Method and device for handling a sterilization container

Abstract

A method for handling a sterilization container (20) with a housing (30) having an opening (33) and a closure (50) for the opening (33), wherein the sterilization container (20) has a 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 filter (51, 52), comprises the following steps: A) Objects (91A; 92A) are inserted into the housing (20) through the opening (33) with the closure (50) open, B) the opening (33) of the housing (20) is closed with the closure (50), C) A sealing bell (82) is placed over the filter (51, 52), and a vacuum is created in the sterilization container (20) with the sealing bell (82), D) A measurement of the pressure profile over time in the sterilization container (20) is carried out, and depending on the pressure profile over time, it is determined whether the sterilization container (20) meets a specified tightness criterion. E) if the sterilization container (20) meets the specified tightness criterion, the items (91A; 92A) are sterilized in the sterilization container (20) sealed in step B) and thus become sterile goods (91S; 92S).

Description

[0001] The invention relates to a method and a device for handling a sterilization container.

[0002] WO 2016 / 039 647 A2 shows a sterilization container and a sterilization device.

[0003] It is therefore an object of the invention to provide a new method and a new device for handling a sterilization container.

[0004] This problem is solved by the subject matter of the main claim and the subsidiary claim.

[0005] A method for handling a sterilization container, wherein the sterilization container has a housing with an opening, a closure for the opening and a filter, wherein the sterilization container is permeable in the area of ​​the filter to gaseous water and to at least some of the components of air, and wherein the method comprises the following steps: A) Objects are inserted into the housing through the opening when the closure is open, B) the opening of the housing is closed with the closure, C) A sealing bell is placed over the filter, and a vacuum is created in the sterilization container using the sealing bell. D) 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 specified tightness criterion. E) if the sterilization container meets the specified tightness criterion, the items in the sterilization container sealed in step B) are sterilized and thus become sterile goods.

[0006] This procedure ensures a safe process in which the sterilization container is not opened between steps B) and E). This is possible because the items to be sterilized are already placed in the sterilization container during the leak test. This procedure makes the leak test in step D) 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 items.

[0007] In a preferred embodiment, the housing is designed as a tub and the closure as a lid. Such a sterilization container is easy to handle and test.

[0008] According to a preferred embodiment, the filter is arranged in the area of ​​the closure. This allows for easy replacement of the filter.

[0009] 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 sterilization container over time, and the leak tightness criterion depends on the leak rate. Leak rates provide a meaningful criterion for leak testing, as they depend on the size of the leaks.

[0010] According to a preferred embodiment, the tightness criterion depends on a leak rate limit, wherein the determined leak rate is compared with the leak rate limit.

[0011] According to a preferred embodiment, the pressure profile over time of the negative pressure in the sterilization container is measured in a measuring chamber, wherein the measuring chamber comprises the volume in the sterilization container and a first volume on the outside of the sterilization container, the first volume being in fluid communication with the volume in the sterilization container. This eliminates the need for a pressure sensor inside the sterilization container.

[0012] According to a preferred embodiment, the sterilization container is sealed if it meets the specified sealing criterion. This increases the assurance that only successfully tested sterilization containers are used for the sterilized goods.

[0013] According to a preferred embodiment, in step E) a sterilizing agent, in liquid or gaseous form, is introduced into the sterilization container and heated. This ensures reliable sterilization.

[0014] According to a preferred embodiment, the sterilizing agent is introduced into the sterilization container via the filter. Therefore, no further openings need to be provided in the sterilization container.

[0015] According to a preferred embodiment, the sterilizing agent comprises at least one first sterilizing agent from a group of sterilizing agents consisting of: - Water, - Hydrogen peroxide with plasma phase, - Hydrogen peroxide without plasma phase, - Ethylene oxide, and - Formaldehyde. Water is particularly advantageous, as any residual water in the sterilization container after sterilization is largely unproblematic.

[0016] 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.

[0017] According to a preferred embodiment, the sterilization device includes a heating element and is designed to introduce a liquid or gaseous sterilizing agent into the sterilization container and heat it via the heating element. This enables reliable sterilization.

