What is biological decontamination?
Biological decontamination refers to the process of removing or reducing microbial contamination to acceptable levels in a given environment.
The goal of biological decontamination is to create a clean and sterile environment, particularly in settings where contamination can have serious consequences, such as pharmaceutical manufacturing facilities, healthcare facilities, research laboratories, and cleanrooms. By effectively reducing microbial populations, biological decontamination helps prevent the spread of infections, maintains product integrity, and ensures the safety of personnel.
What are the features of biological decontamination?
- Unlike the disinfection process carried out in regular clean rooms, biological decontamination offers the advantage of achieving a high and consistent concentration of cleaning agents within a confined and relatively limited area. This method proves to be highly effective in achieving a sterile and aseptic environment for critical surfaces.
- It’s important to note that biological decontamination primarily focuses on treating surfaces and enclosed spaces, and may not yield the same level of effectiveness on internal or hidden surfaces of objects.
Vaporized Hydrogen Peroxide VHP Technology key features:
Broad-Spectrum Bactericidal Effect
VHPT demonstrates an extensive range of effectiveness against various microorganisms, making it highly efficient for sterilization and disinfection purposes.
Good Material Compatibility
VHPT is compatible with a wide range of materials, including sensitive equipment and surfaces, minimizing the risk of damage or corrosion during the disinfection process.
Easy Validation of Disinfection Process
The disinfection process using VHPT is easily validated, allowing for reliable monitoring and verification of its effectiveness, ensuring consistent and accurate disinfection outcomes.
Safe and Environmentally Friendly
VHPT produces water and oxygen as its decomposition products, making it a safe and environmentally friendly disinfection method. There are no harmful or toxic byproducts generated during the process.
Uniform Gas Distribution
VHPT technology ensures a more uniform distribution of the hydrogen peroxide vapor, enabling thorough and effective coverage throughout the disinfection area, reducing the likelihood of untreated areas.
Atmospheric Pressure and Low-Temperature Sterilization
VHPT operates under atmospheric pressure conditions and low temperatures, eliminating the need for high-pressure systems or extreme heat. This characteristic makes it suitable for sensitive materials or equipment that may be affected by traditional sterilization methods.
Comparison of space fumigation and disinfection methods
| Process | Broad- Spectrum | Material Compatible | Ease to Use | Cycle time | Validation | EHS |
| Formaldehyde | ++ | + | – | + | + | – |
| ETO | +++ | + | ++ | – | +++ | + |
| chlorine dioxide | +++ | – | + | + | ++ | + |
| PeraceticAcid | +++ | + | + | + | ++ | + |
| Ozone | +++ | + | ++ | ++ | ++ | + |
| hydrogen peroxide | +++ | +++ | +++ | +++ | +++ | +++ |
| Disinfection method | Advantage | Disadvantage |
|---|---|---|
| Peracetic acid spray | Strong decontamination ability |
|
| Ozone | Sterilization broad-spectrum, no residue and harmful contamination after disinfection |
|
| Chlorine dioxide | Broad-spectrum disinfection is efficient, produced and used on site and can be stored for a short time |
|
| Formaldehyde | Strong disinfection effect, mild nature, good material compatibility |
|
| Atomized hydrogen peroxide | Broad-spectrum disinfection is efficient |
|
Comparison of vaporization and atomization sterilization methods
| Difference | Vaporized hydrogen peroxide decontamination | Atomized hydrogen peroxide decontamination |
| Hydrogen peroxide solution | 30~35% | ＜8% |
| Generated | Flash steaming/heating vaporization | Pressure/ultrasound/rotary flap |
| Sterilization mechanism | The vaporization process is controlled below the VHP condensation point to ensure that hydrogen peroxide is in a gaseous state and the gas diffuses to air and surface sterilization | The atomization process keeps small droplets of hydrogen peroxide in the air to achieve the purpose of sterilization |
| Uniformity | Uniform distribution and good dispersion performance | Agglomerates into small droplets with uneven distribution |
| Control | In the adjustment stage, the VHP concentration is controlled to rise to the sterilization concentration in an increasing form, and the VHP concentration and humidity are strictly controlled during the sterilization stage | With only the atomization effect, it is not easy to achieve precise control |
| Sterilization time | It depends on the size of the space | After the disinfection is completed, it needs to stand for about 1~2h |
| Discharge time | Hydrogen peroxide remains vaporized and therefore has a shorter emission time. | Disinfectants attached to the surface of objects are not easy to remove. |
| Corrosive | The effect on the material is relatively mild | A high concentration of hydrogen peroxide condensed liquid is relatively corrosive on the contact surface |
| Bactericidal effect | 6-log | 4-log to 6-log |
| Sterilization broad-spectrum | Clostridium difficile, MRSA, VRE, Acinetobacter bauncei and viruses | MRSA and Acinetobacter bougonii, etc |
| Surface residue | Lower | Higher |
| Consistency of sterilization | Based on the consistency of gas distribution and high diffusivity, good distribution control can be obtained | Varies depending on the uniformity of the distribution of relative humidity, temperature, and concentration in the room |
What is the VHP Sterilizer for cleanroom?
