Self-piercing quarantine sterilization process verification device and method for infection control sterilization

Abstract

This invention discloses a self-puncturing, isolated sterilization process verification device and method for infection control sterilization, relating to the field of sterilization technology. This invention protects sterilization indicators from external air and humidity. Before sterilization, residual sterilization media does not interact with the sterilization indicators prematurely. Only when the sterilization program is initiated does the corrugated telescopic tube axially extend under vacuum, pushing a puncture needle to puncture the easily peelable membrane at the opening of the loading tube containing the sterilization indicators, allowing the sterilization media to smoothly enter the loading tube. At this point, the diffusion stage of the sterilization process begins, and the exposed sterilization indicators start to contact the injected sterilization media, allowing for monitoring of the sterilization effect. This invention improves the accuracy of sterilization monitoring results and avoids the influence of external air humidity, oxygen, residual sterilization media, and other factors on the sterilization monitoring results.

Description

Technical Field

[0001] This invention relates to the field of sterilization technology, and more specifically to a self-puncturing, isolating sterilization process validation device and method for infection control sterilization. Background Technology

[0002] The standards for monitoring the sterilization effect of medical devices clearly stipulate that, based on the specific types of items to be sterilized, a representative PCD (Sterilization Process Validation Device) should be selected to comprehensively monitor the sterilization effect. This device accurately simulates the most stringent sterilization challenge scenarios. It contains sterilization indicators such as chemical and biological indicators, and is placed in the sterilization chamber along with the items to be sterilized. After the sterilization process is initiated, the PCD is fully exposed to a specific pressure, temperature, and sterilization medium environment throughout the sterilization cycle. The color change of the sterilization indicators determines whether the preset standards have been met, ensuring that medical devices can be safely released in batches.

[0003] Low-temperature sterilization technology demonstrates superior sterilization capabilities, effectively eliminating various microorganisms such as vegetative bacteria, spores, fungi, and viruses. Particularly noteworthy is its significant advantage in sterilizing tubular medical devices, as these are considerably more challenging to sterilize than conventional solid medical devices.

[0004] Currently, most low-temperature sterilization process validation devices on the market use a method of placing sterilization indicators directly inside the device for sterilization monitoring. However, with the widespread availability of reusable low-temperature sterilization process validation devices and the strong residual nature of the sterilization media within these devices, even after vacuuming following the sterilization process, it is difficult to completely remove the sterilization media from the external environment. Therefore, the sterilization media tends to remain inside the low-temperature sterilization process validation device for extended periods, leading to significant accuracy issues with this method of directly placing the sterilization indicators. Specifically, after the entire device is placed in the sterilization chamber, the residual sterilization media inside can easily interact prematurely with the sterilization indicators, causing the indicators to prematurely indicate sterilization success. Furthermore, some hospitals have reported that some devices show sterilization success as early as the initial heating stage of the sterilization process (before the formal sterilization process begins). The use of such devices poses a significant risk and can easily lead to hospital-acquired infections.

[0005] Therefore, it is particularly urgent and important to develop a more accurate and reliable sterilization process verification device to address this issue. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide a self-puncturing isolation sterilization process verification device and method for infection control sterilization, which improves the accuracy of sterilization monitoring results and avoids the influence of factors such as external air humidity, oxygen, and residual sterilization media on the sterilization monitoring results of sterilization indicators.

[0007] The technical solution of this invention is as follows:

[0008] A self-puncturing, isolating sterilization process validation device for infection control sterilization includes a housing with a cavity inside. One end of the cavity is open and detachably sealed. The cavity has a tube interface connected to a sterilization medium diffuser tube, which is placed inside the housing. The housing has a penetration hole. A puncture assembly is located inside the cavity. The puncture assembly includes a corrugated telescopic tube sealed at both ends. The corrugated telescopic tube is made of silicone and filled with air. One end of the corrugated telescopic tube is fixed inside the cavity, and the other end faces the cavity opening and is equipped with a puncture needle. A loading tube is detachably installed at the cavity opening. One end of the loading tube is open and sealed with an easy-tear membrane. The end of the loading tube with the easy-tear membrane faces the puncture needle, and a sterilization indicator is placed inside the loading tube.

