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Introduction to hydrogen peroxide dry mist sterilization system

2019-09-29
The increasingly mature technology and strong practical demand for the application of Hydrogen Peroxide dry mist sterilization in the space sterilization of pharmaceutical plants:
1. Currently commonly used methods for space sterilization in the pharmaceutical industry
Ozone, formaldehyde, H 2 O 2 ( including: vaporization, dry source of gas, dry mist of power supply, etc.)
2 , the current common problems in the space sterilization of the pharmaceutical industry:
2.1, the growing awareness of health and environmental protection and the problem of formaldehyde odor.
2.2, the cost-effective problem between the high cost of large sterilization equipment and low usage times.
2.3. Problems between the sterilization ability of ozone and the production requirements of the aseptic workshop.
2.4. Material compatibility (corrosion) problems of high concentration peroxidation sterilization.

Second, the development and advantages of hydrogen peroxide space dry mist sterilization system Hydrogen peroxide dry mist sterilization has been applied to European pharmaceutical factories for nearly 20 years, especially in recent years, the use of formaldehyde space in the EU is restricted. In the large environment of bacteria, dry sterilization of hydrogen peroxide has been rapidly developed. As an important pillar of the global economy, the pharmaceutical industry has always been advancing with the times. With the release and implementation of the new domestic GMP, domestic pharmaceutical companies have a better understanding of the pharmaceutical situation in the EU and the US, and are key in the pharmaceutical industry. For the first time, the concept of sterilization of hydrogen peroxide was proposed for aseptic preparation companies. Although it could not be quickly spread to various categories, we can already see the whole industry from the abandonment of formaldehyde disinfection in the EU. Both managers and participants are trying to find a product that can replace formaldehyde for sterilization.
With more and more attention and new technologies, the author has also come into contact with some new technologies that have played a positive role in solving this problem. Here, I hope that through the analysis of some problems and the discussion of technology, pharmaceutical companies, especially aseptic preparation companies, can find a more convenient, safe and reliable way of sterilization. At the same time, it provides some helpful references for companies that have purchased and will purchase formaldehyde-sterilized products to replace formaldehyde.
So what are the advantages of using hydrogen peroxide in the space sterilization of pharmaceutical plants than with formaldehyde? Let's take a detailed comparison of various aspects involved in the disinfection of pharmaceutical plants by using hydrogen peroxide dry mist as an example.

Comparison of Orphem Hydrogen Peroxide Space Dry Mist and Traditional Formaldehyde Fumigation
project Power supply hydrogen peroxide dry fog formaldehyde
toxicity toxic free and safe It is strongly carcinogenic and can be inherited from generation to generation, causing deformity of offspring. (The majority of female employees in general pharmaceutical factories).
odor Colorless, tasteless Stimulating odor,
Sterilization effect Sterilization effect of 4-6 log values is broad-spectrum and efficient, in line with pharmacopoeia requirements for space sterilization
Sterilization efficiency meets the requirements of the Pharmacopoeia for space sterilization
Sterilization time The whole process: 3-4 hours, safe production Sterilize for 12 hours, exhaust air for 48 hours to be put into production

Residue
No residue in the surface space, no need to clean It is necessary to clean the white crystal after sterilization and it is difficult to completely remove it.
Residual neutralization No need to neutralize Need to neutralize and clean
Certification and verification Complete verification data, and 3Q certification materials Developed regions in Europe and the United States have abandoned this approach,
Residue detection Dräger Hydrogen Peroxide Tester Difficult to detect

Disinfection cost
Simply increase the cost of pre-purchasing equipment. Problems that can be solved: shorter downtime; simpler and more convenient operation; better protection of personnel, more comfortable working environment; help to improve production efficiency and maintain personnel stability. Lower disinfection costs, problems caused by long-term production stoppages, possible personnel safety and high payouts, frequent replacement of high-efficiency, severely affected exports, poor production environment and frequent staff turnover, recruitment And training costs

At the same time, what we need to understand is the actual impact of disinfection and sterilization on pharmaceutical companies as a necessary part of pharmaceutical companies:

Comparison of actual impact on pharmaceutical companies
1 Employee safety
Regardless of the production of that kind of product, regardless of the production technology, no matter which process is entered, safety *** is a universal principle. The hazards of formaldehyde are mainly manifested in: strong carcinogenicity, strong teratogenicity, and intergenerational hazards (ie, pregnant women poisoning can cause fetal malformations). Today, with the popularity of the Internet, people are becoming more aware of the dangers of formaldehyde. Therefore, as an important resource for enterprises, employees must be protected.
Orpheum dry mist hydrogen peroxide uses 7.5% hydrogen peroxide, its toxicity (LD) value, lower than salt, is recognized as a safe, environmentally friendly disinfectant, widely used in the EU.
2 Application Convenience A pharmaceutical company's production characteristics are characterized by numerous links. Therefore, emergency disinfection and small-scale disinfection are indispensable. Formaldehyde obviously cannot cope with this sudden situation, and Orpheum is "small, fast, and spiritual." "The characteristics are very suitable
3 Expert attitude Experts' attitude towards formaldehyde can be attributed to four words: helpless, because the residue of formaldehyde is difficult to monitor, and it is also known to be harmful, but "the law does not blame" can only be passed. For hydrogen peroxide, experts can use "history to see" to evaluate the cause, *** hydrogen peroxide can achieve sterilization requirements, second, hydrogen peroxide residue can be verified, third, hydrogen peroxide is harmless, Fourth, hydrogen peroxide is received by the European Union and the FDA.
4 Invisible influence of personnel
We know that employees in pharmaceutical companies are difficult to recruit, so how to attract employees to stay in the company, especially front-line operators. Nowadays, all operators understand the hazards of formaldehyde, so when pushing the process of formaldehyde, they can push it. Long-term use of formaldehyde is not conducive to employees' peace of mind, which can potentially lead to high levels of employee turnover. However, we have been exposed to many cases of formaldehyde poisoning and malformation. We even came into contact with a company, a traditional and important enterprise. When we first came to our door, we thought that our equipment was expensive and not adopted, but it was just a few After a month, a female worker was poisoned and a deformed child was produced. Then we purchased our equipment. However, due to the accident, the company's economic loss, reputation loss and its large.

Third, the principle and composition of the Orphem hydrogen peroxide space dry mist sterilization system
1, first we understand what is dry fog?
1.1 , the size of the dry fog:
Dry fog: refers to liquid particles with a diameter between 1 and 10 microns.

1.2 , characteristics of dry fog:
1.2.1 Irregularity: Dry fog particles perform irregular motion (Brown Motion principle)
1.2.2 non-condensing: dry mist droplets are not easy to condense together to produce large droplets;
1.2.3 does not adhere: dry fog particles will rebound after surface contact (such as the wall), not easy to adhere
The smaller and more uniform the dry mist particles, the more obvious the characteristics of the dry fog.

2 , Orpheum power supply hydrogen peroxide space dry mist sterilization system
2.1 Equipment principle:
The Orpheum Dry Mist Sterilization System uses a power source (without the use of compressed air), uses the Venturi principle to draw air at high speed, and gives the air a large enough kinetic energy. The gas is allowed to collide with the disinfectant at high speed to produce dry mist particles having a diameter of less than 5 microns. Allow the disinfectant to disperse in the form of dry mist particles in a sterile clean area that requires sterilization to achieve a thorough sterilization effect instead of fumigation. The principle is very simple, but it needs to be solved: instantaneously providing sufficient kinetic energy of air to achieve uniform 3-5 micron particles, heat dissipation and noise reduction, and equipment space occupation. And Ufim's unique boron-cobalt alloy self-lubricating instrument nozzle design expands the efficiency of dry fog equipment, greatly reduces space occupation, and solves the problem of heat dissipation and noise reduction. These technologies are all in any case. These characteristics are also very suitable for pharmaceutical companies.

2.2 dry mist sterilization program composition
Space sporicide + space dry mist sterilization equipment
2.3 The scope of application of dry fog sterilization program
1. The dry mist sterilization scheme can be safely used for disinfection and sterilization of clean room spaces and equipment. Applications include pharmaceutical, biotechnology, medical product production, food production, cosmetics production, and health care product production.
2, dry fog sterilization program can be safely used in various levels: sterile clean room, sterile laboratory, micro-organism room, sterile room, isolator, RABS, sterile transfer cabin disinfection.
3, dry fog sterilization program can be safely used for stainless steel, plastic, glass, floor, wall and other surface and space disinfection.

2.4 Orpheum dry fog sterilization operation guide:
*** Step: Confirmation of the placement of the device:
The device location follows the following principles:
Keep the nozzle away from walls and equipment to avoid blocking the spray, preferably in locations where dry mist is easy to spread.
Step 2: Place the equipment in place, install sufficient disinfectant, connect the power supply, and set the spray time according to the disinfectant dosage.
The third step: turn off the air conditioner, fresh air exhaust, close the doors and windows.
Step 4: Start button to start the spray button to start dry fog sterilization (please read the product instructions before use)
Step 5: The equipment is sterilized, and the set amount will stop automatically after spraying, and it will stand for 90 minutes.
Full exhaust for 30-60 minutes, sterilization is complete.
From the start of sterilization to the production of the feed, the entire sterilization process takes about 3 hours (including ventilation).

