System and apparatus for testing the hermetic sealing of containers for the sterilization of instruments and related container

Abstract

A system is described for carrying out the verification of the hermetic seal of containers used for the sterilization of instruments, comprising a pressure control device, a monitoring system, and a data recorder, wherein the pressure control device is provided for create both a negative pressure and a positive pressure inside a container, the monitoring system is provided to detect pressure changes inside the containers reporting them in real time, and the data recorder is provided to archive the results of a Leak testing for traceability and documentation purposes. An apparatus and a container for the sterilization of instruments are also described.

Description

[0001] SYSTEM AND APPARATUS FOR TESTING THE HERMETIC

[0002] SEALING OF CONTAINERS FOR THE STERILIZATION OF

[0003] INSTRUMENTS AND RELATED CONTAINER

[0004] The present invention refers to a system for checking the hermetic seal of containers used for the sterili zation of instruments .

[0005] The present invention also refers to an apparatus of a system for checking the hermetic seal of containers used for the sterili zation of instruments .

[0006] The invention also refers to a modi fied container for checking the hermetic seal of containers used for the sterili zation of instruments .

[0007] In general , the present invention refers to : containers specially designed for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic instruments ; devices to veri fy the ef fectiveness or maintenance of sterili zation inside the container .

[0008] In particular, the present invention refers to : seals , for example doors , covers , valves , locks ; sterili zation chambers ; means of aseptic storage .

[0009] The state of the art is represented by utility model DE 2020- 12010704 U1 concerning a container for sterile surgical instruments composed of at least two housing parts that j oin together hermetically . The container is equipped with a vapor-permeable passage element and at least one internal air control valve , as well as at least one indicator .

[0010] At least one internal air control valve and at least one indicator may be located on a wall of a part of the housing or on the passage element .

[0011] A vapor-permeable passage element can be closed by a sealing lid .

[0012] Furthermore , the state of the art is represented by utility model DE 2020- 11051767 U1 concerning a medical sterile container with a pressure-activated sterili zation status detection device , comprising hermetically closing upper and lower parts . There is no mention of leak tests or speci fic checks on the tightness of the container .

[0013] The state of the art mentioned above may present the following critical issues during the use of containers . It is important to pay particular attention during the use , handling and maintenance of containers to ensure their integrity and hermetic seal , thus preserving the sterility of their contents and the safety of patients during surgical procedures .

[0014] Frequent Use of Containers : containers are often used to hold sets of surgical instruments needed for frequent procedures . This means that a single container could be sterili zed and used multiple times throughout the day .

[0015] Container overloading : one of the common problems is overloading of containers with weights that exceed the recommended load handling limit , often over 10kg . Due to this excess weight , containers can fall to the ground, usually right on the edges , causing damage .

[0016] Need for thermo-disinfection; after each use , containers should be heat-disinfected or saniti zed before being reused . During this process , containers are separated and, i f possible , filters are removed . They are then loaded onto instrument washer trolleys , usually upside down to avoid water accumulation, which can cause damage .

[0017] Marks and damage during thermal disinfection : during the thermal disinfection step, the bottom o f the container can be placed on the trolleys in a rough way, causing marks and damage . These marks can af fect the airtight seal between the bottom and the lid .

[0018] Damage during manual washing : when washing manually, especially with large containers , it is easy for the edges of the containers to hit the edges of the sinks , causing damage and marks to the edge of the container .

[0019] Damage during handling : during loading and unloading from autoclave baskets or handling trolleys , containers can suf fer impacts , particularly on the handles and label holders . These components , being screwed or riveted, could loosen the correct coupling tension, putting the hermetic seal at risk .

[0020] Possibility of pinching the gasket : sometimes , when closing the lid, the sealing gasket may be pinched i f the lid is not positioned correctly and hastily . This can cause damage or cuts to the gasket , compromising the hermetic seal , especially in the corners .

[0021] Risk for internal sterility : all these critical issues can damage the containers and put their hermetic seal at risk . This could result in the loss of sterility within the container, resulting in patient safety risks during surgical procedures .

[0022] The obj ect of the present invention is solving the aforementioned prior art problems by providing an innovative system for veri fying the correct hermetic seal of the containers used in the sterili zation of surgical instruments , by effectively addressing the critical issues that emerge from the use of the containers .

[0023] The characteristics of a system of this type are listed below .

