Simply describe the status quo of the pharmaceutical factory spatial sterilization, introducing the advantages of hydrogen peroxide for the spatial sterilization of pharmaceutical manufacturers, and expounds Kang Kang TechnologySterilization of hydrogen peroxideThe principle, composition, use and verification of the system, and the specific case is listed. Analyze the most important thing to choose space sterilization equipment in the pharmaceutical factory. Detailed explanation has also been involved in corrosive, diffusivity, and verification of pharmaceutical staff concerns in hydrogen peroxide.

Surface disinfection was used for surface disinfection using hydrogen peroxide, such as the wound disinfection in the hospital.

For space disinfection, it is generated in medical applications, mainly used for sterilization and disinfection of medical devices, resulting in a hydrogen peroxide sterilization cabinet, and is still widely used in our hospitals.

It is characterized by sufficient hydrogen peroxide, which can be thoroughly sterilized, but space sterilization cannot be performed, and the price is extremely expensive.

Later, manySterilization of hydrogen peroxideThe way, the release and implementation of the new version of GMP have brought a revolutionary industrial upgrade to pharmaceutical companies, and how many pharmaceutical companies have passed the new version of GMP, how to combine new GMP and their own enterprises production conditions must be considered. The problem. Among them, the sterilization link is the weight.

This paper is a brief introduction to the drug factory spatial sterilization.

 

 

one, a one singleHydrogen peroxide dry fog sterilizationThe increasingly mature technology used in the pharmaceutical factory sterilization and a strong production practical demand background.

1. It is currently a common way to sterilize in the pharmaceutical industry.

Ozone, formaldehyde, H2O2 (including: vaporization, gas source dry fog, power supply dry mist, etc.)

2. Currently, the problem of spatial sterilization of pharmaceutical industry:

2.1, people 's increasingly enhancement between health and environmental awareness and formaldehyde toxic smell.

2.2, the cost and cost-effective problem between the high-sized sterilization equipment is high.

2.3 The problem of sterilization of ozone and the production requirements of sterile workshop production.

2.4, high-concentration sterilization of material compatibility (corrosive) issues have become a problem that is more and more concerned from multiple companies.

 

Second, the development and advantages of dry fog sterilization system in hydrogen peroxide spatial

Hydrogen peroxide sterilization has been used in European drugs. In particular, in recent years, in the European Union restricts the use of formaldehyde space sterilization, hydrogen peroxide sterilization is rapidly developed. The pharmaceutical industry as an important pillar of the global economy has never advancing with the times.

With the release and implementation of China's new GMP, domestic pharmaceutical companies have a further understanding of the Pharmaceutical situation in the European Union and the United States. For the first time in the pharmaceutical industry, hydrogen peroxide is proposed for the sterile preparation enterprises. The concept of sterilization of the class, although it is unable to popularize each category, but from the EU to abandon the abandonment of formaldehyde disinfection, we have been able to see the entire industry, whether it is managers or participants trying to find an aldehyde Sterilize products.

With more and more attention and new technologies, the author has also exposed to some new technologies that have played a positive role in the solution of the problem.

Here, there is a more convenient, safe and reliable sterilization method that can help pharmaceutical companies, especially sterile preparations.

At the same time, companies that have been purchased and willing to purchase hydrogen peroxide sterilization products have some helpful references.

 

At the same time, we need to know more about the actual impact of pharmaceutical companies, disinfection and sterilization on pharmaceutical companies:

 

Comparison of actual impact on pharmaceutical companies

1, employee safety

Whether it is engaged in the production of the product, no matter that production technology, no matter that the production process, safety first is the principle of a four seas. The hazard of formaldehyde is mainly reflected in: strong cancer, strong deodorant, and separation harm (ie, pregnant women can cause malformation of the fetus). Today, today, people understand the harm of formaldehyde, so as the most important resources of the company: employees, it must be protected.

