Discussion on treatment methods and equipment of aluminum-plastic composite cover (including aluminum cover)
2021-09-23 11:24:17
The aluminum-plastic composite cover (including aluminum cover) is the main packaging material for the production of sterile powder injection. In order to ensure that it meets GMP requirements, it must be treated accordingly. According to the current 98 version of GMP, the low requirement for the non-zui final sterilization process is completed under the cleanliness of 100,000 grades. Therefore, the current treatment of aluminum-plastic composite covers (including aluminum cover) by various pharmaceutical companies Not the same, no uniform standard. For example, some after ultraviolet irradiation, through the transfer window into the rolling cover operation area; some are sterilized by ozone sterilization; some are heated and disinfected by electric oven. The forthcoming new version of GMP (currently the draft for comments, hereinafter referred to as the new version of GMP) puts forward higher requirements for the production of sterile drugs: the introduction of the “dynamic cleanliness†indicator requires that the environment for each step of production should be achieved. Appropriate dynamic cleanliness standards require clean areas to be designed to meet the appropriate cleanliness requirements, including “static†and “dynamic†standards, which classify the cleanliness required for sterile pharmaceutical production as Class A, Class B, and C. Four levels of level and level D. For the production of sterile pharmaceutical products that are not sterilized by non-zui, the products before the capping are regarded as being in an incompletely closed state, and the capping process is required to be completed in the Class A clean zone under the B-level background. Based on the new GMP requirements for production operations, it is necessary to discuss the treatment methods and equipment of aluminum-plastic composite covers (including aluminum covers).
1 New GMP requirements for aluminum-plastic composite cover (including aluminum cover) 1.98 version GMP and new GMP requirements for cleansing of sterile pharmaceutical products The new version of GMP differentiates the cleanliness required for the production of sterile drugs into four levels: A Class, B, C and D grades require “static†and “dynamic†requirements for the cleanliness of the aseptic production area; while the current version 98 of the GMP classifies the cleanliness of the clean areas of pharmaceutical production. Four levels: 100, 10,000, 100,000 and 300,000, with static indicators. The details are shown in Table 1, Table 2, and Table 3.
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1.298 GMP and new GMP requirements for non-zui terminally sterilized sterile preparations Compared with the new GMP, the requirement for non-zui terminally sterilized sterile preparations is qualitatively different from that of the 98th GMP, and the requirements are significantly improved. The details are shown in Table 4.
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It can be seen from the comparison in Table 4 that since the new GMP requires aluminum-plastic composite cover (including aluminum cover) to be rolled in the Class A clean area under the B-level background, this requires the aluminum-plastic composite cover (including the aluminum cover) to enter the B-class. In the background, the Class A clean area is treated accordingly and the corresponding standards are met, even though the four indicators of particles, floating bacteria, sedimentation bacteria and surface microorganisms meet the requirements. Compared with the current requirements for the completion of the capping operation in the 100,000-class clean area, there has been a leap-forward improvement. This puts new demands on the selection process and equipment for the aluminum-plastic composite cover (including aluminum cover).
2 Traditional aluminum-plastic composite cover (including aluminum cover) treatment method and comparison Before discussing the above issues, it is necessary to review the commonly used aluminum-plastic composite cover (including aluminum cover) treatment method, through retrospect and contrast, to find Better aluminum-plastic composite cover treatment and corresponding equipment under the new GMP.
2.1 The treatment with electric heating oven is treated by electric heating oven. Dry heat sterilization principle: It is a physical sterilization method by using thermal factors to detoxify proteins by oxidation, denaturation, charring and electrolyte concentration poisoning to kill microorganisms. The article is heated to a certain temperature in an electric heating oven for a period of time to achieve the purpose of killing microorganisms. In the past, the ordinary aluminum cover was treated with a double-twisted oven, except that the surface oil of the aluminum cover was removed and disinfected accordingly. In recent years, the aluminum cover was also sent to a hot air circulating oven at 120 ° C for 2 h sterilization. Although this method can achieve the sterilization effect, it is not suitable for the sterilization treatment of the aluminum-plastic composite cover.