[0024] Reproducible veri fication of the seal : the proposed solution allows a reproducible veri fication of the hermetic seal of the containers Using a speci fic vacuum system and a vacuum gauge , it is possible to evaluate whether there are vacuum leaks inside the container, identi fying any sealing problems .

[0025] Direct testing of the original container : the solution allows directly testing the original container, without the need to individually check the constituent parts (bottom and lid) , allowing to simpli fy the control process and save time . Versatile test methods : the test can be carried out either by creating a negative pressure inside the container or by applying positive pressure . This flexibility allows locating leaks under di f ferent conditions .

[0026] Finding the exact location of leaks : in case a leak is found during the test , it is possible to precisely identi fy the exact location where the leak occurs . Using a soapy solution and positive pressure , the bubbles reveal the leak point , allowing for an accurate diagnosis .

[0027] Furthermore , a possible test for leaks using negative pressure inside the container can be considered . This test involves the creation of a negative pressure inside the container, while on the outside of the container, near the critical points such as the bottom / lid coupling point and the various rivets , a " torch" is used from which smoke escapes , generally white smoke generated by heating glycerol which is non-toxic . In the event that a leak occurs , the smoke is drawn back by the negative pressure generated inside the container . This method is already success fully used to detect leaks and is an additional option for accurately identi fying leak points . Use of certi fied and validated instrumentation : the solution uses certi fied and validated instrumentation to guarantee reliable and precise results during the leak test .

[0028] Reproducibility and regulatory compliance : the proposed test method is highly reproducible and helps ensure the regulatory compliance necessary to demonstrate the tightness of couplings . This is essential for container manufacturers .

[0029] Overcoming the limitations of the previous standard : this solution overcomes the limitations of the technical standard UNI EN 868- 1 : 1999 , which required a test with a vacuum bell , but which today is no longer applicable due to the embossing present on the container lids in aluminium .

[0030] The obj ect of the present invention is therefore solving the aforementioned prior art problems by providing a system for carrying out the veri fication of the hermetic seal of containers used for the sterili zation of instruments which represents , in particular, a signi ficant advancement in the veri fication of the hermetic seal of the containers used in the sterili zation of surgical instruments .

[0031] Another obj ect of the present invention is providing a system that allows for the implementation of a reliable , reproducible and regulatory compliant method for identi fying and solving leakage problems during use , thus helping to ensure patient safety during surgical procedures Furthermore , an obj ect of the present invention is providing an apparatus that allows the hermetic seal of containers used for the sterili zation of instruments to be veri fied by appropriately connecting a vacuum or pressure generation device with a detection device to monitor variations in pressure , and a control means for managing the process of generating vacuum or pressure .

[0032] Furthermore , an obj ect of the present invention is providing a modi fied container that allows speci fic leak tests to be carried out during the use of containers used for the sterili zation of instruments and to facilitate leak tests during sterili zation .

[0033] The above and other obj ects and advantages of the invention, as will appear from the following description, are achieved with a system for veri fying the hermetic seal of containers for the sterili zation of instruments as claimed in claim 1 . Furthermore , the above and other obj ects and advantages of the invention are achieved with an apparatus and a container as described in the respective independent claims .

[0034] Preferred embodiments and non-trivial variants of the present invention form the subj ect matter of the dependent claims .

[0035] It is understood that all attached claims form an integral part of this description .

[0036] It will be immediately obvious that countless variations and modi fications can be made to what i s described ( for example relating to shape , dimensions , arrangements and parts with equivalent functionality) without departing from the scope of the invention as appears from the attached claims .

[0037] The system for testing the hermetic tightness of containers for the sterili zation of instruments allows extending the functionality of the solution for testing the tightness of containers during use , providing di f ferent configuration options and speci fic components to guarantee maximum precision and reliability in tests sealing .

[0038] The present invention will be better described by some preferred embodiments , provided by way of example and not by way of limitation, with reference to the attached drawings, in which:

[0039] FIG. 1 shows a top view of a lid of a standard carry-over container used for transportation;

[0040] - FIG. 2 shows an internal view of the lid of the standard carry-over container;

[0041] - FIG. 3 shows the long side front view of the bottom of the container used for sterilization;

[0042] - FIG. 4 shows a short side front view of the bottom of the container;

[0043] FIG. 5 shows a top view of the modified cover;

[0044] FIG. 6 shows an internal view of the modified cover;

[0045] - FIG. 7 shows a front view of the threaded valve for vacuum / suction connection;

[0046] - FIG. 8 shows a long side front view of the bottom of the container for performing leak tests on the lids of sterilized containers;