The hydrogen peroxide of Kang Kang hydrogen peroxide is 7.5% hydrogen peroxide, its toxicity (LD) value, lower than salt, is a recognized safety, environmentally friendly disinfectant, widely used.

 

2. Application convenience

A production characteristics of pharmaceutical companies are numerous links. Therefore, emergency disinfection and small disinfection are essential, formaldehyde is obviously unable to cope with this burst, and the characteristics of Kang Kang "small, fast" is very suitable.

 

3, expert attitude

Experts treat formaldehyde can be attributed by four words: no choice but, because the residue of formaldehyde is not easy to monitor, and also knows harmful, but "law is not responsible" can only have to have passed. For hydrogen peroxide, experts can evaluate "喜 闻 闻 见\\ Fourth, hydrogen peroxide is received by the EU and FDA.

 

4, personnel invisibility

We know that the employees of the pharmaceutical enterprises are relatively difficult, so how to attract excellent employees, especially the first-line operator.

Today, all operators understand the hazard of formaldehyde, so it can be pushed when performing formaldehyde.

Long-term use of formaldehyde is not conducive to employee peace of mind, which will potentially cause loss of high levels of employees. And we have come into contact with many enterprises in formaldehyde poisoning, manephrograph, and we have even contacted a business, traditional important enterprises, when we came to our initial, we believe that our equipment is very expensive, no adoption, but just a few After a month, a female worker was poisoned, and the situation of malformation was produced, and then we purchased our equipment. However, due to the accident, the economic loss, reputation loss and its large.

 

Third, the principle and composition of the dry fog sterilization system of the hydrogen peroxide spatial

1. First of all, let's know what is dry fog?

1.1, dry size:

Dried fog: refers to liquid particles in a diameter of 1 to 10 μm?

 

 

 

1.2, dry fog characteristics:

1.2.1 Impractive: The dry fog particles are not ruled (Brown motion principle)

1.2.2 Do not condense: dry fog is not easy to condense together to produce large droplets;

1.2.3 No adhesion: After the fog particles are in contact with the surface, if the wall will rebound, it is not easy to attach

The smaller the dry fog particles, the more average the above dry fog characteristics.

 

2, 皕 皕 电源 过 hydrogen peroxide spatial dry fog sterilization system

2.1 Equipment principle:

The Kangkang fog sterilization system uses the power supply (no need to use compressed air), using the principle of venturi to inhale air, and give the air enough kinetic energy in the nozzle. Allows the gas to collide with the disinfectant to generate dry fog particles having a diameter of less than 5 microns. Let the disinfectant are dispersed in the form of dry fog particles in need to sterilize

Sterile cleansing zone, thus achieving thorough sterilization, can replace fumigation. The principle is very simple, but it is necessary to solve: instantly provides a high-quality kinetic energy to make the particles to achieve a uniform 3-5 micron, heat dissipation noise reduction, and the equipment space take up three problems. And the unique boron alloy has a lubricating function of the lubricating function, which enlarges the efficacy of the dry fog equipment, which greatly reduces the space occupancy, solves the problem of heat dissipation and noise reduction. These technologies are world-leading anyway. These features are also very applicable to the pharmaceutical factory.

2.2 Maked Sterilization Scheme

Space killing agent space dry fog sterilization equipment

2.3 Scope of application of dry fog sterilization

1. Dry fog sterilization can be safely used in disinfection sterilization of clean room space and equipment, and applicability includes pharmaceutical, biotechnology, medical products production, food production, cosmetics production, and health products.

2, dry fog sterilization can be safe for various levels: sterile cleansing workshop, sterile laboratories, microbial rooms, sterile rooms, isolators, RABS, sterilized sterile sterilization.

3, dry fog sterilization solutions are safe for stainless steel, plastic, glass, floor, wall and other surfaces and space disinfection.

2.4 Kangkong Shot Sterilization Operation Guide:

Step 1: Confirmation of the location of the device:

Equipment location follows the following principles:

The nozzle is away from the walls and equipment to avoid obscuring sprays, and the position of easy dry fog diffusion is better.