A VHP (Vaporized Hydrogen Peroxide) sterilizer is a device that uses vaporized hydrogen peroxide to sterilize equipment and surfaces. VHP sterilizers work by releasing a mist of vaporized hydrogen peroxide into the air, which effectively kills bacteria, viruses, fungi, and other microorganisms. This type of sterilization is often used in medical facilities, laboratories, and other settings where a high level of cleanliness is required. VHP sterilizers are highly effective and can sterilize a wide range of materials, including medical equipment, surfaces, and air. They are also safe to use and do not leave any harmful residue behind. In a cleanroom VHP sterilizer, the hydrogen peroxide gas is generated and then circulated throughout the cleanroom, effectively sterilizing the entire workspace. The VHP sterilizer is typically used in cleanrooms, laboratories, and other controlled environments where it is important to maintain a high level of cleanliness and prevent contamination.
What are the differences between VHP and DHP Sterilizer?
Both VHP and DHP are commonly used as disinfection methods in cleanroom environments, but they differ in their application and delivery.
- Vaporized Hydrogen Peroxide (VHP): VHP involves the generation of a fine mist or vapor of hydrogen peroxide that is distributed throughout the cleanroom space. VHP systems typically consist of a generator or vaporizer that converts liquid hydrogen peroxide into a vapor, which is then dispersed throughout the cleanroom using specialized equipment. The vaporized hydrogen peroxide is effective in disinfecting surfaces, equipment, and the air within the cleanroom.
- Dry Hydrogen Peroxide (DHP): DHP, also known as aerosolized hydrogen peroxide or hydrogen peroxide gas plasma, is a method where hydrogen peroxide is converted into a gas or plasma state. DHP systems use specialized generators to produce the gas or plasma, which is then introduced into the cleanroom environment. The gas or plasma interacts with the contaminants and surfaces within the cleanroom, leading to disinfection.
While both VHP and DHP utilize hydrogen peroxide for disinfection, their main difference lies in the state of hydrogen peroxide used (vapor vs. gas/plasma) and the methods of delivery. VHP relies on vaporizing liquid hydrogen peroxide, while DHP involves the generation of a gas or plasma from hydrogen peroxide. The choice between VHP and DHP depends on factors such as the specific cleanroom requirements, the size and configuration of the cleanroom, and the desired disinfection efficacy.
VHP produces oxygen-free radicals by vaporizing
hydrogen peroxide solution to act on microorganisms on the surface and environment, which specifically destroys the cell structure and has a broad-spectrum bactericidal effect. It is necessary to control the humidity of the sterilized space to avoid condensation caused by excessive VHP water content.
Dry sterilization process
Dehumidification – The relative humidity of the space is reduced to the parameter set point so that the air can act as a carrier for hydrogen peroxide gas and the concentration of hydrogen peroxide gas is maintained above the saturated dew point level during the sterilization phase.
Conditioning – Hydrogen peroxide gas is continuously injected into the dry air stream, replacing the air in the sterilized environment, so that the hydrogen peroxide concentration continues to rise rapidly.