[0009] Preferably, the easy-peel film comprises, from the outside to the inside, an outer protective layer, a first adhesive layer, a barrier core layer, a second adhesive layer, an easy-peel layer, a third adhesive layer, and an inner sealing layer. The outer protective layer is made of PET film, the first adhesive layer is coated with polyurethane adhesive, the barrier core layer is made of aluminum foil, the second adhesive layer is coated with modified acrylic adhesive, the easy-peel layer is made of PE film, the third adhesive layer is coated with modified acrylic adhesive, and the inner sealing layer is made of PE film.

[0010] The easy-open film of this invention has an outer protective layer made of PET film, which possesses excellent mechanical strength, scratch resistance, and chemical resistance. This effectively protects the internal structure of the easy-open film, preventing damage during transportation and storage. It also provides some waterproof and anti-fouling capabilities, extending the film's service life. The first adhesive layer is coated with polyurethane adhesive, exhibiting excellent bonding strength and ensuring a tight bond between the outer protective layer and the barrier core layer without delamination, while maintaining the overall flexibility and ease of opening. The barrier core layer is made of aluminum foil with a purity ≥99.7%, providing core barrier performance and effectively preventing the penetration of gases, liquids, and volatile substances, especially residual hydrogen peroxide, making it a crucial layer for preventing hydrogen peroxide from entering the loading tube. The second adhesive layer is coated with a modified acrylic adhesive, offering mild bonding performance. This ensures stable adhesion between the barrier core layer and the easy-open layer while also providing excellent easy-open characteristics, leaving no residue or tearing during opening and preventing damage to the barrier structure of the easy-open film during the opening process. The easy-open layer is made of PE film, specifically linear low-density polyethylene (LLDPE), which possesses excellent peelability and flexibility. Its adhesion strength to the second and third adhesive layers is controlled within a reasonable range, enabling convenient peeling while also enhancing the overall flexibility of the easy-open film to prevent breakage upon puncture. The third adhesive layer is coated with a modified acrylic adhesive, consistent with the material of the second adhesive layer, ensuring a tight bond between the easy-open layer and the inner sealing layer. It also matches the easy-open characteristics of the easy-open layer, ensuring smooth separation between layers during peeling without affecting the sealing performance of the inner sealing layer. The inner sealing layer is made of PE film, possessing excellent heat-sealing properties. It allows for a tight heat seal between the easy-open film and the loading tube opening, forming a sealed space to prevent external impurities and residual sterilization media from entering. It also exhibits good compatibility, not reacting chemically with the sterilization indicators inside the loading tube, ensuring the safety of the sterilization indicators.

[0011] Preferably, the outer protective layer has a thickness of 6-8 μm, the first adhesive layer has a thickness of 3-5 μm, the barrier core layer has a thickness of 7-12 μm, the second adhesive layer has a thickness of 2-4 μm, the easy-peel layer has a thickness of 5-8 μm, the third adhesive layer has a thickness of 2-4 μm, and the inner sealing layer has a thickness of 8-12 μm.

[0012] Preferably, the hydrogen peroxide permeation rate of the easy-peel membrane under the conditions of 23°C, 50%RH, and 30mg / L hydrogen peroxide concentration is 0.007-0.009g / m³. 2 • 24h; Oxygen permeability at 23℃ and 50%RH is 0.2-0.4 cm. 3 / m 2 • 24h • 0.1MPa; Water vapor transmission rate at 38℃ and 90%RH is 0.18-0.25g / m³ 2• 24h; the puncture force is 0.9-1.4N under the conditions of 23℃, 50%RH, needle diameter 1mm, and puncture speed 10mm / min; the opening force is 1.2-1.8N.