Step 2: Equipment is in place, install a sufficient disinfectant, connect the power supply, and set the spray time according to the amount of disinfectant.

Step 3: Close the air conditioner, new wind exhaust, close the doors and windows.

Step 4: Start button Start Spray button to start dry fog sterilization (please read the product instructions before use)

Step 5: The equipment is bactericidal, the spray is complete, and the quantity will be automatically stopped, and stand for 90 minutes.

The whole drainage is 30-60 minutes, sterilized.

From the start of sterilization to enter the feed, the entire sterilization process is about 3 hours (including ventilation).

2.5 皕 皕 空 干 Sterilization System Verification System:

The main verification content includes three parts:

2.5.1, hydrogen peroxide dry fog sterilization system sterilization efficacy verification

Atomized hydrogen peroxide sterilization system sterilization is verified, no special bacteria, LRV meets USP requirements. Through the challenge of biological indicator, according to the US Pharmacopoeia USP, Bacillus and Bacillus, Bacillus, Bacillus, Bacillus, Bacillus, Bacillus, were used as challenge test bacteria, and decreased by 4-6 logarithmic units after sterilization, which can prove that the system is in space Killing capabilities for various microorganisms during sterilization

2.5.2, material compatibility verification (corrosive verification, more than 40 material challenge experiment reports in EU drug factory)

2.5.3, residual verification (perfect for residual verification materials)

Use professional instruments to detect residues. Enterprises can pass the space residual detector, and the hydrogen peroxide-sensitive detection tube is used, and the residual amount of hydrogen peroxide is verified after 1-1.5 hours.

Use standard: OSHA (US Occupational Safety and Health Authority)

Residual requirements: less than 1 ppm (1.43mg / m3)

It should be noted that the 2010 version of the GMP requires that the residual amount must be detected if you use fumigation.

Recommended Test Instrument: German Delg Accuro Gas Residue Detection

2.6 Kangkang Space Sterilization System Case (Customer Consent)

 

First, verify the workshop:

Production line B line, clean workshop AB area 380m3, C region 970m3.

 

Second, verification requirements: The ABC area of clean work needs to reach sterilization requirements.

 

Third, verification purposes:

1. Verify that disinfective efficacy: sterilization of Novoli spore agents under dry in the dry mist. (According to USP)

2, material compatibility verification: Whether the power-on dry fog is sterilized to cause corrosion of the workshop material. (According to ASTM)

3. Residual verification: The residue of the lase agent after dry fog sterilization. (According to OSHA)

 

Fourth, biological indicator variety

Above), require: breathable sheet shape. It is recommended that two biological indicators are tested simultaneously.

Disinfection: Black Bacillus or Bacillus 103 Bacillus strip, requires: a breathable sheet shape. It is recommended that two biological indicators are tested simultaneously.

 

V. Preparation before the test

1, prepare tool

1) 1.0-1.5 meters high stool or 6, to place a cooking equipment.

2) Several sterile petri dishes: used to place buds.

3) Goggles and gas masks (at least two sets): Take spore strip.

4) Aseptic tweezers and collected dishes to store the obtained buds.

 

2. Calculate the amount of spore agent

It should be noted that the sterilization disinfection of different clean areas will vary depending on the requirements of the new GMP:

For the A / B area: need to achieve sterilization requirements (ie 6 logs to spores) is used: 5-6ml / m2

For C / D zone: need to achieve disinfection requirements (ie 3 logs to spores) is used: 2-3ml / cubic meter

Specific workshop volume and killing agent usage

 

3, confirm the device placement position

The injection direction of the power space is the spray direction and the horizontal portion of the spray head into 45 ° angle, and the initial speed of dry fog is sprayed is very fast. Since it is inertia, a small distance from the dry fog leaves the head is an arc motion, inertia The role disappears the dry fog in the space as a non-regular Brown movement, diffuses to each corner of the relatively sealed space.

