible wall").
    Checking these containers for leaks is a technical challenge, in particular since there are several influences on the container between the production of the container and its use, which can cause leaks or holes and the like. Such influences can occur, for example, through packaging, sterilization (for example by means of gamma radiation), transport, storage, unpacking, and overall manual manipulation and the like.
    A two-stage inspection method has therefore become established in the prior art, in which an exact inspection is first carried out at the place where the container is manufactured and, secondly, a further inspection is carried out directly before use (at the “point of use”).
    The check at the manufacturing site works in such a way that helium is introduced into the container. It should be noted that this really only applies to the container itself. Any hoses, connectors, filters and the like will not be tested. The container filled with helium is arranged in a vacuum chamber. The leak tightness or the presence of a leak can be concluded by evacuating the vacuum chamber and the detection of helium present in the vacuum chamber which has escaped from the container due to any leakage. This measurement is highly sensitive. Leaks less than 5 pm in size can be detected. However, the container is heavily loaded at the same time, since the action of helium causes the container to expand and inflate like a balloon. Using this prior art method is a major one
    81627 32 / fr
    2/17
    However, accuracy cannot be achieved at the place of use, since corresponding devices for high vacuum and the like are not readily available.
    Leaks that occur only after this check has been carried out at the production site cannot of course be detected in this way.
    As mentioned, a check is also carried out directly at the point of use. The container is subjected to a relatively low pressure (approx. 30 millibars) and monitored for about half an hour. From the pressure development it can be concluded that a gas has escaped from the container. If this is too large, a leak can be concluded. However, this method cannot detect leaks as small as 20 pm or smaller.
    The method carried out in the prior art at the place of manufacture of the containers is also not practical because the (industrial) systems, such as the volume chamber and the provision of helium, can only be provided with great difficulty there.
    However, the sensitivity to leaks with a size of more than 20 pm at the place of use is ultimately not sufficient, since it can be assumed that holes over 3 to 5 pm can lead to unsterility inside the container (so-called “bacterial ingress”) . In short, a hole size of over 3 to 5 pm allows bacteria to enter the interior of the container.
    The object of the invention is therefore to provide a method and a device which make it possible to reduce the risk of non-sterility of a flexible container for fluid medicaments and similar products, for example from the pharmaceutical production process.
    3/17
    With regard to the method, this object is achieved with the features of claim 1. With regard to the device, this is done by the features of claim 10.
    With regard to the procedure, this is done by
    the container (that is to say the test object) is at least partially - preferably completely - covered with a gas-permeable layer,
    the container, including the gas-permeable layer, is arranged in a flexible, essentially gas-tight bag (the escape of smaller amounts of fluid after closing may be acceptable, depending on the application),
    the essentially gas-tight bag is evacuated by pumping it out through a bag opening,
    - The container is filled with an inert gas, and
    - The presence of noble gas, which escapes from the container through the gas-permeable layer via the bag opening, is detected.
    By using a gas-permeable layer and an additional, essentially gas-tight bag, the vacuum chamber used in the prior art can be eliminated from the process. On the one hand, this has the advantage that complex measuring apparatuses, as described in connection with the inspection at the manufacturing site in the prior art, are no longer necessary. At the same time, the container is prevented from swelling, thereby preventing the introduction of new damage, in particular leaks.
    Because by evacuating the space between the container to be checked and the essentially gas-tight bag, the ambient pressure (via the essentially gas-tight bag and the gas-permeable layer) ultimately acts on the flexible container from the outside.
    The gas-permeable layer allows the even in the evacuated state of the space between the flexible container and the substantially gas-tight bag
    4/17
    Migration of helium, which emerges from the container via a leak, by pumping out of the essentially gas-tight bag to a detection device.
    A fleece or the like can preferably be used as the gas-permeable layer.
    The gas-permeable layer can be made of plastic.
    In summary, the method according to the invention has the advantage, on the one hand, of the necessary accuracy, since leaks with sizes of less than 3 to 5 pm can be recognized, and, on the other hand, the flexible container to be tested is subjected to less mechanical stress, which increases the risk of leakages introduced by the check decreased.
    The container can be filled with the inert gas before, during or after the bag is evacuated.
    With regard to the device, the object is achieved by a set comprising a flexible container for a fluid, in particular for a fluid medicament, and a gas pressure container for holding a noble gas. This also reduces the need for laborious laboratory facilities at the inspection site, since appropriate noble gas is supplied directly with the flexible container. This prefabrication of the flexible container together with the gas pressure container also eliminates sources of error when carrying out the check, which can easily arise when the container is filled with inert gas. For example, by applying too much pressure or incorrectly connecting an external pressure source to the container (for example, because connections do not fit together precisely enough or the like).