With the development of science and technology, the aluminum-plastic composite cover has gradually replaced the ordinary aluminum cover with its advantages of easy pullability, sealing, aesthetics and practicality. When the above method is used for sterilization, the heating temperature causes deformation and melting of the plastic body portion of the aluminum plastic cover. Some enterprises have a method for treating aluminum-plastic composite cover: one is to be cleaned with purified water, and then dried in an oven at 70-80 ° C; the other is soaked with clean alcohol and then dried in an oven at 50 ° C. At present, the disinfection method of the aluminum-plastic composite cover after being rinsed by purified water is not scientifically verified, let alone sterilization; and the method of drying after alcohol soaking is only for disinfection. Instead of sterilizing, at the same time, because it requires the use of alcohol solution in the production process, the operation needs to be completed in the explosion-proof area.
2.2 The method of ultraviolet irradiation treatment destroys and changes the DNA (deoxyribonucleic acid) structure of the microorganism by ultraviolet irradiation, so that the bacteria immediately die or cannot reproduce the offspring, thereby achieving the purpose of sterilization. Ultraviolet sterilization is a pure physical disinfection method. It has the advantages of simple and convenient, broad spectrum and high efficiency, no secondary pollution, easy management and automation. Generally, UV lamps are installed in a certain space for disinfection. When sterilizing with ultraviolet light, it is necessary to use an irradiation dose to achieve the irradiation dose required to kill the target microorganism. There are certain requirements for the irradiation dose: 10,000 uW·s/cm2 should be achieved when killing the general bacterial propagule; 100000 uW·s/cm2 should be reached when killing the bacterial spore; the resistance of the virus to ultraviolet light is between the bacterial propagule and the spore. Between; the target microorganism to be disinfected should not be lower than 100,000 uW·s/cm 2 . The irradiation dose is the product of the irradiation intensity of the ultraviolet lamp used at the surface of the irradiated article and the irradiation time. Therefore, according to the irradiation intensity of the ultraviolet light source, the time required for the irradiation can be calculated.
When disinfecting the aluminum-plastic composite cover (including the aluminum cover), the aluminum cover is usually unpacked and dispersed in the disinfection area and irradiated with ultraviolet rays for 2 to 12 hours to achieve the purpose of disinfection. Since the ultraviolet irradiation intensity is inversely proportional to the square of the irradiation radius, the sterilization ability decreases as the irradiation distance increases, and the installation position of the ultraviolet lamp limits the sterilization space, and the penetration force is limited by the humidity and the dead angle, and cannot be completely disinfected, especially The inner and middle portions of the aluminum-plastic composite cover tray are difficult to disinfect. The principle of bactericidal treatment of ultraviolet light is mainly limited by the types of bacteria inhibition and sterilization, and the cleanliness that can be achieved is limited, let alone the sterilization.
2.3 The mechanism of formaldehyde treatment by formaldehyde fumigation is mainly alkylation. The aldehyde group in the formaldehyde molecule can react with amino groups, carboxyl groups, hydroxyl groups, sulfhydryl groups in microbial proteins and nucleic acid molecules, thereby destroying biomolecules. Active, lethal microorganisms. Formaldehyde is a sterilizing agent that kills all microorganisms, including bacterial propagules, spores, fungi and viruses. The formaldehyde gas sterilization effect is reliable, easy to use, and has no damage to the disinfected and sterilized articles.
The formaldehyde-plastic sterilizer is used to sterilize the aluminum-plastic composite cover (including the aluminum cover), and the formaldehyde gas is first introduced for a certain period of time. Then, air is introduced to remove the formaldehyde gas, and the residual formaldehyde needs to be neutralized. The entire process is disinfected for more than 5 hours.
Although the formaldehyde fumigation sterilization effect is strong, the residual formaldehyde is not easily discharged naturally, the process takes a long time, the efficiency is low, and the cost is high, and the non-broad spectrum sterilization. At the same time, the secondary pollution of formaldehyde fumigation residue, its residual polymer seriously pollutes the environment, affects the quality of the drug and damages the health of the operator.
2.4 Treatment of ozone by ozone sterilization The molecular structure is unstable at normal temperature and pressure, and quickly decomposes into oxygen (O2) and single molecular oxygen (O). The latter has strong activity and is extremely strong against bacteria. The oxidation can destroy the bacterial cell membrane and kill it. The excess oxygen atoms will recombine into ordinary oxygen (O2), without any toxic residues, and it is a non-polluting disinfectant. Ozone is also a broad-spectrum fungicide that kills bacterial propagules, spores, viruses, fungi, etc., and can destroy botulinum toxins.