[0018] 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.

[0019] 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: Fig. 1 in a longitudinal section a housing of a sterilization container, Fig. 2 in a longitudinal section the housing of Fig. 1 with a filling and with a closure in the open state, Fig. 3 in a longitudinal section the sterilization container of Fig. 2 in a closed state, Fig. 4 in a longitudinal section a test device for the sterilization container of Fig. 3 for carrying out a leak test, Fig. 5 in a longitudinal section the sterilization container of Fig. 4 with a seal, Fig. 6 in a longitudinal section a sterilization device for the sterilization container of Fig. 5, and Fig. 7 a device for leak testing according to Fig. 4 and for sterilization accordingly Fig. 6.

[0020] 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.

[0021] Fig. Figure 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. These sterilization containers 20 are primarily designed as rigid or semi-rigid containers.

[0022] The housing 30 has a base 31, side walls 32, an opening 33, handles 34 and locking elements 35.

[0023] The handles 34 are shown folded downwards and can be folded outwards for carrying.

[0024] 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.

[0025] Fig. Figure 2 shows in longitudinal section the sterilization container 20 with the housing 30 and with a closure 50 in the open or unsealed state.

[0026] Items 91A, 92A have been inserted into the housing 20 through the opening 33 and, in the exemplary embodiment, stand on the base 31 of the housing.

[0027] Items 91A and 92A are items to be sterilized. Examples of items 91A and 92A include surgical instruments, surgical tools, syringes, implants, packaging, containers, and surgical devices. These items are often placed in sieve baskets.

[0028] The closure 50 has filters 51, 52, a seal 53 and locking elements 55.

[0029] Filters 51 and 52 are 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.

[0030] Filters 51 and 52 can, for example, be designed to allow only molecules smaller than 0.15 µm or smaller than 0.20 µm to pass through. The relevant size depends on the intended use and location of items 91A and 92A.

[0031] Filters 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.

[0032] Filters 51 and 52 can also have paper or fleece as filter material.

[0033] 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.

[0034] The locking elements 55, in conjunction with the locking elements 35 of the housing 30, enable the closure 50 to be securely held on the housing 30.

[0035] Fig. Figure 3 shows in a longitudinal section the sterilization container 20 with housing 30 closed by the closure 50.

[0036] Items 91A and 92A are in sterilization container 20, but they are not yet sterilized.

[0037] Fig. Figure 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.

[0038] The test device 80 has a measuring device 81, a sealing bell 82, a vacuum generating device 84, a controllable valve 85 and a pressure sensor 86.

[0039] The test device 80 functionally has a measuring device 111 for measuring the pressure profile over time and an evaluation device 113 for determining whether the sterilization container 20 meets the specified tightness criterion.

[0040] The sealing bell 82 is placed over the filter 51, 52 and seals the area around the filters 51, 52 against the environment on the outside of the sterilization container 20.

[0041] The sealing bell 82, together with the sterilization container 20, defines a measuring chamber 88, which comprises the 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.

[0042] 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 designed to generate a vacuum. The vacuum generating device 84 can, for example, operate with a water jet pump and / or a diaphragm pump.

[0043] The negative pressure 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.

[0044] 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.

[0045] 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 83, or in the first volume 83 and 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.

[0046] 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 filters 51 and 52. Even brand-new sterilization containers 20 have a leakage rate. A very low leakage rate due to very small openings is usually acceptable, as bacteria and germs cannot pass through such small openings.

[0047] However, it is critical if the openings leading to the leak 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 below) is defective. Fig. 2) is damaged or the closure 50 does not fit the housing 30 well.

[0048] 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.

[0049] Depending on the pressure profile over time, it can therefore be determined whether the sterilization container 20 meets a specified tightness criterion.

[0050] Preferably, a leak rate measurement is performed. The leak rate q is proportional to the pressure change per unit time of the pressure change, or to the derivation of the pressure curve. Furthermore, the leak rate q is proportional to the measurement volume defined by the sterilization container 20. With a defined measurement volume, the pressure change over a defined period can be used directly as a leak tightness criterion.

