Method and device for handling a sterilisation container
The method and device for handling sterilization containers use a sealing bell to create a measuring chamber for pressure and volume measurement, addressing the challenge of leak testing without opening the container, ensuring reliable leak testing and sterilization integrity.
Patent Information
- Application Number
- PCT/EP2025/069220
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-07-08
- Filing Date
- 2025-07-04
- Publication Date
- 2026-01-15
AI Technical Summary
Existing methods for handling sterilization containers lack a reliable and efficient way to test for leak tightness without opening the container, which can lead to errors due to misplacement or improper reattachment of closures, compromising the integrity of the sterilization process.
A method and device that utilize a sealing bell to create a measuring chamber within the sterilization container, allowing for the generation of negative pressure to measure the pressure profile over time, combined with a volume measurement, to determine if the container meets predetermined tightness criteria, ensuring accurate leak testing and subsequent sterilization without opening the container.
Ensures reliable leak testing and sterilization by maintaining the container's integrity, preventing errors from re-opening and ensuring that only leak-tight containers are used for sterilization, thereby guaranteeing the sterility of the contents.
Smart Images
Figure EP2025069220_15012026_PF_FP_ABST
Abstract
Description
[0001] Method and device for handling a sterilization container
[0002] The invention relates to a method and a device for handling a sterilization container.
[0003] WO 2016 / 039 647 A2 shows a sterilization container and a sterilization device.
[0004] German patent DE 103 45 492 A1 discloses a container enclosed in a sterilization chamber. The container has semipermeable, filtered passages that allow sterilization media to enter the container. The sterilization chamber has a vacuum pump for evacuating the chamber and a cassette containing liquid hydrogen peroxide, the hydrogen peroxide being vaporized in a vaporizer and filling the sterilization chamber with hydrogen peroxide in the vapor phase.
[0005] WO 2022 / 172 304 A1 shows a sterilization chamber with a pump and tubing, and a container placed inside the chamber. The device measures both the weight of the container and the instruments it contains, and the volume occupied by the container and instruments, in order to determine a density value for the contents of the sterilization chamber. Depending on the density value, the sterilization process is varied, for example, the amount of steam, the temperature and pressure during washing and drying, and the overall handling time of the container.
[0006] CN 2 11 927 208 U shows a portable device for testing a sterilization box.
[0007] JP S62 67418 shows a procedure for checking for leakage.
[0008] The CN 1 13 367 302 A shows a tester for the tightness of a sterilization box.
[0009] US 2013 / 0280134A1 depicts a sterilization container. DE 112019005589T5 depicts leak integrity indicators for sterilization containers.
[0010] It is therefore an object of the invention to provide a new method and a new device for handling a sterilization container.
[0011] This problem is solved by the subject matter of the main claim and the subsidiary claim.
[0012] A method for handling a sterilization container, wherein the sterilization container has a housing with an opening, a closure for the opening and at least one filter, wherein the sterilization container is permeable to gaseous water and to at least some of the components of air in the area of the at least one filter, and wherein the method comprises the following steps:
[0013] A) A sealing bell is placed over the at least one filter of the sterilization container sealed with the closure, wherein the sealing bell together with the sterilization container defines a measuring chamber comprising a free volume in the sterilization container and a first volume on the outside of the sterilization container, wherein the free volume is in fluid communication with the first volume via the at least one filter, and a negative pressure is generated in the measuring chamber via the sealing bell.
[0014] B) A measurement of the pressure profile over time of the negative pressure in the measuring chamber is carried out,
[0015] C) preferably a measurement is carried out to determine a volume measurement value that characterizes the volume of the measuring space,
[0016] D) It is determined whether the sterilization container meets a predetermined tightness criterion, wherein the tightness criterion depends on the pressure profile over time of the negative pressure in the measuring chamber and preferably on the volume measurement.
[0017] This method advantageously allows for a leak test of the sterilization container. The additional determination of the volume measurement enables a better assessment of the leak tightness, as different sterilization container sizes or pre-filling before the volume measurement lead to changes in the free volume and thus also to changes in the pressure profile over time. The volume measurement, which characterizes the free volume in the sterilization container, includes, in particular, the free volume within the sterilization container and the volume enclosed by the sealing bell. Since the volume enclosed by the sealing bell is predetermined or defined by the design, the volume measurement in this case characterizes the free volume in the sterilization container. Furthermore, the volume enclosed by the sealing bell is typically significantly smaller than the free volume in the sterilization container.