Decontamination – Maintain the concentration of hydrogen peroxide gas required for sterilization and control humidity during sterilization Aeration Stop the injection of hydrogen peroxide gas, replace the air in the environment, and crack hydrogen peroxide through the lysate to discharge all hydrogen peroxide.
Wet sterilization process
Conditioning – Hydrogen peroxide gas is continuously injected into the dry air stream, replacing the air in the sterilized environment, so that the hydrogen peroxide concentration continues to rise rapidly.
Decontamination – Maintain the concentration of hydrogen peroxide gas required for sterilization Aeration Stop hydrogen peroxide gas injection, replace the air in the environment, and crack it with the lysate.
Different Sterilization Process
| Dry method | Wet method |
| Humidity control throughout each stage of the cycle | No need to control humidity |
| No supersaturated steam, no condensation generation | The saturated steam is too high, and it is slightly condensed |
| Dry gaseous hydrogen peroxide is light in weight, easy to diffuse, and evenly distributed | Microdroplet hydrogen peroxide weighs heavily, is not easy to diffuse, and is unevenly distributed |
| The sterilization concentration can be set to achieve uniformity | The sterilization concentration needs to be high and not easy to control |
| The process is repeatable | The condensation point is difficult to control and the repeatability is not strong |
Different Removal of residue and residue
| Dry method | Wet method |
| No condensation and faster drainage | Coagulation makes the debris removal process longer than that of the dry sterilization process |
| Gaseous hydrogen peroxide is discharged quickly and has no residue | The surface residue is large and corrosive |
Different Verification method
| Dry method | Wet method |
| The distribution of biological indicators and the culture results were representative | There are few verification points, and the results are not representative |
| Highly reproducible validation | Weak reproducibility |
Different Sterilization effect
| Dry method | Wet method |
| Highly permeable, can penetrate HEPA for efficient sterilization | The permeability is poor, and HEPA is difficult to sterilize efficiently |
| High repeatability | Weak repeatability |
| Good sterilization effect and consistency | The sterilization effect is difficult to standardize, sometimes good and bad, and it is not easy to design the sterilization program |
Hydrogen peroxide space decontamination concerns
- Corrosion risk in sterilization process: how to avoid corrosion risk in sterilization process, hydrogen peroxide does not condense, and is well compatible with color steel plate, electronic instruments and equipment materials;
- Hydrogen peroxide emissions: effects on air conditioning and its pipelines;
- Sterilization consistency and stability: hydrogen peroxide dispersion uniformity;
- Compliance: Level 3 permissions, sterilization data integrity, audit trail and electronic signature;
- Color steel plate signal shielding: generator remote control and data transmission stability problems.
The selected hydrogen peroxide sterilization technology is safe, controllable and reliable
The hydrogen peroxide concentration is controllable and uniform throughout the process, non-condensing, better material compatibility, and minimizes the risk of corrosion.
Conduct comprehensive and scientific evaluation and testing of color steel plate compatibility and form a report;
The selected hydrogen peroxide sterilization technology is safe, controllable, and reliable
- Pay attention to the temperature of the outlet of the hydrogen peroxide generator, the risk control of integration with the environment and the local condensation in the process, and the uniform distribution of the vertical distribution of hydrogen peroxide needs attention;
- Pay attention to the design of the generator outlet, need to be able to cope with different application scenarios and environments, the generator outlet is best to selectively close or adjust the size of the opening according to the actual position requirements, to avoid high-concentration hydrogen peroxide gas directly blown on the color steel plate, causing corrosion to the local color steel plate;
- The hydrogen peroxide degradation process after sterilization (you can choose to catalyze the degradation of low concentrations and then turn on ventilation), choose a lower risk and more environmentally friendly way to reduce the impact of the residual discharge process on the air conditioning pipeline and the external environment;
Hydrogen peroxide drainage
The traditional fresh air replacement and exhaust mode is easy to condense in the environment of low external temperature, and has high requirements for corrosion resistance of air conditioning units and pipelines.