[0051] Preferably, the tightness criterion depends on the leakage rate determined in this way.

[0052] Preferably, the tightness criterion depends on a leak rate limit, and the determined leak rate is compared with the leak rate limit.

[0053] Fig. Figure 5 shows a longitudinal section of the sterilization container 20.

[0054] The sterilization container 20 has met the tightness criterion, and preferably the sterilization container 20 is sealed in this case with one or more seals 56 to indicate that it has successfully passed the tightness test.

[0055] 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.

[0056] Fig. Figure 6 shows in a longitudinal section the sterilization container 20, which is arranged in a schematically depicted sterilization device 94.

[0057] The sterilization device 94 has a housing 95, a heater 96, a steam generating device 97 and a sealing bell 98.

[0058] The sealing bell 98 defines a space 99 which is in fluid contact with the inside of the sterilization container via the filter 51, 52.

[0059] Steam is generated via the steam generation device 97 and supplied to the room 99 and thus also via the filter 51, 52 to the interior of the sterilization container 20.

[0060] 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 usually maintained for a predetermined period of time in order to achieve sterilization and destroy all bacteria and germs inside the sterilization container 20. This also applies to the area of ​​the filter 51, 52.

[0061] Through sterilization, items 91A, 92A become sterile goods 91S, 92S, which can be used, for example, for an operation.

[0062] In this example, water or steam is used as the sterilizing agent.

[0063] Other sterilizing agents can also be used. Sterilizing agents are also referred to as sterilizing agents.

[0064] Preferably, the sterilizing agent comprises at least one first sterilizing agent from a group of sterilizing agents consisting of: - Water, - Hydrogen peroxide with plasma phase, - Hydrogen peroxide without plasma phase, - Ethylene oxide, and - Formaldehyde.

[0065] In summary, the procedure for providing sterile goods 91S; 92S in the sterilization container 20 comprises the following steps: A) Items 91A, 92A are inserted into the housing 20 through the opening 33 when the closure 50 is open, B) the opening 33 of the housing 20 is closed with the closure 50, C) A sealing bell 82 is placed over the filter 51, 52, and a negative pressure is created in the sterilization container 20 via the sealing bell 82, D) A measurement of the pressure profile over time of the sterilization container pressure is carried out, and depending on the pressure profile over time, it is determined whether the sterilization container 20 meets a specified tightness criterion. E) if the sterilization container 20 meets the specified tightness criterion, the items 91A, 92A are sterilized in the sterilization container 20 sealed in step B) and thus become sterile goods 91S, 92S.

[0066] A major advantage of the procedure is that the sterilization container 20 with the items 91A, 92A contained therein is sealed once, and both the leak test and the sterilization are carried out in the sealed state.

[0067] 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.

[0068] 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.

[0069] Fig. Figure 7 shows a schematic longitudinal section of a device 104 that can perform both a leak test and sterilization.

[0070] The device 104 represents an advantageous combination of the test device 80 of Fig. 4 and the sterilization device 94 of Fig. 7 dar.

[0071] 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 steam generating device 97, the pressure sensor 86, a temperature sensor 107 and a sealing device 102.

[0072] 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.

[0073] The control device 100 is designed to receive and evaluate measurement signals from the pressure sensor 86 and the temperature sensor 107.

[0074] The sealing bell 101 defines a space 103 which is in fluid contact with the interior of the sterilization container 20 via the filters 51.

[0075] The control device 100 can generate a vacuum in the room 103 and in the sterilization container 20 for the leak test via the vacuum generation device 84 and then use the pressure sensor 86 to record the pressure profile over time and thereby check the leak tightness.

[0076] 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. In addition, heating can be carried out in the interior of the housing 106 via the heater 96, and this can be monitored, controlled, and / or regulated by means of the temperature sensor 107.

[0077] After successful sterilization, the sterilization container 20 is preferably sealed by the sealing device 102.

[0078] The device 104, which can also be called a sterilization device, makes very safe sterilization possible.