[0047] - FIG. 9 shows a view of the bottom of the container, front view, short side;

[0048] - FIG. 10 shows a top view of the standard lid used for sterilization, specifically in the Pasteur bio-barrier technology;

[0049] - FIG. 11 shows a detailed internal view of the standard cover;

[0050] FIG. 12 shows a front view of the Pasteur system cap to ensure that air passes only through the Pasteur system;

[0051] - FIG. 13 shows a long side front view of the bottom of the container;

[0052] - FIG. 14 shows a short side front view of the bottom of the container;

[0053] - FIG. 15 shows a top view of the lid modified for leak testing with the Pasteur bio-barrier technology;

[0054] FIG. 16 shows a front view of the screw closing the threaded hole for valve insertion connected to the suction / insuf flation system for leak testing;

[0055] FIG. 17 shows an internal view of the modified cover;

[0056] - FIG. 18 shows a plan view of the gasket to hermetically close the holes for balancing the pressure of the container;

[0057] - FIG. 19 shows a long side front view of the bottom of the container; and

[0058] - FIG. 20 shows a short side front view of the bottom of the container.

[0059] Referring to the Figures, it is possible to note that a system according to the present invention for checking the hermetic seal of containers used for the sterili zation of instruments includes a pressure control device , a monitoring system, and a data recorder .

[0060] Advantageously, the pressure control device is provided to create both a negative pressure and a positive pressure inside a container, the monitoring system is provided to detect pressure variations inside the containers reporting them in real time , and the data recorder is intended to archive the results of a leak test for traceability and documentation purposes .

[0061] The implementation of the leak test preferably takes place without the use of internal air control valves or vapor permeable passage elements .

[0062] The present invention also refers to an apparatus of a system for carrying out the veri fication of the hermetic seal of containers according to the present invention such as the one previously described, this apparatus comprising a vacuum or pressure generation device , an adaptable connector to be connected to a container, a sensing device to monitor the change in pressure or vacuum inside the container, and control means to manage the process of generating vacuum or pressure .

[0063] Preferably, such vacuum or pressure generating device comprises a suction pump or an air compressor .

[0064] Preferably, such an adaptable connector is intended to be compatible with a variety of existing container types without requiring structural modi fications to the containers themselves .

[0065] Preferably, such sensing device is equipped with a vacuum gauge or pressure gauge to accurately measure the change in pressure or vacuum .

[0066] Preferably, such control means are configured to perform a leak test by vacuum or pressure inside a container and to record the test results .

[0067] The present invention also relates to a modi fied container used to veri fy the hermetic seal of containers used for the sterili zation of instruments , comprising :

[0068] - a lid suitable for use in sterili zation and leak testing processes , including locking mechanisms , at least one gasket for an airtight seal , and openings to allow pressure balancing, air removal and passage of a steam-type sterili zing agent during the sterili zation process ; at least one opening to allow pressure balancing, air removal and passage of the steamtype sterili zing agent during the sterili zation process ;

[0069] - a bio-barrier, such as the Pasteur system or other system;

[0070] - traceability elements , such as labels or a Data Matrix to track leak tests ;

[0071] - handles to facilitate transport ;

[0072] - closing elements , such as hooks to ensure a secure closure between the lid and container, closing screws to seal threaded holes not in use .

[0073] Preferably, the modi fied container may comprise the following additional elements in order to allow speci fic leak testing during the use of containers used for the sterili zation of instruments , such speci fic tests being carried out via the lid of the modi fied container connected to the compartment of the container to be tested, and through the compartment of the modi fied container connected to the lid of the container to be tested :

[0074] - a threaded hole to allow the insertion of the air intake / insuf flation valve for leak testing;

[0075] - a threaded bush to allow the insertion of the air intake / insuf flation valve for leak testing; data matrix to allow the traceability of leak tests;

[0076] - a gasket to hermetically close the holes for balancing the pressure of the container.

[0077] The Container Control System (CCS) is a system designed to guarantee the correct sealing of containers used in the sterilization of surgical instruments using saturated steam. The system allows optimizing the sterilization process and guaranteeing the sterility of the material inside the containers during cooling, storage and transport .

[0078] CCS represents a fundamental system to guarantee the safety and effectiveness of the sterilization process of surgical instruments, minimizing the risk of contamination during the post-sterilization steps, such as cooling, storage and transport.