[0013] The easy-peel film used in this invention has excellent barrier properties, effectively preventing residual hydrogen peroxide from entering the loading tube: using aluminum foil as the core barrier layer, combined with a multi-layer composite structure design, ensures that the hydrogen peroxide permeation is <0.01g / m³. 2 • For 24 hours, it can block the penetration of residual hydrogen peroxide from the outside, protecting the performance and safety of the sterilization indicator inside the loading tube, thus solving the technical pain point of insufficient barrier properties of existing easy-peel films. Simultaneously, the easy-peel film of this invention has a puncture force of 0.9-1.4N, making it easy to puncture with a needle. Furthermore, the easy-peel layer design allows for easy manual peeling with moderate force, leaving no residue or tearing, avoiding potential hazards caused by improper peeling and further enhancing the user experience. The easy-peel film has a high degree of material matching among its layers, and is integrally formed through a hot-pressing composite process, ensuring strong interlayer adhesion and no delamination. This allows it to adapt to different transportation and storage environments, extending the shelf life of the loading tube.

[0014] Preferably, the opening end of the cavity is sealed by a sealing plug.

[0015] Preferably, the puncture assembly includes a support block and a needle seat. The support block is fixed in the cavity, one end of the corrugated telescopic tube is fixed to the support block, and the other end is fixed to the needle seat. The puncture needle is fixed to the needle seat.

[0016] Preferably, the shell is made of polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), polyetheretherketone (PEEK) or polypropylene (PP); the needle is made of medical grade 316L stainless steel, titanium alloy, ceramic or polytetrafluoroethylene, and the tip of the needle is in the shape of a polygonal pyramid, cone or rhombus.

[0017] Preferably, the sterilization medium diffusion tube is made of polytetrafluoroethylene.

[0018] Preferably, the self-puncturing isolation sterilization process verification device for infection control sterilization is suitable for various mainstream sterilization methods such as hydrogen peroxide plasma sterilization (45-60℃), ethylene oxide sterilization (37-55℃), formaldehyde sterilization (50-80℃), and peracetic acid sterilization.

[0019] Secondly, the present invention provides a method for validating a self-puncturing, isolated sterilization process for infection control sterilization, which is validated using the aforementioned self-puncturing, isolated sterilization process validating device for infection control sterilization, and includes the following steps:

[0020] S1 places the self-puncturing, isolated sterilization process verification device for infection control sterilization and the medical device to be sterilized into the sterilization chamber and starts the sterilization program. First, during the vacuuming stage, as the vacuum level in the sterilization chamber increases, the air filled in the corrugated telescopic tube expands under the action of the internal and external pressure difference, and the corrugated telescopic tube extends axially towards the easy-peel membrane. When the vacuum level reaches the preset vacuum threshold, the needle punctures the easy-peel membrane, exposing the sterilization indicator to the sterilization environment.

[0021] S2 then injects the sterilization medium, which diffuses along the sterilization medium diffusion tube into the cavity. Finally, it enters the loading tube through the punctured easy-peel membrane and comes into contact with the sterilization indicator. When the sterilization reaches the predetermined conditions, the sterilization indicator will indicate that the sterilization is successful. At this time, the sterilized medical device can be removed.

[0022] S3 removes residual sterilization media through multiple vacuuming and ventilation cycles. During ventilation, there is no pressure difference between the inside and outside of the corrugated expansion tube. At this time, the silicone corrugated expansion tube will retract back to prepare for the next sterilization use.

[0023] Compared with the prior art, the present invention has the following advantages:

[0024] The self-puncturing isolation sterilization process verification device for infection control sterilization of the present invention is designed in strict accordance with the sterilization principle and program operation stages. Its core advantages are reflected in: (1) Dual protection of physical isolation and pressure triggering: In the natural environment or in the sterilization chamber where the sterilization program has not been started but the sterilization medium remains, the sterilization indicator is completely isolated from the outside world by the dual physical isolation of the sealing plug and the easy-to-peel membrane; only in the vacuum stage of the sterilization program (a specific negative pressure is formed in the chamber), the corrugated telescopic tube gradually elongates axially under the vacuum and finally drives the puncture needle to puncture the easy-to-peel membrane just before the sterilization medium is injected, so as to achieve accurate exposure of the sterilization indicator. (2) Eliminate the premature interaction between the residual sterilization medium and the sterilization indicator and false positive results: Traditional devices lack a pressure response mechanism, and the sterilization indicator directly contacts the residual sterilization medium in the sterilization chamber, resulting in premature interaction with it; the device of the present invention avoids the interference of the sterilization medium in the non-sterilization stage by means of pressure triggering exposure design, and ensures that the indication result truly reflects the entire sterilization process. (3) Program synchronization and result reliability: The device responds to the pressure change cycle of the sterilization program and completes the puncture action during the vacuuming stage, exposing the sterilization indicator before the sterilization diffusion stage, ensuring precise matching of the contact timing with the sterilization medium, and significantly improving the accuracy and reliability of the monitoring results. (4) All-scenario residual protection: Traditional devices not only cannot isolate residual sterilization media in the sterilization chamber, but their own surfaces and gaps are also prone to adsorbing residual sterilization media, causing continuous interference to the sterilization indicator; the device of the present invention, through an integrated sealing structure design, not only blocks the intrusion of residual sterilization media inside the sterilization chamber, but also avoids the influence of residual sterilization media carried by the device itself on the sterilization indicator during repeated sterilization, realizing interference-free monitoring throughout the process, and completing the exposure process of the sterilization indicator without external power source or manual intervention. The automated design significantly simplifies the sterilization operation process, reduces human operation error, effectively improves the efficiency of the sterilization process, ensures seamless connection between the verification steps and the sterilization process, and ensures stable and controllable sterilization quality. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the structure of the self-puncturing, isolated sterilization process verification device for infection control sterilization of the present invention.

[0026] Figure 2 This is a schematic diagram of the structure of the easy-peel film of the present invention.

[0027] In the diagram, 1 is the shell; 2 is the cavity; 3 is the sterilization medium diffusion tube; 401 is the corrugated telescopic tube; 402 is the needle; 403 is the support block; 404 is the needle seat; 5 is the loading tube; 6 is the easy-peel membrane; 601 is the outer protective layer; 602 is the first adhesive layer; 603 is the barrier core layer; 604 is the second adhesive layer; 605 is the easy-peel layer; 606 is the third adhesive layer; 607 is the inner sealing layer; 7 is the sterilization indicator; and 8 is the sealing plug. Detailed Implementation

[0028] To enable those skilled in the art to better understand the technical solutions of this invention, the technical solutions of this invention will be clearly and completely described below in conjunction with the embodiments of this invention.

[0029] The structure of the self-puncturing, isolated sterilization process validation device used in the following embodiments for infection control sterilization is as follows:

[0030] like Figure 1 As shown, the device includes a housing 1, which can be made of PC, ABS, or PEEK. A cavity 2 is provided inside the housing 1. One end of the cavity 2 is sealed by a sealing plug 8, which is threaded to the opening of the cavity 2. A sealing gasket is placed between the cavity 2 and the sealing plug 8 to ensure the cavity 2 is airtight. The cavity 2 has two pipe interfaces, each connected to a sterilization medium diffusion tube 3. The sterilization medium diffusion tube 3 is made of polytetrafluoroethylene (PTFE), with an inner diameter of 1 mm, an outer diameter of 2 mm, and a length of 1 m. The sterilization medium diffusion tube 3 is placed inside the housing 1. The housing 1 has several through holes to facilitate the entry of the sterilization medium into the housing 1 and its diffusion along the sterilization medium diffusion tube 3 into the cavity 2.

[0031] like Figure 1 As shown, a puncture assembly is provided inside the cavity 2. The puncture assembly includes a corrugated telescopic tube 401 with both ends sealed, a support block 403, and a needle seat 404. The corrugated telescopic tube 401 is made of silicone (such as methyl vinyl silicone) and is filled with air. One end of the corrugated telescopic tube 401 is fixed to the support block 403, which is fixed inside the cavity 2. The other end faces the opening of the cavity 2 and is fixed with the needle seat 404. A needle 402 is fixed on the needle seat 404. The needle 402 is made of medical-grade 316L stainless steel, titanium alloy, ceramic, or polytetrafluoroethylene. The end of the needle 402 is in the shape of a polygonal pyramid, cone, or rhombus. The sealing plug 8 is threaded with a loading tube 5. When the sealing plug 8 is threaded at the opening of the cavity 2, the loading tube 5 is placed inside the cavity 2. One end of the loading tube 5 is open and the opening is sealed by an easy-to-remove membrane 6. The end of the loading tube 5 with the easy-to-remove membrane 6 faces the needle 402. Chemical indicators and biological indicators are placed inside the loading tube 5.