[0079] Naturally, various variations and modifications are possible within the scope of the present application. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] WO 2016 / 039 647 A2

[0002]

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 a filter (51, 52), wherein the sterilization container (20) in the area of ​​the filter (51, 52) is permeable to gaseous water and to at least some of the components of air, and wherein the procedure comprises the following steps: A) Objects (91A; 92A) are inserted into the housing (20) through the opening (33) with the closure (50) open, B) the opening (33) of the housing (20) is closed with the closure (50), C) A sealing bell (82) is placed over the filter (51, 52), and a vacuum is created in the sterilization container (20) with the sealing bell (82), D) A measurement of the pressure profile over time in the sterilization container (20) is carried out, and depending on the pressure profile over time, it is determined whether the sterilization container (20) meets a specified tightness criterion. E) if the sterilization container (20) meets the specified tightness criterion, the items (91A; 92A) are sterilized in the sterilization container (20) sealed in step B) and thus become sterile goods (91S; 92S). [2] Method according to claim 1, wherein the housing (30) is designed as a tub and the closure (50) is designed as a lid. [3] Method according to claim 1 or 2, wherein the filter (51, 52) is arranged in the area of ​​the closure (50). [4] Method according to one of the preceding claims, wherein in step D) a leak rate is determined as a function of the pressure profile of the vacuum in the sterilization container (20), and wherein the tightness criterion depends on the leak rate. [5] Method according to claim 4, wherein the tightness criterion depends on a leak rate limit value, the determined leak rate is compared with the leak rate limit value. [6] Method according to one of the preceding claims, wherein the measurement of the pressure profile over time of the negative pressure in the sterilization container (20) is carried out in a measuring chamber (88), wherein the measuring chamber (88) comprises the volume (37) in the sterilization container (20) and a first volume (83) on the outside of the sterilization container (20), wherein the first volume (83) is in fluid communication with the volume (37) in the sterilization container (20). [7] Method according to any of the preceding claims, wherein the sterilization container (20) is sealed when the sterilization container (20) meets the specified tightness criterion. [8] Method according to one of the preceding claims, wherein, for sterilization in step E), a sterilizing agent is introduced in liquid or gaseous form into the sterilization container (20) and is heated. [9] Method according to claim 8, wherein the sterilizing agent is introduced into the sterilization container (20) via the filter (51, 52). [10] Method according to claim 8 or 9, wherein the sterilizing agent comprises at least one first sterilizing agent from a group of sterilizing agents consisting of: - Water, - Hydrogen peroxide with plasma phase, - Hydrogen peroxide without plasma phase, - Ethylene oxide, and - Formaldehyde. [11] Device (80) for handling a sterilization container (20) with a housing (30) having an opening (33) and a closure (50) for the opening (33), wherein the sterilization container (20) has a filter (51, 52), wherein the sterilization container (20) is permeable in the area of ​​the filter (51, 52) to gaseous water and to at least some of the components of air, wherein the device comprises a sealing bell (82), a vacuum generating device (84), a measuring device (111) and an evaluation device (113), wherein the sealing bell (82) is designed to allow the sealing bell (82) to be placed over the filter (51, 52) of a sterilization container (20) closed with a closure (50), wherein the vacuum generating device (84) is at least temporarily in fluid contact with the sealing bell (82) and is designed to generate a vacuum in the sterilization container (20), wherein the measuring device (111) is configured to perform a measurement of the pressure profile over time in the sterilization container (20), wherein the evaluation device (113) is configured to determine, depending on the pressure profile over time, whether the sterilization container (20) meets a predetermined tightness criterion, wherein the sterilization device (94) is configured to sterilize the items (91A; 92A) in the sealed sterilization container (20) and thus make them sterile goods (91S; 92S). [12] Device according to claim 11, wherein the sterilization device (94) has a heater (96) and is designed to introduce a sterilizing agent in liquid or gaseous form into the sterilization container (20) and to heat it via the heater (96). [13] Device according to claim 12, wherein the sterilization device (94) is designed to introduce the sterilizing agent into the sterilization container (20) via the sealing bell (82).

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