    In this case, the container has an opening which can be closed essentially gas-tight (the emergence of smaller amounts of fluid after closing may be acceptable depending on the application) and which is designed in such a way that it is followed by an opening
    5/17 outside gas-tight fluid connection between the container and the
    Gas pressure vessel can be manufactured.
    The bag can also be part of the set according to the invention.
    The invention also makes it possible to test the container together with attachments such as hoses, connectors, valves and the like.
    More than one bag opening can be provided, with the shortest possible routes for a noble gas to a detector can be achieved by clever placement on the bag, for example on opposite sides.
    The container can be made of polyethylene, ethylene vinyl acetate,
    Fluoropolymers or mixtures thereof.
    Protection is also sought for the use of a set according to the invention in the method according to the invention.
    Further advantageous embodiments of the invention are defined in the dependent claims.
    As mentioned, the container can be filled by bringing the container through an opening with a gas pressure container filled with the noble gas into a preferably gas-tight, fluid connection to the outside.
    In a very particularly preferred embodiment, the gas pressure container can be arranged - preferably completely - within the essentially gas-tight bag before the evacuation. As a result, no hoses need to be led out of the bag, the edges of which would have to be laboriously sealed to the outside. In addition, this allows the process to be carried out particularly easily. The activation of the gas pressure container can function contactlessly via any type of electromagnetic waves. Since the essentially gas-tight bag can also be flexible or elastic, this could be the case
    6/17
    Filling the container with inert gas can also be triggered by a switch on the gas pressure container operated by the bag.
    An embodiment can also be very particularly preferred in which the process of establishing the fluid connection between the gas pressure container and the container takes place automatically and mechanically.
    In other words, by fully arranging the
    Gas pressure container inside the bag, the bushings necessary in the prior art for hoses from a helium source into the test chamber and the additional risk of tightness caused thereby are avoided.
    Helium can preferably be used as the noble gas, since it has the smallest molecular weight of the noble gases and therefore - as long as this can be said about the corresponding size scales - has the smallest “dimensions”. As a result, the smallest possible holes or leaks in the container can be discovered (since larger noble gas atoms may not be able to pass through the corresponding holes).
    The measurement accuracy can be beneficial if the essentially gas-tight bag is kept evacuated by constant pumping. This means that pumping can only be stopped when a representative signal from the detection device is present. Of course, it is also possible to perform the pumping, for example in a pulsed manner, or to control or regulate it in some other way, for example in order to save energy.
    For example, mass spectrometers can be used as detectors to detect the presence of the noble gas exiting through the bag opening.
    The fluid can preferably be a fluid drug. However, the invention can also be used for similarly valuable products, such as, for example, precursors of pharmaceuticals and other substances which occur in the (bio) pharmaceutical production process, the tightness of the container even on very small scales
    7/17 is important. The fluid may also preferably be a liquid. In a very preferred embodiment, the fluid can be a liquid drug.
    The flexible container can be used - preferably exactly once - for storing and / or transporting a fluid medicament if no leak was detected during the check. The container can then be disposed of. In this case, one speaks of so-called single-use bags.
    It may be beneficial to the measurement accuracy if the method is carried out on a preferably completely emptied container. The method can be used particularly effectively in those containers which are so flexible that they can be substantially completely emptied without the use of a vacuum.
    With regard to the set, the gas pressure container can be connected to the container via the closable opening, a hose and / or pipe connection preferably being present.
    It can particularly preferably be provided that the gas pressure container is relatively small. In particular, this means that its capacity is such that an amount of the noble gas which the gas pressure container stores does not exceed twice the nominal capacity of the container under normal conditions, that is to say at ambient pressure. The capacity can be particularly preferred such that this volume does not exceed the nominal capacity of the container and very particularly preferably three quarters and in particular half of the nominal capacity.
    Further advantages and details of the invention result from the figures and the associated figure description. Show:
    Fig. 1 is a schematic representation of the experimental setup for the
    Implementation of the method according to the invention and
    8/17
    2a and 2b are schematic illustrations of the set according to the invention and the set according to the invention after covering with the gas-permeable layer.
    In one embodiment of the method according to the invention, helium is used as the noble gas.
    The experimental setup is shown purely schematically in FIG. 1 and can be carried out so compactly that the tightness can also be checked reliably at the place where the container 2 is filled. The container 2 is flexible and is designed, for example, as shown schematically in FIG. 2a. This is at least partially - preferably completely - covered with the gas-permeable layer 3.
    The container 2 is in a set with the gas pressure container 7. The gas pressure container 7 is connected to the container 2 via a hose connection and the opening 6 on the container 2. The opening 6 can be closed in a gastight manner and is only indicated schematically in FIG. 1 as the point of intersection of the hose connection with the container 2.