The ozone sterilization box uses a unique high-efficiency circulation technology to pass the gas in the chamber into the ozone generator through the internal circulation pump to form a clean ozone gas, and then refill it into the cavity, and rapidly increase the ozone in the unit by using the internal circulation. The concentration in time. The ozone gas is evenly distributed, and Zui exerts the ability of ozone permeation sterilization to effectively eliminate the sterilization and dead angle. At the same time, the equipment also uses ozone and negative ions combined sterilization, greatly improving the sterilization effect. Generally, the aluminum-plastic composite cover (including the aluminum cover) is sterilized by an ozone sterilization tank, the ozone concentration is greater than 20 ppm, and the sterilization time is 2 h/batch.
As a non-polluting disinfectant, ozone can be disinfected and sterilized, especially for items that cannot be autoclaved. Because ozone gas diffuses in space, there is no disinfection dead angle, and it is disinfected and sterilized by this method. It is easy to operate, safe and reliable, and adapts to automatic management and control. This kind of sterilization method has high efficiency and no secondary pollution. Its broad-spectrum bacteriolysis can meet various standards of cleanliness, and it is a scientific, reliable and practical sterilization method.
2.5 Treatment of ethylene oxide by ethylene oxide sterilization can be alkylated with carboxyl groups (-COOH), amino groups (-NH2), sulfhydryl groups (-SH) and hydroxyl groups (-OH). Causes the protein to lose its response gene, hinders the normal chemical reaction and metabolism of the protein, leading to microbial death. Ethylene oxide also inhibits biological enzyme activity. Ethylene oxide is highly penetrating and can penetrate micropores to achieve a corresponding depth inside the product, thereby improving the sterilization effect. Currently, medical devices are widely sterilized by using ethylene oxide.
Ethylene oxide sterilizer is a special equipment for low temperature fumigation sterilization of articles enclosed in a sterilization chamber with ethylene oxide gas under certain conditions of temperature, pressure and humidity. Increased temperature enhances bactericidal action and is typically used at temperatures of about 55 ° C for most thermally unstable articles. Dry microorganisms must be moistened with moisture to kill. The relative concentration of commonly used disinfectants is 40% to 60%, and the disinfection time is 6 to 24 hours. The ethylene oxide sterilizer must be installed in a well ventilated area away from fire and static electricity, and the air in the room should be replaced by an exhaust device. After using a dedicated exhaust pipe, the residual gas discharged is treated by harmless analysis, and the residual ethylene oxide is <15.2 mg/m3 in the sterilized article, and the concentration in the sterilization environment is <2 mg/m3.
Sterilized with ethylene oxide, it has a broad spectrum of sterilization, strong penetrability (can penetrate through cloth, carton and polyethylene film), thorough sterilization, no damage to articles, easy storage of articles after sterilization, etc. . However, ethylene oxide is a flammable and explosive toxic gas with a molecular formula of C2H4O. It has an aromatic etheric taste and is easily volatilized into a gas at room temperature. When the concentration is too high, it can cause an explosion. Therefore, special attention should be paid to the safety of installation, operation and storage of ethylene oxide.
2.6 Treatment with aluminum lid cleaning machine Based on the principle of moist heat sterilization, the article uses the pressure steam or other moist heat sterilization medium to kill the microorganisms in the sterilizer, which is effective for the sterilization of zui in heat sterilization, and uses a wide range of methods. Due to the large latent heat of saturated steam, the penetrating power is strong, and the protein is easily denatured or solidified. This method not only has a reliable sterilization effect, but also can reduce the sterilization temperature and reduce the action time. It is a commonly used sterilization method in the production process of pharmaceutical preparations. . The damp heat sterilization method generally adopts 121 ° C, and the sterilization time is 20-30 min; depending on the nature of the article, it can also be selected from 115.5 ° C, 30 min sterilization or 126.5 ° C, and 15 min sterilization. If the product is extremely sensitive to heat, the temperature of the moist heat sterilization can be appropriately reduced, but special measures are required to ensure that sufficient sterility assurance value is obtained. In addition to verification with biological indicators, it must be in the production process. The microorganisms were continuously and strictly monitored to demonstrate that the sterility assurance value after sterilization was not lower than the set standard.
