[**]pplication of ozone in pharmaceutical production
[**]lthough ozone disinfection has long been recommended in China's GMP verification, the application of ozone in pharmaceutical production has only become popular in recent years. The following aspects have been used more successfully:
1. Disinfection of pipeline containers
In pharmaceutical production, pharmaceutical containers are used a lot, and they are connected with pipelines, valves, and instruments to form a production unit. For its disinfection, the better traditional method is to soak it in alcohol. The reaction tank storage tank is small, one ton and a half tons, and the large one is ten tons or several tons. They must be filled with alcohol. The amount of alcohol used can be imagined. [**]fter disinfection, the alcohol is released, but there will be alcohol residues at the corners and joints of the instrument valves. To remove these residual alcohol, nitrogen should be blown until it is blown dry. The amount of alcohol used is large, the disinfection time is long, and the operation process is complicated. The same problem exists with high-pressure steam disinfection, which is very laborious.
Now it is relatively much easier to use ozone disinfection instead. The specific method is: inject high-concentration ozone directly into the pipe container, and maintain a certain concentration of ozone tail gas to meet the disinfection requirements. Because the inner surface of the pipe container is disinfected, the ozone concentration should be higher. The design concentration we use is greater than 50ppm.
The advantages of using ozone to disinfect pipe containers are very obvious. The ozone generator can be used in a mobile manner to disinfect different tanks. Each production unit can be disinfected in time before each material change. The use efficiency is very high and very convenient. Do not use so much alcohol, nitrogen, or high-pressure steam. Therefore, it can be promoted in pharmaceutical factories.
2. Disinfection of clean areas using central air conditioning purification system
In pharmaceutical factories, generally speaking, the clean area is large, and the purification and disinfection of each clean area is mostly completed by the central air conditioning purification system. The traditional disinfection method is formaldehyde fumigation. [**]s mentioned above, formaldehyde fumigation has many disadvantages. It is a good method to use ozone disinfection instead. The method is to place the ozone generator directly in the air duct of the air conditioning purification system, which is called a built-in ozone generator. Ozone is sent to each clean area along with the air flow of the air duct to disinfect the clean area. The remaining ozone is sucked into the return air outlet and taken away by the central air conditioner. The ozone generator can also be placed outside the central air conditioning duct, and the ozone is injected into the central air conditioning duct, and then sent to each clean room, which is called an external ozone generator. The external ozone generator is easy to install and maintain, but the manufacturing cost is a little higher. The disinfection effect of the two methods is the same. [**]ccording to the requirements of the Ministry of Health's disinfection specifications, the ozone concentration for air disinfection is 5ppm, but in fact, the disinfection of the clean area is not only the disinfection of the air, but also the disinfection of the surface of objects, so our design concentration is 10ppm. Turn on the machine for two hours before going to work every day and turn it off when going to work, so that the floating bacteria and sedimentation bacteria in the clean area can meet the GMP requirements within one day.
3. Disinfection of confined spaces
For clean rooms outside the central air conditioning purification system, or other rooms that need to be disinfected, they need to be disinfected separately. The method is to select an ozone generator, install it directly in the room or place it outdoors (gas distribution in pipes), set the disinfection time according to the needs, and automatically shut down when the disinfection is completed, so it is very convenient to use.
For rooms with cleanliness requirements, a filter is installed in the machine to make the ozone generator have a self-cleaning function. The ozone concentration is designed to be 10-20ppm. Select and use it according to the size of the room space. [**]s long as the ozone concentration requirements are met, the purpose of disinfection can be achieved. It is much easier than fumigating the room with chemical reagents.
4. Surface disinfection of objects
In the process of drug production, raw materials, tools, packaging materials, etc. are often disinfected on the surface, and disinfection cabinets and transfer windows are often used. The traditional method is to use ultraviolet disinfection. The main problem is that the disinfection is not thorough, so it is okay if it is used in occasions with low requirements such as transfer windows. But it is far less effective than ozone. Disinfection cabinets made of ozone generators are very popular in pharmaceutical factories. [**]s long as things that are not afraid of ozone corrosion can be placed in the cabinet for disinfection. The ozone concentration can be designed to be higher. It can be obtained above 100ppm.
5. Disinfection of water used in pharmaceutical factories
There are many places where water is used in pharmaceutical factories, including medical water, disinfection water, cleaning water and drinking water. Different process flows are adopted according to different water quality requirements. The disinfection process can achieve satisfactory results with general ozone water treatment methods. I will not introduce it in detail here.
It should be noted that water used for medical injections must not have heat sources. Heat sources are endotoxins left after the death of bacteria and viruses. Whether ozone can eliminate heat sources remains to be determined through research. If it is determined that ozone can remove heat sources in water, then the application of ozone in pharmaceutical production can open up a new path.
[**]bove, only a few examples of the application of ozone in pharmaceutical production are introduced. It can be seen that ozone has a lot to do in pharmaceutical production. GMP verification provides broad opportunities for the development of ozone technology. We must seize this opportunity and make breakthroughs in new research topics. The responsibility of ozone workers is to produce high-quality ozone generators with stable and reliable performance to serve pharmaceutical production and benefit mankind. Then we have done more beneficial work for the health of the public.