    The container 2 is completely encased by the gas-permeable layer 3, the gas-permeable layer 3 being designed as a fleece in this exemplary embodiment. The container 2 coated with the gas-permeable layer 3 is together with the
    Hose connection and the gas pressure container 7 arranged in the essentially gastight bag 4. The interior of the bag 4 is connected to the detector 8 via the bag opening 5 (likewise shown only schematically as an intersection between the bag 4 and a connection of the detector 8 to the bag 4). In this case, the detector 8 also comprises a vacuum pump for evacuating the bag 4 as well as the complete, necessary hardware and software for detecting helium in the gas stream, which is created by the evacuation.
    The gas-permeable layer 3 reduces any destructive forces on the container 2 during evacuation. At the same time, the gas-permeable layer 3 allows the migration of a leak from the outer bag 4 even when it is evacuated
    9/17
    Container 2 escaping helium to the bag opening 5. The helium which has escaped can be pumped out from the bag opening 5 in the direction of the detector 8. In other words, the gas-permeable layer 3 prevents the outer bag 4 from sealing any holes in the container 2 during evacuation.
    The bag opening 5 can be present in the measurement set-up in multiple designs (on the container 2), for example on opposite sides of the container 2. As a result, the shortest possible routes to the detector 8 can result for the helium that has escaped.
    Of course, the container 2 must be removed from the
    Gas pressure container 7 are filled. This can happen either before, during or after the evacuation. When filling after the evacuation, the opening 6 must be opened accordingly, which can function, for example, in a contactless manner by transmitting electromagnetic waves.
    In this exemplary embodiment, the gas pressure container 7 is dimensioned such that, after opening the opening 6, the noble gas (helium) takes up about half the nominal volume of the container 2 (at an ambient pressure of about 1 bar). (This results in a differential pressure between the inside of the container 2 and the space between the container 2 and the essentially gas-tight bag 4 of about 1 bar, since the space is indeed evacuated.)
    An exemplary embodiment of the set according to the invention comprising the flexible container 2 and the gas pressure container 7 is shown photographically in FIG. 2a. It can be seen how the gas pressure container 7 is connected to the container 2 via a small (black) hose. The opening of the container 2 can be closed, the closing mechanism in this exemplary embodiment being assigned to the gas pressure container 7 or arranged therein. The container 2 also has further connections, which can be seen on the right-hand side of the image and are used, for example, for filling and emptying the container 2.
    The exemplary container 2 shown in FIG. 2a is designed as a so-called single-use bag, i. H. it is intended for disposal after a single use.
    10/17
    Such containers can have a nominal volume of, for example, 10 liters.
    2b shows the container 2 together with the gas pressure container 7 in the state completely encased or surrounded by the gas-permeable layer 3 and arranged inside the bag 4. After the bag 4 has been closed, the arrangement is as shown in FIG. 2b. (The detector 8 is not shown in FIG. 2b.) It should be pointed out that, in the evacuated state, there will of course as a rule no longer be any distance between the gas-permeable layer 3 and the container 2 and the bag 4. These distances are only shown in FIG. 2b for the sake of clarity.
    The gas pressure container can then release a defined amount of helium into the container 2. For example, a special valve can be used for this. The gas pressure container 7 (also called “helium applicator”) is also intended for single use in the present case, but can of course also be used
    Reuse trained.
    When the container 2 is filled with the helium from the gas pressure container 7, there is a gas-tight fluid connection between the gas pressure container and the interior of the container 2 towards the outside (i.e. to the space between the container 2 and the bag 4).
    Due to the relatively small amount of helium, an overpressure (i.e. a pressure in the container 2 that far exceeds the normal ambient pressure level of 1 bar) is avoided.
    As already mentioned, the evacuation can take place before or after the helium has been introduced into the container 2. However, a too long waiting time between the filling of the container 2 and the detection of the helium by the detector 8 should not elapse, since otherwise diffusion of the helium through the container 2 can falsify the measurement result.
    11/17
    In any case, a leak in the container 2 is inferred if the amount of helium detected by the detector 8 exceeds a certain limit value.
    A further advantage of using the gas-permeable layer can be that the volume to be evacuated is essentially gas-tight bag 4, which increases the ratio of the helium (if there is a leak) to the ambient air.
    Whether or not there is a leak (because, for example, the limit value has been exceeded) can be output, for example, via a user interface on the detector 8.
    Overall, the invention can ensure a lower mechanical load on the container 2 to be checked, which reduces the safety risk and the test effort.