[0079] The main components and functionalities of the CCS are described below: saturated steam sterilization process: the CCS is designed to be used in conjunction with the saturated steam sterilization process. The process takes place inside an autoclave or a sterilization chamber and involves several steps, including the removal of air, the introduction of steam, the achievement of sterili zation parameters , the actual sterili zation step, the drying and baric balancing; sterili zation containers : the CCS is speci fically intended to allow monitoring and guaranteeing the hermetic seal of the containers used for the sterili zation of surgical instruments . Containers of this type consist of two parts : the bottom, where the instruments are placed, and the lid, which must be hermetically closed to ensure sterility .

[0080] Types of containers

[0081] Sterili zation containers may vary in their construction . Below are some common types : a . Container with Bio-Barrier Filter : these containers are equipped with disposable or multiuse filters (made of paper or PTFE ) to allow the suction of air, the introduction of steam during the sterili zation step and to filter the air during storage to keep the internal / external pressure level . The filters are generally positioned on the lid, but in some cases they can also be present on the long side of the base . b . Bio-Barrier Valve Containers : these containers use an automatic two-way valve in place of filters to allow air and vapor to pass through . The design of the valves prevents the entry of microorganisms after sterili zation . The bio-barrier is usually riveted to the lid and is not removable . c . Containers with Pasteur System Bio-Barrier : this type of container uses a tortuous concentric path known as the Pasteur system as a bio-barrier system . This system is generally removable to facilitate cleaning . Purpose of the Bio-Barrier : The bio-barrier present in sterili zation containers is intended to ensure that the material inside the container remains sterile after the sterili zation process . During cooling, storage and transportation, the volume of air inside the container can vary, and the bio-barrier prevents the accidental entry of contaminating particles or microorganisms . d . Carry-over containers : in addition to standard sterili zation containers , there are also carry-over containers . These containers are completely airtight , with non-perf orated bottom and lid, and are used for handling dirty instruments safely .

[0082] Bottom-lid coupling in containers and "Critical Points" : the hermetic coupling between the bottom and the lid of containers is a critical aspect for the sterili zation of surgical instruments . The presence of gaskets , handles and nameplate holders , as well as the fixing of the valves , helps to ensure that the sterili zation process occurs safely and that the sterility of the contents is preserved during all subsequent steps , including cooling, storage and transportation .

[0083] Perfect seal between bottom and lid : in all containers used for sterili zation, it is essential to guarantee a perfect seal between the bottom and the lid . This means that only the bio-barrier system needs to allow air to pass through to manage pressure variations . The hermetic seal between these two parts is essential for maintaining the sterility of the contents .

[0084] Sealing gasket : a gasket is mounted around the entire perimeter of the container lid to ensure an airtight seal between the lid and the bottom . This seal plays a crucial role in ensuring hermetic insulation between the two components of the container .

[0085] Critical coupling point : the coupling between the bottom and the lid represents the main critical point of the containers . I f the assembly is not perfect and the hermetic seal is not guaranteed, during the steps in which the container draws air from the outside to rebalance the pressure , air could infiltrate more easily from a defective point of the coupling rather than passing through , through the bio-barrier system . The passage of external air inside the container from a point without a filtering system could compromise the sterility of the contents .

[0086] Handles for handling : each container is equipped with handles provided to facilitate handling . These handles are installed on the body of the container and allow it to be moved safely . Generally, they are fixed using screws passing through the inside of the bottom of the container or with rivets .

[0087] Tag holders for traceability : on the outside of the containers there are tag holders where identi fication tags or labels are placed for traceability purposes . These label holders are also usually fixed with screws passing inside the bottom of the container or with rivets .

[0088] Fixing the valves in containers with a valved bio-barrier : in containers with a valved biobarrier, the valves are securely fixed to the l id using through rivets . This ensures that the valve remains integrated into the container without the possibility of dismantling, thus contributing to the ef fectiveness of the bio-barrier system .

[0089] Container lid section : the container lid section has a central hole located near the Pasteur type filter system . This hole allows the insertion of a dedicated connector to test the container ' s tightness . By unscrewing the screw in the central hole , the connector can be screwed on, allowing the seal to be checked . A ring made of silicone or silicone material is provided to ensure a hermetic seal of the holes through which air passes into the Pasteur system .

[0090] Additional version with modi fied carryover container : an additional version of the carryover container has been developed, which includes fittings for air intake and blowing . With this version of the carry-over container, it is possible to use the lid to test the tightness of the bottom of standard containers . Furthermore , using the bottom of the modi fied carryover container, it is possible to test the lid of standard containers . For this version, a dedicated pump for air intake and insuf flation is available , together with a precision digital vacuum gauge , which has been validated and certified for testing purposes.