[0018] A method for handling a sterilization container, wherein the sterilization container has a housing with an opening, a closure for the opening and at least one filter, wherein the sterilization container is permeable to gaseous water and to at least some of the components of air in the area of the filter, comprises the following steps:
[0019] AA) Objects are inserted into the housing through the opening when the closure is open,
[0020] BB) The opening of the housing is closed with the closure, CC) A sealing bell is placed over the filter, and a vacuum is created in the sterilization container with the sealing bell, DD) A measurement of the pressure profile over time in the sterilization container is carried out, and depending on the pressure profile over time, it is determined whether the sterilization container meets a predetermined sealing criterion.
[0021] EE) if the sterilization container meets the specified tightness criterion, the items in the sterilization container sealed in step BB) are sterilized and thus become sterile goods.
[0022] This procedure enables reliable sterilization without opening the sterilization container between steps BB and EE. This is possible because the items to be sterilized are already placed in the sterilization container during the leak test. This procedure ensures that the leak test in step DD is meaningful. Errors that could occur, for example, due to the closure being mixed up after the leak test or incorrectly reattached after the test, are eliminated. The procedure provides sterilized goods.
[0023] According to a preferred embodiment, the sterilization container is sterilized after step D). The result is a sterilization container with sterile goods whose leak tightness has been tested.
[0024] According to a preferred embodiment, the sterilization container is sterilized provided that it meets the specified leak-tightness criterion. This increases the assurance that no leaking sterilization containers are sterilized.
[0025] According to a preferred embodiment, the sterilization container is not sterilized if the specified tightness criterion is not met.
[0026] According to a preferred embodiment, the sterilization container, sealed with the closure, remains closed between step A) and sterilization. This ensures that the leak test remains valid and prevents errors caused by an interim opening.
[0027] According to a preferred embodiment, items to be sterilized are placed in the housing before step A), and the sterilization container is closed. This ensures that the free volume reduced by the items is measured correctly in step C), and the leak test can be performed with the items already inserted.
[0028] According to a preferred embodiment, before step A), items to be sterilized are inserted into the housing through the opening with the closure open, and the sterilization container is closed.
[0029] In a preferred embodiment, the housing is designed as a tub, and the closure is designed as a lid. This facilitates handling of the sterilization container. In a preferred embodiment, at least one filter is arranged in the area of the closure. This facilitates replacement.
[0030] According to a preferred embodiment, the at least one filter is arranged in the area of the housing. This enables a stable connection between the at least one filter and the housing.
[0031] According to a preferred embodiment, in step D) a leak rate is determined as a function of the pressure profile of the negative pressure in the measuring chamber over time, and the tightness criterion depends on the leak rate. Leak rates are meaningful for a tightness test because they correlate with the size of the leaks.
[0032] According to a preferred embodiment, in step D) the leakage rate is determined as a function of the volume measurement. The leakage rate is typically dependent on the volume of the measuring chamber.
[0033] According to a preferred embodiment, the tightness criterion depends on a leakage rate limit, and the determined leakage rate is compared with the leakage rate limit. This allows for a clear definition of tightness.
[0034] According to a preferred embodiment, a previously separated test volume is brought into fluid contact with the measuring chamber via the sealing bell, and the volume measurement is determined as a function of the resulting pressure change. This enables volume measurement with minimal equipment and comparatively high accuracy.
[0035] According to a preferred embodiment, the isolated test volume upstream of the fluid connection with the measuring chamber has a pressure that differs from the pressure in the measuring chamber. This makes the measurement more accurate. According to a preferred embodiment, both step B) and step C) are performed using the vacuum generated in step A). The volume measurement can advantageously be carried out under vacuum in the sterilization container, and using the already generated vacuum reduces the test duration.
[0036] According to a preferred embodiment, the volume measurement is performed using an imaging technique. Imaging techniques can be performed relatively quickly.
[0037] According to a preferred embodiment, the pressure profile over time is measured using a pressure sensor located in the first volume. This eliminates the need for a pressure sensor in the sterilization container.
[0038] According to a preferred embodiment, the sterilization container is sealed if it meets the specified tightness criterion. This prevents errors caused by using sterilization containers that do not meet the tightness criterion.
[0039] According to a preferred embodiment, a sterilizing agent in liquid or gaseous form is introduced into the sterilization container and heated. This enables reliable sterilization.
[0040] According to a preferred embodiment, the sterilizing agent is introduced into the sterilization container via the at least one filter. Therefore, the provision of additional openings for the sterilizing agent is not necessary.
