The application of ozone in the pharmaceutical industry

2025-01-07 102
The Chinese GMP regulations have extremely strict requirements for drug production (especially sterile goods), and ozone sterilization is strongly recommended in the GMP validation process. Compared with various traditional sterilization methods, ozone sterilization has many characteristics, so ozone generators have a wide range of uses in the pharmaceutical industry.
According to the volume of the clean workshop, an appropriate ozone generator can be selected to send ozone into the workshop through the HVAC supply and return air system. During disinfection, seal about 90% of the fresh air inlet valve and the return air outlet valve, so that all the disinfected clean room air passes through the purification system duct to form a circulating state. Daily 1-hour air sterilization can replace chemical fumigation and equipment surface sterilization. It can also be used as a standalone unit in any clean room with a return air outlet for disinfection and sterilization.
2、 Transfer window effect
Materials can be transferred between cleanrooms of different levels or between non cleanrooms and cleanrooms using specially designed transfer windows with ozone generators.
3、 Sterilization of materials, tooling molds, factory uniforms, etc
According to the sterilization target, ozone room temperature sterilization box or ozone sterilization drying box is selected for particles. For example, the ozone room temperature sterilization box used for sterilizing aluminum-plastic composite caps in powder injection production lines involves multiple processes of water washing or alcohol immersion before drying in an oven.
4、 Sterilization of closed container pipelines
For disinfection and sterilization of closed containers such as infusion, material pipelines, filtration systems, material storage tanks, reaction tanks, etc., an ozone generator with a built-in oil-free air pump can be used to produce a hundred level purification pressure, and ozone can be introduced into the equipment or system that needs to be sterilized.
5、 Used for process water treatment
Ozone generators can be used for terminal sterilization of process water.
6、 Sterilization of powder materials and some traditional Chinese medicine materials
Introducing ozone into a sealed container and utilizing the flipping or mixing effect of the materials in the container to sterilize powder materials and some traditional Chinese medicine materials has addressed the long-standing issue of difficulty in sterilizing powder materials or some traditional Chinese medicine materials.

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