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[**]pplication of ozone in pharmaceutical production
[**]lthough ozone disinfection has long been recommended in China's GMP verification, the application of ozone in pharmaceutical production has only become popular in recent years. The following aspects have been used more successfully:
1. Disinfection of pipeline containers
In pharmaceutical production, pharmaceutical containers are used a lot, and they are connected with pipelines, valves, and instruments to form a production unit. For its disinfection, the better traditional method is to soak it in alcohol. The reaction tank storage tank is small, one ton and a half tons, and the large one is ten tons or several tons. They must be filled with alcohol. The amount of alcohol used can be imagined. [**]fter disinfection, the alcohol is released, but there will be alcohol residues at the corners and joints of the instrument valves. To remove these residual alcohol, nitrogen should be blown until it is blown dry. The amount of alcohol used is large, the disinfection time is long, and the operation process is complicated. The same problem exists with high-pressure steam disinfection, which is very laborious.
Now it is relatively much easier to use ozone disinfection instead. The specific method is: inject high-concentration ozone directly into the pipe container, and maintain a certain concentration of ozone tail gas to meet the disinfection requirements. Because the inner surface of the pipe container is disinfected, the ozone concentration should be higher. The design concentration we use is greater than 50ppm.
The advantages of using ozone to disinfect pipe containers are very obvious. The ozone generator can be used in a mobile manner to disinfect different tanks. Each production unit can be disinfected in time before each material change. The use efficiency is very high and very convenient. Do not use so much alcohol, nitrogen, or high-pressure steam. Therefore, it can be promoted in pharmaceutical factories.
2. Disinfection of clean areas using central air conditioning purification system
In pharmaceutical factories, generally speaking, the clean area is large, and the purification and disinfection of each clean area is mostly completed by the central air conditioning purification system. The traditional disinfection method is formaldehyde fumigation. [**]s mentioned above, formaldehyde fumigation has many disadvantages. It is a good method to use ozone disinfection instead. The method is to place the ozone generator directly in the air duct of the air conditioning purification system, which is called a built-in ozone generator. Ozone is sent to each clean area along with the air flow of the air duct to disinfect the clean area. The remaining ozone is sucked into the return air outlet and taken away by the central air conditioner. The ozone generator can also be placed outside the central air conditioning duct, and the ozone is injected into the central air conditioning duct, and then sent to each clean room, which is called an external ozone generator. The external ozone generator is easy to install and maintain, but the manufacturing cost is a little higher. The disinfection effect of the two methods is the same. [**]ccording to the requirements of the Ministry of Health's disinfection specifications, the ozone concentration for air disinfection is 5ppm, but in fact, the disinfection of the clean area is not only the disinfection of the air, but also the disinfection of the surface of objects, so our design concentration is 10ppm. Turn on the machine for two hours before going to work every day and turn it off when going to work, so that the floating bacteria and sedimentation bacteria in the clean area can meet the GMP requirements within one day.
3. Disinfection of confined spaces
For clean rooms outside the central air conditioning purification system, or other rooms that need to be disinfected, they need to be disinfected separately. The method is to select an ozone generator, install it directly in the room or place it outdoors (gas distribution in pipes), set the disinfection time according to the needs, and automatically shut down when the disinfection is completed, so it is very convenient to use.
For rooms with cleanliness requirements, a filter is installed in the machine to make the ozone generator have a self-cleaning function. The ozone concentration is designed to be 10-20ppm. Select and use it according to the size of the room space. [**]s long as the ozone concentration requirements are met, the purpose of disinfection can be achieved. It is much easier than fumigating the room with chemical reagents.
4. Surface disinfection of objects
In the process of drug production, raw materials, tools, packaging materials, etc. are often disinfected on the surface, and disinfection cabinets and transfer windows are often used. The traditional method is to use ultraviolet disinfection. The main problem is that the disinfection is not thorough, so it is okay if it is used in occasions with low requirements such as transfer windows. But it is far less effective than ozone. Disinfection cabinets made of ozone generators are very popular in pharmaceutical factories. [**]s long as things that are not afraid of ozone corrosion can be placed in the cabinet for disinfection. The ozone concentration can be designed to be higher. It can be obtained above 100ppm.
5. Disinfection of water used in pharmaceutical factories
There are many places where water is used in pharmaceutical factories, including medical water, disinfection water, cleaning water and drinking water. Different process flows are adopted according to different water quality requirements. The disinfection process can achieve satisfactory results with general ozone water treatment methods. I will not introduce it in detail here.
It should be noted that water used for medical injections must not have heat sources. Heat sources are endotoxins left after the death of bacteria and viruses. Whether ozone can eliminate heat sources remains to be determined through research. If it is determined that ozone can remove heat sources in water, then the application of ozone in pharmaceutical production can open up a new path.
[**]bove, only a few examples of the application of ozone in pharmaceutical production are introduced. It can be seen that ozone has a lot to do in pharmaceutical production. GMP verification provides broad opportunities for the development of ozone technology. We must seize this opportunity and make breakthroughs in new research topics. The responsibility of ozone workers is to produce high-quality ozone generators with stable and reliable performance to serve pharmaceutical production and benefit mankind. Then we have done more beneficial work for the health of the public.
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