However, due to different layouts in different enterprises, the layout of space under certain environmental conditions directly affects the slowness of dry fog spread. In order to quickly reach the entire clean area diffusion completely mixed uniformly uniform, better sterilization effect, be sure to fully consider and accurately place the number of equipment.

 

6. Verification process

1. Turn off the air conditioner, fresh air, return the wind; make the air to be sterilized into complete static. Close the connection gate of the AB area and the C region, the gate of the C zone and the non-cleaning zone, as shown (5 doors at the purple lines are needed when the spray is in the spray). Fully open the clean internal area All doors where the dry fog sterilization room is easy to spread to each corner. (Key links, need to be guaranteed to stand completely and need to review).

2, place the biological indicator, must be placed to the least position, and record the placement position of different spser spores. (Placed 106 buds)

3, according to the above drawpoint: note the nozzle orientation, equipment or stainless steel bench (please note: the room height is 2.2-1.5 meters height, the room height is 1.2-1.5 meters. ;), Link the masking machine, the glass door is opened to the most dry fog diffusion. Confirmation of the location of the device: Figure (1, 2, 3, 4, 5, 6)

4. Record the temperature and humidity of the clean area. Then, the temperature and humidity monitor is placed in the glass door that is easy to observe, so that the temperature and humidity after the spray is completed.

5. Adjusting spore agents: 11000ml; 2 1000 mL; 31000mL; 41000 mL; 51000 mL; 61000ml.

6, connect the device to the power supply (220V).

7. Press in turn 1, 2, 3, 6, 5, start the button on the location of the device, each table is 15 seconds countdown to facilitate leaving the injection area. After the countdown, the device automatically begins to spray, and after the sporge preparation set by the injection, the apparatus automatically stops. When removing, remember to close the door that needs to be closed immediately.

8, record time, spray 1000ml for 60 minutes.

After 11, 60 minutes, the equipment automatically stops spray, starts standing, recording time, and ensures that one hour of standing time. If you need to start other areas to sterilize other areas at this time, you need to wear ordinary goggles and gas masks (activated carbon) into the clean zone, remove the equipment, pay attention to the equipment, must keep the entry and out of the door to close the door. If you don't need to sterilize other workshops, you don't have to take out the equipment.

12. After the stationary time, the laboratory personnel take the eyepiece and mask, collecting spore strips, and placed in a medium as soon as possible. The medium conductors are numbered in order to track the placement of spore strips. Set a positive control and blank control. Note: Culture temperature and time need to be carried out according to the specified buds.

11. For the workshop for 45 minutes, turn on the air conditioning system, normal mode of operation. Production can be made.

The time required for the entire sterilization process: 165 minutes.

The results showed that all negative after 65 sporoscons were cultured.

 

Third, hydrogen peroxide replaces several aspects of the most concerned when the formaldehyde is sterilized

How to achieve space sterilization effect is optimized under the premise of good disinfectant?

Most disinfection products are liquids, so a basic cognition is that if disinfectant is gasified, the diffusion is best, and it is inevitable to sterilize effect is also ideal. This is also what people have always hope. But if the product is completely gasified, the cost of the equipment is very high, and many large equipment on the market can only be "vaporized\\ The difference between the word, the difference is far. The first is that there is no technology. Coupled with many enterprises, there is not much, and large equipment is invested high. There is a small number of uses, which is very low. However, if the product is simple atomization, the diffusion is very poor, there will be many problems (such as dead angles, condensate, etc.). Can't reach corporate requirements, not applicable to the spatial sterilization of pharmaceutical manufacturers. The pharmaceutical factory is mainly considering the following aspects:

 

1, material compatibility (corrosive):

In Europe and the United States, the developed countries have been discarded in the large environment of abandoning formaldehyde, and the new version of GMP is published and implemented as an opportunity. Many manufacturers have doctrine, with imported, domestic, and cottage. And the momentum is more intensified, but a common problem in front of these manufacturers is: How to solve material compatibility issues. It is well known that hydrogen peroxide is carried out by oxidation, but it is inevitably brought about corrosion resistance to the material while the oxidation is initiated. This is also a major reason why some people still have an attitude toward hydrogen peroxide.

