Application scope of ozone generator in pharmaceutical production

Although the ozone sterilization method has already been recommended in the GMP verification in China, the application of the ozone generator in the production of drugs has only begun to heat up in the past two years. The ozone generator is used more successfully in the following aspects:

(I) Disinfection and sterilization of containers

In the production of medicines, there are a lot of pots used in the jars. They are connected by pipeline valves and meters to form a production unit. Disinfecting it, the traditional method is better to use alcohol soaking. The reaction tank, a small one ton and a half tons of storage tanks, and several tens of tons of tons of tons, must be filled with alcohol. The amount of alcohol can be as much as one can imagine. After disinfecting, the alcohol is let go, but at the turning point, the joint of the instrument valve will also have residual alcohol. To remove these residual alcohols, use nitrogen to blow until dry. The amount of alcohol is large, the disinfection time is long, and the operation process is complicated. Using high-pressure steam also has the same problem and is very laborious.

Now use ozone disinfection technology to replace, relatively speaking, save much more. The specific method is: directly into the pipeline container with high concentration of ozone, to maintain a certain concentration of ozone exhaust gas, you can achieve the requirements of disinfection and sterilization. Because the inner surface of the pipeline container is disinfected, the ozone concentration is higher, and our design concentration is greater than 50 ppm.

       Ozone generators have obvious advantages in disinfecting and sterilizing pipeline containers. They can be used in a mobile manner and disinfect different tanks. Each production unit can be disinfected in time before each refueling. The use efficiency is very high and it is very convenient. Do not use so much alcohol, do not use nitrogen, and do not use high-pressure steam. Therefore, it can be promoted in pharmaceutical factories.

(II) Disinfection and disinfection of the clean area by the central air-conditioning purification system

In pharmaceutical factories, in general, the clean area has a large area, and central air-conditioning purification systems are used to complete the purification and disinfection of the clean areas. The traditional method of disinfection is fumigation with formaldehyde. As mentioned above, there are many drawbacks of formaldehyde fumigation. It is a good idea to replace it with ozone disinfection. The method is to place the ozone generator directly in the air channel of the air conditioning purification system, which is called built-in ozone generator. Ozone flows into the clean areas along with the air flow of the air ducts, disinfects and sterilizes the clean areas, and the remaining ozone is sucked into the air outlet and is taken away by the central air conditioner. Ozone generators can also be placed outside the central air-conditioning outlet, ozone into the central air-conditioning duct, and then sent to the clean room, known as the external ozone generator. The external ozone generator is easy to install and overhaul, but the manufacturing cost is higher. Both methods have the same disinfection effect. According to the requirements of the Ministry of Health's disinfection regulations, the ozone concentration for air disinfection is 5ppm, but in fact, disinfection in the clean area is not only disinfecting the air, but actually includes disinfecting the surface of the object. Therefore, the concentration we design is 10ppm. Turning on the computer for two hours before going to work every day and shutting it off after work can ensure that the planktonic bacteria and sedimentation bacteria in the clean area meet the requirements of GMP within one day.

According to the inspection report, the ozone concentration in each clean area of ​​the ozone generator reached more than 10 ppm within 40 minutes, and all the bacteria tests were qualified. And it is qualified every day, completely replacing the disinfecting formaldehyde fuming. At the same time, non-production operations have been reduced, energy consumption has been reduced, and satisfactory results have been achieved.

(c) Disinfection and sterilization of space

Clean rooms other than the central air-conditioning purification system, or other rooms that need to be sterilized, need to be individually sterilized. The method is to use an ozone generator and install it directly in the room. According to the need to set the disinfection time, the end of the disinfection will be automatically shut down, so it is very convenient to use.

For rooms with cleanliness requirements, filters are installed inside the machine to make the ozone generator self-cleaning. The ozone concentration is designed at 10-20ppm. According to the size of the room space selection use. As long as the ozone concentration is met, sterilization and sterilization can be achieved. It's much easier than fumigation of a room with chemical reagents.

(4) Disinfection and Sterilization of Articles

In the production of drugs, it is often necessary to surface sterilize raw materials, tools, and packaging, and often use disinfection cabinets, transfer windows, etc. The traditional method is ultraviolet disinfection. The problem is mainly because the disinfection is not thorough. Therefore, it is possible to use it in places with low requirements such as transfer windows. However, it is far less effective than ozone. Disinfection cabinets that can be made with ozone generators are very popular in pharmaceutical factories. As long as things are not afraid of ozone corrosion can be placed in the cabinet for disinfection. The ozone concentration can be designed to be a little higher. Can obtain more than 100ppm.

(5) Disinfection and sterilization of water

There are many places where water is used in pharmaceutical factories, such as medical water, disinfection water, cleaning water and drinking water. According to different water quality requirements, different processes are used, and the disinfection process can achieve satisfactory results with normal ozone water treatment methods. This is not described in detail here.