Application of ozone in pharmaceutical GMP certification

Guangzhou Jiahuan Electrical Technology Co. , Ltd. is one of the professional manufacturers of large, medium and small ozone equipment in China. Since its establishment, the company has been committed to in-depth research and meticulous promotion of ozone (O3) processing technology. We are able to design and produce treatment solutions for different application targets for different environmental requirements, and to support the improvement of production and quality of life. In the long-term production and practice process, for the production of pure water in beverages, purification of food and daily necessities workshops, GMP certification of cosmetics and medicines, medical and health care, cultivation of agricultural aquaculture, treatment of tap water and groundwater, clean water quality of sauna swimming pools, processing of paper dyes, Provide scientific and reasonable methods and ancillary services for clothing dyeing and washing, sewage treatment, chemical oxidation synthesis, etc.

The company brand 'Guangjiahuan' has become a well-known brand in the ozone industry. The products are exported to Europe and the United States, and the market share has doubled year by year. The products range from small household disinfection machines and oxygen generators to large-scale ozone equipment and oxygen production equipment for industrial production applications. The production and supply of different needs and services for different customers is the direction that Jiahuan has been working hard for a long time.


Principle construction

The high-concentration ozone generator produced by our company is a high-concentration ozone generating equipment dedicated to air purification and water treatment. It uses zui new ozone generating device and various protection function circuits inside, which has excellent performance and extremely long life span.

The principle of production is to use air or oxygen extracted by an oil-free air compressor, and after compression, multi-stage filtration, cold drying, adsorption drying, etc., to remove substances that may be damaged in the air or oxygen, which may cause damage to subsequent equipment. The purity of the oxygen component is further increased, and the cleaned high-purity oxygen is used as an ozone generating gas source, and in a high-voltage corona discharge, it is catalytically converted into a high-concentration ozone gas. Its strong oxidizing ability can oxidize and remove all kinds of pollutants, and achieve the effects of deodorization, decolorization and bleaching, sterilization and disinfection, degradation of organic matter and heavy metal substances. At the same time, in the process of use, it is not only efficient and rapid, but also stably decomposes into oxygen in the environment, so there is no residue, no secondary pollution and poison to the surrounding environment.

According to the operating characteristics of the ozone generator, its complete set of generating equipment mainly consists of a gas source system, an ozone generating system, a high voltage power supply, and a control system.

The gas source preparation part is a front system in the ozone disinfection system, and its function is to provide the ozone generator with the required quality and quantity of gas. The gas source preparation part has various forms to choose from (air, gaseous oxygen, liquid oxygen, etc.). The main considerations for the selection of different forms of gas source preparation are the scale of gas supply, site conditions and operating energy consumption.

The ozone generation is the core of the ozone disinfection system, and its role is to produce enough ozone gas for the sterilization process. Its investment accounts for more than 60% of the total ozone disinfection, and the operating energy consumption accounts for about 50%-70%. Part of the ozone generation varies depending on the form of the ozone generator. The factors to be considered in the selection of ozone are mainly ozone production, equipment investment, and operating energy consumption.

The ozone generator produced by our company mainly has the following characteristics:

Gas source: The oxygen source is the oxygen source taken by the oxygen-making mechanism. The purified oxygen after filtration and drying can achieve a purity of ±95%, which effectively improves the efficiency of the ozone generator and ensures the high concentration of ozone gas.

Power supply: High-frequency high-voltage inverter technology is adopted. The energy consumption of the ozone generator is only one quarter of the traditional power frequency generator, and the automatic control technology realizes unmanned operation.

Pipe fittings: Optimized design of dehydroxylated quartz discharge tubes for higher durability, strength and efficiency, and high voltage shock loads. At the same time, the influence of the impurity components received at work is smaller.

Structure: With advanced mechatronics technology, the equipment is compact and has a small footprint. The outer casing is made of stainless steel and has good adaptability to various environments.

Operation: easy operation and maintenance, no more than 30 minutes of installation and commissioning when the water and electricity are fully installed, no more than 60 minutes, the operator can be skilled.


Design Basis

In the process of designing and making the plan, it is necessary to strictly implement national and local health and safety regulations, fully consider all factors, and rationally design to ensure that the microbiological indicators in the space to be treated can meet the standards required by Party A. .

In the design process, the scientific attitude is adhered to, which is characterized by advanced technology, economical rationality, safety and reliability, simple operation and convenient operation. The main reference for design is as follows:

A. Relevant data provided by the demand side

B. Guidelines for the Validation of Pharmaceutical Production;

C. Ministry of Health "Disinfection Technical Specifications";

D. "Administration of GMP New Technology and New Product Information Collection for Pharmaceutical Equipment";

E. National Pharmaceutical Administration's GMP Validation Guide .


Configuration

In the purification and disinfection, the ozone concentration can be used to achieve the concentration requirement in one hour. If it is kept for 1-1.5 hours, the mechanical equipment and the surface sedimentation colony of the building body can be completely killed, completely replacing the chemical fumigation disinfection, and no Pollution and residual toxicity.

