Sterilization treatment and packaging system for liposome local anesthetic packaging bottle

Abstract

The invention discloses a sterile treatment and packaging system for a liposome local anesthetic packaging bottle, which relates to the technical field of medicine packaging and comprises a final sterilization treatment module, a ready-to-use packaging module, a sterile barrier module, a process and quality control module and a sterilization effect verification module, the final sterilization treatment module is responsible for performing terminal sterilization on the sealed container filled with the liposome local anesthetic, it is ensured that the medicine is sterile and the structural integrity of the liposome is not damaged, instant use is achieved through the ready-to-use packaging module, the medicine preparation time is shortened, the material compatibility is high, interaction with the liposome medicine is avoided, and the service life of the liposome local anesthetic is prolonged. Dual protection is provided through the outer package design of the sterile barrier module, it is ensured that the product is kept in a sterile state before storage, transportation and clinical use, a reliable sterile barrier is constructed by combining vacuum sealing and antibacterial materials, it is ensured that the whole process from delivery to an operating table is in a sterile state, secondary pollution is avoided, and clinical medication safety and efficiency are remarkably improved.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical packaging technology, specifically to a sterilization treatment and packaging system for liposome local anesthetic packaging bottles. Background Technology

[0002] Liposome local anesthetics (such as bupivacaine liposomes) are widely used in surgery due to their long-acting analgesic properties. Liposome local anesthetics are a new type of formulation that prolongs the duration of action of local anesthetics through liposome carrier technology. Currently, bupivacaine liposomes are the representative of these drugs and have been approved for postoperative analgesia in many countries around the world. A single dose can cover the acute pain period of 72 hours after surgery, reducing the amount of opioids used. The liposome components (phospholipids, cholesterol) have good biocompatibility and lower systemic toxicity risk than traditional local anesthetics. They are suitable for local infiltration and nerve blocks, such as intermuscular groove brachial plexus and popliteal sciatic nerve blocks. However, existing products have serious defects. Currently, commercially available bupivacaine liposomes are packaged in glass vials. Traditional heat sterilization at 121°C steam will destroy the liposome structure. Furthermore, the current packaging design does not take into account the ease of operation on the operating table, resulting in long preparation time for intraoperative drugs and increasing the risk of contamination due to multiple operation steps. Summary of the Invention

[0003] This invention provides a sterilization process and packaging system for liposome local anesthetic packaging bottles, which can effectively solve the problems mentioned in the background art, such as non-sterile packaging of existing liposome local anesthetics, cumbersome operating room operation, and high risk of contamination.

[0004] To achieve the above objectives, the present invention provides the following technical solution: a sterilization treatment and packaging system for liposome local anesthetic packaging bottles, comprising a terminal sterilization treatment module, a ready-to-use packaging module, a sterile barrier module, a process and quality control module, and a sterilization effect verification module; The terminal sterilization module is responsible for terminal sterilizing the sealed packaged liposomal local anesthetic. The ready-to-use packaging module includes a specially designed bottle, rubber stopper, and aluminum cap. The sterile barrier module maintains the sterility of the product during storage and transportation through medical-grade vacuum sealing and outer packaging design. The process and quality control module aims to ensure the consistency of product quality, while the sterilization effect verification module verifies the sterilization effect of the sterilization technology.

[0005] According to the above technical solution, the terminal sterilization module achieves terminal sterilization of sealed packaged drugs while ensuring the structural integrity of liposomes. Specifically, sterilization technology is used to completely kill microorganisms, while low-temperature process is used to protect the liposome encapsulation rate of ≥95%.

[0006] According to the above technical solution, the electron beam irradiation sterilization is to sterilize the sealed container filled with liposome local anesthetic by irradiating it with an electron beam dose of 15-25kGy, thereby destroying the microbial DNA through the high-energy electron beam; The dosage range is precisely controlled by adjusting the electron beam energy and irradiation time, with the sterilization temperature controlled to ≤30℃ and the dosage uniformity Dmax / Dmin ≤1.5.

[0007] According to the above technical solution, the hydrogen peroxide low-temperature plasma sterilization involves filling liposomes into vials, placing the vials on a special tray of the hydrogen peroxide low-temperature plasma sterilizer, with a 1cm gap between the vials.