The automatic aluminum cover cleaning machine is a device for cleaning and sterilizing aluminum-plastic composite cover (including aluminum cover), which can be continuously operated in the same container for rinsing, sterilization, drying, cooling and discharging. The cleaning mainly depends on the airflow. Impact, the drum can be rotated at a static or slow speed and the cleaning efficiency is extremely high. The cleaning process has no damage to the aluminum-plastic composite cover (including the aluminum cover). Moreover, the discharge port is enlarged, and the extrusion and damage of the aluminum cover are avoided during discharge. Two problems to be described here are: the sterilization is by wet heat sterilization, and the drying is by vacuum drying.
3 According to the new GMP requirements for the treatment of aluminum-plastic composite cover (including aluminum cover) and equipment selection 3.1 The new GMP requirements for aluminum-plastic composite cover (including aluminum cover) processing requirements to ensure aluminum-plastic composite cover (including aluminum cover) The rolling process can be completed in the Class A clean zone under the B-level background. When selecting the treatment method for the aluminum-plastic composite cover (including the aluminum cover), we should control the particles, floating bacteria, sedimentation bacteria and surface microorganisms. Start. To achieve the above requirements, it is necessary to clean and control the particles, and to sterilize to control the floating bacteria, sedimentation bacteria and surface microorganisms.
3.2 Discussion on the treatment of several aluminum-plastic composite covers (including aluminum cover) Compared with the above requirements, there are six ways and equipment for electric heating oven, ultraviolet irradiation, formaldehyde fumigation, ozone sterilization, ethylene oxide sterilization and aluminum cover cleaning machine. The analysis is shown in Table 5.
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It can be seen from Table 5 that only the fully automatic aluminum cover cleaning machine with damp heat sterilization can be cleaned and sterilized, and is compatible with aluminum-plastic composite cover and aluminum cover, which is a reliable aluminum-plastic composite cover ( With aluminum cover) cleaning and sterilization methods.
4 Conclusion Through analysis and comparison, it can be seen that the treatment of aluminum-plastic composite cover (including aluminum cover) under the new GMP requirements requires cleaning to achieve particle control and sterilization to control floating bacteria, sedimentation bacteria and surface microorganisms. Under the manufacturing environment and factory standards of the current manufacturer of aluminum-plastic composite cover (including aluminum cover), the automatic plastic cover cleaning machine with damp heat sterilization is used to clean and sterilize the aluminum-plastic composite cover (including aluminum cover). More suitable choice. Unless the domestic aluminum-plastic composite cover (including aluminum cover) can produce a Class A clean area under the B-level background, the aluminum cover can be sterilized in an oven, and other sterilization methods can be used for the aluminum-plastic composite cover.
1 New GMP requirements for aluminum-plastic composite cover (including aluminum cover) 1.98 version GMP and new GMP requirements for cleansing of sterile pharmaceutical products The new version of GMP differentiates the cleanliness required for the production of sterile drugs into four levels: A Class, B, C and D grades require “static†and “dynamic†requirements for the cleanliness of the aseptic production area; while the current version 98 of the GMP classifies the cleanliness of the clean areas of pharmaceutical production. Four levels: 100, 10,000, 100,000 and 300,000, with static indicators. The details are shown in Table 1, Table 2, and Table 3.
1.298 GMP and new GMP requirements for non-zui terminally sterilized sterile preparations Compared with the new GMP, the requirement for non-zui terminally sterilized sterile preparations is qualitatively different from that of the 98th GMP, and the requirements are significantly improved. The details are shown in Table 4.
It can be seen from the comparison in Table 4 that since the new GMP requires aluminum-plastic composite cover (including aluminum cover) to be rolled in the Class A clean area under the B-level background, this requires the aluminum-plastic composite cover (including the aluminum cover) to enter the B-class. In the background, the Class A clean area is treated accordingly and the corresponding standards are met, even though the four indicators of particles, floating bacteria, sedimentation bacteria and surface microorganisms meet the requirements. Compared with the current requirements for the completion of the capping operation in the 100,000-class clean area, there has been a leap-forward improvement. This puts new demands on the selection process and equipment for the aluminum-plastic composite cover (including aluminum cover).