[0091] Modified landfill container with air fittings: the modified landfill container has been further adapted with the addition of air intake and insufflation fittings. These fittings are located on both the lid and the bottom of the hauling container. This configuration allows for greater flexibility in performing leak testing on various components of standard containers.

[0092] Version with direct modification of the sterilization container: a further option involves direct modification of the standard sterilization container. This modification includes the addition of a central hole near any filter system. By unscrewing the screw in the hole, it is possible to apply the dedicated connector after inserting a gasket to hermetically seal the openings of the filtration system. This configuration allows direct leak testing of the sterilization container without the need for an additional carryover container.

[0093] Below are additional notes that provide an overview of the various considerations and features of the CCS system:

[0094] Use of the UNI EN 868-1:2009 standard: the aforementioned UNI EN 868-1:2009 standard is intended only for the manufacturer.

[0095] Adaptability to different bio-barrier systems: the project was studied using a container with biobarrier with a Pasteur system. It is logical that with the appropriate modifications it can be applied to any container with bio-barrier systems other than the Pasteur system.

[0096] Unique identification of components: it is possible to apply a Data Matrix, a QR Code or other system that makes the components of the container unique, allowing the monitoring and linking of leak test data to each component. The data can be stored and viewed using dedicated software.

[0097] App to document leak tests: an app is being developed that will document leak tests carried out on containers, associating the results, graphs and notes with specific components. The technician will be able to indicate whether the test was passed or not and add notes.

[0098] Customer database to store results: a database will be created to enter container leak test results for different customers (hospitals) over time, providing a history of tests performed.

[0099] Customizable advanced sealing systems: advanced sealing systems can be provided for dif ferent types of containers , with the aim of hermetically closing the accesses to the filter system during leak tests .

[0100] Lack of existing solutions : currently there is no container equipped with a system to carry out correct , repeatable and reproducible leak tests , nor is there a dedicated system to test the container for leaks .

[0101] Use of existing devices for aspiration and insuf flation : initially, it is suggested to use existing devices for aspiration and insuf flation, such as pumps and certi fied digital vacuum gauges . In the future , an ad hoc device with a vacuum regulation valve could be developed .

[0102] Increased safety in the use of containers : the proposed changes can provide greater safety in the use of containers by enabling leak testing of the bottom-to-lid fit and promoting the use of safe containers .

[0103] Compliance with the UNI EN ISO 11607- 1 standard : the proposed changes to guarantee terminal sterili zation and maintenance of sterility are in line with the UNI EN ISO 11607- 1 standard, which establishes the minimum requirements for the use of packaging systems that provide appropriate sterile barrier systems.

[0104] What is shown in Figures 1 to 20 is described in detail below.

[0105] FIG. 1: top view cover. FIG. 1 represents the lid of a standard carry-over container used for transporting dirty instruments. Not having a biobarrier, the carry-over container cannot be used to sterilize instruments. The main components of this cover are listed below.

[0106] Lid (1) : the upper part of the carry-over container, responsible for the hermetic seal.

[0107] Lid Latches (2) : mechanisms or fasteners that ensure the lid remains securely closed.

[0108] FIG. 2: internal view cover. FIG. 2 shows the lid (1) of the standard carry-over container seen from the inside. Inside the lid, it is possible to note the following additional important details.

[0109] Gasket Seat Edges (3) : these edges form the perimeter of the cover and provide a surface for installing the gasket.

[0110] Gasket (4) : the gasket is a fundamental element to guarantee the perfect seal between the lid and the bottom of the carry-over container.

[0111] FIG. 3: container bottom, front view, long side. FIG. 3 shows the long front side of the bottom of the carry-over container. This component is essential to ensure the sterilization of surgical instruments. The key elements highlighted in the figure are listed below.

[0112] Container bottom (5) : this is the lower part of the carry-over container, intended to house and protect surgical instruments.

[0113] Label holder (6) : a dedicated area to place identification labels or tags for traceability purposes .

[0114] Latch system (7) : the mechanism or latches that keep the bottom and lid of the container securely together.

[0115] Handle (8) : a handle provided to facilitate safe transportation of the container.

[0116] FIG. 4: container bottom front view, short side. FIG. 4 represents the short front side of the bottom of the carry-over container. This view provides an additional perspective of this component. The key elements highlighted in the figure are listed below.

[0117] Container bottom (5) : the bottom part of the carry-over container, which provides space for surgical instruments.

