GMP workshop space ozone disinfection sterilization

Ozone disinfection space

The discovery and research of ozone

1840 Netherlands Shu Bei result found ozone OZONE, derived from the Greek word meaning son Ozein "bad", this odor identified as O3, and named OZONE ozone. Since then, European scientists first began to study the characteristics and functions of ozone found that broad-spectrum sterilization effect, began industrial production applications, where a Swedish Beef beef stored for ozone preservation, since 1870, is now has developed space disinfection, food processing, water treatment, chemical and other fields.

First, since the ozone in the sector

It is now widely understood atmospheric ozone layer is a natural barrier to block the sun's ultraviolet, which is composed of sunlight a particular wavelength spectrum of light irradiation generated after a thunderstorm to a special kind of people will breathe fresh taste is in fact the air increase in the ozone concentration (usually around 0.04PPM) easy to be detected, the reason why the ozone concentration increase, because the lightning (high power) ionizing oxygen in the air to form ozone, forest, tourist areas particularly fresh air, because the plants CO2 absorption process of manufacturing a [O], oxygen atoms in the formation process, some form O2 (oxygen we breathe) part of the O3 (ozone) is the ubiquitous nature of ozone and ultraviolet sunlight in control of bacterial survival balance, protect human health.

Second, the basic properties of ozone

Human studies have found through the ozone, ozone has unstable characteristics and strong oxidizing ability. Ozone is an oxygen molecule (O2) carrying an oxygen atom (O) component, therefore he is an allotrope of oxygen. Ozone and oxygen, the difference between the table below:

  Table one of the main properties of oxygen and ozone

Table I. As can be seen, compared with oxygen, ozone than the major, flavored, colored, soluble in water, easy to decompose. Because ozone (O3) is carried by the oxygen molecule composed of one atom of oxygen, determines that it is only a temporary form of portable oxygen atoms in addition to oxidized spent outside, there is a combination of the remaining oxygen (O2) into a stable state. Ozone is a very strong oxidizing substances, the redox potential after F2. Use of its oxidation, can be destroyed in a relatively short period of bacteria, viruses and other microorganisms biological structures, so that loss of viability. So there is no secondary pollution ozone work produced for human environmental needs, this is the biggest advantage of ozone technology. The main application of ozone sterilization in artificially. This is mainly a strong oxidation ability of ozone, oxygen atoms can be oxidized bacterial cell wall, until its body through the wall of the unsaturated bond and seize compound bacterial life, its role is instantly completed, the ozone sterilization effect quickly determine in its high reduction potential, II, shows the reduction potential of the ozone disinfection materials comparison.

Table II Comparison redox potential

Third, ozone generation principle

   1, the UV method

   Ozone is produced artificially photoelectric method, to produce a wavelength λ = 185nm (10-9m) of the UV spectrum, such light most easily absorbed by O2 to achieve the effect of ozone is generated in the United States called the ozone lamp.

Photochemical ozone has the advantage of high purity, humidity insensitive to temperature, with good reproducibility, these features for ozone therapy and as an instrument for human ozone standard source is very appropriate, but the disadvantage is the high energy consumption.

2, electrochemical method

DC electrolysis using an oxygen-containing gas by electrolytic ozone generation. Electrolysis ozone with high concentrations, pure ingredients, the advantages of high solubility in water, there will be a good prospect.

3, the corona discharge method

Corona discharge method is an imitation of nature, lightning produce ozone methods, through artificial alternating high voltage electric field is generated in the gas corona, corona of free energy ions dissociate O2 molecules, the collision polymerization of O3 molecules.

Corona discharge type ozone generator is the most widely used, relatively low energy consumption, the single largest ozone production, the market share of the highest ozone generator. Now the world's single most productive of 300Kg / h, is the use of corona discharge principle.

Ozone disinfection applications in space

   I. Features:

1, Sterilization

Ozone on bacteria, fungi, bacteria and other microorganisms with a strong force to kill it to kill the virus is through direct destruction of their RNA and NDA material industry completed, and kill bacteria, virus-like organisms first process is the role of the cell membrane of ozone and then destroy the membrane organization until dissolved death.

2, in addition to different odor

 Ozone removes mildew, fishy smell, such as smell is very effective, it can be quickly oxidative decomposition odor chemicals.

3, mildew preservation

Diffuse ozone gas, disinfection no dead ends, the machine can achieve self-run and sterilization mildew. Fruits Vegetables not only bactericidal against mildew, extend shelf life, and can quickly break down fruit and vegetable respiration excluded collar its rapid maturation and ethylene gas.
   4, expelling harmful insects
The identification and expulsion of the FDA on mice have effect on the storage bins for disinfection of clothing, can prevent infestation.

Second, surface disinfection

In the pharmaceutical manufacturing process often raw materials, tools, packaging materials for surface disinfection, disinfection cabinet is often used, the transfer window, the traditional method is to use ultraviolet disinfection, the problem is not thoroughly disinfected, so if used in areas such as transfer windows and other less demanding situations is possible, to a far less ozone effect. "Disinfection technical specifications" in the introduction, the immersion in the ozone gas in the surface, the contact time, the surface of bacteria can be killed.