[0032] Taking hydrogen peroxide plasma sterilization as an example, the above-mentioned device and the medical device to be sterilized are placed in the sterilization chamber. When the sterilization program is started, the device undergoes a complete pressure change cycle with the sterilization chamber: First, in the vacuuming stage, as the vacuum level in the sterilization chamber increases, the air filled in the corrugated expansion tube 401 expands under the action of the internal and external pressure difference, and the corrugated expansion tube 401 extends axially towards the easy-peel membrane 6; when the vacuum is reached to the preset vacuum threshold (e.g., -80kPa), the needle 402 just punctures the easy-peel membrane 6, exposing the chemical and biological indicators to the sterilization environment before the diffusion stage (hydrogen peroxide vaporization injection) of the sterilization program. Then, liquid hydrogen peroxide is injected and vaporized and diffused to form a uniform sterilization environment; then, the plasma generator is activated to generate high-energy particles to destroy the microbial structure. Hydrogen peroxide gas and high-energy particles enter the housing 1 of the device through the penetration hole and gradually diffuse along the sterilization medium diffusion tube 3 into the cavity 2. Finally, they pass through the punctured easy-peel membrane 6 into the loading tube 5 and come into contact with the chemical and biological indicators. When sterilization reaches the predetermined conditions, the chemical and biological indicators will indicate successful sterilization, at which point the sterilized medical device can be removed. Finally, residual sterilization medium is removed through multiple vacuuming and ventilation cycles. During ventilation, there is no pressure difference inside and outside the corrugated telescopic tube 401, at which point the silicone corrugated telescopic tube 401 will retract, ready for the next sterilization. During the next sterilization, a new loading tube 5 containing chemical and biological indicators is installed to prevent residual sterilization medium carried by the device during repeated sterilization from affecting the chemical and biological indicators.

[0033] Compared to the passive response mode of traditional devices that are "open throughout the process", the device of this invention achieves programmed synchronization of the contact timing between chemical indicators, biological indicators and sterilization media through an active control mechanism of "pressure triggering - mechanical puncture - precise exposure". This fundamentally avoids the problem of residual sterilization media interacting with sterilization indicator 7 in advance, which would lead to premature sterilization qualification. It ensures that the monitoring results truly reflect the key parameters (concentration, contact time, plasma intensity) of the entire sterilization process.

[0034] To ensure the barrier properties of the easy-peel membrane 6, enabling it to effectively block oxygen, water vapor, and sterilization media (such as hydrogen peroxide gas), and to prevent residual sterilization media from prematurely interacting with chemical and biological indicators and affecting the accuracy of monitoring results, this invention designs the easy-peel membrane 6 as follows: Figure 2As shown, from the outside to the inside, it includes an outer protective layer 601, a first adhesive layer 602, a barrier core layer 603, a second adhesive layer 604, an easy-peel layer 605, a third adhesive layer 606, and an inner sealing layer 607. The outer protective layer 601 is made of PET film, the first adhesive layer 602 is coated with polyurethane adhesive, the barrier core layer 603 is made of aluminum foil, the second adhesive layer 604 is coated with modified acrylic adhesive, the easy-peel layer 605 is made of PE film, the third adhesive layer 606 is coated with modified acrylic adhesive, and the inner sealing layer 607 is made of PE film. The easy-peel film 6 of this invention has excellent barrier properties, effectively preventing external residual sterilization media from penetrating into the loading tube 5, protecting the chemical and biological indicators inside the loading tube 5 from premature interaction with the sterilization media, and ensuring the accuracy of the device's monitoring results.