[0118] Handle (8) : a handle located on the short side of the bottom to facilitate transport.

[0119] Label holder (6) : a specific area for attaching identification labels or traceability tags .

[0120] Latch Hook (Lid / Bottom) (7a) : a fastener that helps ensure the lid and bottom of the container remain securely together.

[0121] FIG. 5: "modified" cover seen from above. FIG.

[0122] 5 represents a lid of a modified carryover container intended to perform leak tests on the container bottoms. This lid features some changes from the standard version to support this purpose. The key elements highlighted in the figure are listed below.

[0123] Modified container lid (8) : the top of the carryover container with the necessary modifications .

[0124] Lid latches (2) : locking mechanisms that ensure an airtight seal.

[0125] Threaded hole (1 / 8 inch) (12) for insertion of the air intake / insuf flation valve for leak testing: a hole specifically provided to allow the insertion of a valve used in leak testing.

[0126] FIG. 6: "modified" lid, internal view. FIG. 6 shows the modified lid (8) of the carry-over container seen from the inside. This lid features the following additional important details.

[0127] Container Lid: again, this is the top of the carryover container with the necessary modifications .

[0128] Lid Latches (2) : the locking mechanisms that ensure an airtight seal.

[0129] Gasket Seat Edges (3) : these edges provide a surface for installing the gasket.

[0130] Gasket: this component is essential to ensure an airtight seal between the lid and the bottom of the carry-over container.

[0131] Threaded hole (1 / 8 inch) (12) for insertion of the air intake / insuf flation valve for leak testing: a hole specifically provided to allow the insertion of a valve used in leak testing.

[0132] FIG. 7: threaded valve for vacuum / suction connection. FIG. 7 shows a threaded valve (10) intended to be connected to the vacuum / suction system. This valve is a key component in performing leak tests and is screwed onto the lid of the dump container. It connects the suction / insuf flation system used to test the tightness of container lids

[0133] FIG. 8: container bottom, front view, long side. FIG. 8 shows the long front side of the bottom of the carry-over container. This component has been modified to perform leak testing on container lids. The key elements to consider are below .

[0134] Modified container bottom (11) : the lower part of the carry-over container, intended to house and protect surgical instruments.

[0135] Label holder (6) : a dedicated area to place identification labels or tags for traceability purposes .

[0136] Latch system (7) : the mechanism or latches that keep the bottom and lid of the container securely together.

[0137] Handle (8) : a handle located on the short side of the bottom to facilitate transport.

[0138] Threaded hole (1 / 8 inch) (12) for insertion of the air intake / insuf flation valve for leak testing: this hole allows the insertion of a valve used in leak testing.

[0139] FIG. 9: container bottom front view, short side. FIG. 9 represents the short front side of the bottom of the carry-over container. This view provides an additional perspective of this modified component for performing leak testing on container lids. Key details are below. Modified Container Bottom: once again, this is the bottom portion of the container intended to house surgical instruments.

[0140] Transport handle (8) : a handle located on the short side of the bottom to facilitate transport.

[0141] Label holder (6) : a specific area for attaching identification labels or traceability tags .

[0142] Latch Hook (7a) : a fastener that helps ensure the lid and bottom of the container remain securely together. This is a critical component for maintaining the sterility of the contents.

[0143] Threaded hole (1 / 8 inch) (12) for insertion of the air intake / insuf flation valve for leak testing: hole used for inserting the valve in leak testing.

[0144] FIG. 10: cover seen from above. FIG. 10 represents a standard lid of a container used for the sterilization of instruments, in particular for the Pasteur bio-barrier technology. This lid is provided to ensure that the contents remain sterile and safe. The key elements highlighted in the figure are listed below.

[0145] Lid for Pasteur bio-barrier technology (13) : the upper part of the container, designed to ensure an airtight seal. Lid Latches (2) : latching mechanisms or fasteners that keep the lid sealed.

[0146] Openings for internal / external air pressure balancing (14) : these openings allow the pressure balancing between the inside and outside of the container, as well as the removal of air and the passage of the sterilizing agent (steam) during the sterilization.

[0147] FIG. 11: Internal view cover

[0148] FIG. 11 shows the standard lid of the sterilization container seen from the inside. This view offers additional details of the internal components :

[0149] Lid for Pasteur bio-barrier technology (13) : upper part of the container, responsible for the hermetic seal.

[0150] Lid Latches (2) : the latching mechanisms that keep the lid securely fastened.