2 Traditional aluminum-plastic composite cover (including aluminum cover) treatment method and comparison Before discussing the above issues, it is necessary to review the commonly used aluminum-plastic composite cover (including aluminum cover) treatment method, through retrospect and contrast, to find Better aluminum-plastic composite cover treatment and corresponding equipment under the new GMP.
2.1 The treatment with electric heating oven is treated by electric heating oven. Dry heat sterilization principle: It is a physical sterilization method by using thermal factors to detoxify proteins by oxidation, denaturation, charring and electrolyte concentration poisoning to kill microorganisms. The article is heated to a certain temperature in an electric heating oven for a period of time to achieve the purpose of killing microorganisms. In the past, the ordinary aluminum cover was treated with a double-twisted oven, except that the surface oil of the aluminum cover was removed and disinfected accordingly. In recent years, the aluminum cover was also sent to a hot air circulating oven at 120 ° C for 2 h sterilization. Although this method can achieve the sterilization effect, it is not suitable for the sterilization treatment of the aluminum-plastic composite cover.
With the development of science and technology, the aluminum-plastic composite cover has gradually replaced the ordinary aluminum cover with its advantages of easy pullability, sealing, aesthetics and practicality. When the above method is used for sterilization, the heating temperature causes deformation and melting of the plastic body portion of the aluminum plastic cover. Some enterprises have a method for treating aluminum-plastic composite cover: one is to be cleaned with purified water, and then dried in an oven at 70-80 ° C; the other is soaked with clean alcohol and then dried in an oven at 50 ° C. At present, the disinfection method of the aluminum-plastic composite cover after being rinsed by purified water is not scientifically verified, let alone sterilization; and the method of drying after alcohol soaking is only for disinfection. Instead of sterilizing, at the same time, because it requires the use of alcohol solution in the production process, the operation needs to be completed in the explosion-proof area.
2.2 The method of ultraviolet irradiation treatment destroys and changes the DNA (deoxyribonucleic acid) structure of the microorganism by ultraviolet irradiation, so that the bacteria immediately die or cannot reproduce the offspring, thereby achieving the purpose of sterilization. Ultraviolet sterilization is a pure physical disinfection method. It has the advantages of simple and convenient, broad spectrum and high efficiency, no secondary pollution, easy management and automation. Generally, UV lamps are installed in a certain space for disinfection. When sterilizing with ultraviolet light, it is necessary to use an irradiation dose to achieve the irradiation dose required to kill the target microorganism. There are certain requirements for the irradiation dose: 10,000 uW·s/cm2 should be achieved when killing the general bacterial propagule; 100000 uW·s/cm2 should be reached when killing the bacterial spore; the resistance of the virus to ultraviolet light is between the bacterial propagule and the spore. Between; the target microorganism to be disinfected should not be lower than 100,000 uW·s/cm 2 . The irradiation dose is the product of the irradiation intensity of the ultraviolet lamp used at the surface of the irradiated article and the irradiation time. Therefore, according to the irradiation intensity of the ultraviolet light source, the time required for the irradiation can be calculated.
When disinfecting the aluminum-plastic composite cover (including the aluminum cover), the aluminum cover is usually unpacked and dispersed in the disinfection area and irradiated with ultraviolet rays for 2 to 12 hours to achieve the purpose of disinfection. Since the ultraviolet irradiation intensity is inversely proportional to the square of the irradiation radius, the sterilization ability decreases as the irradiation distance increases, and the installation position of the ultraviolet lamp limits the sterilization space, and the penetration force is limited by the humidity and the dead angle, and cannot be completely disinfected, especially The inner and middle portions of the aluminum-plastic composite cover tray are difficult to disinfect. The principle of bactericidal treatment of ultraviolet light is mainly limited by the types of bacteria inhibition and sterilization, and the cleanliness that can be achieved is limited, let alone the sterilization.