[0035] Example 1

[0036] In this embodiment, the easy-peel film 6 comprises, from the outside to the inside, a 7μm thick PET outer protective layer 601, a 4μm thick first adhesive layer 602 coated with polyurethane adhesive, a 9μm thick 99.8% pure aluminum foil barrier core layer 603, a 3μm thick second adhesive layer 604 coated with modified acrylic adhesive, a 6μm thick LLDPE easy-peel layer 605, a 3μm thick third adhesive layer 606 coated with modified acrylic adhesive, and a 10μm thick PE inner sealing layer 607.

[0037] Example 2

[0038] In this embodiment, the easy-peel film 6 comprises, from the outside to the inside, a 6μm thick PET outer protective layer 601, a 3μm thick first adhesive layer 602 coated with polyurethane adhesive, a 7μm thick 99.7% pure aluminum foil barrier core layer 603, a 2μm thick second adhesive layer 604 coated with modified acrylic adhesive, a 5μm thick LLDPE easy-peel layer 605, a 2μm thick third adhesive layer 606 coated with modified acrylic adhesive, and an 8μm thick PE inner sealing layer 607.

[0039] Example 3

[0040] In this embodiment, the easy-peel film 6 comprises, from the outside to the inside, an 8μm thick PET outer protective layer 601, a 5μm thick first adhesive layer 602 coated with polyurethane adhesive, a 12μm thick 99.9% pure aluminum foil barrier core layer 603, a 4μm thick second adhesive layer 604 coated with modified acrylic adhesive, an 8μm thick LLDPE easy-peel layer 605, a 4μm thick third adhesive layer 606 coated with modified acrylic adhesive, and a 12μm thick PE inner sealing layer 607.

[0041] The barrier properties, puncture resistance, and easy-to-peel properties of the easy-peel film 6 in Examples 1-3 were tested using the following methods:

[0042] (1) Barrier performance

[0043] The oxygen, water vapor, and hydrogen peroxide barrier properties were tested according to GB / T 1038.1-2022 "Test Methods for Gas Permeability of Plastic Films and Sheets Part 1: Differential Pressure Method". The test conditions for hydrogen peroxide barrier property were: temperature 23℃, relative humidity 50%RH, hydrogen peroxide concentration 30mg / L, and test time 24h; the test conditions for oxygen barrier property were: temperature 23℃ and relative humidity 50%RH; and the test conditions for water vapor barrier property were: temperature 38℃ and relative humidity 90%RH.

[0044] (2) Puncture performance

[0045] The test was conducted in accordance with ISO 7765-2:2025 "Plastic films and sheets – Determination of impact strength by free-falling dart impact method – Part 2: Instrumented puncture test". The test conditions were: temperature 23℃, relative humidity 50%RH, 402 needle diameter 1mm, and puncture speed 10mm / min.

[0046] (3) Easy-to-open performance

[0047] The test was conducted in accordance with ASTM F88 / F88M-23, "Standard Test Method for Sealing Strength of Flexible Barrier Materials".

[0048] The test results are shown in Table 1:

[0049] Table 1 Performance test results of the easy-peel film 6 in Examples 1-3

[0050]