[0041] A device for handling a sterilization container, which has a housing with an opening, a closure for the opening, and at least one filter permeable to gaseous water and at least some of the components of air, wherein the device comprises a sealing bell, a vacuum generation device, a first measuring device, a second measuring device, and an evaluation device, wherein the sealing bell is configured to allow the sealing bell to be placed above the at least one filter of a sterilization container closed with a closure, and thereby, together with the sterilization container, to define a measuring chamber comprising a free volume in the sterilization container and a first volume on the outside of the sterilization container, wherein the free volume is in fluid communication with the first volume via the at least one filter.wherein the vacuum generation device is at least temporarily in fluid contact with the sealing bell and is configured to generate a vacuum in the measuring chamber, wherein the first measuring device is configured to perform a measurement of the pressure profile of the vacuum in the measuring chamber over time, wherein the second measuring device is configured to perform a measurement to determine a volume measurement value characterizing the volume of the measuring chamber, and wherein the evaluation device is configured to check whether the sterilization container meets a predetermined tightness criterion, wherein the tightness criterion depends on the pressure profile of the vacuum in the measuring chamber over time and on the volume measurement value.
[0042] A device for handling a sterilization container with a housing having an opening and a closure for the opening, wherein the sterilization container has a filter, wherein the sterilization container is permeable to gaseous water and to at least some of the components of air in the area of the filter, wherein the device has a sealing bell, a vacuum generating device, a measuring device and an evaluation device, wherein the sealing bell is configured to allow the sealing bell to be placed over the filter of a sterilization container closed with a closure, wherein the vacuum generating device is at least temporarily in fluid contact with the sealing bell and is configured to generate a vacuum in the sterilization container, wherein the measuring device is configured toto perform a measurement of the pressure profile over time in the sterilization container, wherein the evaluation device is configured to determine, depending on the pressure profile over time, whether the sterilization container meets a predetermined tightness criterion, wherein the sterilization device is configured to sterilize the objects in the sealed sterilization container and thus make them sterile.
[0043] According to a preferred embodiment, the sterilization device is designed to introduce the sterilizing agent into the sterilization container via the sealing bell. This allows the sealing bell to be used for both leak testing and sterilization, thus accelerating the sterilization process. This device can be combined with the preceding device or its individual features.
[0044] Further details and advantageous embodiments of the invention will become apparent from the exemplary embodiments described below and illustrated in the drawings, which are in no way to be understood as limiting the invention, as well as from the dependent claims. It is understood that the features mentioned above and those to be explained below can be used not only in the combinations specified, but also in other combinations or individually, without departing from the scope of the present invention. The drawings show:
[0045] Fig. 1 shows a longitudinal section of the housing of a sterilization container.
[0046] Fig. 2 shows a longitudinal section of the housing of Fig. 1 with a filling and with a closure in the open state,
[0047] Fig. 3 shows a longitudinal section of the sterilization container from Fig. 2 in its closed state.
[0048] Fig. 4 shows a longitudinal section of a test device for the sterilization container of Fig. 3 for carrying out a leak test.
[0049] Fig. 5 shows a longitudinal section of the sterilization container of Fig. 4 with a seal, Fig. 6 shows a longitudinal section of a sterilization device for the sterilization container of Fig. 5,
[0050] Fig. 7 shows a device for leak testing according to Fig. 4 and for sterilization according to Fig. 6 and
[0051] Fig. 8 shows a top view of the sterilization container from Fig. 6 and Fig. 7.
[0052] In the following, identical or similarly functioning parts are designated with the same reference symbols and are usually described only once. The description builds upon itself across figures to avoid unnecessary repetition.
[0053] Fig. 1 shows a longitudinal section of the housing 30 of a sterilization container 20. Such a sterilization container 20 is also referred to as a sterile container or sterilization container. These sterilization containers 20 are particularly often designed as rigid or semi-rigid containers.
[0054] The housing 30 has a base 31, side walls 32, an opening 33, handles 34 and locking elements 35.
[0055] The handles 34 are shown folded downwards and can be folded outwards for carrying.
[0056] In the exemplary embodiment, the housing 30 is designed as a tray with an upper opening 33. However, the opening 33 can also be provided, for example, on the side or at the bottom.
[0057] Fig. 2 shows in a longitudinal section the sterilization container 20 with the housing 30 and with a closure 50 in the open or unclosed state.
[0058] Items 91A and 92A have been inserted into the housing 20 through the opening 33 and, in the exemplary embodiment, rest on the base 31 of the housing. Items 91A and 92A are items to be sterilized. Examples of items 91A and 92A are surgical instruments, surgical tools, syringes, implants, packaging, containers, and surgical devices. These items are often placed in sieve baskets.
[0059] The closure 50 preferably has at least one filter 51, 52, a seal 53 and closing elements 55. Preferably, the closure 50 has at least two filters 51, 52.
[0060] The closure 50 is preferably designed as a lid.
[0061] The at least one filter 51, 52 is designed to allow water vapor (gaseous water) and gases such as oxygen, nitrogen, and carbon dioxide to pass through, while preventing bacteria and germs from passing through. It can also be described as a bio-barrier filter.