1.1 Why is hydrogen peroxide produces corrosive

First, the sterilization of hydrogen peroxide is oxidized by releasing hydrogen oxygen bond (O-H):

 

2h2o2 \\u003d 2 h2o o2

 

During its bactericidal process, any object media that is exposed to the surface microorganism is subjected to oxidation of hydrogen peroxide while being killed, which is why we usually use: material tolerance, material compatibility, etc. Vocabulary comes to describe corrosive problems.

1.2 In the pharmaceutical enterprise, hydrogen peroxide to material corrosion property

Ozone disinfection, the epoxy floor, formaldehyde, is required to consider the corrosion of the internal core of the high-efficiency filter, so it needs to know which materials are more varying to corrosion when selection of hydrogen peroxide sterilization equipment.

The corrosion of hydrogen peroxide is smaller than the peroxoacetic acid, chlorine dioxide, but has corrosive in some materials, wherein the most representative is: color steel plate, galvanized plate, because these two materials are more Corroded by hydrogen peroxide. And the appearance is different, we cannot use "corroded" in general, we must objectively, and true treatment,:

1.2.1 color steel plate

The color steel plate is "standard\\ The corrosivity is mainly corrosive, and an important measurement indicator of the quality of the color steel plate is the denseness of the paint layer, the better, this point is especially important for hydrogen peroxide. For example, the corrosion of the hydrogen peroxide to color steel plate is due to the softening of the steel plate and the paint layer, causing the paint layer to foam and fall off during decomposition to form water and oxygen.

1.2.2 galvanized plate

The galvanized sheet is mainly used in an efficient pipeline, and the hydrogen peroxide does not corrode the plate, but the coating process (plating process) above the plate is oxidized, and since the layer coating is very thin, it will be Hydrogen peroxide thoroughly penetrates, thereby disappearing, its appearance is, the fading of galvanized sheets.

1.3 Analysis of the factors affecting the corrosion of color steel plates and galvanized plates

After analyzing the reasons for the color steel plate, galvanized plates are corroded, let's take a closer analysis, what factors can affect the corrosion of hydrogen peroxide to materials:

1.3.1 Unit hydrogen peroxide concentration: The concentration of hydrogen peroxide contains in unit volume when sterilized. This indicator is determined by the following factors:

A) Hydrogen peroxide concentration: no matter which method, the lower the initial hydrogen peroxide concentration, the lower the concentration of hydrogen peroxide, the smaller the corrosivity of the material.

B) Situation of hydrogen peroxide: no matter which method, the unit volume is the amount of amount, the lower the unit hydrogen peroxide concentration, the smaller the corrosivity of the material.

C) Whether it is simple hydrogen peroxide: a hydrogen peroxide-containing solution containing peroxoacetic acid is extremely large, and the corrosion effect is far from hypocarbon disinfectant, because the corrosion of peroxoacetic acid exceeds Hydrogen peroxide and it is easy to form residues

1.3.2 Adhesion to the surface of the material: The smaller the attachment ability, the smaller the particles, the closer the gaseous, so it is difficult to form a droplet on the surface of the material. In contrast, the stronger the attachment ability, the more the particles are large, the more easily attached to the surface of the object form corrosion.

1.3.3 Dependency on humidity: If there is a very stringent start humidity requirement, it will indicate that this manner requires a lot of hydrogen peroxide, and therefore, it is objectively improved the risk of corrosion. . Since all spatial hydrogen peroxide sterilization is not true, therefore, the rising humidity is caused, and a wind direction of the material compatibility is, the starting and humidity and the humidity after the exhaustion (not exhausted) In contrast case, if the moisture change is changed, the smaller the risk of corrosiveness. Therefore, when the equipment works, through the naked eye, it can clearly determine the impact of the humidity on humidity. Those influential, all the naked eye, in the same material, the same disinfectant conditions, its corrosivity must be higher than the naked eye The way.