2.5 Orpheum Space Dry Mist Sterilization System Verification System:
The main verification content consists of three parts:
2.5.1 , sterilization effectiveness of hydrogen peroxide dry mist sterilization system
The sterilization effect of atomized hydrogen peroxide sterilization system is verifiable, no special bacteria are required, and LRV meets USP requirements. Through the bio-indicator challenge test, according to the USP USP, black Bacillus subtilis and Bacillus stearothermophilus were used as challenge test bacteria, which decreased by 4-6 log units after sterilization, which can prove that the system is in space. Killing ability of various microorganisms during sterilization
Third, when hydrogen peroxide replaces formaldehyde sterilization, it is worth paying attention to. How to achieve space sterilization effect under the premise of having a good disinfectant solution?
Most disinfection products are liquids. Therefore, a basic understanding is that if the disinfectant can be vaporized, then the diffusion is good, and the sterilization effect is also ideal. This is what people have always hoped for. However, if the product is completely vaporized, the cost and use cost of the equipment are very high. At present, many large-scale equipments on the market can only be "vaporized", but can not be truly vaporized. The difference between words is a far cry. The first is technically impossible. In addition, many companies do not have a large number of “big eliminations” in a year. The large equipment investment is high and the number of uses is small, so the cost performance is very low. However, if the product is simply atomized and the diffusivity is very poor, there will be many problems (such as dead ends, condensate, etc.). It does not meet the requirements of the company and does not apply to the sterilization of pharmaceutical plants. When choosing a sterilization equipment, the pharmaceutical company mainly considers the following aspects:
1 material compatibility (corrosive) :
In the developed environment of developed countries in Europe and the United States, the new version of GMP was released and implemented as an opportunity. Many manufacturers came to the market, and there were imported, domestic and cottage. And the momentum is getting worse, but a common problem facing Yokohama in front of these manufacturers is how to solve the problem of material compatibility. It is well known that hydrogen peroxide sterilization is accomplished by oxidation, but at the same time as the initial oxidation, it is inevitable to cause corrosiveness to the material. This is also the main reason why some people are hesitant about hydrogen peroxide sterilization.

1.1 Power supply dry mist sterilization Why is it less corrosive:
1.1.1 Low concentration of hydrogen peroxide: Compared with traditional hydrogen peroxide, the disinfectant of Orpheum dry mist sterilization equipment is produced by a special European process, and the hydrogen peroxide activity is very high. Therefore, under the premise of fully guaranteeing the efficacy of sterilization. The concentration of hydrogen peroxide used is much lower than that of conventional hydrogen peroxide (about 5-6ml) / cubic. The concentration of hydrogen peroxide in contact with the color steel plate is about 1/10 of that of vaporized VHP sterilization equipment.
1.1.2 Short sterilization time: globally effective sporicidal agent, spores for 5 minutes. It can achieve 6-8 log unit killing rate against B. subtilis and T. thermophilus in 30 minutes, which is in full compliance with the pharmacopoeia. The contact time between the disinfectant and the color steel plate of the equipment is greatly shortened.
1.1.3 Ou Feimu Europe 20 years of dry fog technology accumulation, Europe's extensive experience in pharmaceutical companies, hospitals. The accurate and uniform 3-5 micron dry atomization effect, the dry fog equipment of the global dry fog effect, reduces the risk of condensate , ensures the disinfectant in the space, does not adhere, does not condense (experiment shows: use a piece of about 1 square meter The glass is placed about 50 cm from the spray port of the device, no droplets are formed, and no wet glass surface is present.
1.14 A material compatibility (corrosion) test report commonly used in more than 40 EU pharmaceutical plants to relieve your material compatibility.

2 dependence on humidity
Hydrogen peroxide sterilization equipment with similar humidity dependence in similar products:
2.1 , the initial speed of the power supply dry fog is 80M/S, which is equivalent to the speed of the high-speed rail. The powerful initial kinetic energy of dry fog particles easily breaks through the blockage of water molecules in the air to reach every corner. It is decided that our equipment can work normally in 10%-75% air humidity environment. In addition, our disinfectant is highly effective in sterilization, and its dosage is less than that in the industry, and less water is sprayed into the space. It directly determines the change of the humidity of the space environment in the whole sterilization process can be guaranteed within 10%. VHP sterilization equipment with small environmental humidity changes in the industry. The entire sterilization process sees the space completely clear and transparent through the glass security door. The veritable one only smells its voice and does not see its shape.