[0062] The at least one filter 51, 52 can, for example, be designed to allow only molecules smaller than 0.15 pm or smaller than 0.20 pm to pass through. The relevant size depends on the intended use and location of the items 91A, 92A. Bacteria and germs larger than these pore sizes cannot pass through the filter.
[0063] The at least one filter 51, 52 can, for example, be mechanically designed as a labyrinth of ring ribs, which prevents the passage of bacteria and germs, but allows smaller molecules to pass through.
[0064] The at least one filter 51, 52 can also consist of paper or a fleece as filter material.
[0065] The at least one filter 51, 52 may also include a bio-barrier valve.
[0066] The seal 53 serves to create a high degree of tightness between the housing 30 and the closure 50 when the sterilization container 20 is closed. The locking elements 55, in conjunction with the locking elements 35 of the housing 30, ensure that the closure 50 is securely held against the housing 30.
[0067] Fig. 3 shows in a longitudinal section the sterilization container 20 with housing 30 closed by the closure 50.
[0068] Items 91A and 92A are in sterilization container 20, but they are not yet sterilized.
[0069] Fig. 4 shows in a longitudinal section the sealed sterilization container 20 with a test device 80 for determining the tightness of the sterilization container 20.
[0070] The test device 80 has a measuring device 81, a sealing bell 82, a vacuum generating device 84, a controllable valve 85, a pressure sensor 86, a pressure generating device 70, a test volume 72 and a controllable valve 74.
[0071] The test device 80 functionally has a first measuring device 111 for measuring the pressure profile over time, a second measuring device 112 for measuring the volume measurement value and an evaluation device 113 for determining whether the sterilization container 20 meets the specified tightness criterion.
[0072] The sealing bell 82 is placed over the at least one filter 51 , 52 and seals the area around the at least one filter 51 , 52 on the outside of the sterilization container 20 against the environment.
[0073] The sealing bell 82 preferably does not seal, or does not completely seal, the connection area between the housing 30 and the closure 50. This allows, on the one hand, a seal in the area of the at least one filter 51, 52 and, on the other hand, a measurement of the tightness in the connection area between the housing 30 and the closure 50. The sealing bell 82 preferably seals only a partial area 120 of the sterilization container (see Fig. 8), wherein the at least one filter 51, 52 is located in this partial area 120. The partial area 120 is thus sealed against the outer surface 122 of the sealing bell 82.
[0074] The connection area between the housing 30 and the closure 50 is preferably located at least partially outside the sealing bell 82. This makes it advantageous to test the tightness of the sterilization container 20.
[0075] The sealing bell 82, together with the sterilization container 20, defines a measuring chamber 88, which comprises a free volume 37 of the sterilization container 20 and a first volume 83 on the outside of the sterilization container 20, wherein the first volume 83 is defined in the exemplary embodiment by the sealing bell 82.
[0076] The vacuum generating device 84 is connected to the sealing bell 82 via the controllable valve 85 and is in fluid communication with the measuring chamber 88 via the controllable valve 85. The measuring device 81 is preferably configured to activate the vacuum generating device 84, and the vacuum generating device 84 is configured to generate a vacuum. The vacuum generating device 84 can, for example, operate with a water jet pump and / or a diaphragm pump.
[0077] The vacuum can be generated, for example, in the range of rough vacuum or fine vacuum. Rough vacuum lies between 1 mbar and just below ambient pressure, which is approximately 1.013 mbar at sea level. Fine vacuum lies between 0.001 mbar and 1 mbar.
[0078] By generating the negative pressure, the side wall of the sealing bell 82 is pressed against the sterilization container 20, resulting in a good seal.
[0079] The sealing bell 82 can be designed to be elastic in the connection area with the sterilization container 20 to further improve the seal. Advantageously, the sealing bell 82 can have a silicone seal that seals between the sealing bell 82 and the sterilization container 20. This allows the sealing bell 82 to be easily placed onto the sterilization container 20, and a good seal can be created by generating a vacuum.
[0080] The pressure sensor 86 is located in the first volume 83 and enables the measurement of the pressure profile over time in the sterilization container 20. Since the filter 51, 52 is permeable to most small molecules, the pressure in the first volume 83 corresponds to the pressure in the sterilization container 20. The pressure in the sterilization container 20 can be measured by the pressure sensor 86 located in the first volume 83, which is defined outside the sterilization container 20. Alternatively, a pressure sensor 86 could be permanently installed in the sterilization container 20 and directly measure the pressure there. In this case, the pressure could be transmitted to the measuring device 81, for example, wirelessly or via an electrical connection provided on the outside of the sterilization container 20.