[0051] As can be seen from Table 1, the easy-peel membrane 6 of Examples 1-3 of the present invention has excellent hydrogen peroxide barrier properties, with a hydrogen peroxide permeation rate of <0.01 g / m³. 2 • 24h, with excellent barrier effect, ensuring that residual hydrogen peroxide cannot penetrate into the loading tube 5 during long-term storage and transportation, fully meeting the sealing and protection requirements of the loading tube 5. Meanwhile, the easy-peel membrane 6 of embodiments 1-3 of this invention has excellent overall barrier performance, which can further enhance the protective effect, with an oxygen permeability ≤0.4cm. 3 / m 2 • 24h • 0.1MPa, water vapor transmission rate ≤ 0.25g / m 2• For 24 hours, it effectively blocks oxygen, water vapor, and other substances, further protecting the stability of chemical and biological indicators inside the loading tube 5. Meanwhile, the easy-peel film 6 of Embodiments 1-3 of this invention, through material matching and thickness optimization of each layer, possesses excellent peelability. The peeling force is controlled at 1.2-1.8N, allowing for easy manual peeling without residue or tearing, preserving the overall structure of the easy-peel film 6. This facilitates rapid opening of the loading tube 5 and prevents hydrogen peroxide residue from adhering to the port of the loading tube 5 due to improper peeling operation. Furthermore, while ensuring excellent barrier and easy-peeling performance, the easy-peel film 6 of Embodiments 1-3 of this invention also possesses a reasonable puncture force, making it easy to puncture and facilitating subsequent puncture by the 402 needle. In summary, the easy-peel film 6 of Embodiments 1-3 of this invention offers excellent barrier performance, easy peeling, and moderate puncture force, making it suitable for packaging loading tubes 5 for long-term storage and long-distance transportation, providing stable and reliable protection.

[0052] The loading tube 5 of the self-puncturing, isolated sterilization process validation device for infection control sterilization of this invention was removed, sealed with a sealing plug 8, and then sterilized 100 times in a hydrogen peroxide plasma sterilization chamber. Subsequently, chemical and biological indicators were directly placed in the chamber 2 without initiating the sterilization program. After 8 hours of observation, both the chemical and biological indicators showed color changes. However, when the chemical and biological indicators were placed in the loading tube 5 and then placed in the chamber 2 without initiating the sterilization program, no color change was observed after 8 hours. This demonstrates that the self-puncturing, isolated sterilization process validation device for infection control sterilization of this invention can avoid the problem of inaccurate sterilization monitoring results caused by premature interaction between residual sterilization media and sterilization indicators 7.

Claims

1. A self-puncturing, isolated sterilization process validation device for infection control sterilization, comprising a housing (1), a cavity (2) disposed within the housing (1), one end of the cavity (2) being open and detachably sealed; a tube interface disposed on the cavity (2) and connected to a sterilization medium diffusion tube (3), the sterilization medium diffusion tube (3) being placed inside the housing (1), and a penetration hole disposed on the housing (1); characterized in that, A puncture assembly is provided inside the cavity (2). The puncture assembly includes a corrugated telescopic tube (401) with both ends sealed. The corrugated telescopic tube (401) is made of silicone and filled with air. One end of the corrugated telescopic tube (401) is fixed inside the cavity (2), and the other end faces the opening of the cavity (2) and is provided with a needle (402). A loading tube (5) is detachably provided at the opening of the cavity (2). One end of the loading tube (5) is open and sealed by an easy-to-remove membrane (6). The end of the loading tube (5) with the easy-to-remove membrane (6) faces the needle (402). A sterilization indicator (7) is placed inside the loading tube (5). During the vacuuming stage of the sterilization procedure, the corrugated telescopic tube (401) gradually elongates axially under the vacuum and eventually drives the needle (402) to puncture the easy-to-remove membrane (6) just before the sterilization medium is injected, so as to achieve precise exposure of the sterilization indicator (7).

2. The self-puncturing, isolated sterilization process validation device for infection control sterilization as described in claim 1, characterized in that, The easy-peel film (6) comprises, from the outside to the inside, an outer protective layer (601), a first adhesive layer (602), a barrier core layer (603), a second adhesive layer (604), an easy-peel layer (605), a third adhesive layer (606), and an inner sealing layer (607). The outer protective layer (601) is made of PET film, the first adhesive layer (602) is coated with polyurethane adhesive, the barrier core layer (603) is made of aluminum foil, the second adhesive layer (604) is coated with modified acrylic adhesive, the easy-peel layer (605) is made of PE film, the third adhesive layer (606) is coated with modified acrylic adhesive, and the inner sealing layer (607) is made of PE film.