[0008] According to the above technical solution, after the hydrogen peroxide vapor sterilization pre-treats the vials containing liposomes, the vials are placed in a hydrogen peroxide vapor sterilizer. The pre-treatment steps include using a tunnel-type air circulation dryer to remove condensate from the surface of the vials at a temperature of 30°C and a wind speed of 1.5 m / s, and loading the vials with a spacing of ≥1 cm and the bottle openings facing upwards. Next, by setting sterilization parameters, including sterilization temperature, hydrogen peroxide concentration, and sterilization time, vacuum drying and analysis are performed after sterilization, with an analysis time of 3-5 hours.

[0009] According to the above technical solution, the ready-to-use packaging module aims to provide a sterile and convenient solution for direct use on the operating table. Specifically, it includes a medicine bottle made of COP material, a pre-sterilized bromobutyl rubber stopper, and an easy-tear sterile package. The medicine bottle, rubber stopper, and aluminum cap are assembled after pre-sterilization treatment to form an internal sterile environment.

[0010] According to the above technical solution, the sterile barrier module maintains the sterility of the packaging during transportation and storage until clinical use, and includes an outer packaging structure and an inner sealing structure.

[0011] According to the above technical solution, the process and quality control module specifically refers to the need to manage the filling environment and perform packaging verification; The filling environment must be a Class A clean environment to complete the liposome filling, and vacuum packaging must be carried out immediately after filling; During the filling process, it is necessary to ensure that the filling accuracy is ±1%, and the torque is controlled at 20-30 N·cm when filling and sealing the cap. Packaging validation includes physical performance testing and stability testing. Physical performance testing includes testing and validation of aluminum cap opening force, rubber stopper puncture force, and bottle pressure resistance.

[0012] According to the above technical solution, the sterilization effect verification module specifically includes verification of the sterilization effect of electron beam irradiation, verification of the sterilization effect of hydrogen peroxide low-temperature plasma, and verification of the sterilization effect of hydrogen peroxide vapor. During the effectiveness verification of the electron beam irradiation sterilization, biological indicators were used. Three biological indicators containing 10⁶ CFU / bottle of Bacillus stearothermophilus were placed in each batch. After sterilization, sterility was confirmed by culture. At the same time, the encapsulation rate after sterilization was verified by HPLC-ELSD to be ≥95%. A safety assessment is also required, with no positive growth after sterilization with biological indicators and residual hydrogen peroxide ≤1μg / g.

[0013] According to the above technical solution, when verifying the effect of hydrogen peroxide low-temperature plasma sterilization, 10 vials were randomly selected for testing. Dynamic light scattering detection revealed the change in D90 of liposome particle size distribution before and after sterilization. The encapsulation efficiency of liposomes was determined by ultracentrifugation to identify changes in encapsulation efficiency before and after sterilization, and drug degradation products were analyzed by HPLC.

[0014] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The terminal sterilization module is responsible for the terminal sterilization of the sealed containers filled with liposome local anesthetics, ensuring the sterility of the drug and the integrity of the liposome structure. Low-temperature sterilization technology is used to avoid the decrease in liposome encapsulation rate caused by traditional heat sterilization. The ready-to-use packaging module enables immediate use, reducing drug preparation time. The material has high compatibility, avoiding interaction with the liposome drug. The pre-sterilized components can be used directly, reducing the risk of contamination. It greatly simplifies the operating table operation process and improves emergency response efficiency. The outer packaging design of the sterile barrier module provides double protection to ensure that the product remains sterile before storage, transportation and clinical use. Combined with vacuum sealing and antibacterial materials, a reliable sterile barrier is constructed to ensure a sterile state from the factory to the operating table, avoiding secondary contamination and significantly improving the safety and efficiency of clinical drug use.

[0015] 2. By combining terminal sterilization, ready-to-use packaging, and sterile barrier modules, the system ensures sterility from production to the operating table, maintaining the integrity of the liposome structure. The ready-to-use design significantly reduces operational steps, eliminating the need for nurses to draw medication in non-sterile areas, shortening administration time, and significantly reducing the risk of contamination, thus improving patient safety. The process and quality control module aims to ensure consistent product quality and prevent secondary contamination, demonstrating good practicality and promotional value. The sterilization effectiveness verification module verifies the sterilization effect of the sterilization technology to ensure sterility, allowing the liposome local anesthetic to reach the operating table in a sterile state. This reduces operational steps, lowers the risk of contamination, and significantly enhances clinical applicability. Attached Figure Description

[0016] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof.