[0081] To determine the tightness of the sterilization container 20, after the sealing bell 82 is attached, the valve 85 is opened (switched to conducting), so that a vacuum is generated in the measuring chamber 88, or in the first volume 83 and in the free volume 37 of the sterilization container 20, via the vacuum generation device 84. Subsequently, the valve 85 is closed (switched to non-conductive), so that the sterilization container 20 and the sealing bell 82 ideally define a closed measuring chamber 88.
[0082] Ideally, the negative pressure in measuring chamber 88 would remain constant. In practice, however, the sterilization container 20 is not 100% airtight, even in the area outside the at least one filter 51, 52. Even brand-new sterilization containers 20 have a leakage rate. A very low leakage rate due to very small openings is usually acceptable, since bacteria and germs cannot pass through such small openings. When measuring under negative pressure in the sterilization container 20, the leakage rate corresponds to the volume of gas entering it per unit of time. The incoming gas leads to an increase in pressure in the sterilization container 20 and thus influences the measured pressure profile.
[0083] The permissible leakage rate for a sterilization container 20 depends on the respective standard, the intended use and the requirements of the sterilization process used.
[0084] A sterilization container must guarantee the sterility of its contents for a defined period after sterilization. A certain leakage rate is permissible as long as it does not lead to contamination and the sterile barrier is maintained.
[0085] The tightness criterion can be defined depending on various criteria:
[0086] The pressure change rate (AP / At) caused by the leak can be determined from the pressure profile over time within a predefined pressure range (e.g., from -200 mbar to -100 mbar or from -100 mbar to -50 mbar). The pressure range can also be defined as a function of a measurement duration, preferably starting at a predefined pressure (e.g., -200 mbar or -100 mbar). For those skilled in the art, "pressure" refers to the differential pressure relative to the ambient pressure. The pressure change rate can then be compared to a pressure change rate limit value, which depends on the measured volume. Since the pressure change rate (e.g., 0.10 mbar / min) at a predefined volume leak rate (e.g.,Since the pressure change rate limit (20 ml / min gas entering the sterilization container 20) is smaller for a larger sterilization container 20 than for a smaller sterilization container 20, this tightness criterion is more accurate than a fixed pressure change rate limit value, provided that sterilization containers 20 of different sizes are used.
[0087] The leak rate AV / At can be determined within a predefined pressure range (e.g., from -200 mbar to -100 mbar or from -100 mbar to -50 mbar). The pressure range can also be defined as a function of a measurement duration, preferably starting at a predetermined pressure. The leak rate can be determined from the pressure profile over time and the measured volume.
[0088] The leak rate (e.g., 20 ml / min) can then be compared to a leak rate limit (e.g., 0.11 mbar / min). The leak rate limit can be chosen independently of the volume measurement or dependent on it. The leak rate (e.g., 20 ml / min) alone allows for an estimation of the tightness or the size of the leakage opening. However, since leakage openings can occur at various locations in a large container, the leak rate limit can also be determined based on the volume measurement.
[0089] It is critical if the openings leading to leakage are so large and the sterilization container 20 is so leaky that bacteria can enter the sterilization container 20 from the outside. This can be the case, for example, if the seal 53 (see Fig. 2) is damaged or the closure 50 does not fit the housing 30 properly.
[0090] A leak causes the pressure in the sterilization container 20 to increase over time t in the direction of atmospheric pressure, as shown by the measuring device 81 with a slight positive slope after the creation of the vacuum.
[0091] Depending on the pressure profile over time, it can therefore be determined whether the sterilization container 20 meets a specified tightness criterion.
[0092] Preferably, a leak rate measurement is performed. The leak rate q is proportional to the rate of change of pressure over time, i.e., to the derivative of the pressure curve. Furthermore, when considering the rate of change of pressure, the leak rate q depends on the measurement volume. For a given measurement volume, such as that of an empty sterilization container 20 of a given size, which approximately corresponds to the volume of the sterilization container 20 or, more precisely, to the sum of the volume of the sterilization container 20 and the first volume 83 of the sealing bell 82, the pressure change over a given period can be used directly as a leak tightness criterion. Preferably, the leak tightness criterion depends on the leak rate determined in this way.
[0093] When the sterilization container 20 is partially filled, the free volume 37 available for the gas is less than the total volume of the empty sterilization container 20. Therefore, the relationship between the leakage rate and the pressure profile changes as the sterilization container 20 is filled with the items 91S, 92S.
[0094] Investigations have shown that the leakage rate in reality depends on the size of the free volume 37 in the sterilization container 20. An empty sterilization container 20, for example, has a free volume of 10.0 l or 100%. A sterilization container 20 in which the free volume, due to the loading with items 91A, 92A, is, for example, only 40% of the total volume of an empty sterilization container 20, or in the example given, only 4.0 l, has a steeper pressure change over time than an empty sterilization container 20, assuming the same passage of molecules or the same leakage rate.
