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Pollution Control - Redefining the safety of disinfection: the advantages of hydrogen peroxide vapor sterilization compared to other methods
Although the market is widely expected for a long time, formaldehyde is ultimately classified as a carcinogen by the World Health Organization, which means that the United States may now follow the rest of the world to impose a ban on the use of this chemical. This modification of the law will lead many industrial sectors to modify their disinfection plans. Fortunately, there is another disinfection method for the presence of hydrogen peroxide vapor, which provides an opportunity to redefine the health and safety risks of large-scale disinfection in a variety of production environments.
The use of hydrogen peroxide vapor is not a new idea in the pharmaceutical industry. It has been used to sterilize sterile isolators for more than 15 years. You don't need to find a deeper reason to ask why, this is a beautifully simple technique, but requires superb control skills, not just a heating plate. . Regardless of the application, the liquid hydrogen peroxide solution needs to be flashed in a controlled manner to ensure uniform distribution of the vapor.
This steaming process continues until the appropriate sterilization conditions are reached and then maintained for a predetermined period of time. The final stage catalyzes the hydrogen peroxide vapor as a harmless decomposition product - water vapor and oxygen - to return the sterilization space to its original condition, but is already in a sterile state. This residue-free property is easy to verify, both in long and short cycles, and is compatible with materials, making the technology perfect.
Since the creation of the HPV sterilization concept, this technology has evolved from small closed systems such as isolators, transfer cabins, etc. to larger spaces such as rooms, suites, and even buildings. However, as the volume of disinfection expands and its unique settings pose challenges, a unique design of the building system is required for HPV sterilization. The resulting verification, health and safety issues need to be considered.
Large area disinfection
The initial hydrogen peroxide vapor sterilization focused on controlling the concentration of HPV throughout the process without exceeding the condensation point, as was done by using a drying cylinder to remove moisture from the environment before and during the cycle. This method is suitable for Adjusting the small-volume environmental conditions, but there are problems with tens or hundreds of cubic meters of space, needless to say, limits the application of HPV in large volume.
Later studies have shown that this method is lower in sterilization efficiency than when the target space reaches the condensation point. It is found that when the concentration of the target environment reaches a peak during the cycle, it will not form a layer on the surface of all exposed objects. The sediment, under the microscope, is a condensed film of about 2 μm, which produces a more effective killing effect. Once the hydrogen peroxide molecules contact the surface of the object, they immediately oxidize to form free radicals to attack the microorganisms, achieve a high level of sterilization, and are broadly effective against bacteria, spores, fungi, molds and viruses.
Therefore, the elimination of restrictions on any environmental conditions is necessary to successfully perform large-area space disinfection, and there have been nearly 3,500,000 cubic feet (99,100 cubic meters) of successful cases. Later, inspired by the direct injection of the sterilized room (the nozzle is usually placed in the center of the room, directly jetting HPV into the environment, that is, without the need to pass through the filter), the sterilization of the isolator has also been newly developed. Hydrogen peroxide vapor is injected directly into the work area, rather than through efficient filtration of the supply and exhaust gases, plus the removal of environmental constraints, the cycle time is completed within 1 hour, and is also evident in certain environments. Improved workflow.
Health and safety
As a disinfection method, the biggest reason for the development of hydrogen peroxide vapor technology in room disinfection applications is that the inherent concept (although incorrect) associates it with many of the drawbacks of formaldehyde fumigation.
From a safety point of view, these two technologies are very different, which is one of the reasons why formaldehyde fumigation is usually only used to deal with emergencies. When using formaldehyde, on-site preparation is usually carried out with as few people as possible, and the entire building needs to remain closed for many days to remove the scent of the monks. A large amount of manual cleaning is required to remove white powder residues, creating potential contaminants that pose a challenge to maintaining a sterile environment.
Compared to hydrogen peroxide vapor, the ward and operating room used in a general hospital can be disinfected in less than 90 minutes, and the general hospital infrastructure is far less sterilizable than most pharmaceutical companies, such as ceilings in the room, no The heating and ventilation device, the air conditioning system runs through the adjacent ward, and the disinfection area is only a stone's throw away from the public passage.