[0017] In the attached diagram: Figure 1 This is a structural block diagram of the aseptic processing and packaging system of the present invention. Detailed Implementation

[0018] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0019] Example 1: like Figure 1 As shown, the present invention provides a technical solution, an aseptic processing and packaging system for liposome local anesthetic packaging bottles, including a terminal sterilization module, a ready-to-use packaging module, an aseptic barrier module, a process and quality control module, and a sterilization effect verification module. Through the synergistic effect of the terminal sterilization module, the ready-to-use packaging module, and the aseptic barrier module, aseptic assurance is achieved throughout the entire process from production to surgery, significantly improving the safety and efficiency of clinical medication. The terminal sterilization module is responsible for terminal sterilizing the sealed liposomal local anesthetics to eliminate the risk of microbial contamination and ensure the structural integrity of the liposomes. The ready-to-use packaging module includes a specially designed bottle, rubber stopper, and aluminum cap to provide convenience for immediate use and reduce the risk of contamination. The sterile barrier module maintains the sterility of the product during storage and transportation through medical-grade vacuum sealing and outer packaging design. The process and quality control module aims to ensure consistent product quality and avoid secondary contamination, while the sterilization effect verification module verifies the sterilization effect of the sterilization technology to ensure a sterile state.

[0020] Based on the above technical solution, the terminal sterilization module achieves terminal sterilization of sealed packaged drugs while ensuring the structural integrity of liposomes. Specifically, sterilization technology is used to thoroughly kill microorganisms and ensure product sterility. At the same time, a low-temperature process is used to protect the liposome encapsulation rate of ≥95%. The microorganisms are Bacillus stearothermophilus. The sterilization technology specifically involves electron beam irradiation sterilization. During the sterilization process, liposome local anesthetics are first filled into the packaging bottle in a Class A clean environment. The liposome local anesthetic is ropivacaine. After capping and sealing, sterilization is performed to ensure a sterile state.

[0021] Based on the above technical solution, electron beam irradiation sterilization is used to sterilize the sealed container filled with liposome local anesthetic by irradiating it with a dose of 20 kGy. The high-energy electron beam destroys the DNA of microorganisms, thereby achieving a sterile effect. The dosage range is precisely controlled by adjusting the electron beam energy and irradiation time, and the sterilization temperature is controlled to be ≤30℃. By optimizing the irradiation parameters and the thermal conductivity of the packaging materials, liposomes are prevented from agglomerating due to high temperature. The irradiation sterilization uses an electron beam E-beam, and the dose uniformity Dmax / Dmin ≤1.5 to ensure sterilization uniformity, consistent sterilization effect, and prevent excessive local dose from causing drug degradation.

[0022] Based on the above technical solutions, the ready-to-use packaging module aims to provide a sterile and convenient solution for direct use on the operating table, reducing operation steps and the risk of contamination. Specifically, it includes a medicine bottle made of COP material, a pre-sterilized bromobutyl rubber stopper, and easy-tear sterile packaging. The medicine bottle, rubber stopper, and aluminum cap are assembled after pre-sterilization treatment to form an internal sterile environment and avoid secondary contamination. COP (Cyclic Oxide Polymer) medicine bottles have a light transmittance of >92% due to their cyclic olefin polymer material, facilitating visual inspection of drugs. They are resistant to low temperatures down to -196℃, meeting ultra-low temperature storage requirements. They are chemically inert, and the bottle surface is hydrophobically treated, resulting in a contact angle ≥90°. They also exhibit low protein adsorption, with a protein adsorption capacity ≤0.1μg / cm³. 2 This reduces drug adsorption and adhesion to the wall, and avoids loss of active drug components; The transparent vial body facilitates intraoperative observation of the drug's condition. Combined with a precision filling process, it ensures uniform dispersion of liposomes, replacing glass vials and avoiding the non-sterile nature and breakage risks of glass vials, thus improving transportation safety. It also integrates QR code laser etching to support drug traceability and expiration date management. The pre-sterilized bromobutyl rubber stopper is highly compatible with COP material vials, maintaining the integrity of the sterile barrier after vacuum sealing. The stopper contains a fluoropolymer coating, with ≤3 particles / needle puncture debris, meeting ISO 8871 standards, reducing intraoperative particulate contamination. Laser-engraved cross-shaped positioning marks assist in precise puncture, ensuring puncture accuracy, reducing operational error rate, and minimizing the risk of debris shedding. Pre-sterilization treatment before irradiation avoids secondary contamination. Specifically, ethylene oxide sterilization is used for pre-sterilization. The easy-tear sterile packaging includes a pre-cut tear-off ring, allowing for one-handed opening in ≤2 seconds and requiring ≤5N of force with one hand. It is ergonomically designed for emergency procedures on the operating table. Furthermore, the aluminum cap and rubber stopper work together to ensure a long-term sterile barrier.