3. The self-puncturing, isolated sterilization process validation device for infection control sterilization as described in claim 2, characterized in that, The outer protective layer (601) has a thickness of 6-8 μm, the first adhesive layer (602) has a thickness of 3-5 μm, the barrier core layer (603) has a thickness of 7-12 μm, the second adhesive layer (604) has a thickness of 2-4 μm, the easy-peel layer (605) has a thickness of 5-8 μm, the third adhesive layer (606) has a thickness of 2-4 μm, and the inner sealing layer (607) has a thickness of 8-12 μm.

4. The self-puncturing, isolated sterilization process validation device for infection control sterilization as described in claim 3, characterized in that, The easy-peel membrane (6) exhibits a hydrogen peroxide permeation rate of 0.007-0.009 g / m³ under conditions of 23°C, 50% RH, and 30 mg / L hydrogen peroxide concentration. 2 • 24h; Oxygen permeability at 23℃ and 50%RH is 0.2-0.4 cm. 3 / m 2 • 24h • 0.1MPa; Water vapor transmission rate at 38℃ and 90%RH is 0.18-0.25g / m³ 2 • 24h; the puncture force is 0.9-1.4N under the conditions of 23℃, 50%RH, needle (402) diameter 1mm, and puncture speed 10mm / min; the opening force is 1.2-1.8N.

5. The self-puncturing, isolated sterilization process validation device for infection control sterilization as described in claim 1, characterized in that, The opening end of the cavity (2) is sealed by a sealing plug (8).

6. The self-puncturing, isolated sterilization process validation device for infection control sterilization as described in claim 1, characterized in that, The puncture assembly includes a support block (403) and a needle seat (404). The support block (403) is fixed inside the cavity (2). One end of the corrugated telescopic tube (401) is fixed on the support block (403), and the other end is fixed on the needle seat (404). The puncture needle (402) is fixed on the needle seat (404).

7. The self-puncturing, isolated sterilization process validation device for infection control sterilization as described in claim 1, characterized in that, The shell (1) is made of polycarbonate, acrylonitrile-butadiene-styrene copolymer, polyetheretherketone or polypropylene; the needle (402) is made of medical grade 316L stainless steel, titanium alloy, ceramic or polytetrafluoroethylene, and the end of the needle (402) is in the shape of a polygonal pyramid, a cone or a rhombus.

8. The self-puncturing, isolated sterilization process validation device for infection control sterilization as described in claim 1, characterized in that, The sterilization medium diffusion tube (3) is made of polytetrafluoroethylene.

9. The self-puncturing, isolated sterilization process validation device for infection control sterilization as described in claim 1, characterized in that, The self-puncturing, isolated sterilization process validation device for infection control sterilization is suitable for hydrogen peroxide plasma sterilization, ethylene oxide sterilization, formaldehyde sterilization, and peracetic acid sterilization.

10. A validation method for a self-puncturing, isolated sterilization process for infection control sterilization, characterized in that, Validation is performed using the self-puncturing, isolated sterilization process validation device for infection control sterilization as described in any one of claims 1-9, including the following steps: S1 places the self-puncturing isolation sterilization process verification device for infection control sterilization and the medical device to be sterilized into the sterilization chamber and starts the sterilization program. First, during the vacuuming stage, as the vacuum level in the sterilization chamber increases, the air filled in the corrugated telescopic tube (401) expands under the action of the internal and external pressure difference, and the corrugated telescopic tube (401) extends axially towards the easy-peel membrane (6). When the vacuum is reached to the preset vacuum level threshold, the needle (402) punctures the easy-peel membrane (6), exposing the sterilization indicator (7) to the sterilization environment. S2 is then injected with sterilization medium and diffuses along the sterilization medium diffusion tube (3) into the cavity (2). Finally, it enters the loading tube (5) through the punctured easy-peel membrane (6) and comes into contact with the sterilization indicator (7). When the sterilization reaches the predetermined conditions, the sterilization indicator (7) will indicate that the sterilization is successful. At this time, the sterilized medical device can be taken out. S3 removes residual sterilization media through multiple vacuuming and ventilation cycles; during ventilation cycles, there is no pressure difference between the inside and outside of the corrugated expansion tube (401), at which time the silicone corrugated expansion tube (401) will retract back for the next sterilization use.

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