Story of two technologies
Why are the two technologies with the same purpose producing such a huge difference in safety? This is because it is harmful to humans to be exposed to a certain level of disinfectant gas. This concentration varies with different gases. Hydrogen peroxide vapor is currently the safest type, based on the OSHA Occupational Safety and Health Administration's allowable exposure limit (PEL) of 1 ppm, and the limit of acute hazard to life and health (IDLH) is 75 ppm. Formaldehyde is 0.5 ppm and 20 ppm.
At the same time, it must be considered that the operability of the technology and the environment can reach the limits of PEL and IDLH. Because of the hydrogen diffusion function (viscous molecules), the diffusivity of hydrogen peroxide vapor is poor, and this limitation can be overcome by nozzles with high kinetic energy. However, this poor diffusion has achieved its safety, because any leaks driven by external forces tend to remain in place. For formaldehyde, it spreads quickly because it is a normal gas, and the unfavorable side is to increase the risk of operator exposure.
This ability to remain in place is as simple as a few simple steps to prevent leaks, and it is important to have a hand-held sensor in the inspection. Operating conditions can be set to a negative pressure mode, and if a rare leak occurs when using hydrogen peroxide vapor, the operator has sufficient time to rearrange and seal the leak point. When using formaldehyde fumigation, the time to complete the same sealing work will be quite limited due to the low PEL limit and faster spreading capacity, and the occurrence of accidents using this technology has been documented. The target area is equipped with a wide range of sensors, combined with a hand-held sensor to determine if the target area is safe to re-enter after disinfection is complete.
It should be noted that chemicals such as formaldehyde spread quickly, but it does not mean that it is better or more thorough. These gas sterilization methods require a high humidity range - usually relative humidity is higher than 65%. To successfully complete the disinfection, the humidity value far exceeding the normal operating standard is required. This humidity is the content of water vapor, and its distribution becomes successful in disinfection. No restrictions.
verification
It is important to verify and confirm the success of the disinfection. Regardless of the scope of application, the use of hydrogen peroxide vapor technology requires consideration of specific environmental factors such as size, structure and environmental conditions. These elements influence the performance of the entire disinfection cycle and can help determine a specific set of parameters for successful disinfection.
Although theoretical analysis can yield a reasonable starting parameter, it must be determined by running a loop development process. Once this set of parameters is completed within the security framework - and confirmed, the operation of a performance verification loop will result in the final verification loop.
The microbial challenge test for hydrogen peroxide application uses Geobacillus stearothermophilus, which requires a 6-log kill rate in a sterile operating environment. This microorganism is also widely recognized as a sterilization process and effect of steam autoclaving. Prove the challenge.
The advanced control system is built into the hydrogen peroxide steam generator, which is different from the various uncertainties in the use of formaldehyde. A continuous feedback loop process that is fully visualized by a variety of sensors, including interrupting, modifying, and abandoning operations when necessary. At the same time, the highly automated production process control complies with the requirements of Chapter 11 of the CFR and meets the current Good Manufacturing Practice GMP requirements.
In summary, hydrogen peroxide vapor is obviously not only a substitute for formaldehyde, but because of its broad-spectrum sterilization efficiency, complete safety management characteristics and perfect process control, the whole process can be verified and supported. Many new applications can be developed in the pharmaceutical and biotechnology sectors.
The advantage of this technology is that it not only kills microorganisms in the area during the sterilization process, it can purify the entire production and processing environment, recover and upgrade to standard working conditions, in daily or emergency situations, peroxidation. Hydrogen vapor forms a new benchmark process.
Reference
Unger-Bimczok B, Kottke V, Hertel C, et al. The influence of humidity, hydrogen peroxide concentration, and condensation on the inactivation of Geobacillus stearothermophilus spores with hydrogen peroxide vapor. J Pharm Innov. 2008;3(2):123- 133.