[0023] Based on the above technical solution, the sterile barrier module maintains the sterility of the packaging during transportation and storage until clinical use, including the outer packaging structure and the inner sealing structure. The outer packaging structure refers to the medicine bottle being covered with a medical-grade vacuum-sealed bag, specifically a medical-grade Tyvek® / PE composite bag, which has the characteristics of puncture resistance, high barrier properties, and tear resistance. The inner sealing structure refers to the double seal of the rubber stopper and the aluminum cap to prevent leakage of the medicine. Meanwhile, the residual oxygen content in the packaging after sterilization is ≤1% to inhibit oxidation reaction. After filling and capping, the packaging is immediately placed in an antibacterial bag and vacuumed to ≤10kPa to isolate external microorganisms from intrusion and maintain a sterile barrier for ≥180 days. This is verified through material barrier performance testing to inhibit microbial growth. It features a built-in humidity indicator card, specifically a cobalt chloride color-changing card, with an accuracy of ±3%RH. This card monitors humidity changes within the packaging in real time, ensuring a dry environment after sterilization with a humidity level ≤10% to prevent liposome hydrolysis. It maintains a sterile state after irradiation until clinical use and triggers a color warning when the relative humidity is >10%. Under conditions of 25℃ / 60%RH, the sterility shelf life is ≥24 months, meeting the needs of operating room inventory. This has been verified through accelerated aging experiments.

[0024] Based on the above technical solution, the process and quality control module specifically refers to the need to manage the filling environment and conduct packaging verification; Ropivacaine filling must be completed in a Class A clean environment. Vacuum packaging should be performed immediately after filling to minimize environmental exposure and reduce the probability of initial contamination. Class A clean area refers to ISO Class 5. During the filling process, it is necessary to ensure that the filling accuracy is ±1% to ensure accurate dosage. When filling and sealing the cap, the torque should be controlled at 25 N·cm to prevent the rubber stopper from shifting. Packaging validation includes physical performance testing and stability testing. Physical performance testing includes testing and validation of aluminum cap opening force, rubber stopper puncture force, and bottle pressure resistance, specifically verified according to ASTM standards. The stability test was conducted through accelerated testing at 40℃ / 75%RH for 6 months. The liposome encapsulation efficiency decreased by ≤5%, the liposome particle size distribution (D90) changed by ≤8.5%, and the drug degradation products were ≤0.1%, which met the quality standards.

[0025] Based on the above technical solution, the sterilization effect verification module specifically verifies the sterilization effect of electron beam irradiation; During the efficacy verification of electron beam irradiation sterilization, biological indicators were used. Three biological indicators containing 10⁶ CFU / bottle of Bacillus stearothermophilus were placed in each batch. After sterilization, the bacteria were cultured to confirm sterility. At the same time, HPLC-ELSD verification was performed to ensure that the encapsulation rate after sterilization was ≥95%, and the analysis of bupivacaine degradation products was ≤0.07%, ensuring that the content was below the safety limit of ≤0.1%. HPLC-ELSD: High Performance Liquid Chromatography-Evaporative Light Scattering Detection. A safety assessment is also required, with no positive growth after sterilization with biological indicators and residual hydrogen peroxide ≤1μg / g.

[0026] Example 2: The sterilization technology specifically involves hydrogen peroxide low-temperature plasma sterilization. During the sterilization process, the liposome local anesthetic is first filled into the packaging bottle in a Class A clean environment. The liposome local anesthetic is ropivacaine. After capping and sealing, sterilization is performed to ensure a sterile state.

[0027] Hydrogen peroxide low-temperature plasma sterilization involves filling ropivacaine injection solution into low-alkali corrosion-resistant borosilicate glass vials, using a rubber stopper made of a breathable material, and an aluminum-plastic combination cap to ensure a tight seal. The vials are then placed on a special tray of the hydrogen peroxide low-temperature plasma sterilizer, with a 1cm gap between the vials to ensure gas flow. By setting sterilization parameters, the sterilization temperature was controlled at 45±2℃, the hydrogen peroxide injection amount was 9mg / L, and the sterilization time was 25 minutes. The sterilization process was specifically divided into a vacuum stage, a hydrogen peroxide injection and diffusion stage, a plasma excitation stage, and a ventilation and desorption stage. During the vacuuming phase, the pressure is reduced to ≤10Pa. During the hydrogen peroxide injection and diffusion phase, the pressure needs to be maintained for 7 minutes. During the plasma excitation phase, the excitation power needs to be 400W and the time needs to be controlled at 17 minutes. During the ventilation and desorption phase, the desorption time is controlled at 5 hours, and the residual amount of hydrogen peroxide is ensured to be ≤1μg / g.