Third, technical indicators ozone

1, the main technical indicators ozone generator ozone concentration (mg / L or g/m3), ozone production (g / h or kg / h) and power consumption (kw · h/kgo3).

2, using standard ozone generator, should be 10mg / L concentration levels of the order of the application of ozone in the air purification sterilization treatment at a concentration of ppm (parts per million) levels, in addition to taste and an air sterilization, requires ozone concentration is low, such as 0.5ppm (1ppm ≈ 2mg/m3)

3, the same generator ozone concentration and yield, with the gas volume changes, the general rule is if a large volume low concentration and high yield. Ozone generator means determines the degree of pollution concentration and production specifications are based.

        4, for air purification host conditionally suspended in 2.0 meters high from the ground, because the O3 gas is higher than the proportion of air, with a natural settling characteristics, can also be placed directly on the host used at higher.

Fourth, the application of the depth of the ozone standard calculation method

1, the use of central air conditioning and cleaning (HVAC) for clean areas were disinfected.

In laboratories, the general said, clean larger, multi-use central air purification system to complete the cleaning and disinfection of the clean area. The method is mounted directly on the ozone generator central air purification system to send, return air main pipe or clean air filter box back in effect, the power control box placed in the engine room. Disinfection off when about 90% of new air inlet valve and external discharge valve, so that the formation of HAVC system and the clean area within the loop. Just start doing daily air sterilization of about 1 to 1.5 hours, instead of chemical reagents major disinfection fumigation needs only 2 to 2.5 hours. Sterilized with the advantages of the program: the use of ozone as clean air carrier (approximately 60m3 per minute of air flow through the ozone generator can be), you can make ozone quickly spread to HAVC system controlled clean room, and the ozone concentration distribution , in a clean area without any additional disinfection equipment, you can achieve the purpose of sterilization cleanroom stove; while HAVC system to kill bacteria and fungi play the effect. Practice development, but also on the HEPA filter ozone plays the role of lysozyme ease, extending its life.

Ozone on the inactivation of microorganisms in the air concentrations and deposition surface inactivation of microorganisms concentration, according to the Ministry of Health in December 1991 promulgated the "disinfection technical specifications" section 4.12 application of ozone disinfection of air in Clause 8.2 provides that " closed air with 5 ~ 10mg/m3 concentration (equivalent to 2.5 ~ 5ppm) ozone for 30 minutes; colonies on the surface of the settlement to 20 ~ 30mg/m3 (equivalent to 10 ~ 15ppm) ". The purpose of the pharmaceutical industry, the application of ozone and ultraviolet light is used instead of chemical fumigation, on the whole clean area of ​​air and mechanical equipment, dielectric material surface subsidence large colonies disinfection. Required ozone concentration of 10 ~ 15ppm, the equivalent concentration of ozone per cubic meter of 20 ~ 30mg.

Let; VI to go clean space volume, V2 is the volume of space HVAC systems, V3 in order to maintain a positive pressure clean area supplemented by new losses caused by wind on ozone

The sterilization space volume (V) is calculated as: V = V1 + V2 + V3

V3 to determine: the use of ozone generator according to several manufacturers of sterilization practice, summed up the experience of more reliable formula is as follows: V3 ≈ HVAC system circulating total air volume m3 / h × 25% (conventional fresh air replacement rate) × 10-20% (keeping clean areas are complementary fresh air) × 39% (half-life computing applications ozone budget), ie V3 = HVAC system circulating total air volume × 1 ~ 2%.

Ozone generator options: press the efficiency of the ozone sterilization, which refer to "disinfection technical specifications" standard to determine the concentration of ozone sterilization (C): bacteria floating in the air, the concentration of ozone sterilization 2 ~ 4ppm; on the object surface settlement colonies, the concentration of 10 ~ 15ppm (reference concentration of ozone sterilization Ministry of Health in December 1991 "Disinfection Technical specifications"). Natural half-life of ozone (S), the reference state is about 23min, an hour of 61% decline. Design: Application of ozone sterilization desired concentration is reached after 60min, maintaining heresy time (1 to 1.5 hours), you can get equipment and road construction surfaces thoroughly to kill bacteria settling effect, to chemical fumigation disinfection effect.

Example: Sterilization space total volume (V) of 1000m3, sterilization requirements for the alternative to chemical fumigation disinfection of equipment and construction road surface subsidence sterilize bacteria. In accordance with the requirements of the ozone concentration in air (C) should reach more than 10ppm (in working condition, translated into 19.63mg/m3), ozone generator ozone after an hour of work natural decline rate (S) is 61%, the machine must be selected The amount of ozone g / h (W):

W = CV / (1-S) = 19.63 × 1000 / (1-61%) ≈ 50.33 (g / h)

Optional hourly output of 50g generator.

Note: If there is no central air conditioning systems (HVAC); adopt uniform distribution piping form ozone.

2, ozone application in the pharmaceutical industry

   The pharmaceutical industry and other industrial clean room clean room is different, especially in the production of sterile preparations and raw material drug production, not only to control airborne aerosol particles generally suspended state, but also to control or number of microorganisms, both to provide a "sterile medicines "production must appropriate air cleanliness environment (clean room). Of course, "sterile" is relative and is a concept of probability.