[0095] In other words, a pressure change with a measured slope may not be acceptable for an empty sterilization container 20, but may be acceptable or meet a tightness criterion for a sterilization container 20 loaded with items 91 A, 92A.
[0096] Therefore, it is advantageous to carry out a measurement to determine a volume measurement value characterizing the free volume 37 in the sterilization container 20, or more precisely, a volume measurement value characterizing the volume of the measuring chamber 88, and subsequently, when determining whether the sterilization container 20 meets the specified tightness criterion, to define the tightness criterion as a function of the pressure profile over time of the negative pressure in the sterilization container 20 and the volume measurement value.
[0097] Determining a volume measurement value that characterizes the volume of the measuring chamber 88 can be carried out in different ways. In the exemplary embodiment, a volume measurement is performed by adding the additional test volume 72 with known volume, pressure and, if necessary, temperature, wherein the test volume has a pressure before being added that differs from the pressure in the sterilization container 20.
[0098] For this purpose, the measuring device 81 can switch the control valve 74 to non-conductive mode, and a predetermined pressure is generated in the test volume by the pressure generating device 70. For this purpose, the pressure generating device 70 can, for example, open a valve to the environment, thereby establishing the ambient pressure with air, and then close the valve again.
[0099] The test volume 72 is then brought into fluid contact with the measuring chamber 88 via the controllable valve 74, and the volume of the measuring chamber 88 can be calculated from the resulting pressure change (possibly taking a temperature change into account). This volume is composed of the first volume 83 and the free volume 37, and thus also characterizes the free volume 37. The calculation can be performed considering air as an ideal gas.
[0100] Alternatively, the volume measurement can be performed using an imaging technique, for example, with a camera or laser scanning. In particular, the free volume 37 can be measured using an imaging technique, and the first volume 83 can be assumed to be constant.
[0101] Provided that all items 91 S, 92S are made of the same material, for example stainless steel, and do not have any closed cavities, the volume measurement can also be made from the density of the material and a measurement of the mass of the material.
[0102] Fig. 5 shows a longitudinal section of the sterilization container 20. The sterilization container 20 has met the leak tightness criterion, and preferably the sterilization container 20 is sealed with one or more seals 56 in this case to indicate that it has successfully passed the leak tightness test.
[0103] In the exemplary embodiment, seals 56 are provided in the area of the locking elements 55, 35, and preferably the seal 56 is destroyed when the locking elements 55, 35 are actuated as required to open the sterilization container 20. The seal(s) 56 can also be attached in the transition area between the closure 50 and the housing 30 to indicate that the sterilization container 20 has been opened.
[0104] Fig. 6 shows in a longitudinal section the sterilization container 20, which is arranged in a schematically represented sterilization device 94.
[0105] The sterilization device 94 has a housing 95, a heater 96, a steam generating device 97 and a sealing bell 98.
[0106] The sealing bell 98 preferably has all the functions of the sealing bell 82, or at least some of them.
[0107] The sealing bell 98 defines a space 99 which is in fluid contact with the inside of the sterilization container via at least one filter 51 , 52.
[0108] Steam is generated via the steam generation device 97 and supplied to the room 99 and thus also via the at least one filter 51 , 52 to the interior of the sterilization container 20.
[0109] The heating element 96 heats the sterilization device 94 and thus also the steam in the sterilization container 20. After reaching a temperature of, for example, 134 °C, this temperature is typically maintained for a predetermined period of time to achieve sterilization and destroy all bacteria and germs inside the sterilization container 20. This also applies to the area of the at least one filter 51, 52. Through sterilization, the items 91 A, 92A become sterile goods 91 S, 92S, which can be used, for example, for surgery.
[0110] In this example, water or steam is used as the sterilizing agent.
[0111] Other sterilizing agents can also be used. Sterilizing agents are also referred to as sterilizing agents.
[0112] Preferably, the sterilizing agent comprises at least one first sterilizing agent from a group of sterilizing agents consisting of:
[0113] - Water,
[0114] - Hydrogen peroxide with plasma phase,
[0115] - Hydrogen peroxide without plasma phase,
[0116] - Ethylene oxide, and
[0117] - Formaldehyde.
[0118] In summary, the procedure for providing sterile goods 91 S; 92S in the sterilization container 20 comprises the following steps:
[0119] A) A sealing bell 82 is placed over the at least one filter 51, 52 of the sterilization container 20 which is closed with the closure 50, wherein the sealing bell 82 together with the sterilization container 20 defines a measuring chamber 88 which comprises a free volume 37 in the sterilization container 20 and a first volume 83 on the outside of the sterilization container 20, wherein the free volume 37 is in fluid communication with the first volume 83 via the at least one filter 51, 52, and a negative pressure is generated in the measuring chamber 88 via the sealing bell 82.