[0151] Openings for internal / external air pressure balancing (14) : these openings allow the pressure to be balanced between the inside and outside of the container, as well as the removal of air and the passage of the sterilizing agent (steam) during the sterilization process.

[0152] Bio-barrier Pasteur system (15) : a bio-barrier system that guarantees that the passage of air occurs only through the Pasteur system.

[0153] Gasket seat edges (3) : these edges serve as a surface for installing the gasket.

[0154] Gasket (4) : this component ensures an airtight seal between the lid and the bottom of the container .

[0155] FIG. 12: cover internal view. Pasteur system cap (16) to ensure that air passes only through the Pasteur system: This cap is a key element to ensure that air passes only through the Pasteur system, helping to maintain the internal environment sterile .

[0156] FIG. 13: container bottom, front view, long side. FIG. 13 shows the long front side of the bottom of the sterilization container. This component is essential for the sterilization and conservation of surgical instruments. The key elements highlighted in the figure are listed below Sterilization container bottom (17) : the lower part of the container, intended to house and protect surgical instruments.

[0157] Label holder (6) : this area is intended for the application of identification labels or tags for traceability purposes. Locking system (7) : the locking mechanism that keeps the bottom and lid of the container securely secured .

[0158] Transport handle (8) : a handle located on the short side of the bottom to facilitate transport.

[0159] FIG. 14: container bottom front view, short side. FIG. 14 represents the short front side of the bottom of the sterilization container. This view offers an additional perspective on this essential component for sterilizing surgical instruments. The key elements highlighted in the figure are listed below.

[0160] Sterilization container bottom (17) : the lower part of the container is designed to house surgical instruments .

[0161] Transport handle (8) : a handle located on the short side of the bottom to facilitate transport.

[0162] Label holder (6) : a specific area to attach identification labels or tags for traceability purposes .

[0163] Latch hook (7a) (lid / bottom) : this fastener ensures that the lid and bottom of the container remain securely together. This is crucial to maintain the sterility of the contents.

[0164] FIG. 15: "modified" cover seen from above. FIG. 15 shows a "modified" lid of a sterilization container intended to perform leak testing using Pasteur bio-barrier technology. This lid has undergone modifications to support these tests. The key elements highlighted in the figure are listed below . "Modified" lid of a sterilization container (18) : the upper part of the sterilization container with the necessary modifications.

[0165] Lid Latches (2) : the locking mechanisms that provide an airtight seal.

[0166] Openings for internal / external air pressure balancing (14) : these openings allow balancing the pressure inside and outside the container, as well as the removal of air and the passage of the sterilizing agent (steam) during the sterilization process .

[0167] Threaded hole (1 / 8 inch) (12) for insertion of the air intake / insuf flation valve for leak testing: this hole is intended to allow the insertion of a valve used in leak testing.

[0168] Data Matrix for Leak Test Traceability (19) : a bar code or marking system used to track and identify the lid.

[0169] FIG. 16: screw closing the threaded hole (20) for inserting the valve connected to the suction / insuf flation system for leak testing: this screw is used to close the threaded hole and seal it when not in use.

[0170] FIG. 17: modified cover, internal view. FIG. 17 shows the "modified" lid of the sterilization container seen from the inside. The key elements highlighted in the figure are listed below.

[0171] "Modified" lid of the sterilization container (21) : it is the upper part of the sterilization container with the necessary modifications.

[0172] Lid Latches (2) : the latching mechanisms that keep the lid securely fastened.

[0173] Threaded hole (1 / 8 inch) (12) for insertion of the air intake / insuf flation valve for leak testing.

[0174] Openings for internal / external air pressure balancing (14) . These openings allow balancing the pressure inside and outside the container, as well as the removal of air and the passage of the sterilizing agent (steam) during the sterilization process .

[0175] Bio-barrier Pasteur system (15) : a bio-barrier system that guarantees that the passage of air occurs only through the Pasteur system.

[0176] Gasket seat edges (3) : these edges serve as a surface for installing the gasket.

[0177] Gasket (4) : this component is essential to ensure an airtight seal between the lid and the bottom of the container.

[0178] Threaded bushing for insertion of the air intake / insuf flation valve for leak testing (22) : this bushing is designed to allow the valve to be inserted in leak testing.

[0179] Pasteur system cap (16) to ensure that the passage of air occurs only through the Pasteur system: this cap is essential to ensure that the passage of air occurs only through the Pasteur system, helping to preserve internal sterility. This gasket ensures that the holes used to balance air pressure can be hermetically sealed when necessary .