2.2 , the same VHP products (vaporization, gas source) sterilization must first adjust the humidity to below 40%, the humidity will rise rapidly to more than 90% after the start of sterilization, the entire space is filled in the water mist, insufficient visibility 1 meter, it is completely a sauna for the workshop, its corrosivity can be imagined.

3 Diffusion is what guarantees the diffusion of such a small device so good? In general, there are three main reasons:
3.1 . Particle Size People refer to 1-10 micron liquid particles as “dry fog”. Dry fog has three basic properties: (1) non-stop irregular Brownian motion (2) difficult to coagulate (3) not easy to adhere. Moreover, the smaller the dry mist particles, the more obvious the nature of the surgery. The particles sprayed out of our equipment reach a uniform 3-5 micrometers, which is close to the gaseous state and completely invisible to the naked eye. It is a veritable dry mist and a dry mist of particles in the same kind of products (which can provide particle size materials). Provide prerequisites for its proliferation.
3.2 . Although the initial kinetic energy equipment is small, the initial speed of fogging can reach 80m/s. This speed is equivalent to that of high-speed rail, and the dry fog can be sprayed to the space 10 meters away in an instant. Provide enough kinetic energy for its diffusion.
3.3 , space concentration
Similar hydrogen peroxide sterilization products: VHP space sterilization concentration needs 1000ppm, air source dry fog space concentration needs at least 700ppm, and our space concentration is only 120-150ppm. It is clear that for dead angles, it is much easier for sporicides to reach 150 ppm working concentration than 1000 ppm, making it difficult to spread.

Four other common hydrogen peroxide sterilization equipment currently on the market
1 VHP : Vapor Hydrogen Peroxide
Please note that this method is to "steam" hydrogen peroxide, rather than "gasifying" hydrogen peroxide, because both the mode of production and the mode of action are in the steam category. The basic principle is to sterilize the killing ability of microorganisms during the condensation process by using hydrogen peroxide vapor. Divided into dry and wet methods, the important difference between the two is the use of desiccant and the dependence on humidity.
The concentration of hydrogen peroxide used by VHP is about 30%. It is flashed by electric heating to 114 degrees Celsius, and then steam is formed at about 60 degrees Celsius. After that, it is divided into two modes: "dry method" and "wet method" to form A 2-6 micron film is used for the purpose. The microcondensation of the film carries hydrogen peroxide molecules for sterilization.
In the early days, this kind of equipment was mainly imported brands. With the introduction of the concept, many domestic manufacturers have already produced their own equipment.

2 gas source atomized hydrogen peroxide
This method uses 0.3-0.35MPa compressed air to atomize the compound disinfectant of hydrogen peroxide and peracetic acid. The core fitting is the nozzle. The disinfectant can form tiny particles. The core component of the sterilization method is the nozzle, and the quality of the nozzle directly determines the size of the mist particles, and the size of the mist particles determines the diffusion effect of the disinfectant. At present, the quality of domestically produced nozzles is uneven, resulting in the actual fog of many devices being visible to the naked eye, that is, at least 40-50 microns, rather than the dry fog propagandized by the manufacturer. The size of the dry fog must be less than 10 microns, and less than 10 Micron dry fog particles are not visible to the naked eye.
This kind of equipment was first introduced in the United States. In recent years, many domestic manufacturers have imitated the equipment after simply purchasing imported nozzles and welding stainless steel tanks themselves.

Four Conclusions Under the new GMP regulations, in the case of people pay more and more attention to health to the environment, the space sterilization program in the clean area must have the following requirements:
1, the program is easy to use, simple to operate, eco-friendly, friendly to people and the environment.
2, the program sterilization effect reaches the pharmacopoeia USP sterilization standard : can achieve a killing rate of 10 4 to 10 6 for Bacillus subtilis and Bacillus stearothermophilus.
3, the material compatibility of the program is better : the compatibility of clean areas and equipment should include: for metal, engineering plastics, rubber, clean room wall panel top, epoxy self-leveling floor, high efficiency air supply, return air, plexiglass , sockets, switches, telephones, on-site display instruments, etc.
4, the program has no residue : to ensure that the sterilant residue after sterilization will not constitute any form of pollution to the drug. Easy to verify, with sufficient verification data.
5, the program spreads very well : full coverage, no dead ends.
In summary, with the fumes of formaldehyde fumigation itself, some unacceptable problems have been rejected by people, and they have been slowly abandoned in production. Under the background of the increasingly mature hydrogen peroxide sterilization technology, hydrogen peroxide is sterilized in the space of pharmaceutical factories. Applications will be accepted and adopted by more and more people. This sterilization method will completely replace traditional formaldehyde fumigation with its obvious advantages. Become the new direction and new normal of future microbial control.

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