[0120] B) A measurement of the pressure profile over time of the negative pressure in measuring chamber 88 is carried out,
[0121] C) A measurement is carried out to determine a volume measurement value that characterizes the volume of the measuring space,
[0122] D) It is determined whether the sterilization container 20 meets a specified tightness criterion, whereby the tightness criterion depends on the pressure profile over time of the negative pressure in the measuring chamber 88 and on the volume measurement.
[0123] A major advantage of the method is that the sterilization container 20 with the items 91A, 92A contained therein is sealed once, and in the sealed state the leak test is carried out taking into account the free volume 37 and preferably subsequently also the sterilization.
[0124] In established procedures, the first step involves testing the leak tightness of a tray / lid combination, for example, with a smoke or water test. If the test is passed, the tray / lid combination is opened and cleaned again, and the instruments are placed in the tray. The tray is then resealed with the lid, and sterilization takes place. However, errors can occur when replacing the lid. For example, the lid might not be properly aligned, or dirt might enter the sealing area. Furthermore, lids can be mixed up, resulting in a lid that is less suitable for the corresponding tray being used. Therefore, the previously performed leak test becomes invalid due to the re-opening.
[0125] In contrast, with the procedure described above, the sterilization container 20 is not opened between the leak test and the sterilization, and the safety of the sterilized goods is increased.
[0126] Fig. 7 shows in schematic longitudinal section a device 104 which can perform both a leak test and a sterilization.
[0127] The device 104 represents an advantageous combination of the test device 80 of Fig. 4 and the sterilization device 94 of Fig. 7.
[0128] The device 104 has a housing 106, a control device 100, a sealing bell 101, the vacuum generating device 84 with the controllable valve 85, the pressure generating device 70, the test volume 72 and the controllable valve 74, the steam generating device 97, the pressure sensor 86, a temperature sensor 107 and a sealing device 102.
[0129] The control device 100 is designed to control the vacuum generating device 84 with the controllable valve 85, the steam generating device 97, and the sealing device 102.
[0130] The control device 100 is designed to receive and evaluate measurement signals from the pressure sensor 86 and the temperature sensor 107.
[0131] The sealing bell 101 defines a space 103 which is in fluid contact with the interior of the sterilization container 20 via at least one filter 51 , 52.
[0132] The sealing bell 101 preferably enables all functions of the sealing bell 82 and / or 98, or at least some of them.
[0133] The control device 100 can generate a vacuum in chamber 103 and in the sterilization container 20 for the leak test via the vacuum generation device 84 and then record the pressure profile over time with the pressure sensor 86. Furthermore, the volume measurement value characterizing the volume of the measuring chamber 88 can be determined via the pressure generation device 70, the test volume 72, and the controllable valve 74. Depending on the pressure profile over time and the volume measurement value, the leak tightness can then be tested.
[0134] If the tightness criterion is met, a vacuum can be created again if necessary, and then steam can be generated via the steam generation device 97 and supplied to the chamber 103 and the sterilization container 20. Additionally, the interior of the housing 106 can be heated via the heater 96 and monitored, controlled, and / or regulated by the temperature sensor 107. After successful sterilization, the sterilization container 20 is preferably sealed by the sealing device 102.
[0135] The device 104, which can also be called a sterilization device, makes very safe sterilization possible.
[0136] Fig. 8 shows the sterilization container from above. The sealing bell 82, 101 is shown in section. The section 120 of the sterilization container 20, which is sealed by the sealing bell 82, 101, is indicated. It is laterally bounded by the sealing bell 82, 101. The section 120 comprises the at least one filter 51, 52.
[0137] Naturally, various variations and modifications are possible within the scope of the present application.
Claims
Patent claims 1. Method for handling a sterilization container (20), wherein the sterilization container (20) comprises a housing (30) having an opening (33), a closure (50) for the opening (33) and at least one filter (51, 52), wherein the sterilization container (20) is permeable to gaseous water and to at least some of the components of air in the area of the at least one filter (51, 52), and wherein the method comprises the following steps: A) A sealing bell (82, 98, 101) is placed over the at least one filter (51, 52) of the sterilization container (20) which is closed by the closure (50), wherein the sealing bell (82, 98, 101) together with the sterilization container (20) defines a measuring chamber (88) which comprises a free volume (37) in the sterilization container (20) and a first volume (83) on the outside of the sterilization container (20), wherein the free volume (37) is in fluid communication with the first volume (83) via the at least one filter (51, 52), and a negative pressure is generated in the measuring chamber (88) via the sealing bell (82, 98, 101). B) a measurement of the pressure profile over time of the negative pressure in the measuring chamber (88) is carried out, C) a measurement is carried out to determine a volume measurement value characterizing the volume of the measuring space (88), D) It is determined whether the sterilization container (20) meets a specified tightness criterion, whereby the tightness criterion depends on the pressure profile over time of the negative pressure in the measuring chamber (88) and on the volume measurement.