Dosing method

Mainly can be divided into direct blowing, pipeline spraying and central air conditioning . The central air conditioning investment can be divided into a centralized centralized air conditioning system, an inducer air conditioning system and a fan coil air conditioning system.

In the actual production operation, according to the different types of central air conditioning, choose the appropriate dosage form. Reasonable use of central air-conditioning air supply equipment, the ozone gas produced by the ozone generator is diffused to the entire controlled area through the air supply equipment of the air-conditioning system (including the fresh air blower), and the ozone gas is mixed by the air-conditioning pipeline of the central air conditioner. Enter the system air and use the internal circulation to make the ozone concentration in the air uniform. By mixing with the system air, kill bacteria, infectious viruses and microorganisms in the ambient air, improve the quality of the ambient air, and ensure the environment. Cleanliness to meet production needs. When using ozone gas for disinfection, it can effectively kill various viruses and germs, and at the same time, it is necessary to add other disinfection measures to achieve the desired sterilization and sterilization purposes. In practice, it has also been found that ozone can also act as a bacteriostatic agent for high-efficiency filters, prolonging their use of odor.



Device Selection

1. Calculate the actual ozone disinfection volume. The implementation volume consists of three parts:

V=V1 (total volume of clean space) +V2 (total volume of air supply duct) +V3 (converted volume of fresh air volume to maintain positive pressure in clean area)

According to the manufacturer's practice of using ozone generator to sterilize and sterilize, the determination of each volume can be summarized as a more reliable empirical formula as follows:

V2 is negligible

V3 ≈HVAC system circulating total air volume m3/h*1.2%

2 , determine the cleanliness level of the entire clean plant

According to the "Disinfection Technical Specifications" and practical application experience (1ppm ≈ 2mg/m3) :

300,000 grades take C=2.55ppm; 100,000 grades take C=5ppm; 10,000 take C=15ppm; 100 grades take C=20ppm.

The floating bacteria in the air: 2-4 ppm, sedimentation colonies on the surface of the object: 10-15 ppm.





Case analysis

For example, the ozone concentration required for disinfection in a clean room of a factory is C=5ppm, the area is 1728.6M, the height is 2.6 meters, and the air supply is 100000m3/h. 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 the object, so the design concentration is C=10ppm.

Actual ozone disinfection volume V= V1+ V2+ V3 =1728.6*2.6+100000*1.2%=4492.8+1200=5692.8 ≈5693m3

Required ozone dosage W= C* V/ (1-S) = 10*2*5693/0.4208=286.82 g/h

Considering the influence of pipelines and other factors, the output of the ozone generator is selected to be 300 g/h.


Recommendations

1. Arrange the normal operation of the machine reasonably. Each machine can continuously disinfect several rooms and disinfect through the pipeline. The disinfection time is 40-60 minutes.

2 , disinfection at the same time can also sterilize, remove mold, deodorant, degrade various types of toxic gases, no secondary pollution, by-products are oxygen.

3 , personnel should not stay in the disinfection environment, so as to prevent ozone from harming physical and mental health.

4 , the pipeline must be installed in the room more than 2 meters in height, so that ozone (ozone is heavier than air) free fall, the sterilization effect will be better.

5. When it is used in combination with the central air conditioner, the ozone output from the ozone disinfection machine is introduced into the air duct of the air conditioner, and the wind is blown to the workshop to be disinfected by the wind of the air conditioner; when it is required to be used independently, the "pipe spray method" is adopted. Dispense the ozone evenly into the workshop where disinfection is required.


Quality assurance

The company's products are produced in strict accordance with national standards, technical parameters meet industry standards, and ozone generators are guaranteed for one year.


Precautions

Be careful to place the device on the ground or on the bracket. The placement surface should be flat and do not move when the device is working.

Do not use it near high-precision electronic equipment. Radio interference may cause malfunctions and other problems of high-precision electronic equipment. (especially in the vicinity of the following equipment: special hearing aids, pacemakers and other medical electronic equipment, fire detectors, other precision automatic control devices.)

Do not disassemble or modify this product, as this may cause damage, leakage and circuit failure of this product.

To avoid excessive moisture, the humidity of the working environment should be kept at ≦ 65% . Water or other liquids entering the product may cause leakage and malfunction of the product. Therefore, keep the working environment of the equipment ventilated and dry during installation and operation. If necessary, install an exhaust fan or air conditioning.

The temperature of the working environment requires 0 °C -33 °C. Too high or too low may affect the performance of this product.

Avoid wiping the device with volatile solutions or organic solvents that may damage the surface of the device.

Qualified dedicated grounding wire, safe and reliable grounding, the capacity of the used line is in order to ensure the elimination of fire hazards. The equipment installer must be instructed to start the repair.

When using ozone, it is strictly forbidden for workers to work in a high-concentration ozone space environment, and workers should work in protective measures in a space environment that exceeds the relevant standard ozone concentration.

Keep in mind that equipment maintenance or repair must be carried out under power and air pressure conditions to ensure safe personnel maintenance.

When starting up, first turn on the air pump switch, then turn on the ozone for 1-2 minutes; turn off the ozone switch first, then turn off the air pump after 1-2 minutes.





Guangzhou Jiahuan Electrical Technology Co., Ltd.

He Gong

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