    Innsbruck, on May 11, 2017
    12/17
    81627 32 / eh
    权利要求:
    Claims (16)
    [1]
    1. A method for checking the tightness of a flexible container (2) for a fluid, in particular a fluid medicament, wherein
    - The container (2) is at least partially - preferably completely - covered with a gas-permeable layer (3),
    - The container (2) including the gas-permeable layer (3) is arranged in a flexible, essentially gas-tight bag (4),
    - The essentially gas-tight bag (4) is evacuated by pumping out through a bag opening (5),
    - The container (2) is filled with an inert gas, and
    - The presence of noble gas, which escapes from the container (2) through the gas-permeable layer (3) via the bag opening (5), is detected.
    [2]
    2. The method according to claim 1, characterized in that the filling of the
    Container (2) takes place in that the container (2) is brought into fluid connection via an opening (6) with a gas pressure container (7) filled with the inert gas.
    [3]
    3. The method according to claim 2, characterized in that the
    Gas pressure container (7) before evacuation - is preferably arranged completely within the essentially gas-tight bag (4).
    [4]
    4. The method according to any one of the preceding claims, characterized in that helium is used as the noble gas.
    [5]
    5. The method according to any one of the preceding claims, characterized in that the substantially gas-tight bag (4) is kept evacuated by constant pumping.
    [6]
    6. The method according to any one of the preceding claims, characterized in that a detector (8) is used to detect the presence of the noble gas emerging through the bag opening.
    [7]
    7. The method according to any one of the preceding claims, characterized in that the flexible container (2) - preferably exactly once for storing and / or transporting a fluid - preferably a liquid medicament - is used if an amount of the bag opening (5 ) escaping, detected noble gas does not exceed a threshold value.
    [8]
    8. The method according to claim 7, characterized in that the container (2) is disposed of after use for storage and / or transport of the fluid.
    [9]
    9. The method according to any one of the preceding claims, characterized in that the method is carried out on a - preferably completely emptied container (2).
    [10]
    10. Set off
    - A flexible container (2) for a fluid, in particular a fluid drug, and
    - A gas pressure container (7) for receiving a noble gas, the container (2) having an opening (6) which can be closed essentially gas-tight and which is designed such that an externally gas-tight fluid connection between the container (2) and the
    Gas pressure container (7) can be manufactured.
    [11]
    11. Set according to claim 10, characterized in that the gas pressure container (7) is connected to the container via the closable opening (6), preferably a hose and / or pipe connection being present.
    [12]
    12. Set according to claim 10 or 11, characterized in that a nominal capacity of the gas pressure container (7) is such that a volume of the noble gas present at ambient pressure does not exceed twice the nominal capacity of the container (2).
    [13]
    13. Set according to claim 12, characterized in that a nominal capacity of the gas pressure container (7) is such that a
    13/17
    81627 32 / eh
    [14]
    14. Set according to claim 13, characterized in that a nominal capacity of the gas pressure container (7) is such that a volume of the noble gas at ambient pressure does not exceed three quarters - preferably half - of the nominal capacity volume of the container (2).
    14/17
    81627 32 / eh
    Ambient pressure volume of the noble gas does not exceed the volume of the container (2).
    [15]
    15/17
    81627, MITS GmbH
    Fig. 1
    Fig. 2b
    15. Set according to one of claims 10 to 14, characterized in that the container (2) is so flexible that it can be substantially completely emptied without using a vacuum.
    16. Use of a set according to one of claims 10 to 15 in a method according to one of claims 1 to 9.
    Innsbruck, on May 11, 2017
    [16]
    16/17
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    DE102015005833A1|2015-05-07|2016-11-10|Sartorius Stedim Biotech Gmbh|Method and device for an integrity test of a test container|
    DE102016000365A1|2016-01-15|2017-07-20|Sartorius Stedim Biotech Gmbh|Method and device for carrying out an integrity test on a flexible test container|
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    AT600142017|2017-02-24|ATGM8004/2019U| AT16562U1|2017-02-24|2017-05-12|Method for checking the tightness of a flexible container|
    PCT/AT2018/060050| WO2018152561A1|2017-02-24|2018-02-23|Method for inspecting a seal of a flexible container|
    EP18719739.7A| EP3500833B1|2017-02-24|2018-02-23|Method for inspecting a seal of a flexible container|
    SG11201903073VA| SG11201903073VA|2017-02-24|2018-02-23|Method for inspecting a seal of a flexible container|
    CN201880004508.5A| CN109983316B|2017-02-24|2018-02-23|Method for testing the tightness of a flexible container and use of an assembly in a method|
    US16/374,020| US11262268B2|2017-02-24|2019-04-03|Method for inspecting a seal of a flexible container|
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