Hydrogen peroxide degradation system can be configured, and the HPSD
hydrogen peroxide degradation system will be automatically turned on after
sterilization to degrade hydrogen peroxide gas in the space, such as degrading to 10ppm and then turning on the air conditioning fresh air system for replacement, reducing the corrosion effect of hydrogen peroxide on clean room air conditioning and pipelines.
Hydrogen peroxide space decontamination concerns
Compliance, compliance with GMP and other regulations
- Hydrogen peroxide sterilization technology The sterilization process is mature, the repeatability is good, and there are special chemical indicators and biological indicators to verify the hydrogen peroxide distribution and sterility assurance level;
- The system has three levels of user management rights (administrator, technician, operator) to meet the requirements of the audit trail function and FDA 21CFR Part 11 electronic signature electronic record;
- Sterilization process data formation data report, alarm record, operation log, data curve can be converted to PDF format export print storage;
- OPC/Modbus communication protocol, support LIMS, BMS, MES, SCADA data acquisition;
Color steel plate signal shielding – The VHP generatorhas a built-in industrial-grade wireless module that is wirelessly connected to the control system, which solves the problem that the traditional wireless router connection method is easily isolated by the color steel plate signal.
Benefits of Cleanroom VHP Sterilizer
Sterilization of Medical Equipment
Cleanroom VHP Sterilizer is a reliable and effective method of sterilizing medical equipment. This technology is crucial in preventing the spread of infections in hospitals and healthcare facilities. The VHP method of sterilization is fast, efficient, and safe for patients and healthcare workers.
Increased Efficiency
Cleanroom VHP Sterilizer is a cost-effective and efficient method of sterilizing surfaces and equipment in cleanrooms. The VHP method of sterilization is fast and requires minimal downtime, which translates to increased productivity.
Cost-Effective
Cleanroom VHP Sterilizer is a cost-effective method of sterilizing surfaces and equipment. The VHP method of sterilization requires minimal maintenance, and the equipment has a long lifespan. The cost of maintenance and support is minimal compared to other sterilization methods.
Vaporized hydrogen peroxide generator
Vaporized hydrogen peroxide generator, supports remote wireless control, and can realize multiple equipment group control, single or multiple equipment simultaneous start and stop control, truly achieving remote supervision. The adjustable nozzle device can spray hydrogen peroxide gas at multiple angles, which can diffuse to the dead corner of the sterilization area to ensure full coverage of the sterilization area.
Maintenance and Support
Maintenance and support are critical factors when choosing a Cleanroom VHP Sterilizer. It is essential to choose a sterilizer that is easy to maintain, and support is readily available. Maintenance should be performed regularly to ensure that the equipment is functioning correctly. Additionally, it is crucial to ensure that spare parts are readily available in case of equipment breakdown.
FAQs:
How does Cleanroom VHP Sterilizer work?
The sterilization process involves introducing VHP into the cleanroom, where it disperses and covers all surfaces. The VHP then reacts with any microorganisms or contaminants, destroying them and leaving the cleanroom sterile.
Is Cleanroom VHP Sterilizer safe?
Yes, Cleanroom VHP Sterilizer is safe when used correctly. The VHP used in the process is non-carcinogenic and non-toxic, making it safe for use in a variety of settings.
What industries use Cleanroom VHP Sterilizer?
Cleanroom VHP Sterilizer is commonly used in industries that require strict cleanliness standards, such as pharmaceuticals, biotechnology, and medical device manufacturing.
What are the benefits of using Cleanroom VHP Sterilizer?
Cleanroom VHP Sterilizer offers many benefits, including fast sterilization, increased efficiency, and cost-effectiveness. It is also highly effective in destroying microorganisms and other contaminants.
How long does the sterilization process take?
The length of time required for the sterilization process varies depending on the size of the cleanroom and the amount of equipment and surfaces that need to be sterilized. Typically, the process takes between 30 minutes to 2 hours.
Is it necessary to prepare the cleanroom before sterilization?
Yes, it is essential to prepare the cleanroom before sterilization. This involves removing any objects or equipment that are not required for the sterilization process and cleaning all surfaces to remove any visible dirt or debris.