Efficient and complete: Operating produce a certain amount of ozone in a relatively closed environment, spread evenly, inclusiveness, good UV germicidal overcome the inherent shortcomings, there are many dead ends, can achieve comprehensive, fast and efficient sterilization purposes.

Easy to operate: sterilization requirements and according to the volume of space, ozone generator to determine the type and amount of ozone, and through validation checks to determine the number of bacteria sterilization time. Sterilization, ozone output directly placed in sterile indoors or HVAC system, you can use 24-hour time controller settings turn off time can be.

High cleanliness: application of ozone as a sterilization agent, stop after 30 minutes, the remaining self-decomposition of ozone can be gradually reduced to oxygen, but also can improve the air quality, optimizing working environment. So ozone is praised as "green disinfectant"

No adverse effects on the machinery and equipment: ozone air planktonic bacteria are inactivated in very low concentrations of ozone required, generally only need 2 ~ 4PPM, settlement colonies on the surface (instead of traditional chemical disinfection fumigation large) only need 10 ~ 15PPM so. Ozone concentration in the air is only 10-15 ppm, the concentration of the chemical fumigation of 500 points. Since the sterilization process time is short, the proper use of corrosive conditions does not constitute an object, which is of particular concern everyone.

Use Economy: air as raw material, work and low energy consumption, low operating costs, good economic returns.

Ozone in pharmaceutical applications:

The application of ozone in the pharmaceutical industry there are several aspects: First, the GMP workshop and equipment, appliance surface disinfection; Second, central air conditioning system disinfection; Third, changing rooms and clothes disinfection; Fourth, production and processing water sterilization purification ; five is the preparation of high concentrations of ozone disinfectant.

(A), the production GMP workshop air sterilization:

(Two), GMP workshop or food purification level options:

Three), BNP ozone model selection recommendations:

      OZ-G-type ozone machine:

Four), a potent ozone generator BNP - G series uses advanced high resistance to temperature quartz glass discharge cell, the following table:

Ozone air disinfection, surface disinfection experiments

First, the equipment

1 Fu Kang cards (BNP) ozone generator, production date or lot number: 2003.10.9

2 aerosol chamber volume of 16m3.

3. FA-1-type microbial air sampler

4 Staphylococcus (8032), 9 `11 generations, preservation of the unit

Second, the method

Test based on the Ministry of Health "disinfection technical specifications" 2002.11, section 2.1.3.4 of

1, the bacterial suspension prepared as follows: 18-24h cultured white staphylococcus (8032) wash down slope by conventional bacterial lawn, and then diluted with nutrient broth aside.

2, the contamination: first two 16m3 aerosol room temperature and relative humidity adjusted, the (BNP) ozone generator placed on the sidewall of the aerosol chamber, aerosol chamber door closed, the power switch bacteria start spraying, spray pressure 0.03-0.04Mpa, flow 0.8m3 / h, with the aerosol generator chamber simultaneously to two aerosol spray contamination 5min.

Three sampling, disinfection: After contamination, standing 5min, the mining center of the transmitter to the aerosol chamber 1m height, respectively, of two sampled aerosol disinfection chamber (sample flow 1.7 m3 / h). Open (BNP) ozone generator, turn the pump switch, timing. Disinfection predetermined time, after disinfection by former French sampled record temperature and humidity.

4 train, count: take down sampler plate, put 37 ℃ for 48h after a few bacteria, calculated under different conditions, the number of bacteria surviving in the air, the natural decline rate and kill rate.

Third, the results

Test temperature 23 ℃ ~ 25 ℃, relative humidity 52% ~ 57% of the time, (BNP) ozone generator disinfection 30 min, Staphylococcus albus in the air each time the kill rate of 99.99%, this time, the air control group the white grape ball natural rate of 31.62 percent decline less (Table).

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CONCLUSIONS

Test temperature is 16 ℃ ~ 20 ℃, relative humidity 30% ~ 46% under the conditions, (BNP) ozone generator disinfection 60min, on 28m3 of natural bacteria in indoor air each time the demise rate reached 90.00% or more.

The safe use of ozone

1, ozone is a safe non-toxic gases. Depth of 0.15ppm of ozone when olfactory thresholds, most people can sniff out. Chinese health standards are: 0.15ppm, 8 hours exposure standards compliance guards. Depth is high, the body will breathe harmful ozone. Staff obviously felt after stimulation of ozone should be avoided. A small amount of breathing beneficial. Following concentrations in the respiratory 0.1ppm ozone on human health effects will be, someone likened the ozone wine.

2, the safe use of ozone sterilizing machine. Fu Kang ozone production due to high levels of ozone, generally avoid using. Fu Kang ozone sterilization time can be set. That is, when people leave in corporate work, the opportunity to automatically generate rich Cannon ozone ozone sterilization certain period of time (the length of time sterilization arbitrarily set) and automatically stops. Sterilization of the day can be any number of times. For larger plants, workers can work on a short boot, for a long time to stop, alternately, to achieve cleaning use.

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