2. Method according to claim 1, wherein the sterilization container (20) is sterilized.
3. Method according to claim 2, wherein the sterilization container (20) is sterilized under the condition that the sterilization container (20) meets the specified tightness criterion.
4. Method according to claim 2 or 3, wherein the sterilization container (20) sealed with the closure (50) remains sealed between step A) and sterilization.
5. Method according to one of claims 2 to 4, in which a sterilizing agent in liquid or gaseous form is introduced into the sterilization container (20) and heated for sterilization.
6. Method according to one of claims 2 to 5, wherein the sterilizing agent is introduced into the sterilization container (20) via the at least one filter (51 , 52).
7. Method according to one of the preceding claims, in which, prior to step A), items to be sterilized (91 A; 92A) are inserted into the housing (30) through the opening (33) with the closure (50) open and the sterilization container (20) is closed.
8. Method according to one of the preceding claims, wherein the housing (30) is designed as a tub and the closure (50) is designed as a lid.
9. Method according to one of the preceding claims, wherein the at least one filter (51 , 52) is arranged in the area of the closure (50) or in the area of the housing (30).
10. Method according to one of the preceding claims, wherein in step D) a leak rate is determined as a function of the pressure profile over time of the negative pressure in the measuring chamber (88), and wherein the tightness criterion depends on the leak rate.
11. Method according to claim 10, wherein in step D) the leak rate is determined as a function of the volume measurement.
12. Method according to claim 10 or 11, wherein the tightness criterion depends on a leak rate limit value, and the determined leak rate is compared with the leak rate limit value.
13. Method according to one of the preceding claims, in which a previously separated test volume (72) is brought into fluid contact with the measuring chamber (88) via the sealing bell (82, 98, 101), and in which the volume measurement value is determined as a function of the resulting pressure change.
14. Method according to claim 13, wherein the separated test volume (72) has a pressure different from the pressure in the measuring chamber (88) prior to the fluid connection with the measuring chamber (88).
15. Method according to claim 13 or 14, wherein both step B) and step C) are carried out using the vacuum generated in step A).
16. Method according to one of the preceding claims, wherein the measurement of the volume measurement value is carried out using an imaging method.
17. Method according to one of the preceding claims, wherein the measurement of the pressure profile over time is carried out with a pressure sensor (86), wherein the pressure sensor (86) is arranged in the first volume (83).
18. Method according to one of the preceding claims, wherein the sterilization container (20) is sealed when the sterilization container (20) meets the specified tightness criterion.
19. Device (80, 94; 104) for handling a sterilization container (20), which has a housing (30) with an opening (33), a closure (50) for the opening (33) and at least one filter (51, 52) permeable to gaseous water and to at least some of the components of air, wherein the device (80, 94; 104) has a sealing bell (82, 98, 101), a vacuum generation device (84), a first measuring device (111), a second measuring device (112) and an evaluation device (113), wherein the sealing bell (82, 98, 101) when placed above the at least one filter (51, 52) of a sterilization container (20) closed by a closure (50) defines, together with the sterilization container (20), a measuring chamber (88) which comprises a free volume (37) in the sterilization container (20) and a first volume (83) on the outside of the sterilization container (20), wherein the free volume (37) is in fluid communication with the first volume (83) via the at least one filter (51, 52), wherein the vacuum generating device (84) is at least temporarily in fluid communication with the sealing bell (82, 98, 101) and is configured to generate a vacuum in the measuring chamber (88), wherein the first measuring device (111) is configured to take a measurement of the to carry out the temporal pressure profile of the negative pressure in the measuring chamber (88), wherein the second measuring device (112) is set up toto perform a measurement to determine a volume measurement value characterizing the volume of the measuring chamber (88), and wherein the evaluation device (113) is configured to check whether the sterilization container (20) meets a predetermined tightness criterion, wherein the tightness criterion depends on the pressure profile of the negative pressure in the measuring chamber (88) over time and on the volume measurement value.
20. Device (80, 94; 104) according to claim 19, in which the sealing bell (82, 98, 101) is configured to seal only a partial area 120 of the sterilization container (20), wherein the partial area (120) comprises the at least one filter (51 , 52).