2.3 The mechanism of formaldehyde treatment by formaldehyde fumigation is mainly alkylation. The aldehyde group in the formaldehyde molecule can react with amino groups, carboxyl groups, hydroxyl groups, sulfhydryl groups in microbial proteins and nucleic acid molecules, thereby destroying biomolecules. Active, lethal microorganisms. Formaldehyde is a sterilizing agent that kills all microorganisms, including bacterial propagules, spores, fungi and viruses. The formaldehyde gas sterilization effect is reliable, easy to use, and has no damage to the disinfected and sterilized articles.
The formaldehyde-plastic sterilizer is used to sterilize the aluminum-plastic composite cover (including the aluminum cover), and the formaldehyde gas is first introduced for a certain period of time. Then, air is introduced to remove the formaldehyde gas, and the residual formaldehyde needs to be neutralized. The entire process is disinfected for more than 5 hours.
Although the formaldehyde fumigation sterilization effect is strong, the residual formaldehyde is not easily discharged naturally, the process takes a long time, the efficiency is low, and the cost is high, and the non-broad spectrum sterilization. At the same time, the secondary pollution of formaldehyde fumigation residue, its residual polymer seriously pollutes the environment, affects the quality of the drug and damages the health of the operator.
2.4 Treatment of ozone by ozone sterilization The molecular structure is unstable at normal temperature and pressure, and quickly decomposes into oxygen (O2) and single molecular oxygen (O). The latter has strong activity and is extremely strong against bacteria. The oxidation can destroy the bacterial cell membrane and kill it. The excess oxygen atoms will recombine into ordinary oxygen (O2), without any toxic residues, and it is a non-polluting disinfectant. Ozone is also a broad-spectrum fungicide that kills bacterial propagules, spores, viruses, fungi, etc., and can destroy botulinum toxins.
The ozone sterilization box uses a unique high-efficiency circulation technology to pass the gas in the chamber into the ozone generator through the internal circulation pump to form a clean ozone gas, and then refill it into the cavity, and rapidly increase the ozone in the unit by using the internal circulation. The concentration in time. The ozone gas is evenly distributed, and Zui exerts the ability of ozone permeation sterilization to effectively eliminate the sterilization and dead angle. At the same time, the equipment also uses ozone and negative ions combined sterilization, greatly improving the sterilization effect. Generally, the aluminum-plastic composite cover (including the aluminum cover) is sterilized by an ozone sterilization tank, the ozone concentration is greater than 20 ppm, and the sterilization time is 2 h/batch.
As a non-polluting disinfectant, ozone can be disinfected and sterilized, especially for items that cannot be autoclaved. Because ozone gas diffuses in space, there is no disinfection dead angle, and it is disinfected and sterilized by this method. It is easy to operate, safe and reliable, and adapts to automatic management and control. This kind of sterilization method has high efficiency and no secondary pollution. Its broad-spectrum bacteriolysis can meet various standards of cleanliness, and it is a scientific, reliable and practical sterilization method.
2.5 Treatment of ethylene oxide by ethylene oxide sterilization can be alkylated with carboxyl groups (-COOH), amino groups (-NH2), sulfhydryl groups (-SH) and hydroxyl groups (-OH). Causes the protein to lose its response gene, hinders the normal chemical reaction and metabolism of the protein, leading to microbial death. Ethylene oxide also inhibits biological enzyme activity. Ethylene oxide is highly penetrating and can penetrate micropores to achieve a corresponding depth inside the product, thereby improving the sterilization effect. Currently, medical devices are widely sterilized by using ethylene oxide.
Ethylene oxide sterilizer is a special equipment for low temperature fumigation sterilization of articles enclosed in a sterilization chamber with ethylene oxide gas under certain conditions of temperature, pressure and humidity. Increased temperature enhances bactericidal action and is typically used at temperatures of about 55 ° C for most thermally unstable articles. Dry microorganisms must be moistened with moisture to kill. The relative concentration of commonly used disinfectants is 40% to 60%, and the disinfection time is 6 to 24 hours. The ethylene oxide sterilizer must be installed in a well ventilated area away from fire and static electricity, and the air in the room should be replaced by an exhaust device. After using a dedicated exhaust pipe, the residual gas discharged is treated by harmless analysis, and the residual ethylene oxide is <15.2 mg/m3 in the sterilized article, and the concentration in the sterilization environment is <2 mg/m3.