[0180] Threaded valve (1 / 8 inch) (10) to be screwed onto the cover of the carry-over container to which the suction / insuf flation system will be connected for the leak test: this valve is intended to be connected to the cover of the container and used in leak test.

[0181] FIG. 18: gasket to hermetically close the holes for balancing the pressure of the container (23) . FIG. 19: container bottom, front view, long side. FIG. 19 shows the long front side of the bottom of the modified sterilization container. This component is essential for the sterilization and conservation of surgical instruments. The key elements highlighted in the figure are listed below Modified sterilization container bottom (24) : the lower part of the sterilization container, intended to house and protect surgical instruments.

[0182] Label holder (6) : this area is intended for the application of identification labels or tags for traceability purposes.

[0183] Locking system (7) : the locking mechanism that keeps the bottom and lid of the container securely secured .

[0184] Handle (8) : a handle located on the short side of the bottom to facilitate transport.

[0185] FIG. 20: container bottom front view, short side. FIG. 20 represents the short front side of the bottom of the modified sterilization container. This view offers an additional perspective on this essential component for sterilizing surgical instruments. The key elements highlighted in the figure are listed below.

[0186] Modified sterilization container bottom (25) : it is the lower part of the sterilization container with the necessary modifications.

[0187] Transport handle (8) : a handle located on the short side of the bottom to facilitate transport. Label holder (6) : a specific area to attach identification labels or tags for traceability purposes .

[0188] Latch hook (7a) (lid / bottom) : this is a fastener that ensures that the lid and bottom of the container remain securely together.

[0189] Data Matrix for leak test traceability (19) : this marking system is used to trace and identify the bottom of the container.

Claims

CLAIMS1 . System for veri fying the hermetic seal of a container used for a sterili zation of instruments , comprising a pressure control device , a monitoring system, and a data recorder, characteri zed in that the pressure control device i s provided to create both a negative pressure and a positive pressure inside the container, the monitoring system is provided to detect pressure changes inside the container and report them in real time , and the data logger is provided to store the results of a leak test for traceability and documentation purposes .2 . System according to the previous claim, characteri zed in that an implementation of the leak test occurs without the use of internal air control valves or vapor-permeable passage elements .3 . Apparatus of a system according to any of the preceding claims , characteri zed in that the apparatus comprises a vacuum or pressure generating device , an adaptable connector to be connected to a container, a sensing device for monitoring the change in pressure orvacuum inside the container, and a control means to manage the process of generating vacuum or pressure.

4. Apparatus according to the previous claim, characterized in that the vacuum or pressure generating device includes a suction pump or an air compressor.

5. Apparatus according to any one of claims 3 or4, characterized in that the adaptable connector is provided to be compatible with a variety of existing container types without requiring structural modifications to the containers themselves.

6. Apparatus according to any one of claims 3 to5, characterized in that the sensing device is equipped with a vacuum gauge or manometer for accurately measuring the change in pressure or vacuum.

7. Apparatus according to any one of claims 3 to6, characterized in that the control means are configured to perform a leak test by vacuum or pressure inside a container and to record the test results.

8. Modified container used to verify an hermetic seal of containers used for the sterilizationof instruments , characteri zed in that it comprises :- a lid suitable for use in sterili zation and leak testing processes , including locking mechanisms , at least one gasket for an airtight seal , and openings to allow pressure balancing, air removal and a passage of a steam-type sterili zing agent during the sterili zation process ; at least one opening to allow pressure balancing, air removal and a passage of the steamtype sterili zing agent during the sterili zation process ;- a bio-barrier, such as the Pasteur system or other system; traceability elements , such as labels or Data Matrix to track leak tests ;- handles to facilitate transport ;- closing elements , such as hooks to ensure a secure closure between the lid and container, closing screws to seal threaded holes not in use .9 . Modi fied container according to the previous claim, characteri zed in that it comprises the following additional elements in order to allow speci fic leak tests during the use of containers used for the sterili zation ofinstruments , said speci fic tests being carried out through the lid of the modi fied container connected to the compartment of the container to be tested, and the compartment of the modi fied container connected to the lid of the container to be tested :- a threaded hole to allow the insertion of the air intake / insuf flation valve for leak testing;- a threaded bush to allow the insertion of the air intake / insuf flation valve for leak testing;- a data matrix to allow the traceability of leak tests ;- a gasket to hermetically close the holes for balancing the pressure of the container .

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