[0028] The sterilization effect verification module specifically verifies the sterilization effect of hydrogen peroxide low-temperature plasma. During the efficacy verification of hydrogen peroxide low-temperature plasma sterilization, 10 vials were randomly selected for testing. Specifically, these were borosilicate glass vials filled with ropivacaine injection solution. Dynamic light scattering detection revealed that the D90 of the liposome particle size distribution changed by 7% before and after sterilization. The encapsulation efficiency of liposomes was determined by ultracentrifugation, and the change in encapsulation efficiency before and after sterilization was 2.2%. Drug degradation products were analyzed by HPLC, and the content of bupivacaine degradation products was found to be 0.07%. Three biological indicators containing 106 CFU / bottle of Bacillus stearothermophilus were placed in each sterilization batch. After sterilization, a positive control culture was performed and incubated at 56°C for 48 hours to confirm sterility. Example 3: The sterilization technology specifically involves hydrogen peroxide vapor sterilization. During the sterilization process, the liposome local anesthetic is first filled into the packaging bottle in a Class A clean environment. The liposome local anesthetic is ropivacaine. After capping and sealing, sterilization is performed to ensure a sterile state.

[0029] After the vials filled with ropivacaine injection are pretreated by hydrogen peroxide vapor sterilization, they are placed in a hydrogen peroxide vapor sterilizer. The pretreatment steps include using a tunnel-type air circulation dryer at a temperature of 30°C and a wind speed of 1.5 m / s to remove condensate from the surface of the vials, and loading the vials with a spacing of ≥1 cm and the bottle opening facing upwards. Next, by setting sterilization parameters, the sterilization temperature was controlled at 55±2℃, the hydrogen peroxide concentration was controlled at 40mg / L, and the sterilization time was controlled at 37 minutes, ensuring that the residual amount of hydrogen peroxide was ≤1μg / g; After sterilization, vacuum drying and analysis are performed for 4 hours to ensure that the residual hydrogen peroxide in the vials meets relevant safety standards.

[0030] The sterilization effect verification module is designed to verify the sterilization effect of hydrogen peroxide vapor. During the efficacy verification of hydrogen peroxide vapor sterilization, 10 vials were randomly selected from each batch for quality control. Specifically, these were borosilicate glass vials filled with ropivacaine injection solution. The liposome particle size distribution was detected by dynamic light scattering, and the D90 change before and after sterilization was 8.5%. The encapsulation efficiency of liposomes was determined by ultracentrifugation, and the change in encapsulation efficiency before and after sterilization was 2.8%. Drug degradation products were analyzed by HPLC, and the limit for analysis of bupivacaine degradation products was 0.09%. For each sterilization batch, place 3 biological indicators containing 106 CFU / bottle of Bacillus subtilis. After sterilization, perform positive control culture and incubate at 37°C for 48 hours to confirm sterility.

[0031] Combining the above examples 1-3, it is easy to see that electron beam irradiation sterilization is suitable for operating rooms and emergency treatment scenarios that require rapid turnover, hydrogen peroxide low-temperature plasma sterilization is suitable for heat-sensitive liposomal drugs, and hydrogen peroxide vapor sterilization is suitable for liposomal drugs packaged in traditional glass bottles. The following table shows a comprehensive comparison of the three sterilization technologies mentioned above in practical implementation:

[0032] Therefore, as can be seen from the table above, electron beam irradiation sterilization technology is comprehensively superior in terms of liposome stability, operational efficiency, and safety, making it the preferred choice for high-end liposome drug packaging in the future.

[0033] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A sterilization and packaging system for liposome local anesthetic packaging bottles, characterized in that: The terminal sterilization processing module, the ready-to-use packaging module, the sterile barrier module, the process and quality control module and the sterilization effect verification module are included. The terminal sterilization processing module is responsible for terminal sterilization of the sealed packaged liposome local anesthetic, the ready-to-use packaging module includes special design of the medicine bottle, the rubber stopper and the aluminum cap, the sterile barrier module maintains the sterile state of the product during storage and transportation through medical grade vacuum sealing and outer packaging design. The process and quality control module aims to guarantee the consistency of product quality, and the sterilization effect verification module realizes verification of the sterilization effect of the sterilization technology.