Sterilized with ethylene oxide, it has a broad spectrum of sterilization, strong penetrability (can penetrate through cloth, carton and polyethylene film), thorough sterilization, no damage to articles, easy storage of articles after sterilization, etc. . However, ethylene oxide is a flammable and explosive toxic gas with a molecular formula of C2H4O. It has an aromatic etheric taste and is easily volatilized into a gas at room temperature. When the concentration is too high, it can cause an explosion. Therefore, special attention should be paid to the safety of installation, operation and storage of ethylene oxide.
2.6 Treatment with aluminum lid cleaning machine Based on the principle of moist heat sterilization, the article uses the pressure steam or other moist heat sterilization medium to kill the microorganisms in the sterilizer, which is effective for the sterilization of zui in heat sterilization, and uses a wide range of methods. Due to the large latent heat of saturated steam, the penetrating power is strong, and the protein is easily denatured or solidified. This method not only has a reliable sterilization effect, but also can reduce the sterilization temperature and reduce the action time. It is a commonly used sterilization method in the production process of pharmaceutical preparations. . The damp heat sterilization method generally adopts 121 ° C, and the sterilization time is 20-30 min; depending on the nature of the article, it can also be selected from 115.5 ° C, 30 min sterilization or 126.5 ° C, and 15 min sterilization. If the product is extremely sensitive to heat, the temperature of the moist heat sterilization can be appropriately reduced, but special measures are required to ensure that sufficient sterility assurance value is obtained. In addition to verification with biological indicators, it must be in the production process. The microorganisms were continuously and strictly monitored to demonstrate that the sterility assurance value after sterilization was not lower than the set standard.
The automatic aluminum cover cleaning machine is a device for cleaning and sterilizing aluminum-plastic composite cover (including aluminum cover), which can be continuously operated in the same container for rinsing, sterilization, drying, cooling and discharging. The cleaning mainly depends on the airflow. Impact, the drum can be rotated at a static or slow speed and the cleaning efficiency is extremely high. The cleaning process has no damage to the aluminum-plastic composite cover (including the aluminum cover). Moreover, the discharge port is enlarged, and the extrusion and damage of the aluminum cover are avoided during discharge. Two problems to be described here are: the sterilization is by wet heat sterilization, and the drying is by vacuum drying.
3 According to the new GMP requirements for the treatment of aluminum-plastic composite cover (including aluminum cover) and equipment selection 3.1 The new GMP requirements for aluminum-plastic composite cover (including aluminum cover) processing requirements to ensure aluminum-plastic composite cover (including aluminum cover) The rolling process can be completed in the Class A clean zone under the B-level background. When selecting the treatment method for the aluminum-plastic composite cover (including the aluminum cover), we should control the particles, floating bacteria, sedimentation bacteria and surface microorganisms. Start. To achieve the above requirements, it is necessary to clean and control the particles, and to sterilize to control the floating bacteria, sedimentation bacteria and surface microorganisms.
3.2 Discussion on the treatment of several aluminum-plastic composite covers (including aluminum cover) Compared with the above requirements, there are six ways and equipment for electric heating oven, ultraviolet irradiation, formaldehyde fumigation, ozone sterilization, ethylene oxide sterilization and aluminum cover cleaning machine. The analysis is shown in Table 5.
It can be seen from Table 5 that only the fully automatic aluminum cover cleaning machine with damp heat sterilization can be cleaned and sterilized, and is compatible with aluminum-plastic composite cover and aluminum cover, which is a reliable aluminum-plastic composite cover ( With aluminum cover) cleaning and sterilization methods.
4 Conclusion Through analysis and comparison, it can be seen that the treatment of aluminum-plastic composite cover (including aluminum cover) under the new GMP requirements requires cleaning to achieve particle control and sterilization to control floating bacteria, sedimentation bacteria and surface microorganisms. Under the manufacturing environment and factory standards of the current manufacturer of aluminum-plastic composite cover (including aluminum cover), the automatic plastic cover cleaning machine with damp heat sterilization is used to clean and sterilize the aluminum-plastic composite cover (including aluminum cover). More suitable choice. Unless the domestic aluminum-plastic composite cover (including aluminum cover) can produce a Class A clean area under the B-level background, the aluminum cover can be sterilized in an oven, and other sterilization methods can be used for the aluminum-plastic composite cover.
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