Can Cleanroom VHP Sterilizer be used on all surfaces?
Cleanroom VHP Sterilizer can be used on most surfaces within the cleanroom, including stainless steel, glass, and plastics. However, some materials may be sensitive to VHP and require special care.
How often should Cleanroom VHP Sterilizer be used?
The frequency of sterilization depends on the specific requirements of the industry and the cleanroom. Generally, cleanrooms are sterilized daily or weekly, depending on the level of use and the risk of contamination.
Can Cleanroom VHP Sterilizer be used on equipment that is sensitive to moisture?
Yes, Cleanroom VHP Sterilizer can be used on equipment that is sensitive to moisture. The VHP used in the process is a dry vapor that does not leave behind any residue or moisture.
What type of maintenance does Cleanroom VHP Sterilizer require?
Cleanroom VHP Sterilizer requires regular maintenance to ensure that it functions correctly. This includes calibrating the equipment, checking for leaks, and replacing any worn or damaged components.
Is training required to use Cleanroom VHP Sterilizer?
Yes, training is required to use Cleanroom VHP Sterilizer. Proper training is essential to ensure that the equipment is used correctly and that the sterilization process is effective.
How can I ensure that my cleanroom remains sterile after the sterilization process?
After the sterilization process, it is essential to maintain a clean environment within the cleanroom. This involves implementing strict cleaning procedures, ensuring that all equipment and surfaces are regularly cleaned, and monitoring the environment for any signs of contamination.
Can Cleanroom VHP Sterilizer be used to sterilize clothing and fabrics?
Cleanroom VHP Sterilizer can be used to sterilize certain types of clothing and fabrics that are commonly used in cleanrooms. However, it is important to note that some materials may be sensitive to VHP and require special care. It is always best to consult with the manufacturer or a trained professional before attempting to sterilize clothing or fabrics with VHP.
VHP Sterilizer Feature:
The VHP sterilizer is a device that uses vaporized hydrogen peroxide (VHP) to sterilize equipment, containers, and spaces. It is known for its broad-spectrum sterilization abilities, including its ability to eliminate thermophilic fat spores. The VHP sterilizer also has a real-time monitoring system to track the concentration of the VHP during the sterilization process, and it can record and report on the sterilization concentration curve. It also has a function that allows for the preservation of sterilization parameters for easy access during future sterilization processes.
One of the key advantages of the VHP sterilizer is its low temperature sterilization process, which allows it to be used in a variety of settings without the need for high temperatures. It also has a hydrogen peroxide solution weighing function to ensure that the solution level is sufficient during the sterilization process. In addition, the VHP sterilizer is known for its quick sterilization process and minimal operating costs.
The VHP sterilizer is suitable for in-line sterilization within equipment, containers, and spaces. It is also known for its low residue levels, as hydrogen peroxide decomposes into water vapor and oxygen, with no hazardous by-products. Its compatibility with materials such as plastic, rubber, and electronics is also excellent. Finally, the VHP sterilizer has a wide sterilization range and can handle large volumes, allowing for fast and even sterilization of large areas.
How to choose cleanroom VHP sterilizer for your cleanroom projects?
There are a few factors to consider when choosing a cleanroom vaporized hydrogen peroxide (VHP) sterilizer for your cleanroom projects:
Size: Make sure the VHP sterilizer is large enough to accommodate the materials or equipment you will be sterilizing.
Capacity: Consider the volume of the VHP sterilizer and the amount of materials or equipment you need to sterilize. Make sure the sterilizer has sufficient capacity to handle your needs.
Certification: Make sure the VHP sterilizer you choose is certified for use in cleanrooms or controlled environments. This ensures that it meets the necessary standards for cleanliness and contamination control.
Features: Consider the features of the VHP sterilizer, such as the type of airflow, the type of exhaust, and the type of lighting. Choose a sterilizer with features that are suitable for your needs.
Maintenance: Choose a VHP sterilizer that is easy to maintain and has a long lifespan.
It’s also a good idea to work with a supplier who has experience in providing cleanroom VHP sterilizers and can help you choose the right product for your needs.