2. The system for aseptic processing and packaging of liposomal local anesthetic vials according to claim 1, wherein: The terminal sterilization processing module realizes terminal sterilization of the sealed packaged medicine under the premise of guaranteeing the integrity of the liposome structure, specifically adopts sterilization technology to completely kill microorganisms, and protects the liposome encapsulation rate ≥ 95% through low-temperature process.

3. The system for aseptic processing and packaging of liposomal local anesthetic vials of claim 2, wherein: The electron beam irradiation sterilization is electron beam irradiation sterilization of the sealed container of the liposome local anesthetic with a dose of 15-25 kGy, which destroys the DNA of microorganisms through high-energy electron beam; The dose range is precisely controlled by adjusting the electron beam energy and irradiation time, the sterilization temperature is controlled to be ≤ 30℃, and the dose uniformity Dmax / Dmin is ≤ 1.

5.

4. The system for aseptic processing and packaging of liposomal local anesthetic vials of claim 2, wherein: The hydrogen peroxide low-temperature plasma sterilization is to fill the liposome into a test tube, and place the test tube on a special tray of the hydrogen peroxide low-temperature plasma sterilizer, and the distance between the bottles is 1 cm.

5. The system for aseptic processing and packaging of liposomal local anesthetic vials of claim 2, wherein: The hydrogen peroxide vapor sterilization is to put the pretreated test tube of the liposome into the hydrogen peroxide vapor sterilizer, the pretreatment step includes using a tunnel type air circulation dryer to remove the condensate on the surface of the test tube at a temperature of 30℃ and an air speed of 1.5 m / s, and the test tubes are loaded with a distance of ≥ 1 cm and the bottle opening facing upwards; Then, the sterilization parameters including sterilization temperature, hydrogen peroxide concentration and sterilization time are set, and vacuum drying analysis is carried out after sterilization, and the analysis time is 3-5 hours.

6. The system for aseptic processing and packaging of liposomal local anesthetic vials of claim 1, wherein: The ready-to-use packaging module aims to provide a sterile and convenient operating table direct use scheme, specifically including a medicine bottle made of COP material, a pre-sterilized bromobutyl rubber stopper and an easy-to-tear sterile package, wherein the medicine bottle, the stopper and the aluminum cap are assembled after pre-sterilization to form an internal sterile environment.

7. The system for aseptic processing and packaging of liposomal local anesthetic vials according to claim 1, wherein: The sterile barrier module maintains the sterile state of the package during transportation and storage until clinical use, including outer packaging structure and inner sealing structure.

8. The system for aseptic processing and packaging of liposomal local anesthetic vials of claim 1, wherein: The process and quality control module specifically refers to the management of the filling environment and the verification of the package. The filling environment needs to be completed in a class A clean environment, and vacuum packaging is carried out immediately after filling. During the filling process, the filling accuracy needs to be ensured to be ± 1%, and the torque needs to be controlled to be 20-30 N·cm during the filling and sealing of the gland. The package verification includes physical performance test and stability test, and the physical performance test includes test and verification of the aluminum cap opening force, the stopper puncture force and the medicine bottle pressure resistance.

9. The system for aseptic processing and packaging of liposomal local anesthetic vials of claim 1, wherein: The sterilization effect verification module specifically includes verification of the electron beam irradiation sterilization effect, verification of the hydrogen peroxide low-temperature plasma sterilization effect, and verification of the hydrogen peroxide vapor sterilization effect. The electron beam irradiation sterilization is verified by biological indicators, 3 biological indicators containing 106 CFU / bottle of Bacillus stearothermophilus are placed in each batch, and the culture after sterilization confirms that there is no sterility. At the same time, the HPLC-ELSD verification is verified, and the encapsulation rate after sterilization is greater than or equal to 95%; Safety evaluation also needs to be carried out, and there is no positive growth after sterilization by biological indicators, and the residual hydrogen peroxide is less than or equal to 1 μg / g.

10. The system for aseptic processing and packaging of liposomal local anesthetic vials of claim 9, wherein: The hydrogen peroxide low-temperature plasma sterilization is verified by randomly selecting 10 vials for detection. Through dynamic light scattering detection, it is found that the D90 of the liposome particle size distribution changes before and after sterilization. The liposome encapsulation rate is measured by ultracentrifugation method to determine the change of encapsulation rate before and after sterilization, and HPLC is used to analyze drug degradation products.

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