1.3.4 Role time: The shorter the actual sterilization time, the lower the corrosive risk.

 

1.4 Power supply dry fog sterilization Why corrosive is small:

1.4.1 Hydrogen peroxide concentration is low: compared with traditional hydrogen peroxide, the disinfectant of Kangkang fog sterilization equipment is produced by special processes in Europe, and the hydrogen peroxide activity is very high. Therefore, under the premise of adequate sterilization efficacy. The concentration is greatly reduced (about 5-6 mL) / cube than the conventional hydrogen peroxide oxide. The concentration of hydrogen peroxide in contact with the color steel plate is about 1/10 of vaporized VHP sterilization equipment.

1.4.2 Sterilization time Short: the world's most efficient ciliary agent, 5 minutes to kill spores. It is possible to achieve 6 to 8 logarithmic fungi in 30 minutes to 6 to 8 logarithmic fungi, fully compliant with the pharmacopoeia. It greatly shortens the contact time of disinfectant and equipment color steel plate.

1.4.3 Kang Europe 20 years of dry fog technology accumulation, the extensive pharmaceutical factory in Europe, hospital use experience. The 3-5 micron dry inlet effect is accurate, the global dry fog effect of dry fog equipment, reducing the risk of condensate, ensuring disinfectant in space, no adhesion, no condensation (experiments show: 1 square meter The left and right glasses are placed at about 50 cm, without droplets, no wet glass surfaces).

1.4.4 More than 40 Material Compatibility (Corrosive) Test Reports (Corrosive) Test Reports in EU Pharmaceutical Factory, and the worries of your material compatibility.

1.5 After detailed analysis of the corrosive factors affecting material corrosion, we compare several common hydrogen peroxide sterilization in the current market. Since IHP (ionized hydrogen peroxide) and fumigation hydrogen peroxide are very uncommon, Therefore, we are mainly compared to VHP, gas source atomized hydrogen peroxide systems, and power-on dry-in-hydrogen peroxide equipment. It should be noted that the quality of the color steel plate is an important reason for impact corrosion. If your color steel plate coating is extremely difficult, the better the corrosion resistance, here is a common color steel plate as an analysis basis.

 

2 depends on humidity

Hydrogen hydrogen peroxide sterilization equipment depending on humidity in similar products:

2.1, power-on dry fog initial speed 80m / s, comparable to high-speed rail speed. The powerful initial kinetic energy of the dry fog particles easily breaks through the block of water in the air to each corner. I decided that our equipment can work normally in a 10% -75% air humidity environment. In addition, our disinfectant is bactericidal, and its usage is the least in the industry, and the moisture that is sprayed in the space is less. Directly determines that the spatial environment of the entire sterilization process can be guaranteed within 10%. VHP sterilization equipment with minimal environmental humidity in the industry. The entire sterilization process is fully clear and transparent through the glass safety door. The veritory only smells its sound, no shape.

2.2, similar VHP products (vaporization, gas sources) must first adjust the humidity to 40%, start sterilization, the humidity will rise rapidly to more than 90%, the whole space is filled in the water mist, the visibility is insufficient 1 meter, it is completely a sauna to the workshop, and its corrosivity is imagined.

Power-type dried sterilization and gas source VHP sterilization work scenario

(The picture above is the two equipment for the customer, the right side of the right side is power supply)

 

3 diffuser

What is the so small device diffusion? Generally, there are three main reasons:

3.1, particle size

People call 1-10 μm of liquid particles as "dry fog\\ Moreover, the smaller the dry fog particles, the more obvious. The particles sprayed out of our equipment achieved a uniform 3-5 microns, close to the gaseous, the naked eye is completely invisible, is a veritable dry fog, and the minimum dry mist in similar products (can provide particle size materials). Provide a prerequisite for its proliferation.

3.2, initial kinetic energy

Although the equipment is small, the initial speed of the fog can reach 80 m / s, which is comparable to the high-speed rail, which can instantly spray the dry mist to 10 meters away. Provide sufficient kinetic energy for its diffusion.

3.3, spatial concentration

Similar hydroxide sterilization products: VHP spatial sterilization concentration requires 1000 ppm, and the concentration of gas source dry homoam is at least 700 ppm, while our spatial concentration is only 120-150 ppm. It is clear that the murderous spore agents reaches 150 ppm of the concentration of 150 ppm more easily than 1000 ppm, and the difficulty is reduced.

Of course, I am saying is good here, not to say that all spaces can be used in one device. Our device is single with effective sterilization space for approximately 150-250 (Class B). If the space is large, the low cost of the equipment can support the "multiple multi-point layout" scheme. Comprehensive coverage can be fully covered without auxiliary equipment such as a fan. The program is very suitable for the complex space layout of the medicine factory clean workshop.

 

Trinity in the current other common hydrogen peroxide sterilization equipment

1 VHP: Vapor hydrogen peroxide

Note that this approach is "steam" chemical hydrogen peroxide, rather than "gasification" hydrogen peroxide, because its production method and function form are in the category of steam. The basic principle is to sterilize the excellent killing ability of microorganisms during condensation process using hydrogen peroxide steam. Divided into dry and wet methods, the important differences between the two are the use of the desiccant and the dependence of the humidity.

The concentration of the hydrogen peroxide in VHP is about 30%, which is flashing by electric heating mode to 114 degrees Celsius, and then steam is formed around 60 degrees Celsius. Since it is divided into two ways of "dry" and "wet method" to form One layer of 2-6 microns of film is purposeful. Sterilizing hydrogen peroxide molecules using this thin film is carried out.

The equipment is mainly imported by imported brands. With the introduction of the concept, many domestic manufacturers have a self-produced equipment.

 

2 gas source atomized hydrogen peroxide

This type is to atomize hydrogen peroxide and hydrogenated compound dispersurifier using 0.3-0.35 MPa of compressed air, and the core fitting is a nozzle, which can form a tiny particle of the disinfectant. The core component of this sterilization is a nozzle, and the mass of the nozzle directly determines the size of the fog particles, and the size of the fog particles determines the diffusion effect of the disinfectant. At present, the quality of the domestic nozzle is uneven, resulting in the actual fog eye eye, that is, at least 40-50 microns, not the manufacturer's dry fog, the size of the dry fog must be less than 10 microns, and less than 10 The dry fog particles of the micron are not visible.

The unit is originally introduced in the United States. In recent years, many domestic manufacturers have simply purchased imported nozzles, and they can mimic the equipment.

 

Four conclusions

Under the new GMP, the spatial sterilization of clean areas must be provided with the following requirements for people's health to the environment.

1. The program is easy to use, simple, ecological environmental, and friendly people and environment.

2, program sterilization efficacy reaches Pharmacopoeia USP sterilization standard: can reach the mortal biseus and the bisechlum of Bacillus from 104 to 106.

3, the material compatibility of the program should be good: the compatibility of clean areas and equipment should include: for metal, engineering plastics, rubber, clean room wall panel top plate, epoxy resin, high-efficiency, ventilation, organic glass , Socket, switch, telephone, on-site display instrument, etc.

4, the program has no residue: ensuring sterilization after sterilization will not form any form of pollution to the drug. Easy to verify, have sufficient verification information.

5, the program diffusion is very good: all-round coverage, no dead angles.

 

In summary, the problem that cannot be overcome with formaldehyde fumigation itself is not accepted by people, slowly being abandoned in production, and hydrogen peroxide sterilization techniques is ripe with a large background, hydrogen peroxide is sterilized in pharmaceutical manufacture Applications will be increasingly accepted by more and more, which will completely replace traditional formaldehyde fumigation. Become a new direction and new normal of future microbial control.

 

 

 

Details specific solutions welcome to inquire !!!